MODULE 5

 PHARMACEUTICS
 MANUFACTURING PHARMACY
 PHARMACEUTICAL DOSAGE FORMS
 PHYSICAL PHARMACY
 JURISPRUDENCE & ETHICS
Manufacturing Pharmacy
Drugs DRUG ESTABLISHMENTS
Drug Products 1. Drug Manufacturer means any establishment engaged in operations
Drug Establishments involved in the production of a drug, including
Drug Manufacturer
Drug Trader
propagation, processing, compounding, finishing,
Drug Importer filling, packing, repacking, altering, ornamenting and
Drug Exporter labeling with the end in view of storage, distribution
Drug Departments or sale of the product: provided that for the purpose
Dosage Form of this regulation the compounding and filling of
Liquid Dosage Forms
prescriptions in drugstores and hospital pharmacies
Solution
Suspension shall not be considered as production operations.
Emulsion a. Ethical Manufacturers
Sterile Products b. Proprietary/ Generic Manufacturers
Other Areas c. Biologicals Manufacturers
Packaging, Labeling & Storage of Drugs
d. Veterinary Products manufacturer
Quality Control
Drug Cosmetics
e. Medicinal Chemical Manufacturers
f. Toll/Contract Manufacturers
MANUFACTURING  the manufacture, propagation, preparation & 2. Drug Trader means any establishment which is a registered owner of the
processing of a drug product in a large scale drug product, procures the materials and packaging
components, and provides the production monographs,
the making by physical, chemical, biological, or any
quality control standards and procedures, but sub-contracts,
other procedure of any article that meets the
the manufacture of such product to a licensed manufacturer.
definition of drugs
In addition, a trader may also engage in distribution, and/or
the manipulation, sampling, testing, or control
marketing of its products.
procedures applied to the final product or any other
3. Drug Distributor/Importer means any establishment that imports raw
part of the process
materials, active ingredients and/or finished
the packaging, repacking, or changing the container,
products for its own use or for wholesale
wrapper or label of any drug package in preparation
distribution to other drug establishments or
for its distribution from the manufacturer to the final
outlets.
user
4. Drug Distributor/Exporter means any drug establishment that exports
mass production of drug products
raw materials, active ingredients and/or
Extemporaneous Compounding  small scale preparation of drug products finished products to another country.
prescription order 5. Drug Distributor/Wholesaler means any drug establishment that exports
specific for a particular patient raw materials, active ingredients and/or
finished products from local establishments
Drugs for diagnosis, prevention, cure, treatment & mitigation of disease in for local distribution on wholesale basis.
man or animals
 recognized in USP or official compendia DEPARTMENTS IN A DRUG ESTABLISHMENT
affect structure & function 1. Research Department  “patent”; “evergreening”
 used as component of the above articles 2. Production Department  involves in actual manufacturing drugs
3. Quality Control Department
Drug Product  finished dosage form w/ or without active ingredients or a 4. Marketing Department responsible for the sale & distribution of drugs
“Placebo” 5. Engineering Department  for installation
Dosage Form  drug & additives 6. Purchasing Department  responsible for procuring raw materials &
 means the pharmaceutical form of the preparation based on packaging materials
official pharmacopoeia. 7. Medical Department  perform clinical studies
Batch  produced from a single order within same cycle of  for physical & health examination
manufacturing
 means a quantity of any drug or device produced during a
given cycle of manufacture. Current Good Manufacturing Practices (cGMP)
Lot  specified portion of batch chapter 21 of the Code of Federal Reguralations Part 211
Batch/ Lo Number  for identification were first promulgated by the US Food & Drug Administration
-Batch number  means a designation printed on the label of a (FDA) in 1963; & finalized in 1979.
drug or device that identifies the batch, and permits were established to ensure that minimum standards are met for
the productions history of the batch including all drug product quality
stages of manufacture and control, to be traced and other cGMPs: UK, European Economic Council, WHO, ASEAN
reviewed.
-Lot number refers to any distinctive combinations of letters
and/or numbers assigned to a particular lot, herein
defined as a portion of a batch.
Liquid Dosage Forms 5.Filling & Packaging
Solution *Gravimetric Filling  for mobile & frothy solutions
*Vacuum Filling  for viscous solutions
General Formulation:
*Pressure Filling  for viscous solutions
1. Active Ingredients  consider solubility & stability
2.Solvent  consider clarity, toxicity, viscosity, comparability, palatability
 water (best solvent) Suspension
3. Co-solvent  used in combination with the solvent to increase General Formulation:
solubility of the solute 1. Active Ingredients  should be insoluble
 Ethanol, Sorbitol, Glycerin, Propylene Glycol,  must be uniformly dispersed
Polyethylene Glycol 2.Dispersion medium  Aqueous /Non-aqueous
4. Solubilizer  surfactant (Tweens) 3. Wetting Agent  displaces the air from crevices of drug particles
5. Viscosity Enhancer/ Controller  improves pourability  Glycerin, Sorbitol Solution, Syrup
& to some extent, palatability 4. Solubilizer  surfactant (Tweens)
 Sugar, PVP, 5. Suspending Agent (Viscosity Enhancer)
Cellulose Derivatives Hydrocolloids  Acacia, Tragacanth, Veegum, Cellulose der.
Classification of Viscosity Enhancing Agent: Clays  Bentonite, kaolin
~Ionic Polymer: Na CMC Others: Agar, Gelatin, Pectin, Gelatinized Starch
~Nonionic Polymer: Cellulose Derivative 6. Buffer
(MC, CMC) 7. Sweetening Agent
6. Buffer  controlling pH to maintain solubility & stability 8. Flavor
 most common; pH 4-7 9. Coloring Agent
 Citric Acid, lactic Acid, Glutaric Acid 10. Preservative
7. Sweetening Agent
8. Flavor General Scheme for Suspension Formulation:
9. Coloring Agent Problems:
10. Preservative  prevent microbial growth 1. Caking
Classification: 2. Partial Solubility of the active ingredient
~Acidic: Phenol(Carbolic Acid) oldest preserv. 3. Polymorphism of the active ingredient
Parabens  synergistic to each other
*Methyl  for molds
*Propyl  for yeasts
(Methyl:Propyl is 9:1)
Benzoic Acid
Sorbic Acid
~Mercurial: Thimerosal Emulsion
~Neutral: Chlorbutanol General Formulation:
~Quaternary Ammonium Salts (NH4): 1. Active Ingredient
Benzalkomium Chloride 2. Aqueous Phase
Cetylpuridium Chloride 3. Oleaginous Phase
General Steps in the Manufacture of Pharmaceutical Solutions: 4. Emulsifier
1. Preparation of formulation material & equipment 5. Antioxidants  protects the emulsified lipids which are
2. Compounding susceptible to oxidation
charge the solute to the solvent  Example: BHA, BHT, Tocopherol,
agitate w/ the use of mixers until solution is homogenous Ascorbic Acid, EDTA
heat may be employed to increase solubility 6. Preservative  should be effective for both phases
ensure complete solution before further processing 7. Sweetener
solutes in small concentrations (such as dyes & intensively 8. Flavoring Agent
colored materials) must be predissolved prior to mixing w/ the 9. Colorant
whole batch 10. Humectant  reduces the evaporation of moisture from the
3. Storage & Aging product
to allow complete blending of all the components  Example: Glycerin, Sorbitol, Propylene Glycol
4. Filtration & Clarification
aim for 3-5 micros or less Manufacturing Process
filter media: Cellulose Nitrate, 1. Oil Phase containing oil-soluble ingredients is heated at about
Polyamide 5-10C above the melting point of the ingredient w/ the
Polyvinylidene Chloride highest melting point.
Nylon 2. Aqueous Phase is heated to the same Temperature
*Types of Filtration: 3. The two phases are mixed.
Gravity Filtration  slow 4. Volatile ingredients are added at the lowest temperature as
Vacuum filtration  large scale possible (usually 45-55C)
Pressure Filtration  fast, to achieve highly polished prod. 5. Adjust the final weight when emulsion reaches 35C
*Classification:
Parallel Filtration  one type of filter Equipments
Series Filtration  more than one filter Mechanical Stirrers
*Types of Filter Paper: Colloid Mills
Fluted Filter Paper  if you need the “filtrate” Homogenizers
Ordinary Filter Paper  if you need the “residue”
Sterile Products
Sterile Preparations:
Categories:
solutions ready for injection
dry soluble products ready to be combined with a solvent prior
to use
suspensions ready for injection
dry soluble products ready to be combined w/ a vehicle prior to 2. Components (Formulation)
use a. Active Drug
emulsions ready for injection b. Solvent/ Vehicle  highest portion
liquid concentrates ready for dilution prior to use  usually Water for Injection, USP
Main Concerns in Parenteral Manufacture WFI  purified by distillation or
1. Production Facilities purification process
easy to clean, safe, sterile equivalent or superior to
5 Sections distillation in removing
a. Materials Support Area  surfaces should be continuous, chemicals & microorganisms
class 10,000 environment Aqueous
 constructed of impervious Water Miscible
materials Vegetable Oils
b. Compounding Area  most stringent control Non-Vegetable Oils
 stainless steel cabinets & counters, c. Other Excipients (Additives):
continuous surfaces Buffer
 Class 10,000 environment Preservative
(Class 100 Chelating Agent
max of 100 particles per feet Isotonicity Adjusting Agent
0.5m or larger) Example: NaCl, Mannitol
c. Aseptic Filling Area  heart of production area Goal: To diminish pain upon
 Laminar Air Flow (LAF) administration
w/ HEPA Filter (High Efficiency d. Container
Particulate Air) e. Closure/ Stoppers
 class 100 f. Production Procedure
sealed ceiling, wall floor g. HEPA Filter (High Efficiency Particulate Air Flow)
 stainless required for incoming air to achieve a class 100
condition
demountable parts for those
equipment in touch w/ product effluent air sweeping downstream at uniform velocity
 sterile cover-all for personnel normally 90ft/min  20% along parallel line
Laminar Air Flow  minimum eddy
 (+) air space
Turbulent  opposite of Laminar Air Flow
 air locks
99.97% efficient in removing from air 0.3 m particles
d. Quarantine Area  storage while waiting for QC results
generated by vaporized DOP (Dioctylphthalate) test
*Quarantine  Yellow
*Reject  Red
Parts (HEPA Filter)
*Accept  Green
B  Blower
e. Finishing Area
E  Electrostatic
P  Prefilter

MOA
-interception
-diffusion
-impaction

Test for Efficiency: DOP Test (air velocity

determination)

Design
Compunding Aseptic Quarantine
Stock Area Filling
Area Storage
Material
Finishing
Support Sterilization
Other Areas

A. Medicinal Plants
site selection
plant material is from one source during same harvest season
=authenticate
processing: Weigh/ Assign a Batch #

Washing

Drying

Garbing
(removal of extraneous materials)

Milling/ Sieving
(particle size reduction)

Storage

Phytochemical Screening
QC Test
Bioassay (Physicochemical & Microbilogical Test)

B. Modified Release Dosage Form

Advantage: Decrease in fluctuation of plasma drug level
Disadvantage: “Dose Dumping”
Requirements for Drug Candidate:
 uniform absorption
administered in small doses
good margin of safety
for chronic disease
Transdermal Drug Delivery System
passage drug from skin surface to systemic circulation
Device Design: Monolith/ Matrix
Rate-Limiting Membrane Type
Liposomes
 lipid bilayer
contains Phospholipids
 use for the delivery of anticancer drugs & dietary
supplements

C. Biopharmaceutical Drugs
produced by Biotechnology
Production:
Active Ingredient

Freeze Drying/ Lyophilization
(Food for the Incas)

Weighing

Fermentation

Filling/ Packaging
•Packaging, Labeling & Storage of Drugs Material Used for Packaging
1. Glass
Constitution of Official Glass Types
Packaging  an economical means of providing presentation,
Type General Description Uses Test
protection, preservation, identification, information,
containment, convenience, & compliance for a drug I Highly Resistant For parenteral Powdered
product Borosilicate Glass Glass Test
II Treated Soda Lime For parenteral Water
Glass Attack Test
Container  device that holds a drug & is or may be in direct contact w/
III Soda Lime Glass For Parenteral Powdered
the drug
Glass Test
Types:
IV General Purpose Soda Other Products Powdered
a. Primary Container  in contact w/ the product
Lime Glass except Parenterals Glass Test
 immediate container
 protect the preparation from the Powdered Glass Test  performed on ground/powdered glass
environment hazard to expose internal surface
b. Secondary Container  for presentation tests the leaching potential of the glass
 encloses the primary containers alkali titrated w/ 0.2N sulfuric acid
Water Attack Test  exposure of the glass
Classification of Containers: w/ sulfuric dioxide at 121C
1. Immediate Container  is that which is in direct contact w/ the Defect in Glass container:
article at all times Minor Defect: Seeds (appears as small bubbles in the glass)
Major Defect: Stone (a small inclusion of any non-glass
2. Well-closed Container  minimally acceptable container
material)
protects the contents from extraneous
Critical Defect: Pin Hole (any opening causing leakage)
solids & from loss of the article under
Limit Test (in mL of 0.020 N acid consumed)
ordinary conditions of handling,
shipment, storage, & distribution Type Test Size/ mL Limit/ mL
3. Tight Container  protects the contents from contamination by I Powdered Glass Test All 1.0
extraneous liquids. Solids, or vapors, from loss of II Water Attack Test 100 or less/ 0.7/0.2
the article, & from efflorence, deliquescence or over 100
evaporation under the ordinary or customary III Powdered Glass Test All 8.5
conditions of handling shipment, storage, & IV Powdered Glass Test All 150 mL
distribution & is capable of tight reclosure. 2. Plastic  does not apply to a single material but rather to a vast
4. Light Resistant Container  protects the contents from number of materials each developed to have desired
photochemical deterioration features
 amber, opaque, blue Advantage: Lightweight, Flexibility, resistance to impact.
5. Hermetic Container  is impervious to air or any other gas under Disadvantage: Permeability, Leaching, Sorption,
the ordinary or customary conditions of Transmission of light,
handling, shipment, storage, & distribution Alteration of container upon storage
 generally sterile Two Types: Thermoplastic: squeeze
Sterile Hermetic Containers  hold preparation intended for Thermoset: firm & light
injection or parenteral Plastic Materials:
administration 1. Polyvinyl Chloride (PVC)  produced when a chlorine atom is
Single-Dose Container  is one that holds a quantity of added to every other carbon in the
drug intended as a single dose polyethylene polymer.
& when opened, cannot be  is rigid & has good clarity
resealed w/ assurance that  useful in blister packaging
sterility has been maintained  has a significant drawback for packaging
 include: Fusion-sealed ampuls medical devices
Prefilled Syringes  it is unsuitable for gamma sterilization, a
Cartridges method that is being used increasingly.
Multiple-Dose Container  is a hermetic container that 2. Polyethylene (PE)  cannot be autoclave
permits withdrawal of  low-density (dropper & sprays)
successive portions of the  high-density (solid oral preparations)
contents w/out changing the 3. Polypropylene (PP)  autoclavable
strength or endangering the 4. Polyethylene Terephthalate (PET):
quality or purity of the -APET (Amorphous Polyethylene Terephthalate Glycol)
remaining portions -PETG (Polyethylene Terephthalate Glycol)
commonly called “Vials”  for beverages
 have excellent transparency & luster
 can be sterilized w/ gamma radiation
Problems Encountered in the use of Plastic Containers:
a. Permeability of the containers to atmospheric oxygen & to moisture
vapor
b. Leaching of the Constituents of the container to the internal contents
c. Absorption of drugs from the contents to the containers
d. Transmission of Lights through the container
e. Alteration to the container upon storage
3. Metal
4. Rubber
5. Paper & Board
Safety Packaging
1. Child-Resistant Container  one that is difficult for most children
under 5 years of age to open or gain
access to the contents or obtain a Other Container Materials
harmful amount of the contents Liner
 based on the principle that a young Inner Seal
child is unlikely to coordinate two or Rubber Stooper
more actions to achieve a successful Coil
opening Dessicant
2. Tamper-Resistant Container  uses an indication or barrier to entry Package Insert
that is distinctive by design, or must
employ an identifying characteristic
which if breached or missing can Permeability  is considered a process of solution & diffusion w/ the
reasonably be expected to provide penetrant dissolving in the plastic on one side &
visible evidence to consumers that diffusing through the other side.
tampering has occurred. Leaching  is a term used to describe the movement of component of
a container into the contents
EXAMPLES OF TAMPER-EVIDENT PACKAGING  may be influenced by:
PACKAGE TYPE TAMPER PROTECTION -temperature
Film wrapper Sealed around product and/or product -excessive agitation of the filled container
container; film must be cut or torn to -solubilizing effect of liquid contents on one or
remove product more of the polymer additives
Blister/strip pack Individually sealed dose units; removal Sorption  is a term used to indicate the binding of molecules to
requires tearing or breaking individual polymer materials, includes both adsorption & absorption.
compartment  occurs through chemical & physical means
Bubble pack Product and container sealed in plastic,
usually mounted on display card; Physical Inspection for Containers (Criteria)
plastic must be cut or broken open to 1. Shape
remove product 2. Volume
Shrink seal, band Band or wrapper shrunk by heat or 3. Finish
drying to conform to cap; must be torn 5. Diameter
to open package 6. Height
Foil, paper, Sealed individual packet; must be torn 7. Weight
plastic pouch to reach product 8. Thickness
Bottle seal Paper or foil sealed to mouth of 9. Color
container under cap; must be torn or 10. Clarity
broken to reach product 11. Leak
Tape seal Paper or foil sealed over carton fl ap or 12. Torque
bottle cap; must be torn or broken to 13. Print
reach product 14. Peeling of Paint
Breakable cap Plastic or metal tear away cap over 15. Cleanliness
container; must be broken to remove 16. Light Transmission
Sealed tube Seal over mouth of tube; must be 17. Stress Crack Resistance
punctured to reach product
Sealed carton Carton flaps sealed; carton cannot be Physico-Chemical Test for Containers
opened without damage 1. Identification
Aerosol Tamper-resistant by design 2. 2. Infra-red Properties
container 3. Thermal Analysis
4. Extractable Substance
5. Non-volatile Residue
Storage Temperature of Pharmaceutical Products 6. Water vapor Permeation/ Transmission
Term Condition 7. Moisture
Cold Place Not exceeding 8C 8. Resistance to water attack
Freezer 24C to 10C
Refrigerator 2  8C Containers:
Cool Between 8C  15C Prescription bottles  are used to dispense liquids of low viscosity
Room Temperature 15C  30C Wide Mouth bottles  are used to dispense viscous liquids
Controlled Room 20C  25C Application Bottles  used for applying liquid medication to a wound
Temperature or skin surface
Warm 30C  40C Round Vials  are used primarily for solid dosage forms as capsule &
tablets
Excessive Heat Above 40C
Aerosol Containers  used for powders to applied by sprinkling
Slide boxes  are used for dispensing suppositories & powders
prepared in packets
Ointment jars & Collapsible tubes  used to dispense semi-solid
dosage forms, such as creams &
ointments
Dropper Bottles  are used for dispensing ophthalmic, nasal, otic, or
oral liquids to be administered
•Quality Control

Standards & Specifications

Product must cover the ff. points:
1. Formula  concise & precise statement of the ingredient
Sources of Variation:
2. Raw Materials Specification  should enumerate the
Materials
characteristics of all materials
Examples:
3. Standard Operating Procedure  step-by-step method
ⓐ Variation between suppliers of same substance
4. Finished Product Specifications  cover all characteristics that
affect the proper ⓑ Variation between batches from same suppliers
performance, purity, safety, ⓒ Variation within a batch
& stability of the product Machines
5. Packaging Material Standards  should be set for everything Examples:
that goes around the ⓐ Variation equipment for the same process
product ⓑ Difference in adjustment of equipment
6. Testing Methods  indispensible in assuming conformity to ⓒ Aging & improper care
standards  Methods
Examples:
ⓐ Inexact procedure
Defects  is an undesirable characteristics of a product ⓑ Inadequate procedures
Defectives  when a unit of a product contains one or more defects ⓒ Negligence
Classifications:  Men
1. According to Measurability Examples:
a. Variable Defect  can be measured directly by instruments ⓐ Improper working conditions
b. Attribute Defect  cannot be measured directly by ⓑ Inadequate training, & understanding
instruments ⓒ Dishonesty, fatigue & carelessness
2. According to Seriousness or Gravity
a. Critical Defect  may endanger life or property & may
render the product non-functional
Ex: Absence of Warning
b. Major Defect  may affect the function of the object, & Statistical Quality Control
therefore, may render the product useless. is the monitoring quality by the application of statistical methods in
Ex: Crack in a Bottle all stages of production.
c. Minor Defect  doest not endanger life or property but
remains a defect. Two basic Quality Control Charts:
Ex: Slight deviation of the color of the label ①Attribute Chart
from the color standards is a chart when makes use of discrete data classifying the number of
3. According to Nature item conforming & the number of items failing to conform to any
a. Ocular Defect  visible specified requirements
Ex: Foreign particulate contamination Example: the control chart for fraction defective known as “P chart”
b. Internal Defect  not seen although present ②Variable Chart
Ex: Subpotent Drug Product is a chart using actual records of numerical measurement on a full
c. Performance Defect  defect in function continuous scale such as meter, grams, liter.
Ex: Suppository that does not melt at body Example: X and R charts
temperature

Accelerated Stability Testing  is used to predict product stability

Factors that accelerate Instability are:
1. Temperature
2. Light
3. Moisture
4. Gravity
5. Agitation
6. Inversion
7. Method of Manufacture
Control Test: Signs of Degradation of Specific Dosage Forms
Solid Preparations: Semi-Solid Preparations: 1. Tablets 6. Topical Nonmetered 10. Small-Volume
1. Assay for the Active Ingredient/s 1. Assay for the Active Ingredient Appearance Aerosols Parenterals
2. Assay for the degradation products 2. Assay for degradation products
3. Disintegration 3. Identification test for active
(cracking, chipping, Appearance Appearance
4. Dissolution ingredients & possible contaminants mottling) Odor Color
5. Content Uniformity 4. Visual Appearance Friability Pressure Particulate Matter
6. Weight Variation 5. Color hardness Weight Loss DIspersability
7. Identification Test for the Active 6. Odor
Ingredient/s & possible 7. Viscosity
color Net Weight (Suspensions)
contaminants 8. Softening Range moisture content Dispensed pH
8. Visual Appearance 9. Loss of Water clumping Delivery Rate Sterility
9. Odor 10. Consistency disintegration Spray Pattern 11. Large-Volume
10. Taste 11. Homogeneity
11. Texture 12. Particle size distribution dissolution 7. Topical Creams, Parenterals
12. Hardness 13. PH 2. Capsules Ointments, Lotions, Appearance
13. Friability 14. Release rate of Active Ingredients
Moisture Tackiness Solutions, & Gels Color
14. Powder Fineness from dosage form
Color Appearance Clarity
15. Moisture Content 15. Sterility Testing
16. Humidity Effect 16. Storage Condition Appearance Color Particulate Matter
17. Color Stability Shape Homogeneity pH
18. Storage Condition
Brittleness Odor Volume &
19. Microbiological Burden Extractbales (when
20. Thickness Dissolution pH
Resuspendability plastic container is
3. Oral Solutions &
(Lotion) used)
Lyophilization Preparations & Products Suspension
for Reconstitution Before Use: Appearance Consistency Sterility
Particle Size Pyrogenecity
1. Assay for the Active Ingredient Precipitation
(original & reconstituted) Closure Integrity
2. Assay for degradation products
 pH Distribution
Liquid Preparations: Color Strength 12. Suppositories
3. Identification test for active
1. Assay for the Active Ingredient ingredients & possible contaminants Odor Weight Loss  Softening Range
2. Assay for degradation products 4. Visual Appearance Redispersability Appearance
3. Identification test for active 8. Ophthalmic & Nasal &
(original & reconstituted)
(suspension) Melting
ingredients & possible 5. Color of Cake Oral Inhalation
contaminants Clarity (solutions) 13. Controlled-Release
6. Odor of Cake Preparations
4. Visual Appearance Membrane Drug
5. Color
7. Odor of Solution 4. Oral Powders Appearance
8. Color of Solution Delivery Systems:
6. Odor Appearance Color
9. pH (original & reconstituted) Seal Strength of the
7. Taste 10. Moisture content of cake Color Consistency
Drug Reservoir
8. Redispersability 11. Clarity of Solution Odor Clarity (Solutions)
9. Suspendability Decomposition
12. Rate of Solution (Lyophilized) Moisture  Particle Size
10. Pourability 13. Container Pressure Products
5. Metered-Dose Resuspendability
11. Viscosity 14. Storage Conditon Membrane Integrity
12. Isotonicity Inhalation Aerosols (Suspension,
13. Particle Size Agglomeration & Drug Strength
Deliver Dose per Ointments)
Drug Release Rate
Particle Distribution
14. Clarity Actuation Strengths
15. Crystallization Number of Metered Sterility
16. Gas evolution Dose 9. Emulsions
17. Specific Gravity Color Appearance
18. pH
19. Refractive Index Loss of Propellant (such as Phase
20. Surface Tension Pressure Separation)
21. Pyrogen Testing Valve Corrosion Color
22. Sterility Testing
Spray Pattern Odor
23. Toxicity Testing
24. Storage Condition Absence of pH
25. Fill Volume Pathogenic Viscosity
26. Leak Test Microorganisms

Aerosols:
1. Assay for the Active Ingredient
2. Assay for degradation products
3. Identification test for active
ingredients & possible
contaminants
4. Net Content
5. Spray Test
6. Leak Test
7. Pressure Measurement
8. Moisture Determination
9. Propellant
10. Valve Delivery Accuracy
11. Particle size distribution
12. Storage Condition
•Drug Cosmetics
Cosmetics  are intended for external application to the human body
for cleansing, beautifying, promoting attractiveness, or
altering the appearance of the user

Classes of Cosmetic Preparations:

1. Cleansing Creams & Lotions  for removing the facial make-up,
surface grime, & oil from the face &
throat through its solvent action.
2. Emollient Creams & Lotions  to prevent or relieve dryness a swell
as protect the skin
3. Hand Creams & Lotions  to make water available to the Stratum
Corneum & to regulate the rate & Eye Makeup  is one of the oldest & most extensively used cosmetics
quantity of water take-up by the Types of Eye Makeup:
Stratum Corneum 1. Eye Shadow  am be manufactured in the form of cream, stick,
4. Suntan Creams & lotions  to prevent melanogenesis liquid, powder, or pressed cake, (used w/ puffer
Ex: The oxidation of Melanin Pigment through brush)
exposure to ultraviolet radiation which 2. Mascara can be made as a cake, cream, or liquid
results in the darkening of the skin.  applied w/ a “wand”
5. Skin Lightener  to ameliorate skin complexion where the skin is 3. Eyebrow makeup  may take the form of crayon, extruded pencil,
dark or has become mottled due to stick, cream, or pressed cake
age or drug therapy 4. Eyeliner  are liquids, cream, or pressed cake
6. Shaving Creams  preparations which make the process of cutting  applied w/ a brush or pencil
hair on or about the face more pleasant, 5. False Eyelashes  made of either natural hair or synthetic fibers.
convenient, & necessary ritual. 6. Cover-up Makeup  used under & around the eyes, takes the
form of cream, powder, cake, or sticks
Basic Material for Cream Preparations: 7. Makeup Remover  for removal of eye makeup that either
1. Beeswax  contributes to cream consistency creams or liquid
 melting point 62-65C 8. Eye Cream or Eyesticks  *Eye Cream  usually a water in oil
2. Mineral oil  a stable hydrocarbon, inexpensive, & not subject emulsion,
to rancidity & odorless *Eyestick  is a wax base containing
3. Borax (Sodium Borate)  the amount of borax used is a critical lubricants & emollients
factor in producing a satisfactory cream
4. Emollients Basic Ingredients of Eye Makeup:
5. Ozokerite & Ceresin  stiffen the cream & prevent the bleeding Petrolatum
of oils when oil content is high. Lanolin
6. Perfume Oil  usually added in the concentration of 0.6% Ceresin
7. Agents used for Skin Lightening & Skin Bleaching Carnauba Wax
Covering Agents used are the pigments Beeswax
 the most efficient pigment is Titanium Dioxide  Stearic Acid
8. Pilomotor agents  Isopropyl Myristate
 Propylene Glycol
Face Powders  is basically a cosmetic product which ha its prime  Gum Tragacanth
function is the ability to complement skin color by  Methyl Cellulose
imparting velvet like finish. Preservatives
Essential Characteristics of Face Powders: Pearlessence
1. Covering Power  the ability to mask skin defects such as skin
shine, enlarged pores, & minor blemishes.
2. Slip  the faculty of spreading over the skin without dragging, &
giving the characteristics smooth feeling
3. Adhesiveness  the ability to cling to the face
4. Absorbancy  the capability of absorbing skin secretions
(perspirations & oiliness) without evidence of
such absorption.
5. Bloom  the ability to impart a velvety, peach like finish, to the
face.

Five Basic Types of Binders used in Compact Face Powder are:

1. Dry Binders: Metallic Stearates
2. Oil Binders: Mineral Oil, Isopropyl Myristate, & Lanolin
Derivatives
3. Water-Soluble Binders: Gums (Tragacanth, Karaya, & Arabic) &
PVP
4. Water-Repellent Binders: Mineral Oil, Fatty Esters of all types of
Lanolin Derivatives.
5. Emulsion Binders: Soap Such as Triethanolamine Stearate, Non-
ionic Emulsifiers & Glyceryl Monostearate
Shampoo Additives: Perfume  is a concentrated alcoholic blend of fragrant materials, sold
1. Foam Binder (Foam Stabilizer)  increase quality, volume & or ready for sale as a finished product for the consumer
stability of lather Categories of Raw Materials for Perfume: (Natural or Synthetics)
2. Conditioning Agents  coat the hair 1. Plant Materials
3. Opacifying Agents  include higher alcohols: Stearyl Alcohol a. Essential Oils (obtained by distillation or expression)
Ceryl Alcohol Clove Oil
4. Clarifying Agents  maintain shampoo clarity: Terpineol Cinnamon Oil
5. Sequestering Agents  prevention of lime soap formation b. Flower Oils
6. Antidandruff Agent  containing Selenium Sulfide/Zinc Pyrithione Jasmine Absolute
7. Thickening Agent  increase viscosity Rose Absolute
8. Preservatives Formaldehyde, Ethanol, Parabens c. Resins, Gums, & Exudations
9. Stabilizers  Antioxidants, Sunscreen, Suspending Agents Gum Styrax
& pH Control Agent  Balsam Peru
10. Other Cosmetic Additives: Perfume & Dye  Benzoin
Labolanum
Shampoo Evaluations:  Myrrh
1. Performance Properties 2. Animal Secretions:
a. Foam & Foam Stability Castoreum
b. Detergency & Cleaning Action  Civet
1. Effect of water harness Musk
2. Surface Tension & Wetting Ambergis
3. Surfactant Content & Analysis 3. Chemical Substances
c. Rising a. Isolate from plant materials
d. Conditioning Action b. Derivatives of plant materials
1. Softness c. Synthetic organic Substances
2. Luster
3. Lubricity Types of Fragrance:
4. Body, Texture, Set Retention 1. Oriental  intense heavy full-bodies fragrance
e. Irritation 2. Cologne Blend  harmonious combination while fragrance
f. Dandruff Control derived from citrus oils
2. Product Characteristics 3. Bouquet  harmonious combination of two or more floral notes
a. Fragrance 4. Floral  flower type
b. Color 5. Chypre  mossy-wood complex w/ sweet citrus top note
c. Consistency 6. Fougere  dominant sweet note w/ mossy, lavender, citrus
d. Package 7. Spice Blend  fragrance combination w/ floral spice
Nail Lacquers or Enamel consist of: 8. Wood Blend  woody notes
1. Primary Film Former: Nitrocellulose is an Outstanding Film Form 9. Aldehyde Blend  blending their specific unique characteristics
2. Secondary Resin  used in conjuction w/out nitrocellulose through superimposition of certain chemical
compositions to improve the degree of film 10. Amber  heavy full bodied powdery, warm scent tone
buil & also to promote better depth, gloss, &
adhesion
3. Plasticizer  control flexibility & elongation of the film
4. Colorants  give an acceptable shade & opacity to the film
5. Specialty Filler  impart certain characteristics iridescence.

Quality Control Checks for Nail Lacquers:

Nonvolatile Content
Drying Time
Smoothness of Flow
 Gloss
 Hardness
Color
Application  Water Resistance
Abrasion
Resistance
Adhesion
Flexibility
Viscosity
ISO (International Organization for Standardization)
has a number of management system standards, each focusing on
different issues affecting global business
Management System Standards:
Quality Management ISO 9000 family
Environmental Management ISO 14,000 family
Food Safety Management ISO 22,000 family
Energy Management ISO 50,001 family

 PAT (Process Analytical Technology)

At-line  sample is removed, isolated from & analyzed in close
proximity to the process stream
On-line  sample is diverted from the manufacturing process &
may be returned.
In-line  sample is not removed from the process steam.
PHARMACEUTICAL DOSAGE FORMS
beatifying, promote, attractiveness & alter physical
I. Solid Dosage Forms appearance
A. Powders
Dosage Form  formulation containing a specific quantity of active
B. Granules ingredient(s) in combination with one or more excipients
C. Capsules  tablets, capsules, syrups, suppositories, etc
D. Tablets
E. Solid Oral Modified-release Dosage The Need for Dosage Forms:
Forms • To protect the drug substance from the destructive influences of
atmospheric oxygen or humidity (coated tablets, sealed ampoules)
F. Inserts • To protect the drug substance from the destructive influence of
1. Suppositories gastric acid after oral administration (enteric-coated tablets)
2. Vaginal Inserts • To conceal the bitter, salty, or offensive taste or odor of a drug
II. Semisolid Dosage Forms substance (capsules, coated tablets, flavored syrups)
• To provide liquid preparations of substances that are either
A. Ointments insoluble or unstable in the desired vehicle (suspensions)
B. Creams • To provide clear liquid dosage forms of substances (syrups,
C. Gels solutions)
D. Miscellaneous Semisolids • To provide rate-controlled drug action (various controlled-release
tablets, capsules, and suspensions)
1. Pastes • To provide optimal drug action from topical administration sites
2. Plaster (ointments, creams, transdermal patches, and ophthalmic, ear,
3. Glycerogelatins and nasal preparations)
III. Transdermal Drug Delivery System • To provide for insertion of a drug into one of the body’s orifices
(rectal or vaginal suppositories)
IV. Liquid Dosage Forms: Single Phase • To provide for placement of drugs directly in the bloodstream or
V. Liquid Dosage Forms: Two-phase/ body tissues (injections)
Dispersed Phase • To provide for optimal drug action through inhalation therapy
VI. Sterile Dosage Forms (inhalants and inhalation aerosols)
VII. Special Dosage Forms Preformulation Considerations:
1. Pharmaceutical Aerosols 1. Physical Description
2. Radiopharmaceuticals 2. Microscopic Examination
3. Biotechnology 3. Heat of Vaporization
4. Melting Point Depression
Introduction 5. The Phase Rule
Drug Delivery  process whereby drugs are delivered to their site of action 6. Particle Size
using a minimum amount of drug necessary to provide & 7. Polymorphism
maintain therapy. Effect over a certain period of time with 8. Solubility
minimum toxicity. 9. Solubility & Particle Size
10. Solubility & pH
Drug Delivery System  means administering drugs as formulated
11. Dissolution
preparations
12. Membrane Permeability
formulations which provide a therapeutic amount of
13. Partition Coefficient
drug to the proper site in the body promptly &
14. pKa/ Dissociation Constants
maintain the desired drug concentration
 products that allow for the uniform release or Five types of stability concern pharmacists:
targeting of drugs into the body 1. Chemical: Each active ingredient retains its chemical integrity and
labeled potency within the specifi ed limits.
 encompass the drug formulation, interaction
2. Physical: The original physical properties, including appearance,
among drugs, formulation matrix, the container &
palatability, uniformity,dissolution, and suspendability
the patient
areretained.
Drug Product  the finished dosage form that contains the active
3. Microbiologic: Sterility or resistance to microbial growth is retained
ingredient, generally, but not necessarily, in association with
according to the specified requirements. Antimicrobial
one or more other ingredients
agents retain effectiveness within specifi ed limits.
Additive/ Excipients/ Pharmaceutic Necessities/ Adjuncts
4. Therapeutic: The therapeutic effect remains unchanged.
agents that are used to the following purposes:
5. Toxicologic: No signifi cant increase in toxicityoccurs.
to solubilize, suspend, thicken, dilute preserve, emulsify,
colorant & flavorant, & medicinal agent Factors of Patients considered in determining a drug dose in clinical
to efficacious dosage forms investigations:
must be “inert” 1. Age
Active Ingredients 2. Pharmacogenetics
3. Body Weight
a. Drugs  agent intended to be use in diagnosis, mitigation, treatment,
4. Body Surface Area
cure, or prevention of disease in MAN & other animals
5. Sex
 agents intended to affect the structure & function of the
6. Pathologic State
body of man & other animals
7. Tolerance (the ability to endure the influence of drug)
b. Cosmetic  agents intended to rubbed, sprinkled, sprayed, introduce,
8. Concominant Drug Therapy
or applied, into the body to be use in cleansing,
9. Time & Condition of Administration
10. Dosage Form & Route of Adminstration
I. Solid Dosage Forms
A. Powders
 small individualized drug particles
 intimate mixtures of finely divided drugs or chemicals intended
to be used internally or externally
Advantages:
flexibility in compounding
relatively dry & devoid of moisture
relatively stable
Disadvantages:
not easily wetted
inaccuracy of the dose
not suitable for dispensing
some powders are hygroscopic & deliquescent
Particle Size Analysis  to obtain quantitative data regarding the
size, shape, & distribution of drug particles &
particles & other components to be used in
the formulation
Simple Diffusion  reduce in particle size
 lipophlic
 unionized/ free from
 Comminution  reduction in particle size
 process of reducing larger solid unit masses
to smaller sizes by mechanical means/
milling
 to aid processing
 to improve solubility up to certain extent
 to reduce bulk volume
Small Scale:
1. Trituration  the use of mortar & pestle
 1:10 dilution/ method
*Three Types of Mortar & Pestle:
(1)Porcelain  soft aggregates/ crystals
(2)Wedgewood  crystal
(3)Glass  smooth surface/ non porous
 solution, suspension, & ointment
 used for staining subsatnce
2. Levigation  commonly used in small scale preparation
of ointments & suspensions to reduce
particle size & grittiness of the added
products
 formation of paste by addition of non-
solvent (levigating agent)
-mineral oil
-glycerin
-propylene glycol
3. Pulverization by Intervention  addition of volatile
substance
Ex: Camphor + Alcohol
I2 Crystals
Large Scale (Mills & Pulverization)
1. Tumbling  drug particles are enclosed in a rotating
chamber
 use motorized blades by shaking or
rotating
 thorough but time-consuming
2. Spatulation  the use of spatula (movement of spatula)
 for non potent powders
3. Sifting  by passing them through sifters
 is not acceptable for the incorporation of
potent drugs into a diluents powder
 for non potent powders
 “Sifters” / Sieves
4. Geometric dilution  to ensure the uniform distribution
of potent drug, which is placed w/
an approximately equal volume of
the diluents in a mortar & is
mixed thoroughly by trituration.
Micronization  a method of producing finer drug particles
under 10m size.
Types of Powders
1. Bulk Powders  dispensing in large quantities
(1) Oral Powders
(2)Dentrifices  mild abrasive;
anticariogenic (prevents cavity formation)
(3)Insufflation  finely divided powders intended to body cavity by
a device known as “Insufflator”
(4)Triturations  are dilutions of potent powdered drugs, prepared
by intimately mixing them w/ a suitable diluents
in a definite proportion of weight.
(5) Dusting Powder  intended to be dusted on the skin by
sprinkling or by means of sifter-top
containers.
(6)Aerosols  administered w/ the aid of inhalers, w/c delivers
micronized drugs in metered quantities
(7)Douche Powder  preparation of vaginal douche
 used for the hygienic effect, some contain
anti0infective agents
Components of Douche Powders:
a. Boric Acid or Sodium Borate
b. Astringents, for example, potassium, alum, ammonium
alum, zinc sulfate
c. Antimicrobials, for example, oxyquinoline sulfae,
povidone iodine
d. Quaternary Ammonium Compounds,
for example, Benxethonium Chloride
e. Detergents, for example, Sodium Lauryl Sulfate
f. Oxydizing Agents, for example, Sodium Perborate
g. Salts, for example, Sodium Citrate, Sodium Chloride
h. Aromatics, for example, Methol, Thymol, Eucalyptol,
Methyl Salicylate, Phenol
2. Divided Powder  “chartulae”; known as individualize powders
 paper tablets; “papelitos”
*Types of Paper in Paper Tablets:
(1)Simple Bond paper  has n moisture resistance
(2)Vegetable Parchment  a thin semiopaque w/ limited
moisture resistance
(3)Glassine  a glazed, transparent paper,
also w/ limited moisture resistance
(4)Waxed paper  a transparent waterproof paper
 use for hygroscopic or deliquescent
powder
May be used only a limited
Glassine
Vegetable Parchment  barrier against moisture is
necessary
Waxed Paper

If powder containing volatile
Glassine components
Terms:
Hygroscopic  absorb moisture from the air
Deliquescent  absorb moisture from the air to the extent that they
liquidify by partially or wholly forming a solution
. e.g. Potassium citrate, sodium nitrate
Efflorescent  release water; boom
Example of Efflorescent Substance:
-Citric Acid
-Ferrous Sulphate
-Atropine Sulphate
Effervescent  producing gas in the form of tiny bubbles
Standards for Vegetable & animal Drugs
Descriptive Term Seive Size Limit
Very Coarse No. 8 NMT 20% pass through No. 60
Coarse No. 20 NMT 40% pass through No. 60
Moderately Coarse No. 40 NMT 40% pass through No. 60
Fine No. 60 NMT 40% pass through No. 100
Very Fine No. 80 No limit Greater fineness
Standard Chemical Drugs
Descriptive Term Seive Size Limit
Coarse No. 20 NMT 60% pass through No. 40
Moderately Coarse No. 40 NMT 60% pass through No. 40
Fine No. 60
No limit Greater fineness
Very Fine No. 120
B. Granules
 prepared agglomerates of powders
 aggregates of powders that adhere or bond to each other to
form larger unit particles
 Sieve Size: No. 4 – No. 12 (coarse to very coarse)
 Granules in Tablet Formulation: No.12 – No. 20
Advantages:
1. Flows well compared to powders
facilitates the transport of the drug material
from the hopper to the tablet press
2. Less surface area
more stable from atmosphere humidity
 less tendency to cake or harden
3. Easily Wetted
 suitable for material that needs
reconstitution prior to use
Granulation  process to prevent segregation of powders
to improve flow properties
to improve compressibility
Methods of Granulation:
1. Wet Granulation  most widely used
 uses binder
 Advantages: -Increased Compressibility
-Improved Dissolution
Disadvantage: -Its not applicable to water/
moisture & heat sensitive
(ex: Aspirin)
*moisten the mass  screen
*granulating fluids  H2O
*fluid bed processing  alcohol isopropanol
fluid bed granulation (liquid is sprayed on
suspended powders)
2. Dry Granulation  for heat & moisture sensitive materials
 particles are aggregated using high pressure
 Disadvantage: Messy
 Processes:
a. Roll Compaction  uses thin sheets
powders are rolled into
dense sheets
sheets are granulated
using a mechanical
granulator
 sieve granules to obtain
desired size
b. Slugging  tablet pressed
 slugging of powders (formation
of large tablets called a “slugs”)
slugs are granulated using an
appropriate equipment
 sieve the granules to obtain
desired size
 poorly formed tablets
Types of Granules:
a. Good Granules  particles that pass through sieve 20 & are
retain at sieve 40
 *Quality of a Good Granulation:
-as spherical as possible
-uniform in content
-normal or bell-shaped distribution of
particle sizes
b. Fines  particles that pass sieve 40
 act as bridges by filling interparticulate spaces
*Excess Fines  there is interparticulate friction
*Excess Granules  there is void spaces
Properties of Granules for Tablet Production
Fluidity/ Flowability
Compressibility
Ways to improve Flowability:
1. Alteration of particle size & size distribution
 use larger particles
 reduces the amount of fines
2. Alter particle shape & texture
 the rounder (more spherical),
the smoother the particles ,
the better (more flowable)
3. Use of Flow Activators:
G  Glidant  to increase friction
A  Anti-adherent
L  Lubricant  to prevent wear & tear
 to facilitate ejection
*If No Lubricant  there is screening sound
striation
stretch mark
*Lubricant must be fine
*Example: Metallic Stearate  prolongs
disintegration time
 decrease
bioavailability
4. Alter process condition
5. Alteration of surface Forces
reduce/ increase electrostatic charges
reduce moisture content
Problems in Fluidity/ Flowability of Granules
a. rat-holling/ piping/ funneling
b. bridging/ arching
c. flooding (solution: Regranulation)
Characterization of Granules:
1. Angle of Repose
2. Carr’s Compressibility Index
3. Hausner’s Ration
4. Bulk Density
5. Critical Orifice Diameter
6. Hopper Flow Rate
Scott Volumeter  used in the determination of Bulk Density
Bulk & Tapped Density data – can help us identify the volume
of the container for the storage of
raw materials
Effervescent Granules
release CO2 gas in water
to increase palatability of vehicle
 mixture of citric acid, tartaric acid, & sodium bicarbonate
Ratio: 1 : 2 : 3.4
 when Tartaric acid is used as the sole acid in
effervescent granules, the resulting granules will
-Lose their firmness & crumble.
 when Citric Acid is used as the sole acid in
effervescent granules, the resulting granules will
-Be sticky & difficult to granulate.
method: 1. Fusion (to release water of crystallization of
ingredients)
2. Addition of moistening binding agent
Method exist for the Determination of Particle size
1. Seiving  passed by mechanical shaking
2. Microscopy  through the use of a calibrated grid
3. Sedimentation  by measuring the terminal settling velocity of
particles through a liquid medium
4. Light Energy Diffraction or Light-scattering  by the reduction in
light reaching the sensor as the particle
5. Laser Holography  in which a pulsed laser is fired through an
aerosol particle spray
6. Cascade Impaction  by an airstream
C. Capsules Characteristics of Added substances to Capsule Formulations:
1. Are harmless in the quantities used
solid dosage form in which one or more medicinal &/or inert
2. Do not exceed the minimum amounts required to provide their
substances are enclosed within a small edible shell usually made intended effect
of gelatin 3. Do not impair the products bioavailability, therapeutic efficacy,
Types of Capsules: or safety
1. Hard Gelatin Capsule (HGC) 4. Do not interfere w/ requisite compendia assays & tests
 aka Dry-filled Capsule Goals in Developing a capsule formulation:
Two-piece Capsule to prepare a capsule w/ the following characteristics:
a. Accurate Dosage
 has 12-15% or 13-16% moisture b. Good Bioavailability
 investigational drug & extemporaneous. c. Ease of Filling & Production
gelatin shells are manufactured in a separate process d. Stability
(dipping PEGs made of manganese bronze in a melted e. Elegance
gelatin mixture) Materials for Capsule Shell Making
shell composed of: 1. Gelatin  result of the partial hydrolysis of collagen obtain form
Gelatin Colorants the skin, white connective tissues & bones of animals
Water 0.15% Sulfur Dioxide  contains important amino acids,
Sugar Titanium Oxide only tryptophan is absent
has two(2) parts: Body & Cap/Head  Two Types of Gelatin: Type A  Acid Hydrolysis
 has 8 sizes (5 to 000) Type B  Basic Hydrolysis
Capsule sizes available for Human use: 2. Plasticizer  for elastcicity & flexibility
Capsule Size Volume Capacity Powder Capacity  Ex: Glycerin
(mL) (mg) Sorbitol
000 1.40 650-200 mg 3. Colorants : FD & C
00 0.95 4. Preservatives: 0.15% Sulfur Dioxide
0 0.68
5. Opacifying Agent: Titanium Dioxide
1 0.50
2 0.37 For large scale, glidants, lubricants & surfactants may also be
3 0.30 employed
4 0.21 Order of Capsule Shell Manufacturing:
5 0.13 60-130 Dipping, Spinning, Drying, Stripping, Trimming, Joining
Large Capsules are available for Veterinary use.  Encapsulation Procedure of Capsules from start to finish:
 0  is the largest capsule size for human use.
Rectification  Separation  Filling  Joining
2. Soft Gelatin Capsules (SGC) 
has 6-10% moisture Printing Banding Ducting & polishing
rendered plastic-like with the addition of plasticizers Capsule Excipients:
(glycerin or sorbitol) 1. Diluent or Filler  to produce the proper capsule fill volume
oblong, oval, spherical, tube, pearl, suppository type Ex: Lactose
filled with pumpable solutions, suspensions, pasty Microcrystalline Cellulose
material or powders Starch
formed, filled, & sealed in a single manufacture 2. Disintegrants  to assist the breakup & distribution of the
process (Plate Process or Rotary Process) capsule’s contents in the stomach
Liquids that may be encapsulated into SGC Ex: Pregelatinized Starch
(1) Water-immiscible volatile & non-volatile liquids: Eroscarmellose
vegetables & aromatic oils Sodium starch Glycolate
aromatic & aliphatic hydrocarbons 3. Lubricants or Glidants  to enhance flow properties
chlorinated hydrocarbons Ex: Fumed Silicon Dioxide
ethers Magnesium Stearate
esters Calcium Stearate
alcohols Stearic Acid
organic acid Talc
(2) Water-miscible non-volatile liquids: 4. Surfactant or Surface-Active Ingredients  to facilitate wetting by
Polyethylene Glycols the gastrointestinal fluids to overcome problems
Polysorbate 80 (non-ionic surface active Ex: Sodium Lauryl Sulfate
agent) Edible Gelatin (Specifications)
(3)Water-miscible & relatively non-volatile Type A Type B
compounds: pH 3.85.5 57.5
Propylene Glycol & Isopropyl Alcohol Isoelectric Point 79 4.75.4
Bloom Strength  measure of gelatin capsule’s rigidity Gel Strength (Bloom) 50300 50300
Encapsulation Process Viscosity (mps) 1575 2075
1. Preparation of Formulation Ash 0.32 0.52
2. Filling Capsule Storage: If too moist  Tacky
3. Sealing If too dry  Brittle
4. Cleaning & Polishing Spansule  a capsule composed of hard gelatin shell containing hundreds
Packaging: of tiny coated beads/ pellets of drugs for sustained release
Cachet  a flat containing drug that has an unpleasant taste
Protection Information is swallowed intact by the patient
Preservative Compliance Parvules  bullet-shaped
Presentation Convenience Troche  a medicinal lozenge, taken by mouth, used to treat conditions of
Identification Container the mouth or throat & also of the alimentary canal
Capsulating Machine (Parts): Peg-ring Pellets or Implants  are sterile, small, usually cylindrical solid object
intended to be implanted subcutaneously to provide
Hopper continuous release of medication over time
Closing palate
D. Tablets
most widely used dosage form
solid dosage form that contain active ingredients & excipients
prepared by either molding or compression
(8) Effervescent Tablets  releases gas in contact w/ water
Two Types of Tablets:
*Bubble action  can assist the
1. Molded Tablets  soft tablets
breakup of the Tablet
 are intended to dissolve slowly in the mouth.
(9) Buccal Tablets flat, oval tablets,
 do not contain disintegrants, lubricants, or
that erode slowly on the cheeks
coatings to slow their rate of dissolution
(10) Sublingual Tablets  flat, oval tablets,
Ex: Tablet Triturates  are small, usually
that placed under the tongue
cylindrical, containing
(11)Instantly-release Tablets
small amounts of potent
(Rapidly dissolving tablets or RDTs)  are
drugs
characterized by disintegrating or
2. Compressed Tablets  hard tablets
dissolving in the mouth within 1
Ex: (1) Compressed Tablets
minute, some within 10 seconds
(2) Multicompressed Tablets
Dissolution in the mouth within
 appear as layered
approximately 15-30 sec. anything slower
 are prepared by subjecting the fill material to
would not be categorized as rapidly
more than a single compression
dissolving.
(3) Layered Tablets
(12) Extended Release Tablets (Controlled-release Tablets)
 are prepared by initial compaction of a position
are designed to release their medication in a
of ill material in a die followed by additional fill
predetermined manner over an extended
material & compression to form two-layered or
period.
three layered tablets, dispensing on the number
(13) Vaginal Tablets/ Vaginal Inserts
of separate fills
 are uncoated, bullet-shaped, or ovoid (egg-
 layer may contain a different medicinal agent,
formed) inserter into the vagina for local
separated for reasons:
effects
physical or chemical incompatibility
 prepared by compression & shaped to fit
staged drug release
smugly on plastic inserter devices that
simply for the unique appearance of the accompany the product
layered tablet
(14) Hypodermic Tablets  were originally used by
(4) Sugar Coated Tablets
physicians in extemporaneous
 (a) Mask the offensive taste of the drug preparations of parenterals
(b) Offers protection
(15) Immediate-Release Tablets  are designed to
*Disadvantage:
disintegrate & release
(a) Adds bulk/weight to th eformulation
their medication with no
(adds 50% to the tablets weigh)
special coatings & other
*Tablet thickness: Microcalliper=
techniques
+15% tolerance
 75% of labeled amount
every 30 minutes
dissolves in 45 minutes.
(b) time-consuming
(16) Dispensing Tablets  better have termed as
(c) needs expertise
“Compounding Tablets”
(4) Film Coated Tablets
(17) Orally Disintegrating Tablet  placed in the oral cavity
 are compressed tablets coated w/ a thin layer of
& can be taken without
a polymer / plastic-like matrials capable of
water.
forming a skinlike film to make the tablet more
durable
 not time-consuming
 does not add weight/ bulk to the formulation
(5) Enteric Coated Tablets
 have delayed-release features
 meant to disintegrate in small intestine
 to prevent gastric mucosa irritation
(6) Gelatin Coated Tablets
 a recent innovation, gelcap, is a capsule-shaped
compressed tablet that allows the coated
product to be about one-third smaller than a
capsule filled w/ an equivalent amount of
powder
(7) Chewable Tablets
 have smooth, rapid disintegration when chewed
or allowed to dissolve in the mouth,
 have a creamy base, usually of special flavored &
colored mannitol
Excipient: Mannitol
Xylitol (Sugar-Free)
 for individuals w/ difficulty in swallowing
Gaviscon®  Sodium Alginate + Calcium
Carbonate + Sodium Bicarbonate
Three Basic Methods in preparing Compressed Tablets:
1. Wet Granulation  widely employed method
 required some steps:
a. Weighing & blending the ingredients
b. Preparing a dampened powder or a damp
mass
c. Screening the dampened powder or damp
mass into pellets or granules
d. Drying the granulation
e. Sizing the Granulation by dry screening
f. Adding lubricant & blending
g. Forming tablets by compression
2. Dry Granulation  the powder mixture is compacted in large
pieces & subsequently broken down or sized
into granules
 for moisture sensitive material
 thermolabile n the during process
Slugging  the powder is slugged, a compressed, into large
flat tablets or pellets about 1 inch in diameter
Roller Compaction  is a method often preferred to slugging
 powder compactors may be used to
increase the density of a powder by
pressing it between rollers at 1-6 tons
of pressure. The compacted material is
broken up, sized, & lubricated, &
tablets are prepared by compression in
the usual manner
 Method of Dry Granulation for Tablet Manufature:
Milling  Mixing  Slugging  Screening

Compression  Mixing w/ disintegrant & lubricant
3. Direct Compression Tabletting  some granular chemicals, like
potassium chloride, possess
free-flowing & cohesive
properties that enable them to
be compressed directly in a
tablet machine without any
need of granulation
Components of Excipients/ Adjuncts used in Tablet Formulation:
A. Essential Components  imparts satisfactory characteristics to the
formulation
1. Diluents/ Fillers  to prepare tablets of the desired size/ bulk
Ex: Starch, Lactose, Mannitol, Kaolin
-Lactose  most common diluents
 water-soluble
readily releases drug
-Mannitol  for water-sensitive
-Sorbitol  highly hygroscopic
2. Binders/ Adhesives  promote adhesion
 promote granular process & cohesive
compacts
Ex: Constarch (Starch, 5-10%), Glucose
Method of Addition:
-added along w/ diluents
-added as a slurry
excess binding  difficulty in compression if colored
3. Disintegrants/ Disintegrating Agents
 promote break up of the tablets after
administration to smaller particles for ready
drug availability
 attract water into the tablet causing the
tablet burst
 break tablet in an aqueous environment
 opposes binder action
 if not effective: no drug release
Ex: Cellulose Derivatives, Clays, Starch (5-20%)
Two Types of Disintegrants
-External: tablet  granules
-Internal: granules  powder
Methods of Addition:
-before compression
-before wet granulation
-half before granulation
-half before compression
B. Compression Aids  impart satisfactory compression
characteristics
Antiadherents,Glidants, Lubricants
 enhance the flow
increase the flowability of the drug material
 prevent the wear & tear of the tableting
machine
 prevent the sticking of the material in the
tableting machine
1. Glidants  enable the granules to flow from a hopper on the
tablet press to the die & for consistent & uniform fill
2. Lubricants  aid in releasing the compressed tablet from the die
3. Antiadherents  prevent the formation of residue films of tablet
granulations on the punches
C. Supplementary Components  give additional desirable physical
characteristics to the finished
products
Miscellaneous adjunts  Colorants, Flavorants,
Sweeteners, Asorbents
 improves the aesthetic appearance
improves the palatability of the preparation
Adsorbents  capable of holding quantities of fluids in an
apparently dry state
Colorants for identity; can use dyes & lakes pigments
-Dyes  water soluble
-Lakes Pigments  dye&salt; water-insoluble
Sweeteners  Naturals: Sucrose, Stevia,
Honey (Apis mellifera)
Synthetic: Aspartame
180X sweeter than sucrose
CI: Phenylketonuria)
Saccharin
 500X sweeter than sucrose
Coloring Pharmaceuticals
Coloring Agents  are used in pharmaceutical preparations for
aesthetics
Agents that have inherent color & employed as colorants:
-Sulfur  Yellow
-Riboflavin  Yellow
-Cupric Sulfate  Blue
-Cyanocobalamin  Bluish Green
-Ferrous Sulfate  Red
-Red Mercuric Iodide  Vivid Red
 have inherent color & are not thought of
as pharmaceutical colorants in the usual
terms
Certified Color Additives are classified:
1. FD & C color Additives : used in food, drugs, & cosmetics
-FD & C Red no.2  also known as Amaranth,
caused cancer in rats
-FD & C Red no. 4  terminated as mashinocherries &
ingested drugs because of unresolved
safety questions
2. D & C color additives  some used in drugs, cosmetics &
medical devices
3. External D & C color Additive  the use of which is restricted
to external parts of the body,
not including the lips or any
other body surface covered
by mucous membrane
COLORS FLAVORS
Pink to Red  cherry, strawberry, apple, raspberry
Brown  choco, maple, caramel, nut molasses,
Yellow to orange  lemon, lime, orange, banana, cherry
Green  lime, mint, menthol, pistachio, spearmint
Off White/ White  vanilla, banana, caramel, mint, custard
Violet o Purple  grape, plum, licorice
Blue  mint, blueberry, plum, licorice, mixed DFR
Speckled  color of speckling or background
corresponding to flavor chosen
Sweetening Pharmaceuticals:
1. Aspartame  breaks down in the body into three components:
-amino acid phenylalanine
-aspartic acid
-methanol
discourages by persons w/ Phenylketonuria
 200 times sweeter than sucrose
2. Cyclamate  has carcinogenic potential
 possible causation of genetic damage & testicular
atrophy
3. Saccharin  130X as sweet as sucrose & is excreted unchanged in
urine; bitter after taste
 sources: Sugar cane, Sugar beet, Sugar maple
4. Stevia Powder  the extract from the leaves of the plant
Stevia rebaudiana bertoni
 natural, nontoxic, & about 30X as sweet as cane
sugars (sucrose)
 can used in both hot & cold
BASELINE TASTE RECOMMENDED FLAVORS
Sweet  honey, mixed fruits, berries, vanilla, maple
Bitter  chocolate, anise, cherry mint, nut, fennel
Salty  butterscotch, melon, maple, peach,
raspberry, mixed citrus/fruit, nut
Sour  citurs, rootbeer, anise, cherry, strawberry,
licorice
Metallic  grape, burgundy, lemon-lime
Alkaline  chocolate, cream, vanilla, mint combination
Advantages of Tablet over some oral Medication:
a. Precision of Dosage
b. Durability of physical characteristics foe extended period
of storage
c. Stability of chemical & physiologic activity of drugs
d. Convenience of administration
Tablet Press: -Single
-Rotatory/ Multiple
Basic Elements/Parts of Tablet Press:
1. Hopper  for storing the material for compressing
2.Feed Frame  for distributing the materials into the dies
3. Dies  for controlling the size & shape of the tablet
4. Punches  for compacting the materials within the dies
 they also shape the tablet
5. Cams tracks  guides the movement of the punches
Types of Tablet Printing
a. Debossed  means imprinted w/ a mark below the surface
b. Embossed  means imprinted w/ a mark above the surface
c. Engraved  means imprinted w/ a code that is cut into the
surface during production
Tablet Coating: Sugar Coating
Film Coating
Enteric Coating
Reasons for Coating Solid Dosage Forms:
(1) To mask unpleasant taste
(2) To protect components form atmospheric degradation
(3) To prevent contact with a drug which is irritating or
potentially allergic
(4) To separate reactive ingredients
(5) To control the site of drug release (enteric coating)
(6) To delay or prolong absorption of the drug component
by retarding release of drug from the dosage form
(sustained-action)
(7) To improve appearance
(8) To change the physical surface of ingredients
Basic Processes used in the application of coating are:
(a) Compression Coating  make possible to some special
dosage forms
(b) Pan Coating  is used in both sugar & film-coating
makes use of coating pans provided w/ a
hot & cold air input system & am
exhaust system to remove moisture &
fine powder generated during the
coating operation.
(c) Air Suspension Coating  one of most dependable
methods for applying film-
coats. The coating material
is atomized & applied to
tablets
(d) Dip Coating  the materials to be coated are usually
placed in baskets & dipped into
containers of coating solutions
 has not been widely accepted because
of the difficulties encountered during
the coating procedure & lack of coat
uniformity
Equipments: (1) Coating Pan (Ex: Accela Cota, Fellegrini)
(2) Steam Jacketed Tanks
(3) Drying Oven
(4)Polishing Drum
Uncoated Tablets should be: sufficiently hard
optimum convexity
minimal friability
rapid disintegration
Sugar Coating  sucrose-base solutions
*Disadvantage: -Significance increase tablet weight
-Requires highly skilled personnel
*Sugar Coating Processes:
(1) Sealing  aka “water proofing”
 separate the core from the water
 uses alcoholic solution of resin
 optional step
 Ex: Shellac
(2) Subcoating  round off the tablet contour rapidly
 improve bond between seal coat & sugar coat
 standardize tablet size
(3) Syruping  particularly demanding & involves three basic
phases
a. Grossing  base color
 application of a syrup solution w/
subcoating powder
b. Heavy Sugar Coating  to build up a
solid color
c. Regular Syrup Coating  desired color
 dilute syrup solution
 finishing w/out permitting
the tablet to become as
dusty as previous two
syrupiing stages
(4) Finishing  initiated when the desired color is attained
(5) Polishing  done in a canvas polishing pan

Film-Coating  thin, skin-tight coating of plastic like material

*Advantage: No significant increase in tablet weight, size, shape
Retain contour of original core
About 2-5% increase in thickness only
*Enteric Coating  form of functional coating
*Film-Coating Solutions may be non-aqueous/ aqueous:
1. Non-aqueous Solutions contain the following types of materials
a. Film-former  capable of producing smooth, thin films
reproducible under conventional coating
conditions & applicable to a variety of tablets
shapes.
 Example: Shellac;
CAP (Cellulose Acetate Phthalate
b. Alloying Substance imparts water-solubility/ permeability
 Example: PEG (Polyethylene Glycol)
c. Plasticizer  imparts flexibility & elasticity
 Example: Castor Oil; Sorbitol;
d. Surfactant  imparts spreadability
 Example: Spans; Tweens;
Polyoxythylene sorbitan derivatives
e. Opaquants  Example: Titanium Dioxide
f. Glossant  provide luster to the tablets w/out a separate
polishing operation
 Example: Beeswax
h. Volatile Solvent  allow the spread of the other components
over the tablets while allowing rapid
evaporation to permit an effective yet
speedy operation
 Example: Alcohol mixed with acetone
2. Aqueous Film-Coating Formulation contains:
a. Film-forming Polymer (7% to 18%): Cellulose ether polymers
b. Plasticizer (0.5 to 2.0%): Glycerin
c. Colorant & Opacifier (2.5% to 8%)
d. Vehicle (water, to make 100%)
Enteric Coating  designed to resist dissolution in the stomach but dissolve
in the less acidic environment of the small intestines (pH
4.8 or greater)
Ex: Shellac, HPMC

*Problems attendant on aqueous Film-Coating:

1. Picking  small amount of film fragments flaking from the tablet Sugar Coated Film Coater
surface (punch) rounded retain original core
 removal of material from the surface of the tablet & 30-50% increase in tablet weight 2-3% increase in tablet weight
adheres to the punch face multi-stage process usually single-stage process
2. Peeling  large amounts of film fragments flaking from the tablet
surface
3. Orange peel effect  roughness of the tablet surface due to Quality Standards & Compendial Requirements:
failure of spray droplets to coalesce 1. Tablet weight & USP weight Variation: 10% of the standard wt
4. Mottling  uneven color distribution  Tablet Weight can be adjusted
5. Bridging  filling-in of the score line or indented logo on the by Lowering the lower punch adjustment knob.
tablet by the film; masking of monogram 2. Content Uniformity: 15% of standard content of A.I.
6. Tablet Erosion  disfiguration of the core tablet when subjected 3. Tablet Thickness: 5% of the standard thickness
for too long the coating solution 4. Tablet Hardness & Friability
7. Wrinkling  caused by improper drying or film former defect 5. Tablet Disintegration
8. Sweating  oil droplets 6. Tablet Dissolution
9. Blistering  reduced adhesion between film & surface of tablet
due to rapid drying The Thickness of the Tablet is determined by the following:
diameter of the die
*Other Problems in Tabletting: amount of fill permitted to enter the die
1. Chipping  removal of edges/ small portion of tablet the compaction characteristics of he fill material
 the separation of small piece of tablet surface after the force of pressure applied during compression
ejection
 breaking of tablet edges while the tablet leaves the
press
2. Capping  the partial or complete separation of the top or
bottom of a tablet from the main body
3. Lamination  multilayered; the separation of tablet into two or
more distinct layers
4. Bloom  dull film due to humid conditions or migration of
plasticizer to surface of coat
5. Spotting  due to migration of plasticizers, dyes or other
additives in the coating formulation
6. Flaking  removal of tablet surface
7. Sticking  adhesion of granulation to the die walls
8. Cracking
9. Weight Variation  causes: -Poor mixing
-Punches (unequal length of lower
punches)
-Poor Flow
-Size & distribution of the Granules
being compressed
10. Hardness Variation  have the same causes as weight
variation
 depends on the weight of material
11. Double Impression  involves only lower punches
 tablet receives the imprint of the punch
E. Solid Oral Modified-release Dosage Forms
dosage forms in which drug release features are based on
time, coarse & location that are designed to accomplish
therapeutic or convenience objectives not offered by
conventional or immediate-release forms
Reasons: a. For drugs, that are not inherently long lasting in
effects.
b. For drugs, that requires multiple dosing
1. Extended Release Dosage Forms (ER)
Controlled, Sustained
provides immediate release of the large amount of drug
that produce the desire effect & followed by gradual
release of remaining amounts
allows the reduction in dosing frequency from that
necessitated by a conventional dosage form
 Problem: Dose Dumping (lead to toxic effects)
2. Delayed Release Dosage Forms (DR)
 designed to release the drug at a time other than
promptly after administration
Example: Enteric Coating (PET)
a. ph dependent
b. enzyme dependent
c. time dependent
3. Repeat Action  contain two single doses of medication,
one for Immediate Release & the
other for Delayed-release (DR)
4. Targeted Release Dosage Forms  describes drug released
directed toward isolating or
concentrating a drug in a body
region, tissue, or site for
absorption of for drug action.
 GITS  type of modified release formutlation consists of a drug
reservoir surrounded by a semi-permeable membrane,
which has a single precision-laser-drilled pore on the drug-
reservoir side.
Characteristics of drugs commonly incorporated into an
Extended-release product:
a. They neither very slow nor very fast rates of absorption & excretion
b. They are uniformly absorbed form the gastrointestinal tract
c. They are administered in relatively small doses
d. They possess a good margin safety
e. They are used in the treatment of chronic rather than acute
conditions
Extended-Release Technology for Oral Dosage Forms
1. Coated Beads, Granules & Microspheres System
the drug is distributed onto beads, pellets, granules, or
other particulate systems
Example: Spansule (SmithKline Beecham) Capsule
a capsule containing beads of different
coating thickness
2. Multitablets System
small spheroids compressed tablets 3.4 mm in diameter
may be prepared to have varying drug release
characteristics
may be placed in gelatin capsule shells to provide the
desired pattern of drug releas
each capsule may contain 8-10 (tablets) minitablets
-uncoated  for immediate release
-coated  for extended drug release
3. Microencapsulation Drug
is a process by which solid, liquids, or even gasses may be
enclosed in microscopic particles by formation of thin
coatings of wall material around the substances
materials used:
-Gelatin  is a common wall-forming material
-Synthetic polymers  polyvinyl alcohol,
ethylcellulose, polyvinyl
chloride
advantages: The administered dose of the drug is
subdivided into small unit that are spread over a
large area of the gastrointestinal tract, which may
enhance absorption by diminishing local drug
concentration
Example: Potassium Chloride (Micro-K Extencaps,
A.H. Robins)
4. Embedding Drug in Slowly Eroding or
Hyrdrophilic Matrix System
the drug substance is combined & made into granules w/
an excipient materials that slowly erodes in body fluids,
progressively releasing the drug for absorption.
Hydrophilic Cellulose Polymers
 are commonly used as the excipient base in
tablet matrix systems.
Hydrocypropyl Methylcellulose (HPMC)
 a free-flowing powder, is commonly used to
provide the hydrophilic matrix
Example: Oramorph SR Tablets (AllPharma)
 contains Morphine Sulfate
5. Embedding Drug in Inert Plastic Matrix
 the drug is granulated w/ an inert plastic material such as
polyethylene, polyvinyl acetate, or polymethacrylate, &
the granulation is compressed into tablets
 the drug is slowly release from the inert plastic matrix by
diffusion.
inert tablet matrix  expended of drug, is excreted w/
the feces
 Example: Gradumet (Abbott)
6. Complex Formation
provides the extended release of the drug because of the
slow dissolution rate
Example: Salts of Tannic Acid (Rynatan) -Wallace
7. Ion exchange Resins
form a complex by the replacement of hydrogen atoms.
Resin-drug Complex  is washed & amy be tableted,
encapsulated or suspended in
an aqueous vehicle.
Example:
-Hydrocodone Polistirex & Chlorampheniramne
Polistirex Supension (Tussionex Pennkinetic
Extended Release Suspension [Celltech])
-Phentermine Resin Capsules (Ionamin Capsules
[Celltech])
incorporates a polymer barrier coating & bead technology
in addition to the ion exchange mechanism
8. Osmotic Pump
 the pioneer oral osmotic pump drug delivery system is the,
Oros System Developed by Alza
is composed of a core tablet surrounded by a
semipermeable membrane coating having a 0.4
diameter hole produced by laser beam
Example: Glucotro XL, Procardia XL, Covera HS
F. Inserts Rectal Suppository  is not usually compressed as
1. Suppositories tablets unlike vaginal
2. Vaginal Inserts suppositories
Suppository Bases:
1. Suppositories 1. Oleaginous Base (Fatty Base)
 solid dosage forms intended to be inserted in body the most frequently employed suppository
orifices where they would melt & dissolve to exert their a. Cocoa Butter, NF  roasted seeds of Theobroma
local or systemic effects Cocoa (fam. Sterculiaceae)
Types of Suppositories: also known as Theobroma Oil
Rectal Suppositories melts at 30-36C (86-97F)
Vaginal Suppositories/ Pessaries ideal suppository base
Urethral Suppositories/ Bougies exhibits marked polymorphism
Features Rectal Vaginal Urethral because of its triglyceride content
Weight 5 grams 3-5 grams Males: 4 g Triglycerides: (a) Oleopalmistostearin
(Infants: 1g) Females: 2 g (b) Oleostearin
Size 1.5 inc long/ varies Males: 3-6 mm Polymorphs: (a) Alpha
32mm diameter (b) Beta more stable
100-150 mm long/ solid until 32C
usually, 140 mm melt between 34-35C
Females: 60-75 mm Phenol & Chloral Hydrate can decrease its
long/ usually 70 melting point when incorporated w/ it.
mm b. Wecobee  source from coconut
Shape Cylindrical & Globular, Slender, c. Witepsol  saturated fatty acis C12-C100
have tapered at Oviform, pencil-shaped, &  main saturated FA is lauric acid
one end or conical pointed at one d. Other examples:
both, resembles (cone- extremity/ hydrogenated fatty acids of vegetable oils
torpedo, bullet shaped) Palm Kernel Oil
or little finger thinner & tapered Cottonseed Oil
containing compounds of glycerin
(for children:
Palmitic Acid
Pencil-like)
Stearic Acid
Age (Children: ½ of For adults For Adult
Glyceryl Monostearte & Glyceryl Monopalmitate
Difference the adult size)
Gender Both Female only Both 2. Water-Soluble or Water-miscible Base
Precaution: Moisten the Tip of the Suppository to
Preparation of Suppositories: prevent mucosal irritation & to
1. Hand Molding (No heat application) facilitate the smooth passage of
 Hand rolling & shaping suppository in the body-orifices.
simplest & oldest method for preparing a. Glycerinated Gelatin  most frequently used in
suppositories preparation of vaginal
 is a historic part of the art of the pharmacist suppositories
2. Cold Compression (No heat application) slower to soften & mix w/ the
cold-grated mass is formed into a mold under physiologic fluids
pressure, using a wheel-operated press b. Polethylene Glycols  polymers of ethylene oxide &
by forcing the mized mass of the base & water
medicaments into special molds using do not melt at body temperature
suppository-making machines but rather dissolve slowly in
the base & other formulative ingredients are the body’s fluid
combined by through mixing, the friction of the  for vaginal administration
process softening the base into a pastelike
consistency 3. Miscellaneous Bases
3. Fusion or Melt Molding (Pour Molding)  generally combination of lipophilic & hydrophilic
most commonly used for producing suppositories substances
on both small or large scale operation  mixtures of oleaginous & water-soluble or water-
common molds used today: Stainless Steel miscible materials
Aluminum  Example: Polyoxyl 40 stearate  a surface-active
Brass agent that is employed
Plastic in a number of
Steps in Molding: commercial suppository
(1) Melting the base base
(2) Incorporating any required medicaments
(3)Pouring the melt into molds General Specifications of an Ideal Suppository Base:
(4) Allowing the melt to cool & congeal into 1. Nontoxic & Non-irritating to mucous membranes
suppositories 2. Compatible with a variety of drugs
(5) Removing the formed suppositories from 3. Melts or dissolves in rectal fluids
the mold 4. Stable on storage: Should not bind or otherwise
4. Compression in a tablet press interfere with release & absorption of drug
a. Carbon Dioxide  releasing tablet substances
b. Vaginal Compressed Tablet
2. Vaginal Inserts/ Vaginal Tablets
 are uncoated, bullet-shaped, or ovoid (egg-formed)
inserter into the vagina for local effects
 prepared by compression & shaped to fit smugly on
“Plastic Inserter “devices that accompany the
product
Methods: Direct Compression
 contains: Antimicrobial Agent
II. Semisolid Dosage Forms
1. Ointments
2. Creams
3. Gels
4. Miscellaneous Semisolids: Pastes
Plaster
Glycerogelatins
1. Ointments
are semisolid preparations intended for external
application to the skin or mucous membranes
may be medicated or not
Uses: Emollients  make the skin more pliable
Protective Barriers
Vehicles  in which to incorporate medication
Ointment Bases:
1. Oleaginous Bases (Hydrocarbon Bases) 3. Water Removable Bases (Water-washable Base)
characteristics: resembles o/w emulsion & creams
 greasy may dilutes with water or aqueous
 non-water washable solutions
 offer the best emollient & occlusive have the ability to absorb serous
effects discharges
a. Petrolatum, USP Example: Hydrophilic Ointment, USP
purified mixture of semisolid hydrocarbon 4. Water Soluble Base (Greaseless Base)
obtained from petrolatum do not add large amount of H2O into the
aka Yellow Petrolatum (Vaseline®), base because they soften easily
Petrolatum Jelly complete water washable
b. White Petrolatum, USP (White Vaseline®) do not contain oleaginous components
purified mixture of semisolid hydrocarbon, used for the incorporation of solid
obtained from petroleum that has been substances
nearly or wholly decolorized. Example: PEG Ointment, NF
c. Yellow Wax  wax obtained from the honeycomb
of Apis Mellifera (European
Methods in the Preparation of Ointments:
Honeybee)
a. Incorporation  mixing of all components, until a
d. Yellow Ointment (Simple Ointment)
uniform mixture is achieved
yellow wax + Petrolatum USP
using mortar & pestle, or a spatula
e. White Ointment, USP
Incorporation of Solid  preparing an ointment by
white wax (yellow wax that has been
Spatulation
bleached) + White petrolatum, USP b. Fusion  mixing all of the component by melting w/
2. Absorption Bases emollient & occlusive effect constant stirring then allowed to cool until
greasy; non-water washable congealed.
 may permit the incorporation of
aqueous solutions in small amount Bleeding  liberation oil or water from ointment
a. Hydrophilic Petrolatum, USP (Aquaphor®)
bases
stearyl alcohol + white wax + cholesterol +
white petrolatum
b. Lanolin (Wool Fat)
wax-like substance from the wool of the 2. Creams  are semisolid preparations containing one or more
sheep (Ovis arie) medicinal agents dissolve or dispersed in either a
Anhydrous Lanolin (Woolfat) w/o or o/o emulsion or in another type of water-
 NMT 0.25% moisture washable base
Hydrous Lanolin (Woolfat)  more preferred than ointments
 NMT 25% moisture  because of the ease in spreadability
Modified Lanolin  lanolin that has been  less viscid (sticky) & lighter than ointments
processed to remove free lanolin  are considered to have grater aesthetic appeal fo
alcohols + excess detergents their non-greasy character, ability to vanish into the
skin upon rubbing, & ability to absorb serous
discharges from skin lesions
 Example: Vanishing Cream  o/w emulsion
 stearic acid
Cold Cream (w/o emulsion)
3. Gels  are semisolid consisting of dispersions of small or large
molecules in an aqueous liquid vehicle rendered jellylike
by the addition of a gelling agent
 among the gelling agent used:
synthetic macromolecules: Carbomer 934
cellulose derivatives: Carboxymethylcellulose/
Hydroxypropyl Methylcellulose
natural gums: Tragacanth
 aka “Jellies”
Two Types of Gels:
(a) Single-Phase Gels  gels in which macromolecules are
distinguished somewhat uniformly
in a liquid vehicle & no apparent
boundary can be seen
(b) Two-Phase Gels  gels made up of flocculated small
distinct particles
 Ex:Milk of Magnesia(7-8.5%MgO)
Classifications of Gels:
 First Classification Scheme:
1. Inorganic Hydrogels  usually two-phase system
Ex: Aluminum Hydroxide Gel
Bentonite Magma (also an ointment base)
2. Organic Gels  usually single-phase system
Ex: Carbopol
Tragacanth
 Second Classification Scheme:
1. Hydrogels  disepersible as colloidal or soluble in
water; they include organic hydrogels,
natural & synthetic gums, & inorganic
hydrogels.
2. Organogels  include the hydrocarbons, animal&
vegetable fats, soap base, greases, & the
hydrophilic organogels.
Example: Petrolatum (semisolid gel)
Plastibase (hydrocarbon type,
combination of mineral oils
& heavy hydrocarbon
waxes)
Epicutaneous Route  drugs are administered topically, or applied to the
Semisolid: Ointments, Creams, Pastes
Solid: Medicinal Powders  are intimate mixture of medicinal substances
Liquid: Lotion  are emulsions or suspensions generally in an aqueous
4. Miscellaneous Semisolids
Pastes  are semisolid preparations intended fro
application to the skin
 are generally contain a larger proportion of solid
material than ointments (25% more of solid
particles)
 stiffer/harder than ointments, so they remain in
place after application & are effectively employed
to absorb serous secretions
 easier to spread & remove than oitment
 can be prepared in the same manner as ointments
CI: Not applied on hairy part of the body
Use: to absorb serous secretions
(for protective action)
Example: Zinc Oxide Paste
Lassar’s Plain Zinc Paste
25% each of Zinc Oxide Paste
Starch w/ white
petrolatum
Plasters  solid or semisolid adhesive masses spread on a
backing of paper, fabric, moleskin, or plastic.
 are applied to the skin to provide prolonged
contact at the site
Use: To prolong the contract of the active
ingredient to the site of absorption
Examples: Salicylic Acid Plaster (10-40%)
use to remove corns & warts
Glycrogelatins  are plastic masses containing:
Glycerin (40%)
Water (35%)
Gelatin (15%)
Medicinal Substance (10%)
are applied to the skin for the long term.
Example: Zinc Gelatin (treatment of
varicose ulcers)
skin, for their action at the site of application or
for systemic drug effects
usually in an inert base such as Talcum
powder or Starch
vehicle
may be preferred over semisolid preparations because of
their nongreasy character & their increased spreadability
over large areas of skin.
III. Transdermal Drug Delivery System Layers of TDDSs:
often called as “Transdermal patches” a. Occlusive Backing Layer  to protect the system form environment
facilitate the passage of the drug from stratum corneum to entry & from loss of drug from the
the systemic circulation system or moisture from the skin
b. Drug Reservoir/ Matrix System  to store & release the drug at the
Two Types of TDDSs: skin site.
1. Monolithic Transdermal System c. Release Liner  removed before application & enables drug
 incorporate a drug matrix layer between the backing & release
frontal layers d. Adhesive layer  to maintain contact w/ the skin after application
2. Membrane-controlled Transdermal System e. Protective Peel Strip
 are designaed to contain a drug reservoir or pouch,
usually in liquid or gel form, a rate-controlling Four Layers for Membrane-controlled & Continuous Transdermal
membrane, & backing, adhesive & protecting layer System:
1. Backing Layer
Advantages & Disadvantages of TDDSS 2. Drug Reservoir
Advantages: 3. Microporous rate-limiting membrane
1. They can avoid gastrointestinal drug absorption difficulties. 4. Adhesive foormulation
2. They can substitute for oral administration of medication when
that route is unsuitable, as with vomiting and diarrhea.
3. They avoid the first-pass effect.
4. They are noninvasive, avoiding the inconvenience of parenteral
therapy.
5. They provide extended therapy with a single application.
6. The activity of drugs having a short half-life is extended through
the reservoir of drug
7. Drug therapy may be terminated rapidly.
8. They are easily and rapidly identified in emergencies.
Disadvantages:
1. Only relatively potent drugs are suitable candidates for Layers of the Transderm-Nitro Transdermal Therapeutic System
transdermal delivery because of the natural limits of drug entry (Summit):
imposed by the skin’s impermeability. 1. Backing
2. Some patients develop contact dermatitis at the site of 2. Drug Reservoir
application from one or more of the system components, 3. Control Membrane
necessitating discontinuation. 4. Adhesive Layer
5. Protective Peel Strip
General Clinical Considerations in the Use of TDDSs
1. Percutaneous absorption may vary with the site of application.
2. TDDSs should be applied to clean, dry skin that is relatively free of
hair and not oily, irritated, infl amed, broken, or callused.
3. Use of skin lotion should be avoided at the application site
because lotions affect skin hydration and can alter the partition
coefficient between the drug and the skin.
4. TDDSs should not be physically altered by cutting (as in an attempt
to reduce the dose) since this destroys the integrity of the Nitro-Dur Transdermal Infusion System:
system. 1. Foil Coverstrip 5. Microporous Tape
5. A TDDS should be removed from its protective package, with care 2. Drug Matrix 6. Absorbent Pad
not to tear or cut into the unit. 3. Release Liner 7. Occlusive Overlay
6. A TDDS should be placed at a site that will not subject it to being 4. Foil Baseplate
rubbed off by clothing or movement (as the belt line).
7. A TDDS should be worn for the full period stated in the product’s
instructions.
8. The patient or caregiver should be instructed to cleanse the hands
thoroughly before and after applying a TDDS.
9. If the patient exhibits sensitivity or intolerance to a TDDS or if
undue skin irritation results, the patient should seek
reevaluation.
10. Upon removal, a used TDDS should be folded in half with the
adhesive layer together so that it cannot be reused. The used
patch, which contains residual drug, should be placed in the
replacement patch’s pouch and discarded in a manner safe to
children and pets Layers of Two-Layer Transdermal Drug Delivery System:
Factors Affecting Percutaneous Absorption: 1. Film Backing
1. Drug Concentration 2. Drug/ Adhesive Layer
2. Large Area of Application
3. Physicochemical attraction to the skin
4. Drugs with molecular weights of 100-800
5. Hydration of the skin
6. Percutaneous absorption
7. The longer the medicated application remain on the skin, the
greater is the total absorption.
Examples of TDDSs: Novel Topical Systems:
1. Transdermal Scopolamine 1. Iontophoresis (IP)
for motion sickness, nausea & vomiting  is an electrochemical method that enhances the transport of
anticholinergic/ antimuscarinic (M1) some solute molecules by creating a potential gradients through
Transdermal Scop  first TDDS the skin w/ an applied electrical current or voltage
1979 (Baxter®)  induces increase migration of ionic drugs into the skin by
 Ciba®  Novartis® electrostatic repulsion.
2. Transdermal Clonidine  Advantages of IP:
first TDDS for Hypertension a. Control of the delivery rates by variation of current density,
pulsed voltage, drug concentration, & ionic strength
3. Transdermal Nitroglycerin b. Eliminating gastrointestinal incompatibility, erratic absorption, &
for the relief of pain associated w/ angina pectoris first-pass metabolism
4. Transdermal Nicotine c. Reducing side-effects & variation among patients
for smoking cessation to prevent withdrawal symptoms & d. Avoiding the risks of infection, inflammation, & fibrosis associated
w/ continuous injection or infusion.
physical dependence e. Enhancing compliance w/ a convenient & non-invasive
5. Transdermal Estradiol therapeutic regimen.
hormone replacement therapy: Disavantage of IP: Skin irritation at high current densities
-primary ovarian failure (this can be eliminated or minimized by reducing
-female hypogonadism the current)
-vasomotor symptoms associated w/ menopause Drugs deliver through IP:
-atrophic vaginitis Pilocarpine-induce sweating in the diagnosis of cystic fibrosis
-Kraurosis Vulvae  aka Briesky Disease Topical:
6. Transdermal Testosterone -Fluoride  to the teeth
Testoderm®  only applied at scrotal skin -Dexamethasone  anti-inflammatory into joints
Androderm®  both the scrotal & at the back of patient -Lidocaine  as a topical anesthetic
 Variation affecting IP:
1. Current  can be direct, alternate, or pulsed & can have
various waveforms, including square, sinusoidal,
triangular & trapezoidal
2. Physicochemical Variables  include the charge, size,
structure & lipophilicity of the
drug.
3. Formulation Factors  include drug concentration, pH, ionic
strength & viscosity
4. Biologic Factors  pertain to the skin, to which the electrodes
are applied, its thickness, permeability,
presence of pores, & so on.
5. Electroendosmotic Flow  results when a voltage difference is
applied across a charges porous membrane,
resulting in a bulk fluid flow in the same
direction as the flow of counter ions.
2. Phonophoresis  synonyms:
-ultrasound
-sonophoresis
-ultrasonophoresis
-ultraphophoresis
 is the transport of drugs through the skin using
ultrasound
 is combination of ultrasound therapy w/ topical drug
therapy to achieve therapeutic drug concentrations
at slected sites in the skin.
 used by physiotherapist
Three Effects of Ultrasound:
1. Cavitation  is formation & collapse of very small
air bubbles in a liquid in contact w/
ultrasound & waves
2. Microstreaming  closely associated w/
cavitations, result in efficient mixing by
inducing eddies in small-volume elements
of a liquid; this may enhance dissolution of
suspended drug particles, resulting in a
higher concentration of drug near the skin,
for absorption
3. Heat Generation  results from the conversion of
ultrasound energy to heat energy & can
occur at the surface of the skin as well as in
deeper layer of the skin.
most often drug administered through
Phonophoresis:
Hydrocortisone
IV. Liquid Dosage Forms: Single Phase
Solutions  are liquid preparations, that contain one or more
chemical substances dissolved in a suitable solvent or
mixture of mutually miscible solvents
 homogenous one-phase system consisting of 2 or more
components
 most commonly used liquid dosage form
Advantages:
(1) Complete homogenous doses
(2) Immediate availability for absorption & distribution
(3) Provides a flexible dosage form
-easy to swallow
-can be used by any route of administration
-easy to adjust dose
General Rules in Preparing Solution:
1. Know the solubility characteristics of the drug or
chemical
b. Choose the proper solvent
3. The salt form of the drug is used
4. When adding salt to syrup, dissolve in a few mL of Topical Solutions:
water then add syrup to volume if an alcoholic 1. Aluminum Acetate Topical Solution (Burrows Solution)
solution of a purely water-soluble drug is used, add  used in dermatologic loton, creams, & pastes
the aqueous solution to the alcoholic solution  astringent wash
Physicochemical: Product of any combination of the three  after dilution of 10-40 part of water, used as wet dressing
states of matter: Solid, Liquid, Gas 2. Aluminum Subacetate Topical Solution
(S-L, L-L, S-G, L-G) starting solution for Aluminum Acetate Solution
Pharmaceutical: Liquid Dosage Forms containing active astringent wash & wet dressing
ingredients dissolve in a suitable solvent  Ration of Aluminum Oxide  HAc:
or a mixture of mutually miscible solvent. Al.Sub  1:2:35
 Solubility: State when the total amount of solute in the Al. Ac  1:13:52
solution & excess particles reaches Equilibrium. 3. Calcium Hydroxide Topical Solution (Limewater; Liquor Calcis)
Descriptive Terms Parts of Solvent needed to  composed of not less than 140 mg of Ca(OH)3 in every
dissolve 1 part of solvent 100mL of solution
Very Soluble <1 used as astringent
Freely Soluble 110  Preparation: Ca(OH)3 more soluble in cold water
Soluble 1030  Dispensing: Dispense the supernatant liquid using a
Sparingly Soluble 30100 “SIPHON”
Slightly Soluble 1001000 4. Coal Tar Topical Solution
Very Slightly Soluble 100010,000 composed of 20% coal tar + 5% Polysorbate 80 (solubilizer)
Insoluble >10,000 nearly black viscous liquid w/ a sharp burning taste & has
Topical Oral (Dental) Solutions: naphthalene-like odor.
local antieczema (contact dermatitis)
 Benzocaine  Topical anesthetic
5. Hydrogen Peroxide Topical Solution (Agua Oxygenada)
 Camphorated  Dental antiinfective.
Bubbling Effect: release of O2
Parachlorophenol
 Carbamide Peroxide Topical  Dental H2O2 catalase O2
Solution  anti-infective 3%  10 volumes
6%  20 volumes
 Cetylpyridinium Chloride  Local antiinfective
Solution & local anti-infective for use topically on the skin & mucous
Cetylpyridinium Chloride membrane
Lozenges 6. Povidone-Iodine Topical Solution
 Erythrosine Sodium Topical  Diagnostic aid (dental complex of I2 + Polyvinylpyrolidone (PVI)
Solution & disclosing agent) Iodine in Povidone Iodine  10%
Erythrosine Sodium Soluble surgical scrub & non-irritating antiseptic solution
Tablets  1:5000  concentration of Iodine which is effective to
 Eugenol:  Dental analgesic combat many common bacteria in distilled water
7. Thimerosal Topical Solution
 Lidocaine Oral Spray:  Topical dental anesthetic
water-soluble organic antibacterial use for its bacteriostatic
 Nystatin Oral Suspension  Antifungal
or fungistatic effect
 Saliva Substitutes  Electrolytes in a
Thimerosal in solution  o.1%
carboxymethylcellulose base
Dispense= 1:5000 concentration
 Sodium Fluoride Oral Solution  Dental caries prophylactic
disinfect skin prior to surgery & as a first aid application to
& Sodium Fluoride Tablets
wounds & abrasions.
 Sodium Fluoride And  Dental caries prophylactic
Phosphoric Acid Gel &
Sodium Fluoride And
Phosphoric Acid Topical
Solution
 Zinc Oxide–Eugenol Mixture  Temporary filling mix.
Types of Solutions:
Aqueous Solutions:
1. Aromatic Water (Medicated Waters)
 clear, saturated aqueous solutions of volatile oils or
other aromatic or volatile substances.
uses: Perfuming
Vehicle
storage: Tight, Light-resistant Bottles
2. Aqueous Acids:
a. Hydracids  do not contain oxygen
b. Oxygen-containing acid
c. Diluted Acids  aqueous solutions of concentrated acid dissolve
in purified water of suitable strength 10% w/v
(except Acetic Acid, 6%)
 Example: Diluted HCl (treatment for Achlorydia/
Hypochlorydia)
 Primary Considerations  Must be sipped using a
straw to protect dental
enamel
 Percentage strength of official undiluted acid is expressed
in % (w/w)
 Percentage strength of official diluted acids is expressed in
% (w/v)
3. Douches  used as cleansing or antiseptic agent directed against a
part or into cavity of the body
 most frequently dispensed in the form of a powder w/
the directions for dissolving in a specified quantity of
warm water
Vaginal Douche  cleanse the vagina
 mostly has antibiotic (Chlorhexidate
Glucorate)
***vagina must be Acidic
4. Enemas  rectal injection employed to evaluate the bowel
Rectal Enema  used to cleanse the bowel in large intestines
before & after surgery
 contain in plastic squeeze bottle
 components:-Na phosphate/Biphosphate
-Docusate Na (Stool Softener)
- Glycerin
- Light Mineral Oil
Examples: Sodium Phosphate Enema
Hydrocortisone Enema
Aminophylline Enema
5. Gargles  for treating the pharynx & nasopharynx
6. Washes  most often used for its deodorant, refreshing or
antiseptic effects
7. Juices  are prepared from fresh ripe fruits
8. Sprays  are applied to the mucous membranes of the nose &
throat by means of “Atomizer” or “Nebulizer”
 aqueous or oleaginous solutions in the form of coarse
droplets or finely divided solid usually introduce into
body cavities especially in Nasopharyngeal Tract.
Sweet or Other Viscid (Sticky) Aqueous Solutions:
1. Syrups  are concentrated solution of sugar such as sucrose in
water.
 Two Types: (a) Medicated  AI
(b) Non-medicated  vehicle
 Methods in Syrup Making:
1. Solution w/ the aid of Heat
 if we want to produce syrup quickly
2. Solution w/ Agitation w/out the aid of Heat
 if we want to prevent sucrose inversion or
caramelization
3. Addition of Sucrose to a flavored or medicated Liquid
4. Percolation
a. Syrup, NF (Simple Syrup)  nearly saturated aqueous solution
of sucrose (85% w/v)
 low solvent capacity for water
soluble drugs
 inherently stable & resistant to
the growth of microorganisms
when properly prepared &
maintained
b. Cherry Syrup  if the drug material requires an acid medium
c. Cocoa Syrup  if the drug is Bitter tasting
d. Orange Syrup  if the drug is stable in acid medium
e. Raspberry Syrup  disguise the sour or salty taste of saline
medicaments
f. Ora-sweet or Ora-sweet SF (Sugar Free)  for extemporaneous
compounding of syrups
2. Honeys  are thick liquid preparations somewhat allied to the
syrups
Oxymel  mixture of Honey & Acetic Acid
3. Mucilages  are thick, viscid, adhesive liquids by dispensing gum in
water.
4. Jellies  are class of gels in which the structural coherent matrix
contains a high portion of liquid, usually water
Nonaqueous Solutions:
1. Alcoholic or Hydroalcoholc Solutions: 4. Oleaginous Solutions
a. Tinctures  from vegetable materials or form chemical a. Liniments (Embrocations)  applied w/ friction or by rubbing
substances  alcoholic or Oleaginous solutions
 alcohol content: 15-80% containing mpre than one
Preparations: Maceration medicinal agent intended to be
Percolation rubbed on the skin
 Examples:  CI: Broken Skin or Bruise Skin
- Iodine Ticture  Label “For external use Only”
- Paregoric, USP  camphorated opium tincture  Two types:
- Opium Tincture, USP  (Laudanum) Alcoholic Liniment  if you want
counterirritant Effect
b. Elixirs  are clear, pleasantly flavored, sweetened hydroalcoholic Rubefacient Effect
liquids intended oral use. Penetrating Action
 alcohol content:5-40%,but most of the time,varies widely Oleaginous Liniment  if you want Massage
Methods: Solution w/ Agitation  less irritating
Admixtures of Solution b. Oleovitamins  are fish liver oils diluted w/ edible vegetable oil
 Two types of Elixirs: of solutions of the indicated vitamins
-Non-medicated  vehicle c. Toothache Drops  for temporary relief of toothache
-Medicated  Antihistamine
Digoxin 5. Medicated Solutions for Vaporization
Barbiturates a. Inhalations  are drugs or solution of drugs administered by the
 Examples: nasal or respirator route for local or systemic
- Aromatic Elixir, NF  22% alcohol effect
Preparation: Always add aqueous solution to alcoholic b. Inhalations (Insufflations)  consist of finely powdered or liquid
solution. drugs that are carried into the
respiratory passage by the use of
c. Spirits (Essences)  are alcoholic solution of volatile substances special delivery system.
prepared usually by simple solution or by c. Inhalants  drugs or combination of drugs which by virtue of
admixture of the ingredients their high vapor pressure, can be carried by an air
 may be taken orally, applied externally, or current into the nasal passage where they exert
used by inhalation effect.
 alcohol Content: >60% alcohol  Examples:
 Methods: Simple Solution - Aromatic Elixir, NF  22% alcohol
Solution w/ maceration
Distillation
2. Ethereal Solutions
a. Collodions  a liquid preparations containing pyroxylin in a
mixture of ethyl ether & ethanol
 is prepared by dissolving pyroxillin (4%) in a 3:1
mixture of ether & alcohol.
 Salicylic Acid Collodions  keratolytic in the
treatment of corns & Other Solutions:
warts a. Nasal Solutions  aqueous solutions designed to be administered to
10% SA the nasal passages in the form of drops or sprays
 Collodion, USP / Flexible Collodions Ephedrine  nasal decongestant (vasoconstrictor)
 water-repellant protective for minor Lypressin  for diabetes
cuts & scratches. b. Otic or Aural Solutions  aqueous solutions designed to be
Flexible Collodions  10% of Salicylic Acid + administered t.o the ear
3% Castor Oil (for flexibility) c. Irrigation Solution  aqueous solutions used to wash or bathe
2% Camphor (for water- surgical incisions, wounds, or other body
proofing) tissues
Pyroxylin  aka Soluble Guncotton
Nitocellulose
Collodion Cotton
 product of reaction of nitric acid & sulfuric
acid on cotton (Gossipiun hirsutum)
 is composed chiefly of cellulose tetranitrate
 harsh to touch& extremely flammable
moisten by 30% alcohol
 4% of Pyroxylin (in collodion), dissolve in 3:1
ratio of ether & alcohol

3. Glycrin Solution  valuable pharmaceutical solvent forming

permanent & concentrate solutions
a. Glycerites  are solutions or mixture of medicinal substances in
Not Less Than 50% Glycerin
 are hygroscopic & should be stored in tightly closed
containers
Extraction  involves the separation of medicinally active portions of plant
or animal tissue from inactive or inert components by use of
selective solvents in standard extraction procedures.
Methods of Extraction:
1. Maceration  Latin word “macerare”, meaning to soak
 15-20C
 2-14 days
 is process in which the properly comminuted drug
is permitted to soak in the menstruum until the
cellular structure is softened & penetrated by
menstruum & the soluble constituents are
dissolved.
2. Percolation  Latin word “per”= through; “colare”= to strain
 allow the solvent to pass through the column of
drugs.
Rate of Flow:
Percolate Slowly NMT 1 mL/min
Percolate at a Moderate Rate 1-3 mL/min
Percolate Rapidly 3-5 mL/min
Solutions Prepared by Extraction Process: (Galenicals)
1. Fluid Extracts (Liquid Extracts)  are alcoholic or hydroalcoholic liquid
preparations of vegetables containing
alcohol as a solvent or as a
preservative, or both, so made that
each mL contains the therapeutic
constituents of 1g of the standard
drug that is represents
 are made by Percolation
Fluid Extracts are made by Percolation w/ the ff. variations:
1. Process A: Percolation method than can be modified for
fluid extracts that must be assayed
2. Process: An Alternative for process A in which percolation
is conducted on a column of drug much
greater in length than in diameter
3. Process D: Boiling Water is used as the menstruum,
alcohol being added as a preservative to
concentrated percolate
2. Extracts are concentrated preparation of vegetable or animal drugs
obtanined by:
-Removal of the active constituents of the respective
drugs w/ suitable menstrual
-Evaporation of all or nearly of the solvent
-Adjustment of the residual masses or powders to the
prescribed standard
 mostly prepared by Percolation
Three Forms of Extracts:
1. Semiliquid Extracts (Liquids)
consistency: Syrup
no intention to remove all of the solvent
2. Pillular (Solid Extracts)
consistency: Plastic
there is an intention to remove nearly or almost
of the solvent
3. Powdered Extracts (Dry Powders)
 there is an intention of removing all of the
solvent
3. Decoctions  are preparations containing water-soluble & heat-stable
constituents extracted from crude drugs by boiling the
latter in water (for 15 minutes)
4. Infusions  are dilute solutions of readily soluble constituents of crude
drugs prepared by short maceration of the drugs w/ either
cold or boiling water.
5. Tincture  are alcoholic or hydroalcoholic solutions prepared form
vegetable materials or from chemical substances.
Process P  Percolation
Process M  Maceration
 A tincture of non-potent drugs contains 10g of the
crude drugs per 100mL of the tincture.
6. Digestion  maceration w/ gentle heat
General Formulation: General Steps in the Manufacture of Pharmaceutical Solutions:
1. Active Ingredients  consider solubility & stability 1. Preparation of formulation material & equipment
2.Solvent  consider clarity, toxicity, viscosity, comparability, 2. Compounding
palatability charge the solute to the solvent
 water (best solvent) agitate w/ the use of mixers until solution is homogenous
3. Co-solvent  used in combination with the solvent to increase heat may be employed to increase solubility
solubility of the solute ensure complete solution before further processing
 Ethanol, Sorbitol, Glycerin, Propylene Glycol, solutes in small concentrations (such as dyes & intensively
Polyethylene Glycol colored materials) must be predissolved prior to mixing w/ the
 Cosolvency/ Blending  the increase in mutual solubility whole batch
of 2 or more partially miscible 3. Storage & Aging
solvents by another agent to allow complete blending of all the components
4. Solubilizer  surfactant (Tweens) 4. Filtration & Clarification
5. Viscosity Enhancer/ Controller  improves pourability aim for 3-5 micros or less
& to some extent, palatability filter media: Cellulose Nitrate,
 Sugar, PVP, Polyamide
Cellulose Derivatives Polyvinylidene Chloride
Nylon
Classification of Viscosity Enhancing Agent:
*Types of Filtration:
~Ionic Polymer: Na CMC
~Nonionic Polymer: Cellulose Derivative Gravity Filtration  slow
(MC, CMC) Vacuum filtration  large scale
6. Buffer  controlling pH to maintain solubility & stability Pressure Filtration  fast, to achieve highly polished product
 most common; pH 4-7 *Classification:
 Citric Acid, lactic Acid, Glutaric Acid Parallel Filtration  one type of filter
7. Sweetening Agent Series Filtration  more than one filter
8. Flavor *Types of Filter Paper:
9. Coloring Agent Fluted Filter Paper  if you need the “filtrate”
10. Preservative  prevent microbial growth Ordinary Filter Paper  if you need the “residue”
Classification: 5.Filling & Packaging
~Acidic: Phenol(Carbolic Acid) oldest preserv. *Gravimetric Filling  for mobile & frothy solutions
Parabens  synergistic to each other *Vacuum Filling  for viscous solutions
*Methyl  for molds *Pressure Filling  for viscous solutions
*Propyl  for yeasts
(Methyl:Propyl is 9:1)
Benzoic Acid
Types of Instability:
Sorbic Acid
1. Chemical Instability
~Mercurial: Thimerosal
a. Incompatibility w/ Ingredients
~Neutral: Chlorbutanol
b. Incompatibility w/ container
~Quaternary Ammonium Salts (NH4): *Leaching  release of compounds within the plastic
Benzalkomium Chloride *Sorption  permeation of compounds outside the plastic
Cetylpuridium Chloride c. Hydrolysis
*Penicillin G & Benzyl Penicillin  -lactam ring is destroyed via
hydrolysis
*Acetylsalicylic Acid  hydrolyzed to acetic acid
& Salicylic Acid
d. Oxidation  by air, trace metals, light or heat
*Remedy: Add Antioxidants or chelating gents (for trace metals)
2. Microbial Contamination
a. Raw Materials
b. Equipment
c. Personnel
d. Packaging Material
*Remedy: Add Preservatives depending on the spectrum of activity
V. Liquid Dosage Forms: Two-phase/ Dispersed Phase Types of Suspension Formation:
A. Suspension  preparations made up of finely divided solids ~Precipitation  organic solvent precipitation
(suspension) distributed uniformly in a liquid vehicle  pH of the medium
where it exhibits minimum solubility. ~Dispersion  ensure uniform wetting of solid
 purposes for formulating a suspension:
-Sustaining Effect Wet Point vs. Flow Point
-Stability ~Wet Point  amount of vehicle to wet all of the powder
-Taste ~Flow Point  amount of vehicle to produce pourability
Reasons: Mask the disagreeable taste of the drug
Easy to swallow General Formulation:
Flexibility in dose adjustment 1. Active Ingredients  should be insoluble
 Properties of a Good Suspension:  must be uniformly dispersed
a. Particle size of the suspension should remain fairly 2.Dispersion medium  Aqueous /Non-aqueous
constant throughout long periods of undisturbed 3. Wetting Agent  displaces the air from crevices of drug particles
standing  Glycerin, Sorbitol Solution, Syrup
b. Dispersed particles of the suspension should settle 4. Solubilizer  surfactant (Tweens)
slowly & should be readily redispersed upon gentle 5. Suspending Agent (Viscosity Enhancer)
shaking of the container Hydrocolloids  Acacia, Tragacanth, Veegum, Cellulose der.
c. The suspension should pour readily & evenly from
Clays  Bentonite, kaolin
its container
Others: Agar, Gelatin, Pectin, Gelatinized Starch
Ideal Characteristics: 6. Buffer
does not settle rapidly 7. Sweetening Agent
no hard cake 8. Flavor
redispersable 9. Coloring Agent
10. Preservative
not to viscous
pharmaceutical elegant General Scheme for Suspension Formulation:
Problems:
standard mesh size where suspended particles 1. Caking
should pass through 2. Partial Solubility of the active ingredient
Ex: Hammer Mill: 4-325 mesh 3. Polymorphism of the active ingredient
20-200 mesh Problems:
particle size range: 10-20 m(ansel) Creaming  upward movement
particles have diameters for the most part Sedimentation  downward movement
greater than 0.1 mcm. Aggregation  reversible
 Preparation: Coalescence  irreversible
1. Comminution of the drug
2. Wetting of Powder  accomplished by levigation to B. Gel/ Magmas
displace air in the crevices of Terminologies:
the particles to make the drug 1. Thixotrophy  is a reversible sol-gel/gel-sol formation w/ no charge
more penetrable by the in volume or temperature, a type of non-newtonian
dispersion medium flow.
Common Levigating Agents: Glycerin 2. Imbibition  gel takes up the liquid but there is no increase in
Propylene Glycol volume
Alcohol 3. Swelling  gel takes up the liquid but there is increase in volume
3. The suspending agent dispersed in the vehicle is
4. Syneresis  occurs when the interaction between particles of the
added to the wetted powder by geometric dilution
dispersed phase becomes so great that on standing
4. The product is brought to final volume using the
 liquid medium is squeezed out from the gel & the gel
vehicle
strikes
 Suspending Agents
 is a form of instability in aqueous & non-aqueous gels
increase viscosity
 instability of preparations resulting to expulsion of the
inhibit agglomerates
liquid from the gel.
decrease the rate at which particles settle
5. Xerogel  when the liquid come out of the gel & only the
 Precaution:
framework remains
Pour suspension in a tight container Example: Gelatin Sheets
Suspensions are not filtered. Tragacanth Ribbons
Label: “Shake well before use” Acacia Tears
Types of Suspension: Official Gels/ Magmas:
Flocculated  loose aggregate a. Bentonite Magma, NF
 higher sedimentation rate  use: Suspending Agent
easily redispersable 5%
 pharmaceutically elegant >4% Thixotropic
 rapid clearance of supernatant b. Aluminum Hydroxide Gel
Deflocculated  separate entities insoluble Al(OH)3 + Hydrated Aluminum Oxide
 lower sedimentation rate CI: Tetracycline
 non-dispersable cake Quinolones
 close packing of the sediment AE: Constipation
 pleasing appearance on standing c. Milk of Magnesia
~Other Examples of Suspension: Ge  Gel 7.85% MgOH
Lo  Lotion MgSO4 +NAOH
Ma  Magma AE: Diarrhea
Mi  Mixtures Magma  a gel mass consisting of floccules of small distinct particles
C. Emulsion  are dispersed systems in which the dispersed phase is
composed of small globules of a liquid distributed throughout
a vehicle in which it is immiscible.
Purposes of Emulsions:
Increased drug stability
Prolonged Drug action
Improved Taste
Improved Appearance
Parts:
Dispersed Phase/ Internal Phase/ Discontinous Phase
Dispersion Medium/External Phase/ Continuous Phase
Emulsifying Agent  acts as the bridge between the 2
immiscible phases
 stabilizer of the internal phase
 retards coalescence of the globules
 Third Phase
(to prepare a stable emulsion)
O/W (oil-in-water) Emulsions: External  Oleaginous
Internal  Aqueous
W/O (water-in-oil) Emulsions: External  Aqueous
Internal  Oleaginous
Types of Emulsions:
1. Oil-in-Water (O/W)
Oil is dispersed as droplets in an aqueous medium
Oral products & external, washable products
 easily diluted & remains stable w/ aqueous solvent
 dissolves amaranth green
 lamp glows on conductivity test
 gives a spotty fluorescence when placed under UV light.
2. Water-in-Oil (W/O)
Water is dispersed as droplets in an oil or oleaginous
medium
Used for external preparations when emollient,
lubricating, or protective properties are desired
 gives a continuous fluorescence when placed under UV
light.
3. Multiple Emulsions ( O/W/O or W/O/W)
4. Microemulsions  appear translucent or transparent & have
droplet diameter in the nanometer size
range
Factors that determine Emulsion Type:
(1) Emulsifier
 Some emulsifiers form either w/o or w/o emulsion,
others form only one type
(2) Phase Ratio (relative amounts of oil & water)
 Phase present in greater concentration tens to be the
external phase.
(3)Order of Mixing
 The phase that is being added by portions tends to be
internal phase
Methods of Preparation:
1,Continental (Dry Gum) Method
 for W/O (4:2:1)
 the emulsifying agent (usually acacia) is mixed w/ the oil
rapidly before the addition of water
2. English (Wet Gum) Method
 for O/W
 the emulsifying agent is added to the water (in which it is
solution) to form a mucilage & then the oil is slowly
incorporated to form the emulsion
 *water + emulsifier + oil is added drop by drop
3. Forbes Bottle (Bottle) Method
 is reserved for volatile oils or less viscous oils & is a
variation of the dry gum method
4. Nascent Soap (In Situ Soap) Method
 alkali + oil
 developed two types of soaps which are calcium soaps &
soft soaps
5. Auxillary Method
an emulsion prepared by either the wet gum or the dry
gum method can generally be increased in quality by
passing it through a hand homogenizer
Microencapsulation  are thermodynamically stable, optically
transparent isotropic mixtures of a biphasic
O/W system stabilized w/ surfactant
Problems in Emulsion Stability:
a. Creaming  the upward or downward movement of the
internal phase of the emulsion
b. Cracking  total separation of the two phase
c. Phase Inversion
Hydrophilic-Lipophilic Balance (HLB) - AWWODS
Surfactant Application (Activity) HLB Value Range
Antifoaming Agents 13 0 3
W/O Emulsifying Agents 36 4 6
Wetting Agents 79 7 9
O/W Emulsifying Agents 818 818
Detergents 1316 1315
Solubilizing Agents 1520 1018
Theories of Emulsification: SOP
1. Surface Tension Theory  the use of surface active (surfactant or
wetting agents as emulsifiers & stabilizers lowers the
interfacial tension of the two immiscible liquids,
reducing the repellent force between the liquids &
diminishing each liquids attraction for its own molecules
2. Oriented-wedge Theory  assumes monomolecular layers of
emulsifying agent curved around a droplet of the
internal phase of the emulsion
3. Plastic or Interfacial Film Theory  places the emulsifying agent
at the interface between the oil & water, surrounding
the droplets of the international phase as a thin layer
film adsorbed on the surface of the drops.
 Types of Emulsifying Agents
General Formulation: (& Stabilizers for Pharmaceutical Systems) are:
1. Active Ingredient 1. Natural
2. Aqueous Phase Carbohydrate Materials
3. Oleaginous Phase Acacia
4. Emulsifier Tragacanth
5. Antioxidants  protects the emulsified lipids which are Agar Produce O/W Emulsions
susceptible to oxidation Chondrus
 have the capability of functioning chemically Pectin
as reducing agnet.
Protein Substances
 Example: BHA, BHT, Tocopherol,
Gelatin
Ascorbic Acid, EDTA
Egg yolk Produce O/W Emulsions
BHT  is the true Antioxidant
Casein
6. Preservative  should be effective for both phases
7. Sweetener 2. Finely Divided Solids
8. Flavoring Agent Colloidal Clays:
9. Colorant Bentonite
10. Humectant  reduces the evaporation of moisture from the Magnesium Hydroxide
product Aluminum Hydroxide
 Example: Glycerin, Sorbitol, Propylene Glycol Magnesium Trisilicate
3. Synthetics
Manufacturing Process Anionic
1. Oil Phase containing oil-soluble ingredients is heated at Monovalent, Polyvalent, & Organic Soaps
about 5-10C above the melting point of the ingredient w/ Triethanolamine Oleate
the highest melting point. Sulfonates  Sodium Lauryl Sulfate
2. Aqueous Phase is heated to the same Temperature Cationic
3. The two phases are mixed. Benzalkonium Cl  Has bactericidal property
4. Volatile ingredients are added at the lowest temperature as
Ionic
possible (usually 45-55C)
Sorbitan Esters
5. Adjust the final weight when emulsion reaches 35C
Polyoxythylene Derivatives

Equipments Nonionic
Mechanical Stirrers Spans
Colloid Mills Tweens
Homogenizers
Span & Tweens  are Polyalkene derivatives.

4. High-Molecular-Weight Alcohols:
Stearyl Alcohol
Cetyl Alcohol Produce O/W Emulsion
Glyceryl Monostearate
Cholesterol
Employed in external used W/O Emulsion
Cholesterol der.

 Cetyl Alcohol  is used to minimize the foam in the

production of emulsion

Examples of Oral Emulsions:

1. Mineral Oil Emulsion (Liquid Petrolatum Emulsion)
 is an O/W Emulsion prepared by the ff. formula:
Mineral Oil  500 mL
Acacia (Finely Powdered)  125 g
Syrup  100 mL
Vanillin  40 g
Alcohol  60 g
Purified Water, to make  1000 mL
2. Castor Oil Emulsion  is used as a laxative for isolated bouts of
constipation & in preparation of the colon
for radiography & endoscopic examination
3. Simethicone Emulsion  is a water-dispersible form of
Simethicone used as a defoaming agent
for the relief of painful symptoms of
excessive gas in the gastrointestinal
tract
Liquid Dosage Forms
Advantage over solids:
Can be easily administered
Better Biovailability

Water  the most commonly used solvent for drug solutions

 the USP recognizes six(6) types of water for the
preparation of dosage forms

Types of Water:
1. Purified Water, USP
 obtained by FRIED
-Filtration
-Reverse Osmosis
-Ion-Exchange
-Distillation
pH 5-7
 used in prescription & manufactured finished
products except parenterals & other sterile
solutions
2. Water for Injection
 purified water that is free of Pyrogens
 obtained by distillation or reverse osmosis
 used for the preparation of parenteral
solutions
 contains Benzyl Alcohol
as bacteriostatic agent
3. Sterile Water for Injection
 water for injection that is sterilized &
packaged in single-dose containers <1L
clear, colorless, odorless liquid sterilized &
suitably packaged & contains no
bacteriostatic agent
4. Bacteriostatic Water for Injection
 sterile water for injection that contains 1 or
more antimicrobial agents
packaged in single or multiple-dose containers
<30mL
5. Sterile Water for Inhalation
 water purified by distillation or reverse
osmosis & rendered sterile
not used for the preparation of parenteral
solutions or other sterile dosage forms
6. Sterile Water for Irrigation  water for injection that
is sterilized & suitably
packaged

Solvents for Liquid Preparations:

1. Alcohol, USP (Ethanol/ Ethyl Alcohol)
 next to water, alcohol is the most useful solvent in
pharmacy
primary solvent for many organic compounds
2. Diluted Alcohol, NF
prepared by mixing equal volumes of alcohol, USP &
Purified Water
3. Rubbing Alcohol
about 70% ethyl alcohol by volume
4. Glycerin, USP (Glycerol)
comparable w/ alcohol
miscible w/ both water & alcohol
5. Isopropyl Alcohol
70% alcohol
7. Propylene Glycol, USP
substitute for Glycerin
8. Purified Water, USP
contain dissolved inorganic salts
VI. Sterile Dosage Forms
Parenterals  intended for use by injection
Two Requirements:
1. Sterile  absence of microorganisms including its Spores Official Types of Injections (USP)
2. Pyrogen-Free  source: Endotoxin (Gram-Negative) 1. Injection: Liquid preparations that are drug substances or
Parenteral Routes solutions thereof
Intra-arterial Joint space Example: Insulin Injection, USP
Intrasynovial Joint fluid are 2. For injection: Dry solids that, upon addition of suitable vehicles,
yield solutions conforming in all respects to the
Intrathecal Spinal column
requirements for Injections
Intra-arterial Arteries
Example: Cefuroxime for injection,USP
Intracardiac Heart
3. Injectable emulsion: Liquid preparation of drug substance
Intravenous, IV Into the vein
dissolved or dispersed in a suitable
Intamuscular, IM Into the muscles emulsion medium
Intradermal, IB/ Intracutaneous Into the skin Example: Propofol, USP
Subcutaneous, SC/ Sub-Q, SQ/ Under the Skin 4. Injectable suspension: Liquid preparation of solid suspended in a
hypodermic suitable liquid medium
IV  100% Bioavailability Example: Methylprednisolone Acetate
Suspension, USP
Labels on containers of Parenteral Products must state the ff: 5. For injectable suspension: Dry solid that, upon addition of suitable
• Name of the preparation vehicle, yields preparation conforming
• Percentage content of drug (For a liquid preparation) in all respects to the requirements for
• Amount of Active Ingredient (For a dry preparation) injectable suspensions
• Route of Administration Example: Imipenem and Cilastatin
• Storage Conditions for injectable suspension, USP
 Expiration Date
• Name of the manufacturer and distributor Single-dose container: A hermetic container holding a quantity of sterile
• Lot Number drug intended for parenteral administration as a
single dose; when opened, it cannot be resealed
Official Solvents & Vehicles for Injections with assurance that sterility has been maintained.
1. Water for Injection, USP  most frequently used solvent in the Multiple-dose container: A hermetic container that permits withdrawal of
largescale successive portions of the contents without
 is purified by distillation or by reverse changing the strength, quality, or purity of the
osmosis remaining portion.
2. Purifi ed Water, USP  that is, not more than 1 mg/100 mL water
for injection, USP Methods of Sterilization
is not required to be sterile, it must be  Sterilization  means destruction of all living organisms and their
pyrogen free. spores or their complete removal from the
3. Sterile water for injection, USP  is packaged in single-dose preparation.
containers not larger than 1 L. (1) Steam (Moist Heat Sterilization)
4. Bacteriostatic water for injection, USP  sterile water for injection is conducted in an Autoclave/employs Steam under pressure
containing one or more  happens at 121C & 15 psi for 15-20 minutes
suitable antimicrobial method of Choice
agents.  MOA: Protein coagulation
 “Not for use in neonates” (2) Dry heat Sterilization
5. Sodium chloride injection, USP  sterile isotonic solution of sodium  carried out in ovens designed for this purpose.
chloride (0.9%) in water for less effective in killing microorganisms than in moist heat
injection.  happens at 150-170C for not less than 2 hours.
6. Bacteriostatic sodium chloride injection, USP MOA: Oxidation
 sterile isotonic solution of sodium chloride in water (3) Sterilization by Filtration
for injection. physical removal of microorganism by adsorption on the
 contains one or more suitable antimicrobial agents, filter medium or by a sieving mechanism
which must be specified on the labeling.  for heat-sensitive solutions
 “Not for use in neonates” (4) Gas Sterilization
7. Ringer’s injection, USP  a sterile solution of sodium chloride, for heat-labile enzyme preparation
potassium chloride, and calcium chloride in  MOA: Alkylation
water for injection.  Ethylene Oxide
8. Lactated Ringer’s Injection, USP  has different quantities of the (5) Ionizing radiation Sterilization
three salts in Ringer’s injection,  by gamma rays & cathode rays
and it contains sodium lactate.

Miscellaneous Solvent:
(1) Fixed Vegetable Oils (2) Glycerin
 IM (3) Alcohol
 SeCoCoPen (4)PEG
Sesame (5) Propylene Glycol
Cottonseed
Corn
Peanut
Validation: 2. Components (Formulation)
1. Biological Indicators a. Active Drug
Bacillus sterothermophilus b. Solvent/ Vehicle  highest portion
moist-heat  usually Water for Injection, USP
 vapor pressure hydrogen peroxide (VPHP)  WFI  purified by distillation or
Bacillus subtilis purification process
dry heat equivalent or superior to
gas sterilization distillation in removing
Bacillus pumilus chemicals & microorganisms
ionizing radiation  Isopropyl myristate  non-aqueous
2. Pyrogen Test vehicle for IM administration
3. Bacterial, Endotoxin Aqueous
 Test: LAL Test Water Miscible
Vegetable Oils
Non-Vegetable Oils
Sterile Preparations: c. Other Excipients (Additives):
Categories: Buffer
solutions ready for injection Preservative
dry soluble products ready to be combined with a solvent Chelating Agent
Isotonicity Adjusting Agent
prior to use
Example: NaCl, Mannitol
suspensions ready for injection
dry soluble products ready to be combined w/ a vehicle prior Goal: To diminish pain upon
to use administration
d. Container
emulsions ready for injection
e. Closure/ Stoppers
liquid concentrates ready for dilution prior to use
f. Production Procedure
Main Concerns in Parenteral Manufacture
g. HEPA Filter (High Efficiency Particulate Air Flow)
1. Production Facilities
required for incoming air to achieve a class 100
easy to clean, safe, sterile
condition
5 Sections
effluent air sweeping downstream at uniform velocity
a. Materials Support Area  surfaces should be continuous,
normally 90ft/min  20% along parallel line
class 10,000 environment
Laminar Air Flow  minimum eddy
 constructed of impervious
Turbulent  opposite of Laminar Air Flow
materials
99.97% efficient in removing from air 0.3 m particles
b. Compounding Area  most stringent control
generated by vaporized DOP (Dioctylphthalate)
 stainless steel cabinets & counters,
continuous surfaces
Parts (HEPA Filter)
 Class 10,000 environment
B  Blower
(Class 100
E  Electrostatic
max of 100 particles per feet
P  Prefilter
0.5m or larger)
c. Aseptic Filling Area  heart of production area
MOA
 Laminar Air Flow (LAF) -interception
w/ HEPA Filter (High Efficiency -diffusion
Particulate Air) -impaction
 class 100
sealed ceiling, wall floor Test for Efficiency: DOP Test (air velocity
 stainless determination)
demountable parts for those
equipment in touch w/ product
 sterile cover-all for personnel Class 100 Environment  defined as total particles do not exceed
100 per cubic foot of air of 0.5 m at
 (+) air space
normal condition
 air locks
d. Quarantine Area  storage while waiting for QC results
*Quarantine  Yellow
*Reject  Red
*Accept  Green
e. Finishing Area

Design
Compunding Aseptic Quarantine
Stock Area Filling
Area Storage
Material
Finishing
Support Sterilization
Special Consideration in the Preparation of
Solutions & Suspensions for Ophthalmic Use:
Sterility
Preservation (Benzalkonium Chloride)
Isotonicity (Boric Acid)
Buffering
Viscosity
Ocular Bioavailability
Packaging

Three Basic Types of Contact Lenses:

1. Hard Contact Lenses
2. Soft Contact Lenses
3. RGP Rigid Gas Permeable
 more comfortable than hard contact lense (for daily use)

Examples of Drugs that do enter breast milk

and may be passed on to nursing infants:
Theophylline
Penicillin
Reserpine
Codeine
Meperidine
Barbiturates
Diltiazem,
Thiazide Diuretics
Sulfonamides
Salicylates
Potent Agents like:
Quinine
Meperidine
Morphine
Meperidinde & Morphine
narcotic analgesics with great
potential for addiction.
Preservatives & their Concentrations Commonly Employed in
Pharmaceutical Preparations:
Benzalkonium Chloride
0.002%  0.01%
Phenylmercuric Nitrate & Acetate
Benzoic Acid
Sodium Bezoate 0.1%  0.2%
Combination of Methylparabens & Propylparaben
Phenol
0.1%  0.5%
Cresol
Chlorobutanol 0.5%
Alcohol 15%  20%
INSULIN  the active principle of the pancreas gland,
 is primarily concerned with the metabolism of carbohydrates
but also influences protein and fat metabolism
 facilitates the cellular uptake of glucose and its metabolism in
liver, muscle, and adipose tissue
 increases the uptake of amino acids and inhibits the
breakdown of fats and the production of ketones.
 is administered by needle, pen device,and pump
 is used in the treatment of diabetes mellitus that cannot be
controlled satisfactorily by dietary regulation alone or by oral
antidiabetic drugs
 improve the appetite and increase the weight in selected cases
of nondiabetic malnutrition and is frequently added to IV
infusions.
Regular insulin  is a sterile aqueous solution of insulin
 was prepared from beef or pork pancreas or both
 is prepared exclusively through biosynthetic means
(human insulin)
Human Insulin  was the first recombinant DNA drug product to
receive approval from FDA
Humulin (Lilly) became available in 1983.
is produced by using a special non–disease-forming
laboratory strain of Escherichia coli and
recombinant DNA technology.
Insulin Lispro  consists of zinc–insulin lispro crystals dissolved in a
clear aqueous fluid.
is rapidly absorbed after SC administration, and
demonstrates no
significant differences in absorption from abdominal,
deltoid, and femoral sites of injection.
Insulin Aspart  is a recombinant, ultra–shortacting insulin using
Saccharomyces cerevisiae (baker’s yeast) as the
production organism
is homologous with regular human insulin except for a
single substitution of the amino acid proline by
aspartic acid in position B28.
Insulin Glulisine (Apidra)  is a recombinant rapid-acting insulin analog
that differs from human insulin by the
replacement of two amino acids on the
beta-chain at positions B3 (i.e., aspargine
replaced by lysine) and B29 (i.e., lysine
replaced by glutamic acid).
is produced by recombinant DNA
technology using a nonpathogenic strain
of E. coli (K12)
equipotent to regular human insulin
whenadministered intravenously.
Isophane Insulin Suspension (NPH Insulin)
 is a sterile suspension in an aqueous vehicle buffered
with dibasic sodium phosphate to pH 7.1 to 7.4.
 is prepared from zinc–insulin crystals modified by the
addition of protamine so that the solid phase of the
suspension consists of crystals of insulin, zinc, and
protamine.
Protamine  is prepared from the sperm or the mature testes
of fish belonging to the genus Oncorhynchus
and others.
NPH  used in some product names stands for neutral
protamine Hagedorn, because the preparation is
neutral (pH about 7.2), contains protamine, and was
developed by Hagedorn.
Isophane Insulin Suspension & Regular Insulin
Humulin 50/50  consists of 50% isophane insulin suspension
and 50% regular insulin.
 achieves a higher insulin concentration (Cmax)
and maximum glucose infusion rates with
more rapid elimination than Humulin 70/30.
 is useful when a greater initial response is
required and for patients who have been using
extemporaneously compounded insulin
mixtures in a 50/50 ratio.
Humulin 70/30  consists of 70% isophane insulin suspension
and 30% regular insulin
 provides an initial response tempered with a
more prolonged release of insulin.
Humalog Mix  is a manufactured premixed insulin consisting of
insulin lispro and neutral protamine lispro (NPL) in a
fixed ratio.
Humalog Mix 50/50  consists of 50% insulin NPLsuspension and
50% insulin lispro injection.
 Humalog Mix 75/25  contains 75% insulin NPL suspension and
25% insulin lispro injection.
~These fixed combinations were developed to give better
control for diabetes patients who use a
combination of short- and long-acting insulins.
~In comparison to Humulin 70/30, Humalog Mix 75/25
demonstrated lower postprandial blood glucose
levels and no difference between the afternoon
and overnight glucose values
~Insulin NPL suspension  was developed as an alternative to
combinations employing NPH
insulin.
~NPH insulin  was unstable over weeks to months when
mixed with lispro insulin.
Insulin Glargine  is a long-acting (up to 24 hours) basal insulin
preparation intended for once daily SC
administration at bedtime in the treatment of type
1 diabetes mellitus in adults and children.
can also be used by adults with type 2 diabetes who
require long-acting insulin.
 is a recombinant, human insulin analog.
Insulin Detemir  is an intermediate to long acting basal insulin, which
is dosed subcutaneously either once or twice daily.
 maintains its long-acting property through slow
systemic absorption.
Insulin Pens  use disposable or single-use cartridges fi lled with either
150 or 300 U of insulinand packaged fi ve per box (21).
are available for a number of insulin types, for example,
regular insulin, insulin isophane, insulin glulisine, and
insulin glargine.
advantage of the pen devices is that they improve the
accuracy of insulin administration when compared to
the traditional vial and syringe administration.
Insulin Infusion Pumps  allow an estimated 300,000 patients to
achieve and maintain blood glucose at nearly
normal levels on a constant basis through
continuous SC insulin infusion (i.e., CSII) (24).
CSII  is achieved through the use of small and lightweight
pumps and eliminates the need for the patient to adhere
rigidly to a regimen of multiple daily injections of insulin.
 is generally recommended for patients more than 10 years
of age.
VII. Special Dosage Forms
1. Pharmaceutical Aerosols Pressurized Package  is commonly used when referring to the
2. Radiopharmaceuticals aerosol container or completed product
3. Biotechnology
Space Sprays  are aerosols used to provide an airborne mist
1. Pharmaceutical Aerosols  include: Room Disinfectants
those products which depend upon the power of a liquefied Room Deodorizers
or compressed gas to dispense active ingredient/s in a finely Space Insecticides
dispensed mist, foam, or semisolid Surface Sprays (Surface Coatings)
are pressured dosage forms that upon actuation emit a fine  are aerosols intended to carry the active ingredient
dispersion of liquid &/or solid materials containing one or to a surface
more active ingredients in a gaseous medium  include: Dermatologic Aerosols
Advantages: Dessert Toppings & Food Spreads
rapid onset of action Cosmetic & Household Aerosols:
prevent first-pass effect, avoidance of GIT degradation
minimize ADRs due to lower dose Types of Pharmaceutical Aerosols:
allows dose titration & ideal for prn medication (1) Solution Aerosols  consists of solutions of active ingrediens in
alternate route to prevent chemical & physical interactions w/ pure propellant & solvents
other drugs given concurrently (2) Dispersions or Suspensions (powder aerosols)
useful when oral & parenteral administration is not suitable  similar to solution aerosols excepts that the active
ingredients are suspended or dispersed
Metered Dose Inhalers (MDIs) throughout the propellant/s or propellant/s or
 pharmaceutical aerosols intended for administration as propellant & sovents phase
fine, solid particles, or as liquid mists via, the respiratory  used for difficult to dissolve compounds
system or nasal passages (e.g. Antibiotics, & Steroids)
particle size: <10micrometer, usually 3-6 micrometers for (3) Emulsions  can be dispersed as a spray, stable foam, or quick-
maximum therapeutic response braking foam
can be O/W or W/O type
(4) Semisolid Preparations  depend on nitrogen to push content
form package
Aerosol Systems:
Two-phase Systems
Liquid Phase (liquefied propellant & product concentrate) Valve Assembly  is to permit expulsion of the contents of the can
Vapor Phase in the desired form at the desired rate, & in the
Three-phase Systems case of metered valves, in the proper amount of
Liquid Propellant dose.
Product Concentrate Parts of Aerosol (Aerosol Valve Assembly):
Vapor Phase 1. Actuator  being pressed for emission of the product
 allows the product to be dispensed in the desired
form, & in a rapid & convenient way
 permits easy opening & closing the valve
Components of Aerosols:
2. Stem  supports the actuator & delivers the formulation in
1. Aerosol propellant  Agent responsible for developing the
the proper form to the chamber of the actuator
pressure within an aerosol container
and expelling the product when the 3. Gasket  placed snugly w/ the stem, prevents leakage of the
valve is opened formulation when the valve is closed
 supplies the necessary force to expel the 4. Spring  holds the gasket in place & is the mechanism by
product & also acts to serve as the which the actuator retracts when pressure is release,
solvent & diluents returning the valve to the dose position
a. Liquefied Gases: 5. Mounting Cup  attached to the aerosol can or container,
-Saturated HC (N-Butane, Propane) hold the valve in place
-Chlorofluorocarbons (CFCs) – phased out 6. Housing  directly below the mounting cup, the housing links
Dichlorodifluoromethane the dip tube & the stem & actuator.
Dichlorotetrafluoroethane 7. Dip tube  extends from the housing down into the product;
Trichloromonofluoromethane brings the formulation form the container to the
-Dimethy Ether valve
-Hydorflurocarbons (more accepted compared
to CFCs) Method of Filling Aerosols (Filling Operations)
b. Compressed Gases: a. Cold Filling  both the product concentrate & propellant must
-Carbon Dioxide be cooled to -34.5C to -40C (-30F to -40C)
-Nitrogen Gas b. Pressure Filling  the products is quantitatively placed in the
-Nitrous Oxide aerosol container, the valve assembly is
2. Product Concentrate  is the active ingredient of the aerosol inserted & crimped into place, & the
combined w/ the required adjuncts, liquefied gas, under pressure, is metered
such as antioxidants, surface active into the valve stem form a pressure
agents, & solvents, to prepare a stable burette.
& efficacious product is used for most pharmaceutical aerosols
3. Container: (a) Tin  plated steel; light & relatively inexpensive  Two advantages over Cold Filling:
(b) Aluminum  preferred for use w/ most MDIs, 1. Less danger of moisture
strong & less reactive than the contamination of the product
other metals 2. Less propellant is lost in the process
(c) Glass  high aesthetic value & minimal
incompatibilities; use is limited to
products w/ low pressure & propellant
percentage
4. Valve  most basic part through which the contents of the
package are emitted;
 regulates the flow of product from the container;
 either spray valve or foam valve.
 2. Radiopharmaceuticals
 is a radioactive pharmaceutical agent that is used for
diagnostic or therapeutic procedures
 a chemical containing a radioactive isotope for use in humans
for the purposes of diagnosis, mitigation, or treatment of a
disease
fundamental unit: Curie (Ci)
international unit of activity:
Becquerel (Bq) = one disintegration/ second
Note: mCi = 37Mbq

Radiopharmaceuticals & their uses:

Nonradioactive Pharmaceutical Use in Nuclear Medicine:
Radiopharmaceutical Uses
1. Acetazolamide (Diamox)  an agent used to treat glaucoma by
Technetium 99mPhytate  Liver imaging & potency studies diuretic action, has been shown to
Technetium 99mHeptagluconate  Kidney imaging, increase cerebral blood flow following
 determining renal function intravenous administration.
Technetium 99mIDA  Hepatobiliary studies 2. Captopril (Capoten)  is used to help diagnose renovascular
Techetium 99mElidronate  Bone imaging hypertension in hypertensive patients with
Technetium 99mInjection  Brain Scanning abdominal bruits, declining renal function,
I-131-Human Serum Albumin  Blood plasma volume/ and poorly controlled hypertension with
 cardiac output determination drug therapy.
Iodohippurate I 131 Injection  Cardiac infarct imaging 3. Cimetidine  reduces the volume and concentration of stomach
acid
NaI- 1125  Localization of ocular tumors
4. Dipyridamole (Persantine)  is used as an alternative to a
Sodium Phosphate Serum Albumin  Thyroid Function
treadmill stress test prior to cardiac
imaging.
Cyanocobalamin 57 capsules  Pernicious anemia 5. Furosemide (Lasix)  a loop diuretic, is administered to help
I 125 Serum albumin injection  Blood Volume Determination confirm or rule out mechanical renal
Iodohippurate I 131 injection  Renal Function obstruction during renal scintigraphy when
Sodium Chromate 51 injection  Blood Volume Determination signifi cant retention of radioactivity is
Sodium Iodide 131 capsules/solution  Thyroid function, Thyroid noted in the renal pelvis
inhibitor  inhibits the reabsorption of electrolytes,
Sodium Pertechnetate 99m injection  Brain & Thyroid scanning most notably sodium, in the ascending limb
Sodium Phosphate 32 solution  Ocular Tumor localization, of the loop of Henle and in the proximal and
Antipolycythemic distal tubules.
Tc 99m Albumin Aggregated Injection  Lung scanning 6. Vitamin B12
Schilling test determines a patient’s capability to absorb
Tc 99m Sulfur Colloid Injection  Liver scanning
radioactive vitamin B12 from the intestine.
Tc 99m labeled RBC  Cardiac pool pumping
Typical urinary excretion of B12 ranges from 15% to 40%.
Tc 99m Methylene Diphosphonate  Bone imaging
Tc 99m Pyrophosphate  Cardiac infarct imaging
Tc 99mSulfur Colloid cooked in  Gastric Emptying Imaging
scrambled eggs
Tl-201 Thalous Chloride  Myocardial Perfusion Scan
3. Biotechnology
 encompasses any technique which uses living organisms
(microorganisms) in the production or modification of
products.
 is the use of microorganism in industry & medicine
Protein  classic example of biotechnology drugs.
 is the first of the novel biotechnologic pharmaceuticals
Techniques used to produce Biotechnologic Products:
1. rDNA Technology
a technique for joining two different DNA molecules
uses other techniques (replication, separation, identification)
that permit production of large quantities of purified
combined techniques, that allow the removal of a specific
piece of DNA out of a larger, more complex molecule DNA
fragments
DNA  Deoxyribonucleic acid,
 has been called the “substance of life”
 constitutes genes, that allow cells to reproduce &
maintain life.
2. MAb Technology  Monoclonal Antibodies
 are produced as a result of perpetuating the
expression of a single beta lymphocyte.
 a highly specific immunoglobulin produced by
cell culture cloning.
3. Polymerase Chain Reaction  is a biotechnologic process whereby
there is substantial amplification
(more than 100,000-fold) of a target
nucleic acid sequence (a gene).
4. Gene Therapy  is a process in which exogenous genetic material is
transferred into somatic cells to correct an
inherited or acquired gene defect.
5. Nucleotide Blockade/ Antisense Nucleic Acids
 focuses on the study of function of specific proteins and
intracellular expression.
Sense sequence  sequence of a nucleotide chain that
contains the information for protein
synthesis is called the
6. Peptide Technology  entails screening for polypeptide
molecules that can mimic larger proteins.
Tissue Plasminogen Activators
are substances produced in small quantity by the inner lining of
blood vessels and by the muscular wall of the uterus
 prevent abnormal blood clotting by converting plasminogen, a
component of blood, to the enzyme plasmin, which breaks
down fibrin, the main constituent of a blood clot.
Monoclonal Antibodies
1. Adalimumab (Humira®)
for reducing signs and symptoms in rheumatoid arthritis
patients who have not responded to previous treatments with
methotrexate and other DMARDs
Offers an attractive alternative for patients who require TNF-α
blocker therapy
also indicated for psoriatic arthritis, ankylosing spondylitis, and
Crohn disease.
TNF-α  is responsible for much of the pain and
inflammation associated with rheumatoid arthritis.
2. Basiliximab (Simulect®)
is an IL-2 receptor antagonist
an example of a chimeric (murine–human) MAb (IgG1K)
produced by rDNA technology
as an immunosuppressive agent
 is indicated for the prophylaxis of acute organ rejection in
patients receiving renal transplants.
3. Bevacizumab (Avastin®)
used in combination with IV 5-fluorouracilbased chemotherapy
for first- or second-line treatment of patients with metastatic
carcinoma of the colon or rectum.
is also being investigated for the treatment of advanced
macular degeneration (AMD), a leading cause of blindness in
older patients.
4. Daclizumab (Zenapax®)
is an immunosuppressive humanized IgG1 MAb produced by
rDNA technology that binds specifically to the alpha unit (Tac
subunit) of the human high-affinity IL-2 receptor that is
expressed on the surface of activated lymphocytes.
is a composite of human (90%) and murine (10%) antibody
sequences.
5. Gentuzumab Ozogamicin (Mylotarg®)
was the fi rst drug specifi cally approved for treating relapsed
AML (acute myeloid leukemia).
6. Ibritumomab Tiuxetan (Zevalin®)
is the first commercially available radiolabeled antibody for
cancer therapy.
7. Infliximab (Remicade®)
is the only approved drug therapy specifically indicated for the
treatment of fistulizing Crohn disease, an inflammation of the
intestine.
8. Muromonab-CD3 (Orthoclone OKT3®)
is a murine MAb that reacts with a T3 (CD3) molecule linked
to an antigen receptor on the surface membrane of human T
lymphocytes.
 blocks both generation and function of the T cells in response
to antigenic challenge and is indicated for treatment of organ
transplant rejection.
 is combined with azathioprine, cyclosporine, and/or
corticosteroids to prevent acute rejection of renal transplants.
9. Omalizumab (Xolair®)
is the first humanized therapeutic antibody for the treatment of
asthma
first approved therapy designed to target immunoglobulin E
(IgE) in the management of asthma.
10. Palivizumab (Synagis®)
is a humanized MAb (IgG1K) produced by rDNA
technology, directed to the epitope in the A antigenic site
of the F protein of respiratory syncytial virus (RSV).
is a composite of human (95%) and murine (5%) antibody
sequences.
is for intramuscular use only
11. Rituximab (Rituxan®)
was the first MAb approved to treat cancer
is used to treat patients with relapsed or refractory low-
grade or follicular CD20 positive beta-cell NHL.
12. Satumomab Pendetide (OncoScint CR/OV Kit®)
is a diagnostic imaging agent that is indicated for
determining the extent and location of extrahepatic
malignant disease in patients with known ovarian
carcinoma
13. Tocilizumab (Actemra®)
is the first IL-6 receptor inhibiting MAb for the treatment of
rheumatoid arthritis.
is a fusion of murine and human components.
inhibits the binding of IL-6 to its receptor
IL-6  a proinflammatory cytokine, plays a primary role in
causing local and systemic manifestations of
rheumatoid arthritis.
14. Trastuzumab (Herceptin®)
 September 1998, became the second MAb approved to treat
cancer
is indicated for the treatment of metastatic breast cancer or
cancer that has spread beyond the breast and lymph nodes
under the arm.
Prodrug  describe a compound that requires metabolic
biotransformation after administration to produce the desired
pharmacologically active compound Ebers Papyrus  the most famous of these surviving memorials of early
Goal Drug  would produce the specifically desired effect, be administered drugs
by the most desired route (generally orally) at minimal dosage  is dominated by drug formulas, w/ more than 800 formulas
& dosing frequency, have optimal onset & duration of activity, or prescriptions being described & more than 700 drugs
exhibit no side effect, & following its desired effect would be mentioned
eliminated from the body efficiently, completely, & w/out is now preserved at the university of Leipzig
residual effect is named for the noted German Egyptologist Georg Ebers,
Lead Compound  is a prototype chemical compound that has who discovered it in the tomb of a mummy & partly
fundamental desired biologic or pharmacologic translated it during the last half of 19 Century
activity. Contributors to the advancement of the Health Sciences
Notable among those whose genius & creativeness has a revolutionary
influence on the development of Pharmacy & Medicine
Pharmaceutical Same therapeutic moiety/API 1. Hippocrates  Greek Physician
alternatives Different salts, esters, or complexes  is credited w/ introduction of scientific pharmacy &
Different dosage forms medicine
Different strength  rationalized medicine, systematized medical
Ex: tetracycline phosphate 250mg  tetracycline knowledge, & put the practice of medicine on a high
HCl 250mg ethical plane
Pharmaceutical Same active ing. is honored by being called the “Father of Medicine”
Equivalence Same dosage form Pharmakon  purifying remedy for good only
Same salts or esters 2. Pedanios Dioscorides  Greek Physician & Botanist, or Pharmaco-
Same route of administration botanist
Same strength/concentration  was the first to deal w/ botany as an applied
Ex: Chlordiazepine HCl 5mg cap science of Pharamcy
(branded)(generic)  wrote “De Materia Medica libri cinque”
Pharmaceutical Process of dispensing pharmaceutical alternatives meaning “Concerning Medical
Substitution Example: ampicillin suspension & ampicillin Matter in Five Volumes”
capsules is considered a milestone in the
Nifedipine 5mg cap & nifedipine 20mg development of pharmaceutical
GITS tab botany & in the study of naturally
Therapeutic Different active ing. occurring medicinal materials
Alternatives Same therapeutic effect or pharmacologic class is an area of study known today as
Example: Ibuprofen aspirin natural product chemistry &/or
Therapeutic Are pharmaceutical equivalents contain identical “Pharmacognosy”
Equivalence amounts of the same active drug ingredient in the Greek Word
same dosage form & route of administration. -Pharmakon  drug
Therapeutic Process of dispensing a therapeutic alternative -gnosis  knowledge
Substitution 3. Claudius Galen  Greek Pharmacist Physician who attained Roman
Citizenship
USP Guideline on Stability of  aimed to create a perfect system of physiology,
Extemporaneous Compounded Formulations: pathology, & treatment.
1. nonaqueous liquids and solid formulations in which the was one of the most prolific authors of his or any
manufactured drug is the source of the active ingredient, other era, having been credited w/ 500 treatises on
not later than 25% of the time remaining until the product’s medicine & some 250 other on philosophy law &
expiration date or 6 months, whichever is earlier; grammar.
2. nonaqueous liquids and solid formulations in which a USP or  originated so many preparations of vegetable drugs
National Formulary (NF) substance is the source of active ingredient, by mixing or melting the individual ingredient that
 a beyond-use date of 6 months; the field of pharmaceutical preparations was once
3. for water-containing formulations prepared from ingredients in solid commonly referred to as “Galenic Pharmacy”
form, ’Galen’s Cerate”  the most famous of the Galen’s
 a beyond-use date not later than 14 days in storage at cold Formula for a cold cream.
temperatures; 4. Paracelsus  Aureolus Theophrastus Bombastus von Hohenheim
4. for all other formulations,  influenced the transformation of Pharmacy from a
 a beyond-use date of the intended duration of therapy or 30 profession based primarily on botanical science to one
days, whichever is earlier based on chemical science
 believed it was possible to prepare a specific medicinal
agent to combat each specific disease & introduced a
host of chemical substances to internal therapy.

Pharmacopeia  from the Greek word

-Pharmakon  drug
-Poiein  make
 the combination indicates any recipe or formula or
other standards required to make or prepare drug
Pharmaceutical Ingredient
1. Acidifying agent  Used in liquid preparations to provide acidic medium 10. Chelating agent  Substance that forms stable water-soluble complexes
for product stability (chelates) with metals; used in some liquid
o Citric acid pharmaceuticals as stabilizers to complex heavy
o Acetic acid metals that might promote instability. In such use,
o Fumaric acid they are also called sequestering agents
o Hydrochloric acid o Edetic acid
o Nitric acid o Edetate disodium
2. Alkalinizing agent  Used in liquid preparations to provide alkaline 11. Colorant  Used to impart color to liquid and solid (e.g., tablets and
medium for product stability capsules) preparations
o Ammonia solution o FD&C Red No. 3
o Ammonium carbonate o FD&C Red No. 20
o Diethanolamine o FD&C Yellow No. 6
o Monoethanolamine o FD&C Blue No. 2
o Potassium hydroxide o D&C Green No. 5
o Sodium bicarbonate o D&C Orange No. 5
o Sodium borate o D&C Red No. 8
o Sodium carbonate o Caramel
o Sodium hydroxide o Ferric oxide, red
o Trolamine 12. Clarifying agent  Used as a filtering aid for its adsorbent qualities
3. Adsorbent  An agent capable of holding other molecules onto its surface Bentonite
by physical or chemical (chemisorption) means 13. Emulsifying agent  Used to promote and maintain dispersion of finely
o Powdered cellulose subdivided particles of liquid in a vehicle in which it
o Activated charcoal is immiscible. End product may be a liquid
4. Aerosol propellant  Agent responsible for developing the pressure emulsion or semisolid emulsion (e.g., a cream)
within an aerosol container and expelling the o Acacia
product when the valve is opened o Cetomacrogol
o Carbon dioxide o Cetyl alcohol
o Dichlorodifl uoromethane o Glyceryl monostearate
o Dichlorotetrafl uoroethane o Sorbitan monooleate
o Trichloromonofl uoromethane o Polyoxyethylene 50 stearate
5. Air displacement  Agent employed to displace air in a hermetically 14. Encapsulating agent  Used to form thin shells to enclose a drug for ease
sealed container to enhance product stability of administration
o Nitrogen o Gelatin
o Carbon dioxide 15. Flavorant  Used to impart a pleasant flavor and often odor to a
6. Antifungal preservative  Used in liquid and semisolid preparations to preparation. In addition to the natural flavorants listed,
prevent growth of fungi. Effectiveness of many synthetic ones are used
parabens is usually enhanced by use in o Anise oil
combination o Cinnamon oil
o Butylparaben o Cocoa
o Ethylparaben o Menthol
o Methylparaben o Orange oil
o Benzoic acid o Peppermint oil
o Propylparaben o Vanillin
o Sodium benzoate 16. Humectant  Used to prevent drying of preparations, particularly
o Sodium propionate ointments and creams
7. Antimicrobial preservative  Used in liquid and semisolid preparations to o Glycerin
prevent growth of microorganisms o Propylene glycol
o Benzalkonium chloride o Sorbitol
8. Antioxidant  Used to prevent deterioration of preparations by oxidation 17. Levigating agent  Liquid used as an intervening agent to reduce the
o Ascorbic acid particle size of a powder by grinding, usually in a
o Ascorbyl palmitate mortar
o Butylated hydroxyanisole o Mineral oil
o Butylated hydroxytoluene o Glycerin
o Hypophosphorous acid o Propylene glycol
o Monothioglycerol 18. Ointment base  Semisolid vehicle for medicated ointments
o Propyl gallate o Lanolin
o Sodium ascorbate o Hydrophilic ointment
o Sodium bisulfi te o Polyethylene glycol ointment
o Sodium formaldehyde o Petrolatum
o Sulfoxylate o Hydrophilic Petrolatum
o Sodium metabisulfite o White ointment
9. Buffering agent  Used to resist change in pH upon dilution or addition of o Yellow ointment
acid or alkali o Rose water ointment
o Potassium metaphosphate 19. Plasticizer  Component of film-coating solutions to make film more
o Potassium phosphate, pliable, enhance spread of coat over tablets, beads, and
o monobasic granules
o Sodium acetate o Diethyl phthalate
o Sodium citrate, anhydrous and dihydrate o Glycerin
20. Solvent  Used to dissolve another substance in preparation of a 27. Tablet binders  Substances used to cause adhesion of powder particles
solution; may be aqueous or not (e.g., oleaginous). in tablet granulations
Cosolvents, such as water and alcohol (hydroalcoholic) and o Acacia
water and glycerin, may be used when needed. Sterile o Alginic acid
solvents are used in certain preparations (e.g., injections) o Carboxymethylcellulose sodium
o Alcohol o Compressible sugar (e.g.,
o Corn oil o Nu-Tab)
o Cottonseed oil o Ethylcellulose
o Glycerin o Gelatin
o Isopropyl alcohol o Liquid glucose
o Mineral oil o Methylcellulose
o Oleic acid o Povidone
o Peanut oil o Pregelatinized starch
o Purifi ed water 27. Tablet and capsule diluents  Inert filler to create desired bulk, flow
o Water for injection properties, and compression
o Sterile water for injection characteristics of tablets and capsules
o Sterile water for irrigation o Dibasic calcium phosphate
21. Stiffening agent  Used to increase thickness or hardness of a o Kaolin
preparation, usually an ointment o Lactose
o Cetyl alcohol o Mannitol
o Cetyl esters wax o Microcrystalline cellulose
o Microcrystalline wax o Powdered cellulose
o Paraffi n o Precipitated calcium carbonate
o Stearyl alcohol o Sorbitol
o White wax o Starch
o Yellow wax 28. Tablet coating agent  Used to coat a tablet to protect against
22. Suppository base  Vehicle for suppositories decomposition by atmospheric oxygen or
o Cocoa butter humidity, to provide a desired release pattern, to
o Polyethylene glycols (mixtures) mask taste or odor, or for aesthetic purposes.
o PEG 3350 Coating may be sugar, film, or thick covering around a tablet.
23. Surfactant (surface active agent)  Substances that absorb to surfaces or Sugar-coated tablets generally start to break up in the stomach.
interfaces to reduce surface or o Liquid glucose
interfacial tension. May be used as o Sucrose
wetting agents, detergents, or
emulsifying agents Film forms a thin cover around a formed tablet or bead. Unless it is
o Benzalkonium chloride enteric, film dissolves in the stomach.
o Nonoxynol 10 o Hydroxyethyl cellulose
o Octoxynol 9 o Hydroxypropyl cellulose
o Polysorbate 80 o Hydroxypropyl methylcellulose
o Sodium lauryl sulfate o Methylcellulose (e.g., Methocel)
o Sorbitan monopalmitate o Ethylcellulose (e.g., Ethocel)
24. Suspending agent  Viscosity-increasing agent used to reduce
sedimentation rate of particles in a vehicle in which Enteric coating passes through the stomach to break up in the
they are not soluble; suspension may be intestines.
formulated for oral, parenteral, ophthalmic, o Cellulose acetate phthalate
topical, or other route o Shellac (35% in alcohol, pharmaceutical glaze)
o Agar Some water-insoluble coatings (e.g., ethylcellulose) are used to
o Bentonite not suitable for oral route administration slow the release of drug in the gastrointestinal tract
o Carbomer (e.g., Carbopol) 29. Tablet direct compression excipient  Used in direct compression tablet
o Carboxymethylcellulose sodium formulations
o Hydroxyethyl cellulose o Dibasic calcium phosphate (e.g., Ditab)
o Hydroxypropyl cellulose 30. Tablet disintegrant  Used in solid forms to promote disruption of the
o Hydroxypropyl methylcellulose mass into smaller particles more readily dispersed
o Kaolin or dissolved
o Methylcellulose o Alginic acid
o Tragacanth o Polacrilin potassium
o Veegum o (e.g., Amberlite)
25. Sweetening agent  Used to impart sweetness to a preparation o Sodium alginate
o Aspartame o Sodium starch glycolate
o Dextrose o Starch
o Glycerin 31. Tablet glidant  Used in tablet and capsule formulations to improve flow
o Mannitol properties of the powder mixture
o Saccharin sodium o Colloidal silica
o Sorbitol o Cornstarch
o Sucrose o Talc
26. Tablet antiadherents  Prevent tablet ingredients from sticking to
punches and dies during production
o Magnesium stearate
32. Tablet lubricant  Used in tablet formulations to reduce friction during
tablet compression
o Calcium stearate
o Magnesium stearate
o Mineral oil
o Stearic acid
o Zinc stearate
33. Tablet or capsule opaquant  Used to render a coating opaque. May be
used alone or with a colorant
o Titanium dioxide
34. Tablet polishing agent  Used to impart an attractive sheen to coated
tablets Carnauba wax
o White wax
35. Tonicity agent  Used to render solution similar in osmotic-dextrose
characteristics to physiologic fluids, e.g., in ophthalmic,
parenteral, and irrigation fluids
o Sodium chloride
36. Vehicle  Carrying agent used in formulating a variety of liquids for oral
and parenteral administration
Generally, oral liquids are aqueous (e.g., syrups) or
hydroalcoholic (e.g., elixirs). Solutions for intravenous use are
aqueous, whereas intramuscular injections may be aqueous or
oleaginous
Flavored, sweetened
o Acacia syrup
o Aromatic syrup
o Aromatic elixir
o Cherry syrup
o Cocoa syrup
o Orange syrup
o Syrup
Oleaginous
o Corn oil
o Mineral oil
o Peanut oil
o Sesame oil
Sterile
o Bacteriostatic sodium
o chloride injection
37. Viscosity-increasing agent  Used to render preparations more resistant
to flow. Used in suspensions to deter
sedimentation, in ophthalmic solutions to
enhance contact time (e.g.,
methylcellulose), to thicken topical
creams, etc.
o Alginic acid
o Bentonite
o Carbomer
o Carboxymethylcellulose
o Sodium
o Methylcellulose
o Povidone
o Sodium alginate
o Tragacanth
PHYSICAL PHARMACY

1. Forces of Attraction 6. pH & Buffer  Physical Properties of Systems:

(a) Additive Property  depends on the sum of the individual properties
2. Gas Laws 7. Rheology of the components present in a system
3. Solubility 8. Micromeritics  total contribution of the atom
4. Colligative Property 9. Phase Equilibria  Example: Molecular Weight
5. Isotonicity 10. Chemical Kinetics (b) Constitute Property  depends on the type & arrangement of the
components present in a system
 kinds of atoms in the molecules
Physical Pharmacy  application of physical & chemical principles  Examples: Refraction of Light
& laws in pharmaceutical sciences Optical Activity
physical chemistry in pharmacy Surface
to understand & develop dosage forms & drug Interfacial Characteristics
delivery systems. (c) Colligative Property  depends on the number of components
 study of physic-chemical properties of present in a system
substances used in drug formulation  number of particles
 Examples: Osmotic Pressure
Freezing Point Depression
Vapor Pressure Lowering
I. FORCES OF ATTRACTION Boiling Point Elevation
INTRAmolecular  forces within a molecule  Types of Properties:
a. Covalent Bond  made by sharing electrons (1) Extensive/ Extrinsic  depends on the size of the amount of material
-Nonpolar [Cl2, CO2, CCl2] –no significant diff. of EN in the system
-Polar [HCl, HCHO] –has significant dif. of EN  mass dependent
b. Ionic bond  affinity between oppositely charged particles Examples: *Volume
 present in salts/ ionic compounds *Weight
 forces that hold ions together in the crystal *Pressure
lattice of a salt *Heat content
INTERmolecular forces hold molecules together (2) Intensive/ Intrinsic  does not depend on the size of the amount of
1. VAN DER WAALS material in the system
1. London Dispersion Forces (LDF)  mass independent
 aka Induced Dipole-Induced Dipole Examples: *Density *Melting point
 result from the tendency of molecules to align *pH *Freezing point
themselves w/ the oppositely charged ends of their *Color *Sublimation temperature
neighbor *Concentration *Optical activity
 bond between nonpolar molecules (no charges) *Boiling point
 weakest bond
2. Dipole-dipole or Permanent Dipole Density, Specific Gravity, & Specific Volume
 aka Keesom Orientation Force 𝑚
Density  mass per unit volume of a substance (g/mL) 𝐷 =
 operate on polar or dipole molecules (polar+polar) 𝑣
 stronger than LDF Specific Gravity  a ratio, expressed decimally, of a weight of a
3. Dipole- Induced Dipole substance to the weight of an equal volume of a
 aka Debye Induction Force standard determined at the same temperature
 bond between a charged (dipole) and an uncharged (if not stated 25C/25C, except when specified in the
particles (induced dipole) monograph & for alcohol which is at 15.56C/
2. Hydrogen Bonding 15.56C)
 bond of Hydrogen with a highly electronegative atom of another 𝑚
𝑆𝑝𝑒𝑐𝑖𝑓𝑖𝑐 𝑔𝑟𝑎𝑣𝑖𝑡𝑦 = 𝐷𝑒𝑛𝑠𝑖𝑡𝑦 =
molecules 𝑣
 special type of dipole-dipole interaction.  Density: g/mL
H  attached to highly electronegative atoms (N, O, F)  Specific Gravity: No unit
H-bond  D-D  LDF Note: Density & Specific Gravity is numerically equal in the metric
system, but they are different when the density is expressed in the
  common system.
relative strength Specific Volume  reciprocal of Specific gravity
3. Ion-ion, Ion-dipole, & ion induced dipole  no unit
 (+) & () interaction in the solid sate 1
𝑆𝑝𝑒𝑐𝑖𝑓𝑖𝑐 𝑉𝑜𝑙𝑢𝑚𝑒 =
 strongest bond 𝑆𝑝𝑒𝑐𝑖𝑓𝑖𝑐 𝐺𝑟𝑎𝑣𝑖𝑡𝑦
 responsible for the solubility of Iodine in Solution by the 𝑉𝑜𝑙𝑢𝑚𝑒
𝑆𝑝𝑒𝑐𝑖𝑓𝑖𝑐 𝑉𝑜𝑙𝑢𝑚𝑒 =
addition of salts. 𝑀𝑎𝑠𝑠

Debye-Huckel Theory:
Strong Electrolytes completely ionize in dilute solutions & the
deviations from ideal behavior are due to electrostatic effects
of oppositely charged ions.
States of Matter: Solid, Liquid, Gas, Plasma
Plasma  aka “Mesophase”, “Liquid Crystals”
 has solid like properties (part solid & part liquid)
 resemble those of a crystal in the formation of loosely
ordered molecular arrays similar to a regular crystalline lattice
& anisotropic refraction of light
The more imperfect the lattice, the harder the solid.
 Tends to flow like liquid under extreme conditions
Two main types of Liquid Crystals:
-Smectic (soap- or grease-like)  mobile in 3 direction
 is most pharmaceutically
important because it forms
a ternary complex mixture
w/ additives
-Nematic (thread-like)  mobile in 2 direction
-Cholesteric  combination of nematic & smectic
Six Distict Crystal System:
1. Cubic (sodium chloride) 4. Rhombic (iodine)
2. Tetragonal (urea) 5. Monoclinic (sucrose)
3. Hexagonal (iodofrom) 6. Triclinic (boric Acid)

Phases of Matter:

Mesophase
 middle: Liquid Crystal
LCD, LED
LCD LED
Thickness thicker thinner
Price Expensive More Expensive
Electric e- e-
Consumption Consumption Consumption
Life span 10 years >10 years
21” 32”

 Cholesteryl Benzoate  the first recorded type of liquid crystal that was
obtained by the application of heat
Starch-Iodine  is an example of Channel-Lattice
II. GAS LAWS
Gases
 have kinetic energy that produces rapid motion
held together by weak intermolecular forces
capable of filling all available space
are compressible
for many, are invisible
 Kinetic Molecular Theory of Gases:
(a) Total volume of gas molecules is negligible as compared to
the volume of space in which they are confined
(b) Gas particles do not attract one another but rather move
independently from each other
(c) Particles exhibit continuous random movement due to their
kinetic energy
(d) Gas molecules exhibit perfect elasticity

1. Boyle’s Law
 Volume is inversely 𝑃1 𝑉1 = 𝑃2 𝑉2
proportional to pressure Constant: n, R, T
 nonlinear relation for Variable: P, V
volume & pressure Relationship: Inverse
2. Charles’ Law
 Volume is directly 𝑉1 𝑉2
= for phase transition to
proportional to 𝑇1 𝑇2
temperature (Kelvin), Constant: P, n, R
273Kstandard Variable: V, T
Relationship: Direct
3. Avogadro’s Law
 Volume is directly 𝑉1 𝑉2
proportional to moles =  The rate of the effusion of
𝑛1 𝑛2
Constant: P, R, T
Variable: V, n
Relationship: Direct
4. Combined/ Ideal Gas Law
 combination of Boyle’s, 𝑃1 𝑉1 𝑃2 𝑉2
= gases.
Charle’s, Avogadro’s 𝑛1 𝑇1 𝑛2 𝑇2
Ideal Gas  exist at STP
T= OC / 273 K
Ideal Gas Constant: R P= 1 atm
R= 0.08206 Latm/ mol k = 760 mmHg
R= 8.314 J/mol k N= 1 mol
V= 22.4 L
6. Gay-Lussac’s law or Amonton’s Law
 Pressure is directly proportional to temperature, if V is constant
7. Clausius-Clapeyron
𝑃2 ∆𝐻𝑣 (𝑇2 − 𝑇1 )
 Latent heat  heat required 𝑙𝑜𝑔 =
𝑃1 2.303 𝑅𝑇2 𝑇1
Where:
happen. P= Pressure
-Hf  heat of fusion (S⇌L) T= Temperature
-Hv  heat of vaporization (L⇌G) Hv = heat of vaporization
-Hs  heat of sublimation (S⇌G) R= gas constant + 8.314 J/molK
8. Grahams Law
𝑅1 𝑀𝑊1
two gases (& diffusion) are
inversely proportional to 𝑅2 𝑀𝑊2
the square roots of their
densities providing the Diffusion  gradual mixing of
temperature & pressure molecules of one gas w/
are the same for two
the molecules of another
gas by virtue of their
kinetic properties
Effusion  passage of a gas
under pressure through a
small opening

5. Dalton’s Law of Partial Pressure

 State that the total 𝑃𝑡𝑜𝑡𝑎𝑙 = 𝑃𝑎 + 𝑃𝑏 + 𝑃𝑐 … 𝑃𝑥
pressure in a mixture of
gases is equal to the sum
of the partial pressure of
each
 gaseous mixtures

Partial Pressure  is the

pressure a gas would
exert if it alone
occupied the whole
volume of the mixture
III. SOLUBILITY Solutions  homogenous mixture of single phase system of two or more
substances
𝑎𝑚𝑜𝑢𝑛𝑡 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑒 -Solute  lesser amounts
𝑆𝑜𝑙𝑢𝑏𝑖𝑙𝑖𝑡𝑦 =  solid, liquid, gas
𝑣𝑜𝑙𝑢𝑚𝑒 𝑜𝑓 𝑠𝑜𝑙𝑣𝑒𝑛𝑡
𝑎𝑚𝑜𝑢𝑛𝑡 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑒 -Solvent  greater amounts
𝑀𝑜𝑙𝑎𝑟 𝑆𝑜𝑙𝑢𝑏𝑖𝑙𝑡𝑦 𝑆 =  liquid, solid, gas
𝑣𝑜𝑙𝑢𝑚𝑒 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑖𝑜𝑛
Molar Solubility= exponent stoichiometric coefficient
USP Terms of Solubility:
Ksp= solubility product constant Terms Parts of Solvent Required to
 product of the molar solubility each component praised to an Dissolve One part of Solute
experimental equal to their stoichiometric coefficient Very Soluble <1
Freely soluble 1-10
 Classification of Dispersed (Particulate) Systems: Soluble 10-30
Classes Definition Range of Examples Sparingly Soluble 30-100
Particle Size Slightly Soluble 100-1,000
1. Molecular is defined as a Less than Oxygen Molecules, Very Slightly Soluble 1,000-10,000
Dispersion mixture of two or 1 nm Ordinary Ions, Practically Insoluble or Insoluble  10,000
(True more components Glucose
Solutions) that form a
homogenous Types of Solution According to the Solubility of the Solute:
molecular  Saturated Solution  solution achieved the maximum solubility
dispersion or one- / in equilibrium
phase system  Unsaturated Solution  less solvent that solute
2. Colloidal  represents a 1nm to 0.5nm Colloidal Silver / dissolve solute in a concentration below
Dispersion system having a (100 angstrom Solutions,  Supersaturated Solution  contains more solvent that dissolve solute
or 10 cm
5
particle size Natural & Synthetic that it would normally contain at a definite
intermediate Polymers temperature.
between that of a
true solution & a Classification of Solvents:
coarse dispersion (a) Protophilic  capable of accepting protons
3. Coarse diameter of Greater Grains of Sand, Examples: Acetone, Ether, Liquid Ammoina
Dispersion particles being than 0.5 m Red Blood Cells, (b) Protogenic  proton-donating compound
larger than 0.5 m (10-5000 Most emulsions & Examples: Formic Acid, Acetic Acid, Sulfuric Acid,
angstrom) Suspension Liquid HCl, Liquid HF
(c) Amphiptrotic  proton acceptors & proton donors
 Types of Colloidal Systems: Examples: Water, Alcohols
(a) Lyophilic  solvent-loving colloids (d) Aprotic  neither accept nor donate protons
 systems containing colloidal particles that interact to an
appreciable extent with the dispersion medium
(b) Lyophobic  solvent-hating colloids Factors affecting Solubility:
 composed of material that have little attraction for the 1. Nature of Solute & Solvent
dispersion medium, due primarily to the absence of a (Polarity): Like dissolve like
solvent sheath around the particles Solubility  maximum amount of solute expressed in grams that
(c) Association  amphiphilic colloids can be dissolved in 100g of water
 characterized by having two distinct regions of Miscibility  ability of one substance to mix with another
opposing solution affinities substance (ex: liquid-liquid; liquid-gas)
 Properties of Colloids 2. Temperature
1. Optical: Faraday-Tyndall Effect  ability to scatter or disperse light temp: sobility of solid in liquid
2. Kinetic: Brownian Motion  colloidal particles appear as tiny points of temp:  solubility of a gas in liquid
light in constant motion when examined Exothermic  solubility: temperature (ex: Sodium Oxalate)
under ultra microscope Endothermic  solubility: temperature (ex: Ammonium
Diffusion  spontaneous movement of particles from a region Nitrate)
of higher concentration to one of lower  Sodium Chloride  neither endo & exo
concentration until equilibrium is achieved.
3. Electric: Nernst Potential  aka “Electrothermodynamic Potential” 3. Pressure (affects Gases only)
 difference in potential between the actual Henry’s Law of Gas solubility  solubility of gas: pressure
surface of the particle & the electroneutral states that the amount of gas dissolved in a solution in
region of the dispersion proportional to the partial pressure of the gas in
Zeta Potential  aka “Electrokinetic Potential” equilibrium w/ the solution
 difference in potential between the surface 4. Particle Size/ Surface Area
of the tightly-bound layers & the particle size: surface area: solubility
electroneutral region of the dispersion 5. Presence of Salts
 has more application in pharmacy (example: Salting-out  presence of salt decreases solubility
decreased zeta potential, results to Salting in  presence of salt increases solubility
flocculation) *Basic or Sub salt  is prepared by:
Partial hydrolysis of a normal salt
Partial Neutalization of a hydroxide
 Low-Molecular weight salts are salty.
 High-Molecular weight salts are bitter.
Different Expressions for concentration:
Molarity is the number of moles (gram molecular weight) of
solute in 1L solution
𝑚𝑜𝑙𝑒𝑠 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑒 𝑤𝑡/𝑀𝑊
𝑀 = =
𝐿 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑖𝑜𝑛 𝐿
Normality is the number of gram equivalent weight of a solute
in 1L solution
𝑀𝑊
𝑤𝑡/
𝑓
𝑁 =𝑀×𝐹 =
𝐿
𝑀𝑤
𝑚𝐸𝑞 𝑤/
𝑓
𝑁= =
𝐿 𝐿
𝑒𝑞𝑢𝑖𝑣𝑎𝑙𝑒𝑛𝑐𝑒 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑒
𝑁=
𝐿 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑖𝑜𝑛
Molality is the number of moles of solute in 1000 grams of
solvent
𝑚𝑜𝑙𝑒𝑠 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑒 𝑤𝑡/𝑀𝑊
𝑚 = =
𝐾𝑔 𝑜𝑓 𝑠𝑜𝑙𝑢𝑡𝑖𝑜𝑛 𝐾𝑔
Mole Fraction is the ratio of moles of one more constituents of a
solutions to the total moles of all constituents
𝑁𝐴 𝑁𝐴
𝑀𝐴 = =
𝑁𝑇 𝑁𝐴 + 𝑁𝐵
Mole Percent is obtained by multiplying mole fraction by 100

 Four Polymorphic Forms of Theobroma Oils:

Unstable Gamma Form Melts at 18C
Alpha Form Melts at 22C
Beta Form Melts at 28C
Stable Beta Form Melts at 34.5C

 Interfacial Phenomenon
Interfacial Phenomenon  attributed to the effects of the molecules
found at the interface (boundary b/w 2
phases)
 Interfacial Tension (L-L only)
 Surface Tension (S-L, L-G)
 Surfactant  Surface-active Agent
 lower the interfacial/ surface tension
Cohesion  attraction among similar molecules
Adhesion  attraction among different molecules
Wetting Phenomenon   contact angle;  wettability
Capillarity tendency of a liquid rises in a tube because of a
combination of adhesion to the walls of the tube and
cohesion between liquid particles
  adhesive force;  capilaarity
 Adsorption  binding of molecules to a surface

Hydrophilc-Lipophilic Balance (HLB) Values

HLB Range USE
0-3 Antifoaming Agent
4-6 w/o emulsifying Agent
7-9 Wetting Agent
8-18 o/w emulsifying Agent
13-15 Detergents
10-18 Solubilzing Agents
IV. COLLIGATIVE PROPERTIES
1. Vapor Pressure Lowering  the addition of a non-volatile solute lowers
the VP of the liquid
 when a nonvolatile solute is added to a
volatile solvent, the solute reduces the
escaping tendency of the solvent
thus, the vapor pressure of the solution is
lowered proportional to the relative number
solute molecules
 A liquid in a closed container will established an equilibrium with
its vapor.
 When equilibrium is reached, the vapor exerts a pressure (vapor
pressure)
 Volatile exhibits vapor pressure
 Nonvolatile  no measurable vapor pressure
Raoult’s Law  lowering of a vapor pressure of a solvent is equal to the
product of the mole fraction of the solute & vapor
pressure of the solvent.
 ?P=P of pure solvent x mole fraction of the solute
2. Boiling Point Elevation
Boiling Point  equilibrium between the liquid & the gas, point at
which the VP equals atmospheric P.
 is the temperature at which the vapor pressure of the
liquid becomes equal to the external atmospheric
pressure (1 atm= 760 mmHg)
The Boiling Point of a solution containing a nonvolatile solute would
be higher than the pure solvent because the solute would lower the
vapor pressure of the solvent
The higher the molecular weight, the higher the boiling point of the
liquid.
3. Freezing Point Depression
Freezing Point  is the temperature at which the solid & liquid phases
are in equilibrium under an external pressure of 1 atm
Presence of salt/ solute will cause lowering of freezing point
Ice cream making
?FP = kfm
Freezing point of water is 0C
Kf (freezing point depression constant)= 1.86C/m
Frezzing point of an Isotonic Solution= 0.52C/m
4. Osmotic Pressure  is the pressure required to offset the movement of
solvent through a semipermeable memebrane
Also defined as the pressure needed to prevent
osmosis
Osmosis  Greek:“Push” or “Impulse”
 net movement of solvent molecules through a
semipermeable membrane from a more dilute solution
to a more concentrated solution
V. ISOTONICITY

 Isotonicity Solutions
(1) Hypertonic Solutions  solutions with more solutes compared to
cell concentration
 solutions that freeze lower than -0.52C
Results: Crenation of the cells (Shrinkage)
(2) Hypotonic Solutions  solutions with less solutes compared to cell
concentration
 solutions that freeze higher than -0.52C
 Results: Swelling & lysis of the cell
(3) Isotonic Solutions  solutions for which a living cell does not gain or
lose water
 solutions with similar osmotic pressure as that
of boy fluids
 has similar concentration as 0.9% (w/v) NaCl
solution

 Methods of Adjusting Tonicity & pH

Class I Method: Addition of a Tonicity Adjusting Agent
(1) Cryospcopc Method ( Freezing Pint Depression Method)
(2) Sodium Chloride Equivalent Method ( E value Method)
E Value  gram of NaCl equivalent to 1 gram of
substance
Isotonic NaCl Concentration  0.9% (w/v) NaCl
Class II Method: Addition of Water & Dilution w/
Buffered Isotonic Solution
(1) White Vincent Method
(2) Sprowl’s Method
 VI. pH & BUFFER

Acid-Base Equilibria
Acid-Base Theory
ACID BASE
Arrhenius yield H+ yield OH
Bronsted-Lowry proton donor proton acceptor
Lewis e- acceptor e- donor

Ionization  is the complete separation of ions in a crystal lattice

when a salt is dissolved
Dissociation  is the separation of ions in solution when the ions are
associated by interionic attraction

Basic Principles of Analysis

A. pH B. Buffer Capacity
 number of grams equivalent of H per liter of soln  ability/ degree (magnitude) of a buffer solution to resist
 pH = -log [H] changes in pH upon addition of acid/alkali
or pH = log 1/[H]  buffer action
pOH= -log[OH]  buffer efficiency
pH + pOH =14  buffer index
acidic = pH < 7.0, pOH >7.0  buffer value
basic= pH >7.0, pOH <7.0 Van slyke
neutral= pH=pOH=7.0  was responsible for a quantitative expression
 () value of pH is possible  amount in g/l of strong acid or a strong base required to be
 > 14 value is possible as well. added to a solution to change its pH by 1 unit.
 Protolysis  a process whereby a proton is transferred from one  higher buffer capacity, lower change in pH.
molecule to another.
 Autoprotolysis  a process whereby there is a transfer of a Maximum Buffer Capacity  occurs when pH = pKa
proton from one molecule to another identical molecule. The Higher the pKa, the stronger the base is.
 Amphoteric  properly where a substance can act either as acid
or base.

Buffers are solutions that have the property of resisting changes in

pH when acids or bases are added to them Pearson’s HSAB principle:
 this property results from the presence of a buffer pair “Hard acids are electron acceptor w/ high positive charges & relatively
which consists of either: small sizes while soft acids have low positive charges & relatively large
-weak acid & some salt of a weak acid sizes. “
/its conjugate base
Solubility of weak acids
 increases as the pH is increased
 in pharmarmecutical formulations may
be affected by the presence of
counterions.
-weak base & some salt of a weak base
/its conjugate acid

Henderson- Hasselbalch equation

aka “Buffe Equation”
pH = pka h log [salt]/[acid] or
pH = pka=log [conjugate base]/[base]
VII. RHEOLOGY
Rheology  Greek terms: rheos “to flow” & logos “study”
 scientific study of the deformation
& flow properties of matter
 elasticity, fluidity, viscosity
Viscosity  measure of the resistance to flow
Absolute Viscosity
Kinematic Viscosity Solids characterized as having fixed shapes
Relative Viscosity  nearly incompressible
Unit: Poise/ Centipoise  have strong intermolecular forces
Stokes/ Centistokes  very little kinetic energy
Methods of Determining Viscosity:  their atoms vibrate in fixed positions about an equilibrium
1. Capillary Viscometer (Ostwald) position, & so there is very little translational motion.
2. Falling Sphere (Hoeppler) (A) Crystalline  the molecules or atoms are arranged in repetitious
3. Cup & Bob (Coutte, Mac Michael, Searle ‘Brookefield – three-dimensional lattice units
rotating spindle/ Bob’ )  have definite geometric froms w/ 6 common
4. Plug Flow crystalline structures
5. Core & Plate (Ferranti-Shirley) Six Distict Crystal System:
Fluidity  reciprocal of viscosity 1. Cubic (sodium chloride) 4. Rhombic (iodine)
Poise  unit used to express kinematic viscosity 2. Tetragonal (urea) 5. Monoclinic (sucrose)
3. Hexagonal (iodoform) 6. Triclinic (boric Acid)
 Newtonian Flow  has linear relationship between shear rate & shear (B) Amorphous  aka “Glasses” or “Supercooled Liquids”
stress  non-crystalline; no definite order
 constant viscosity w/ increasing rate  have no definite & sharp melting points
 example: Water, Ethanol, Acetone,  Examples: Cocoa, Tannins
Glycerin, Benzene
 Non-Newtonian Flow Polymorphs  solids that have more than one crystalline form
A. Shear-dependent Viscosity  have different physical properties including different
1. Plastic Flow  aka Bingham Bodies melting points & solubilities
2. Pseudoplastic  shear-thinning  Examples: Theobroma Oils, Chloramphenicol,
 shear stress; viscosity Carbamazepine
3. Dilatant  shear-thickening 1. Enantiotropic  reversible change from one polymorphic form to
  shear stress;  viscosity another
B. Time-dependent Viscosity 2. Monotropic  transition in one direction only
1. Thixotropy  decreased viscosity w/ increased time of shear 3. Isotropic  properties are identical in all direction
 gel-sol transformation 4. Anisotropic  properties are different in all direction
2. Rheopexy  increased viscosity w/ decreased time of shear
 antithixotropy Amorphous Crystalline
 sol-gel transformation Solubility  
Reactivity  
Stability  
Melting Point  
X-ray Diffraction
 Method used to
differentiate
amorphous vs.
Crystalline “Noise” Definite Peaks
-no definite
peaks

Insulin  Amorphous: Rapid Acting

Crystalline: Long-acting
Amlodipine  Besylate: more stable
(innovator: Norvasc®, Amvasc®)
Camsylate
Cocoa Butter  suppository:  (most stable)
Azithromycin  Monohydrate: Azith®
Dihydarte (more stable): Zthromax®
VIII. MICROMERITICS
Micromeritics  study of small particles
*micro (small)
*meritics (measure)
Types of Properties of Particles:
(1) Fundamental  inherent in all individual particles
 Examples: Size, Shape, Density, Volume B. Porosity  study of voids
(2) Derived  combination of fundamental properties
 Examples: Bulk Density, Granule Volume, Porosity Types of Porosity
A. Particle Size (a) Intraparticle Porosity
Coarse >1000 m 𝑉𝑔 − 𝑉𝑏
%𝑖𝑛𝑡𝑟𝑎 = × 100%
Conventional 50-1000 m 𝑉𝑔
𝑖𝑛𝑡𝑟𝑎
Fine 1-50 m = × 100%
Very Fine 0.1- 1 m 𝑉𝑔
Ultra Fine <0.1 m
(b) Interparticle Porosity
𝑉𝑏 − 𝑉𝑔
Methods of Determining Particle Size %𝑖𝑛𝑡𝑒𝑟 = × 100%
𝑉𝑔
a. Official Method 𝑖𝑛𝑡𝑒𝑟
-Sieve Analysis = × 100%
𝑉𝑏
20
40 (c) Total Porosity
Increase mesh #,
60 𝑖𝑛𝑡𝑟𝑎 − 𝑖𝑛𝑡𝑒𝑟
decrease mesh size %𝑡𝑜𝑡𝑎𝑙 = × 100%
80 𝑉𝑏
Receiver 𝑉𝑏 − 𝑉𝑝
= × 100%
Mesh #: # of square openings per linear inch 𝑉𝑏
*disadvantage: Attribution of Particles
%total≠ % intra + % inter
Sample: 100 g powders cannot be!!
20 5g
40 15g
Smaller – lower Types of Volume:
60 25g
Larger – upper 1. True Volume/ Particle (Vp)
80 35g
CP 20g volume of the particles w/o voids
1. % is smaller than mesh 40 2. Granular Volume (Vg)
25 + 35 + 20 volume of particles + intraparticle spaces
× 100% = 80% volume of intraspace
100
2. % is larger than mesh 60 3. Bulk Volume (Vb)
5 + 15 + 25 volume of particle + intra + inter
× 100% = 45%
100  Vp + intra + inter
3. % is smaller than20 but larger than 80 Vg + inter
15 + 25 + 35
× 100% = 75%
100 C. Properties of Powders for Granulation
1. Fluidity
b. Optical Microscopy  use of a microscope to measure individual Angle of Repose  is the angle assumed by a cone-like pile of
particles powder relative to the horizontal base
 Advantage: Individual Particles can be seen  is a characteristics related to the interparticulate
 Disadvantage: Very Tedious, 2D-image only friction.
Three Measurements:  fixed funnel method
(a) Ferret Diameter  2 tangents separated 𝑕
by the longest distance tan 𝜃 =
𝑟
(b) Martin’s Diameter  distance that will bisect the 𝑜𝑝𝑝𝑜𝑠𝑖𝑡𝑒
𝑡𝑎𝑛𝑔𝑒𝑛𝑡 =
particle into halves 𝑎𝑑𝑗𝑎𝑐𝑒𝑛𝑡
(c) Projected Area of the Cycle  diameter of the circle that 2. Compressibility
will enclose the particles Carr’s Index Hausner’s Ration
c. Sedimentation Method 𝑉𝑜 − 𝑉𝑓 𝑉𝑜
 sedimentation rate or free fall velocity of particles 𝐶𝐼 = × 100% 𝐻𝑅 =
𝑉𝑜 𝑉𝑓
 apparatus: Andreasen Apparatus
 Principle: Stokes Law  Sedimentation Rate is directly Where: Vo= initial volume
proportional to the Density of Vf = final volume
Particle, Diameter of Particle, &
Gravitational pull. O = Vo= Vf (not compres.) >1 Vo >Vf (compressible)
d. Automatic Particles Counters 1-99  = Vo>Vf (compressible) 1 Vo=Vf (not compressible
 Coulter counter 100  =Vf=O <1 Vo<Vf 
Principle: Electric Resistance
HIAC/Royco Instrument
Principle: Light Blockage
Gelman Counter
Principle: Faraday-Tyndall Effect
IX. PHASE EQUILIBRIA

Phase Diagram  represents the states of matter that exist as

temperature & pressure are varied

 Gibb’s Phase Rule  used to determine the number of independent

variables (temp, pressure, conc) that must be set in
order to define a system
 F= C P + 2 (1-component)
 F= C P + 1 (2-component)
 F= C P (3-component)

F = degrees of freedom
C = number of components
P = number of phases

Triple Pointis the temperature and pressure at which the three phases  1-component System
(gas, liquid, and solid) of that substance coexist in
thermodynamic equilibrium.  2-component System
Critical Point a point on a phase diagram at which the liquid and gas  aka “Condensed System”
phases of a substance have the same density, and so are  system in which the vapor phase is ignored & only the solid
indistinguishable &/or liquid phases are considered
 Supercritical Fluid  may be formed when the temperature  under normal condition of 1 atm
& pressure of a liquid go beyond the  Phase Rule: F= C P + 1
critical points  Binodal curve  area within the curve represents a 2-phase
Critical Temperature  the temperature above which a gas cannot be system
liquefied  any point beyond it, is a single phase
Critical Pressure  the pressure to liquefy a gas at its critical temperature Critical Solution Temperature  temperature beyond which
every proportion of A & B will
exist as 1-phase
 maximum temperature to
 Latent Heat/ Molar Heat obtain a one phase system
 heat necessary for 1 mole of a gas, solid or liquid to change to Tie Line  line from which a system separates into phases of
another phase constant composition
 either gained or lost  used to approximate the proportions of components
 NOTE: without latent heat, no phase transition A&B existing at a particular temperature
Heat of Fusion  The heat absorbed as a substance changes phase from Conjugate Phases  phases of constant composition that
liquid to solid separate when a mixture is prepared
 aka solidification within the boundary of the 2-phase system
Heat of Vaporization  heat absorbed when a substance changes Eutectic Point  is the point where solid A, solid B, & the liquid
phase from liquid to gas phase co-exist
Heat of Sublimation  is the amount of heat needed to  3-phase co-exist
change solid to gas Ex of Eutectic Mixture: Camphor + Menthol + Phenol
 3-component System
 aka “Ternary System”
 temperature & pressure are both made constant
 consists of 2 liquids that are partially miscible to each other
& a 3rd component or co-solvent which has affinity to both
immiscible layers
Apex: 100% of each component
Base: opposite the apex; 0% of each component

 Phase  a homogenous, physically distinct portion of a system that

is separated from other portions of the system by bounding
surface
X. CHEMICAL KINETICS

Chemical Kinetics  is the study of the rates of reactions & the

mechanism by which these reactions occur
 Application in pharmacy:
Stability & bioavailability of
pharmaceutical Products

Rate of Reaction  aka “Degradation Rate”

 is the velocity with which the reaction occurs
 depends on:
- Reactant concentration
- Temperature
- pH
- Presence of solvents or additives

Order of Reaction is the way in which the concentration of the drug or
reactant in a chemical reaction affects the rate
 zero-order
 first-order
 second-order

Zero-Order the drug concentration changes with respect to time at

Reaction a constant rate
the rate of reaction is independent of the concentration
of the reactants

First-Order the rate of reaction is dependent on the concentration

Substrate  the interactant whose physical or chemical
Reaction of drug remaining
properties are observed experimentally
most drugs follow this order of reaction
PBE  Proton Balance Equation
Half-life (t1/2) is the period of time required for the amount or
concentration of a drug to decrease by
one-half or 50%
Shelf-life (t90)  is the period of time where 90% of the original
concentration is left & 10% is already degraded
PHARMACEUTICAL JURISPRUDENCE & ETHICS
Introduction:
Jurisprudence Statutory Laws Affect the Pharmacy Profession & Its Practice:
Jurisprudence  is defined as a system of laws. RA 5921 The Pharmacy Law June 23, 1969
 is the science of philosophy of laws (as amended by EO 174)
Legal principles that govern the manner in which in which RA 3720 Foods, Drugs, Devices & Cosmetic Act June 22, 1963
professionals practice can be divided into three basic (as amended by EO 175)
categories: EO 119 Reorganizing the Bureau of Food and Drugs, DOH
1. Statutes laws  laws that have been passed by AO 43 s. 1999 Current Good Manufacturing Practice for Cosmetic
legislative bodies such as the Senate & Products
the Congress. AO 42 s. 1982 Drug Registration of Herbal &/or Traditional Drugs,
 dictate the activities of person subject Both Local & Imported
to the law AO 55 s. 1988 Requirement for Labeling Material of
 enable regulatory agencies to function Pharmaceutical Products
pursuant to the mandate of a AO 64 s. 1989 Amendments of AO No. 55, s 1988
legislative body. AO 56 s. 1989 Revised Regulations for the Licensing of Drug
 provide penalties for whose who fail to Establishments & Outlets
comply with the law. AO 67 s. 1989 Revised Rules & Regulations for Registration of
2. Regulatory law  is promulgated by government Pharmaceutical Products
agencies for the enforcement & AO 4 s. 1992 Policy & Requirements for Availing of
understanding of the law. Compassionate Special Permit for Restricted Use of
3. Common law  encompasses those areas of law that Unregistered Drug & Device Product & Preparation
have evolved over hundred of years of AO 27 s. 2001 Rules & Regulations for Licensing Local
judicial decision. Manufacturers of Vaccines & Biological Products
AO 47-A s. 2001 Rules & Regulations on the Registration, Including
Ethics
Approval & Conduct of Clinical Trials, & Lot or Batch
Ethics  the moral principles of practice
Release Certification of Vaccines & Biologic
 is the science of morality
Products
Objectives of Ethics:
RA 8203 Special Law on Counterfeit Drugs Sept. 4, 1996
1. To make clear to us why one act is better than another
RA 6675 Generics Act of 1988 Sept. 13, 1988
2. To live an orderly social life
3. To appraise & criticize intelligently the moral conduct AO 62 s. 1989 Rules & Regulations to Implement Prescribing
& ethical system; & Requirements under the Generics Act of 1988
4. To seek the value of life. AO 63 s. 1989 Rules & Regulations to Implement Dispensing
Professional Ethics  is a branch of moral science that treats of Requirements under the Generics Act of 1988
the obligations which a member of a AO 90 s. 1990 Amendment to A.O. 62 s. 1989
profession owes to the public to his RA 6425 Dangerous Drug Act March 30, 1972
profession & to his clients. RA 9165 The Comprehensive Dangerous Drug Act of June 7, 2002
Bioethics  is the term used to describe the application o ethics 2002
to biological sciences, medicine & related fields. RA 7432 Senior Citizen Act Feb. 7, 1992
 is a systemic study of moral conduct in life sciences RA 9257 Expanded Senior Citizen Act of 2003 Feb. 26, 2004
& medicines RA 9994 Expanded Senior Citizen Act of 2010 July 27, 2009
Importance of Bioethics: RA 7581 The Price Act May 27, 1992
1. To provide awareness to the health team or workers of RA 7394 Consumer Act of Philippines April 13, 1992
the “do’s & don’t” of medical practice RA 9502 Universally Accessible Cheaper & Quality July 4, 2008
2. To enrich one’s competence by understanding that the Medicines Act of 2008
patient is a person & a holistic individual RA 9711 Food & Drug Administration Act of 2009 June 3, 2009
Universal Principles of Biomedical Ethics: EO 851 abolished FDA & created BFAD
a. Autonomy  a form of personal liberty, where the RA 8293 The Intellectual Property Code of the June 6, 1997
individual is free to choose & implements Philippines
one’s own decisions, free from deceit,
duress, constraint or coercion Other Administrative Orders
b. Veracity  binds both the practitioner & the patient in an AO 107 s. 1991 Guidelines on Dispensing Multiactive-Ingredient
association of truth. Fixed Dose Combination Drug Product
c. Beneficence  acts of mercy & charity or any action that
AO 220 Prescribes the condition & Requirement for GMP
benefits another or apply measures for Production records must be kept for 2 yrs after
the benefits of the sick batch distribution is completed
d. Nonmaleficence  means never to use treatment to Each critical step in production process must be
injure or wrong the sick performed & checked by 2 competent &
e. Confidentiality  is an important aspect of trust that responsible individual.
patients place in health care Other Executive Order
professionals EO 266 Institutionalizes the Continuing Professional
f. Justice  is the concept of fairness, just desserts and Education (CPE) Programs of the various
entitlements. Professional Regulatory Boards (PRBs) under the
g. Role Fidelity  means that the practitioner practice supervision of the Philippine Regulatory
faithfully within the constraints of the role Commission
July 25, 1995
makes CPE mandatory requirement for the
renewal of professional licenses
REPUBLIC ACT NO. 5921 –THE PHARMACY LAW (as amended by EO 174)
Title AN ACT REGULATING THE PRACTICE OF PHARMACY AND SETTING STANDARDS OF PHARMACEUTICAL EDUCATION IN THE
PHILIPPINES AND FOR OTHER PURPOSES,
Objectives To govern:
(a) the standardization and regulation of pharmaceutical education;
(b) the examination for registration of graduates of school of pharmacy and
(c) the supervision, control and regulation of the practice of pharmacy in the Philippines.
Composition of  Secretary of Education,
Council of  Undersecretary of Health Services,
 Food and Drug Administrator
Pharmaceutical  Chairman of the Board of Pharmacy
Education  PRC Pharmacy Board Chairman
 Dean of the College of Pharmacy, representing accredited private schools of pharmacy
 Representative of bona fide national pharmaceutical organization in the Philippines.
Functions of the a) To promulgate rules and regulations relative to Pharmaceutical Education in the Philippines:
Council b) To submit such rules and regulations, which shall have a binding effect, for implementation to the proper agencies such as the
Department of Education, the Board of pharmacy, the bona fide national pharmaceutical organizations in the Philippines and
others;
c) To recognize and accredit colleges of pharmacy in the different private colleges and universities; and
d) To approve the accreditation of community or prescription pharmacies, pharmaceutical manufacturing laboratories and hospital
pharmacies for purposes of pharmacy internship.
Composition of Chairman and two members
Board of Pharmacy
Qualifications of a) A natural-born citizen of the Philippines ;
Board Members b) A duly registered pharmacist and has been in the practice of pharmacy for at least ten years;
c) Of good moral character and of recognized standing in the pharmaceutical profession;
d) At the time of appointment, not a member of the faculty of any school, college or university offering courses in pharmacy or
college of pharmacy; and
e) A member of good standing of any bona fide national pharmaceutical association of the Philippines.
Powers and duties a) To examine applicants for the practice of pharmacy;
of the Board.- b) To issue certificates of registration of pharmacists;
c) To reprimand any pharmacist or to suspend or revoke his certificate of registration on the grounds as provided for in Section
thirteen hereof, after a formal administrative investigation has been conducted by it;
d) To promulgate from time to time the necessary rules &regulation for the effective enforcement of this Act, subject to the
approval of the President upon advice of the Commissioner of Civil Service;
e) To study the conditions affecting the practice of pharmacy in the Philippines;
f) To check the employment of qualified personnel in drug stores, hospital pharmacies, drug or pharmaceutical laboratories and
similar establishments for which the Board may designate inspectors from the Board of Pharmacy; and
g) To encourage the development of botanical gardens and their inspection, particularly the propagation of Philippine medical
plants with the cooperation of the Dept. of Agriculture and Natural Resources.
Grounds for a) Conviction by a court of competent jurisdiction of any violation as penalized in sections forty and forty-one hereof;
reprimand, b) Immoral or dishonorable conduct which includes conviction by a competent court of any criminal offense involving moral
suspension or turpitude;
revocation of c) Fraud or deceit in the acquisition of the certificate of registration;
registration d) Gross negligence, ignorance or incompetence in the practice of this profession resulting in the injury, damage or death of
certificate another;
e) Malpractice, including aiding or abetting the commission of criminal abortion or sex crimes through illegal compounding,
dispensing or sale of abortive or sex drugs, as the case may be;
f) Acting as a dummy of an alien or a person who is not qualified to establish and operate a retail drugstore;
g) Addiction to alcoholic beverage or to any habit- forming drug rendering him incompetent to practice his profession;
h) Insanity;
i) False or extravagant or unethical advertisements wherein other things than his name, profession, limitation of practice, office
and same address and the like are mentioned; and
j) Violations of any provision of the Code of Ethics which may be adopted as part of the Rules and Regulations of the Board.
Candidate for a. He shall be a natural-born citizen of the Philippines.
Board Examination b. He shall be of good moral character;
c. He shall have completed an Internship Program
d. He shall have graduated with a degree of Bachelor of Science in Pharmacy
Ratings required  General average of seventy-five per cent
 No ratings below fifty percent in more than 2 subjects
 Fails to pass in three successive attempts  need to attend a pre-board review course from a duly accredited college of pharmacy
Practice of  Prepare or manufacture, analyze, assay, preserve, store, distribute or sell any medicine, drug chemicals, cosmetics,
Pharmacy pharmaceuticals, devices or contrivances used in pursuance thereof
 Render pharmaceutical service in any office or drug and cosmetic establishment where scientific, technological or professional
knowledge of pharmacy is applied
 Engage in teaching scientific, technological or professional pharmacy subject in a college of pharmacy; or conduct
 Undertake scientific pharmaceutical research for biological and bacteriological testings and examinations.
Prerequisite for  At least twenty-one years of age
the Practice of  Has satisfactorily passed the corresponding examination given by the Board of Pharmacy
Pharmacy  Holder of a valid certificate of registration duly issued to him by said Board.
Definition of terms
a "Pharmacy" or "Drug Store" means a place of establishment where drugs, chemical products, active principles of drugs, pharmaceuticals, proprietary
medicines or pharmaceutical specialties, devices, and poisons are sold at retail and where medical, dental and veterinary
prescriptions are compounded and dispensed.
b. "Drug or Pharmaceutical Laboratory" or "Pharmaceutical Manufacturing Laboratory" means an establishment where pharmaceuticals, propriety
medicines or pharmaceutical specialties are prepared,
compounded, standardized and distributed or sold.
c. "Wholesaler" means and includes every person who acts as merchant, broker or agent, who sells or distributes for resale pharmaceuticals, propriety
medicines or pharmaceutical specialties.
e. "Drug" means (1) Articles recognized in the current official United States Pharmacopoeia or the United States Official National Formulary(USP-NF),
official Homeopathic Pharmacopoeia of the United States, official National Drug Formulary, or any supplement to any of them; and
(2) articles intended for use in the prevention of disease in man or animals;
(3) articles (other than food) intended to affect the structure or function of the body of man or animals; and articles intended for use as
a component of any articles specified in clauses (1), (2) or (3), but do not include devices or their components, parts or accessories.
f. "Pharmaceuticals", "Proprietary Medicines" or "Pharmaceutical Specialties" means any drug, preparation or mixture of drugs marked under a trade
name and intended for the cure, mitigation, treatment, or prevention of
disease in man or animals.
g. "Device" means instrument, apparatus, or contrivances including their components, parts and accessories, intended
(1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; or
(2) to affect the structure or any function of the body in man or animals.
h. "Biological Products" are viruses, sera, toxins and analogous products used for the prevention or cure of human diseases.
i. "Poison" is any drug, active principle or preparation of the same, capable of destroying life or seriously endangering health when applied externally to
the body or introduced internally in moderate doses.
j. "Cipher" means a method of secret writing that substitutes other letters or characters for the letter intended or transpose the letter after arranging them
in blocks or squares.
k. "Code" means a system of words or other systems arbitrarily used to represent words.
l. "Secret Keys" means characteristics styles or symbols kept from the knowledge of others or disclosed confidentially to but one or few.

 Detailman  represents any duly authorized manufacturer, dealer, distributor, representative or wholesaler of drugs, pharmaceuticals & biologic
products whose primary duty is to introduce the product made by the manufacturer
 graduate of a College of Pharmacy
 an initial fee of 150 pesos is needed upon registration
 to be employed, he needs to possess the necessary credentials issued by the Board of Pharmacy
 Administrative Investigation shall be conducted by all members of the BOP. In case of suspensions, it shall be for a period of not more than 6 months.
 The BOP, upon receipt of a formal complaint under oath against a pharmacist, shall furnish the latter a copy of the complaint which he shall answer
within 10 days from receipt.
 All prescriptions shall be attached to the prescription book & numbered consecutively & shall be preserved for two years.
 Record for sale of poisons must be kept for a period of 5 years.

Provisions Relative to Dispense of Violent Poisons  Every pharmacist who dispenses, sells or otherwise delivers any of the violent poisons intended for
medicinal use, to wit:
1. Arsenical preparations
2. Phosphorus
3. Corrosicve Sublimate
4. Atrophine
5. Strychnine
6. or Any of their salts
7. Hydrocyanic acid or Prussic acid
8. Oil of Mirbane (Nitro-benzene)
Label: Red Paper w/ the word “Poison” in large letters & a vignette representing a skull & bones.
The books kept for the purpose of recording the sale of poison & shall be preserved for a period of at least 5 years.
REPUBLIC ACT No. 3720 –FOOD, DRUGS, DEVICES, & COSMETICS ACT (as amended by EO 175)
Title AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS BEING MADE AVAILABLE TO THE PUBLIC BY
CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO.
Objectives a) Establish standards and quality measures for foods, drugs, and devices and cosmetics.
b) Adopt measures to ensure pure and safe supply of foods and cosmetics, and pure, safe, efficacious and good quality drugs and
devices in the country.
c) Adopt measures to ensure the rational use of drugs and devices.
d) Strengthen the Bureau of Food and Drug
FDA Functions  To administer and supervise the implementation of this Act and of rules and regulation issued pursuant to the same.
 To provide for the collection of samples of food, drug and cosmetic.
 To analyze and inspect food, drug and cosmetic in connection with the implementation of this Act.
 To establish analytical data to serve as basis for the preparation of food, drug and cosmetic standards, and recommend standards of
identity, purity, quality and fill of container.
 To issue certificate of compliance with technical requirements to serve as bases for the issuance of license and spot-check for
compliance with regulations regarding operation of food, drug and cosmetics manufacturers and establishments.
 To levy, assess and collect fees for inspection, analysis and testing of products and materials submitting in compliance with the
provisions of this Act.
 To certify batches of antibiotics and antibiotic preparations
FDA Divisions  Inspection and Licensing Division
 Laboratory Division
Adulterated Drugs  If it consists in whole or part of any filthy, or decomposed substances
or Devices  It has been manufactured, prepared or held under unsanitary conditions
 It is composed of any poisonous or deleterious substances
 It contains any color other than a permissible one
 It purports to be an official drug and its strength differs from, or its safely, efficacy, quality or purity falls below the standards set
forth
 It has been mixed or packed or substituted so as to reduce safety, efficacy, quality, strength or purity
 Methods, facilities or controls used do not conform to current good manufacturing practices
Misbranded Drugs  Labeling is false or misleading
and Devices  It did not contain (a) the name and place of business of the manufacturer, importer, packer, or distributor, and
(b) an accurate statement of the quantity of contents in terms of weight, measure or numerical count.
 If any word or information required is not prominently placed with conspicuousness
 If it is for use of man and contains any quantity of narcotic or hypnotic substances
 It is not designated solely by a name recognized in an official compendium
 Unless its labeling bears (a) adequate directions for use, and
(b) such adequate warnings against use
 It purports to be the drug the name of which recognized in an official compendium
 It has been found to be a drug liable to deterioration unless its label bears a statement of precautions
 Its container is so made, formed of filled as to be misleading
 It is an imitation of another drug
 It is offered for sale under the name of another drug
 It is dangerous to health when use in dosage recommended or suggested in the labeling
 If it purports to be, or is represented as a drug composed wholly or partly
Definition of terms
(a) "Bureau" means the Bureau of Food and Drugs.
(b) "Secretary" means the Secretary of Health.
(c) "Department" means the Department of Health.
(d) "Person" includes individual, partnership, corporation and association.
(e) "Food" means (1) articles used for food or drink for man,
(2) chewing gum, and
(3) articles used for components of any such article.
(f) "Drugs" means
(1) articles recognized in the current official United States Pharmacopoeia-National Formulary (USP-NF), official Homeopathic Pharmacopoeia of the
United States, official National Drug Formulary, or any supplement to any of them: and
(2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than
food) intended to affect the structure of any function of the body of man or animals; and (4) articles intended for use as a component of any
articles specified in clauses (1), (2), or (3) but do not include devices or their components, parts or accessories.
(g) "Device" means instruments, apparatus, or contrivances, including their components, parts, and accessories, intended
(1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; or
(2) to affect the structure or any function of the body of man or animals.
(h) "Cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any
part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and
(2) articles intended for use as a component of any such articles.
(i) "Label" means a display of written, printed, or graphic matter upon the immediate container of any article and a requirement made by or under
authority of this Act that any word, statement, or other information appearing on the label shall not be considered to be complied with unless
such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such
article, or is easily legible through the outside container or wrapper.
(j) "Immediate container" does not include package liners.
(k) "Labeling" means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or
(2) accompanying such article.
l) "New drugs" mean:
(1) any drug the composition of which is such that said drug is not generally recognized among experts qualified by scientific training and experience to
evaluate the safety, efficacy, and quality of drugs as safe, efficacious and of good quality for use under the conditions prescribed, recommended,
or suggested in the labeling thereof.
(2) Any drug the composition of which is such that said drug, as a result of previous investigations to determine its safety, efficacy and good quality for
use under certain conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent
or for a material time under new conditions.
(3) "New drugs" shall include drugs
(a) containing a newly discovered active ingredient;
(b) containing a new fixed combination of drugs, either by molecular or physical combination;
(c) intended for new indications;
(d) in an additional new mode of administration; or
(e) in an additional dosage of strength of the dosage form, which meets the conditions as defined under the new drug.
The definition of "new drugs" covers, to the extent applicable, "new devices."
(n) "Food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming
a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing,
manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation
intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience
to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended
use.
o) "Batch" means a quantity of any drug or device produced during a given cycle of manufacture.
p) "Batch number" means a designation printed on the label of a drug or device that identifies the batch, and permits the productions history of the batch
including all stages of manufacture and control, to be traced and reviewed.
q) "Director" means Director of Bureau of Food and Drugs.
r) "Distribute" means the delivery or sale of any drug or device for purposes of distribution in commerce, except that such term does not include a
manufacturer or retailer of such product.
s) "Expiry or expiration date" means the date stated in the label of a drug or device after which the drug is not expected to retain its claimed safety,
efficacy and quality or potency or after which it is not permissible to sell the drug or device.
t) "Export" means to bring out of the Philippines by sea, land, or air.
u) "Import" means to bring into the Philippines by sea, land, or air.
v) "Manufacture", in relation to a drug, or device where applicable, means any and all operations involved in the production of a drug or device including
propagation, processing, compounding, formulation, filling packing, repacking, altering, ornamenting, finishing and labeling with the
ends in view of its storage, sale or distribution; Provided, that the term shall not apply to the compounding and filling of prescriptions
in drugstores and hospital pharmacies.
w) "New veterinary drugs" means drugs intended for use of animals including any drug intended for use in animal feeds but not including animal feeds
within the contemplation of the implementing rules and regulations.

Office Order No. 1 Series of 1988

Subject IMPLEMENTATION OF EXECUTIVE ORDER NO. 119, REORGANIZING THE BUREAU OF FOOD & DRUGS, DEPARTMENT OF HEALTH
Organization of 1) Office of the Director 5) Laboratory Services Division 7) Administrative Division
the BFAD  Director  Physico-Chemical Section  Planning & Budget Section
 Drug Information Unit  Microbiological section  Personnel Section
2) Regulation 1 (Outlets)  Toxicology Section  Cash Collection & Disbursement
 Inspection Section  Research Section Section
 Licensing Section  Experimental Animal Section  Accounting Section
3) Regulation 2 (Manufacturer) 6) Legal, Information, & Compliance  Supply & Property Section
 Inspection Section Division  Records & Communication
 Licensing Section  Legal, Research, & Investigational Section
4) Product Services Division Section  Building & facilities Maintenance
 Food Product Section  Public Assistance, Information & Section
 Drug & Medical Device Compliance
Product Section  Advertising & Promotion Section
 Cosmetic Product Section
 Household Hazardous
Substances Section
Regulation 1 Plans, directs & supervises the implementation of rules, regulations and standards operating procedures in inspections & licensing
(Outlets) of the following establishments:
A. Retail Drugstores D. Drug Department
B. Hospital Pharmacies  General Wholesaler
C. Retail Outlets For Non-Prescription Drugs  Distributor, Importer, Exporter Finished Products
E. Retailer Of Household Hazardous Substances
F. Distributor/ Importer/ Exporter Of Finished Food Products
Regulation 2 Plans, directs & supervises the implementation of rules, regulations and standards operating procedures in inspections & licensing
(Manufacturer) of the following establishments:
A. Drug Manufacturer D. Drug Department
B. Dug Assay Laboratory Importer/ Export In Bulk
C. Drug Producer Distributor/ Importer/ Exporter , which is at the same time a manufacturer
E. Food & Food Products Manufacturer/ Processor
F. Cosmetic Manufacturer
G. Household Hazardous Substance Manufacturer
ADMINISTRATIVE ORDER No. 55 s. 1988
Subject REQUIREMENTS FOR LABELLING MATERIALS OF PHARMACEUTICAL PRODUCTS
General Requirements
The minimum mandatory information that shall be included in the
labelling materials are:
1. Name of the product (Generic name alone or with Brand name, as
the case may be)
2. Dosage form and strength
3. Pharmacologic category
4. Rx symbol, in case of prescription drugs
5. Name and complete address of manufacturer and trader, when
applicable
6. Net content
7. Formulation
8. Indication(s)
9. Contraindication(s), precaution(s), warning(s)
10. Mode of administration/directions for use
11. Batch and lot number
12. Expiry/ expiration date and date of manufacture
13. Registration number
14. Storage conditions
15. For Rx products: Foods, drugs and devices and Cosmetic Act
prohibits dispensing without prescription
All information required to appear on the label must be:
a. Written in English or Filipino
b. Clearly and prominently displayed
c. Readable with normal vision without straining. The color contrast, the
position and spacing of the information must be taken into consideration
in complying with labeling requirements.
Specific Requirements
Rx symbol  should be printed in a type size no less than one fifth (1/5)
of the height of the principal displayed panel.
Formulation
 Active ingredient(s) must be stated in their generic names (INN).
 The amounts of the active ingredient(s) shall be expressed in the
metric system or unit of potency, when applicable, as specified in the
official compendia.
 The salt or chemical form(s) of active ingredient(s) must be stated,
when applicable.
 Multiple components must be enumerated in the order of decreasing
pharmacologic activity, when applicable.
Preparations using isoprophyl alcohol must be indicated on its label the
following additional information:
1) "For use in the hospital or sickroom as a rundown or for general
massage purposes. This compound made from isopropyl alcohol does
not contain nor is it offered as a substitute for ethyl or grain alcohol."
2) "FLAMMABLE."
3) "WARNING: For External Use Only." (To be printed in red color) and
also, "Keep out of reach of Children."
Batch/Lot Number
 The batch and/or lot number must be printed on each strip of ten
(10) blister units.
Expiry/Expiration Date
The expiry or expiration date shall be expressed in terms of the month
and the year. In such cases, the last day of the month is assumed as
the expiration date.
Biological Products
 The name and proportion of any antimicrobial agent in the product.
 The name of any adjuvant in the product or any substance which,
when administered with an antigen, modifies the immune response
to that antigen.
 The name of the species of animal or organism from which the
product has been prepared.
 For monoclonal antisera, the name of the species source
 For viral vaccines produced in animal cells or cell cultures, the name
of the cell culture substrate
 The potency of biological products shall be expressed as potency unit
or weight of active substances per dose.
 The potency unit to be used shall be the International Unit has been
established.
 Date of manufacture which pertains to the date (month and year)
The principal display panel must:
a. Contain the particulars required under 2.1.1 to 2.1.6
b. Comprise 40% of the total surface of the container, except in
the case of the rectangular container where the total area of
the principal display panel must equal to the product of the
height and width of the entire side of the container. For any
other shaped container presenting an obvious principal display
panel such as the top of a triangular or circular container, the
size of the area shall consist of the entire top surface.
On the label of the immediate container outside of the principal display
panel will appear the following information:
 Formulation
 Indication(s)
 Mode of administration/directions (s) for use
 Batch and lot number
 Expiry/ expiration date and date of manufacture
 Registration number
 Storage conditions
 For Rx: Foods, Drugs and devices and Cosmetic Act prohibits
dispensing without prescription
Other information and additional detail shall appear on the other
labeling materials such as inserts/leaflets or wrapper cartons.
Injections
 The name and quantity of all excipients in the product except
where Section 6 applies.
 Recommended routes of administration such as "intravenous",
"intramuscular", or "subcutaneous".
 Where an antimicrobial agent is not included in the product, the
words "Use only once or discard any remaining portion"
 Where the contents of the container are to be used on one
occasion only, the words "single use" or "single dose".
 Where the products consist of a concentrated solution for
injection, a direction not to administer the solution undiluted and
a direction to dilute the solution with the specified diluents to the
appropriate volume before use.
Large Volume Injections
 The names and quantities of all excipients and active substances in
the nominal volume of fluid in the container, listed in descending
order of magnitude within each group of chemically similar
substances.
 Where one or more substances are amino acids and/or protein, a
statement of the total amount of nitrogen in the nominal volume
of fluid in the container.
 The nominal osmolality.
 A statement which specifies whether the solution is nominally
"hypotonic" or "hypertonic".
 The nominal pH range of the solution.
 The words "single use" or "single dose".
Products for External Use
 "FOR EXTERNAL USE ONLY" printed in red color must appear on
the principal display panel of the label.
Small Containers
 Capacity of 10 milliliters or less and the container is enclosed in a
primary pack.
Exempted from Complying w/ the labeling Requirement:
 If the products are enclosed in a transparent covering
 If the products are compounded by the pharmacist
 If the products are used solely for investigational use
 If the products are donated by foreign agencies

Definition of Terms
1. "Labeling materials" includes the label on the immediate container, and the other printed materials that are made available with the product at the
time of purchase and/or where the product is used, such as the outer wrapper cartons, leaflet/package insert accompanying the
product, which provide the accurate and necessary detailed information for the identification and proper used of the product.
2. "Product" refers to pharmaceutical products which mean any pharmaceutical or biological product intended for used in the diagnosis, cure mitigation,
treatment or prevention of disease in human, or to affect the structure or any function of the human body.
3. "Brand Name" refers to the proprietary/trade name assign to the product by the drug establishment.
4. "Generic Name” refers to the identification of drugs and medicines by their scientifically and internationally recognized active ingredients determined
by the Bureau of Food and Drugs of the DOH.
5. "Pharmacologic category" refers to the classification of the product based on its therapeutic action as specified in the product registration.
6. "Formulation" refers to the name (s) and amount (s) of active medicinal ingredients per dosage unit expressed in the metric system.
7. "Indication" refers to the approved clinical use of the product based on substantial and scientifically supported evidence of the safety and efficacy of
the drug in the given dosage form.
8. "Dosage Form" means the pharmaceutical form of the preparation based on official pharmacopoeia.
9. "Mode of administration" refers to the site and manner the product is to be introduced in to or applied on the body.
10. "Warnings" refers to statements regarding the occurrence of potential hazards and side effects associated with the use of the product and the
limitation of its use.
11. "Contraindications" refers to statements regarding the conditions wherein the use of the product may cause harm to the patient.
12. "Precautions" refers to the instruction and special care required in the used of the product to avoid undesired effects and to ensure the safe and
effective use of the drug.
13. "Date of manufacture" for products other than biological products means the date (month and year) during which processing of the bulk product,
from which the goods are to be filled, is completed.
14. "Batch number" refers to any distinctive combination of letters and/or numbers, assigned to a particular batch herein defined as any product
produced during a given cycle of manufacture. The batch number permits the production history of the batch including all stages of
manufacture and control, to be traced and reviewed.
15. "Lot number or Control number” refers to any distinctive combinations of letters and/or numbers assigned to a particular lot, herein defined as a
portion of a batch.
Lot  means a batch or any portion of a batch of a drug produced by a continuous process, an amount of drug produced in a unit time or
quantity in a manner that assures its uniformity & in either case which is identified by a distinctive lot umber & has uniform character &
quality within specified limits
16. "Expiration” or "expiry date” refers to the date after which the product is not expected to retain its claimed safety, efficacy and quality or potency or
after which it is not permissible to sell, distribute or use said product.
17. "Net Content" refers to the total amount/quantity/number of the dosage form in a certain container of a product expressed in metric system.
18. "Storage condition" refers to the prevailing specified range temperature, humidity and other environmental factors within which optimal stability of
the product is ensured based on laboratory data.
19. "Principal display panel" refers to the part of a label that is most likely to be displayed, presented, shown or examined under customary condition of
display for retail use.
20. "Area of the principal display panel" refers to the area or surface of the container/package where the principal display panel is located.
21. "Primary pack" is the first pack containing the individually wrapped products, strip blister packs.

ADMINISTRATIVE ORDER No. 64 s. 1989 : Amendments of AO No. 55 s. 1988

List A (Annex A)
List of Pharmaceutical Products classified as Prohibited or Regulated by the DDB:
I. Prohibited Drugs II. Regulated Drugs
1. Alfentanil A. Available in the Market B. Not available in the Market
2. Codeine Sulfate 1. Amobarbital 1. Aobarbital
3. Codeine Phosphate 2. Amphetamine 2. Butabarbital
4. Dihydrocodeine 3. Barbital 3. Ethchlorvynol
5. Fentanyl Citrate 4. Chloral Hydrate 4. Pentobarbital/ Hydrocodone
6. Hydrocodone 5. Dexamphetamine 5. Mecloqualone
7. Morphine 6. Ephedrine 6. Methamphetamine
8. Opium 7. Ethinamate 7. Methaqualone/ Diphenhydramine
9. Opium/ Alcohol (Elixir Paregoric) 8. Flunitrazepam 8. Methylprylon
10. Pethidine (Meperidine) 9. Nitrazepam 9. pentobarbital
10. Paraldehyde 10. Pipradol
11. Pentozocine 11. Secobarbital
12. Pentothal
13. Propoxyphene
14. Pseudoephedrine
15. Heroin
List B
List of Products Requiring Strict Precaution in Prescribing, Dispensing, & Use
ADMINISTRATIVE ORDER No. 56 s. 1989
Subject REVISED REGULATIONS FOR THE LICENSING OF DRUG ESTABLISHMENTS AND OUTLETS
DRUG ESTABLISHMENTS  means any organization or company involved in the manufacture, importation, repacking, and/or distribution of drugs or
medicine
Types of Drug Establishments
Drug Manufacturer means any establishment engaged in operations involved in the production of a drug, including propagation, processing,
compounding, finishing, filling, packing, repacking, altering, ornamenting and labeling with the end in view of storage, distribution
or sale of the product: provided that for the purpose of this regulation the compounding and filling of prescriptions in drugstores
and hospital pharmacies shall not be considered as production operations.
Drug Trader means any establishment which is a registered owner of the drug product, procures the materials and packaging components, and
provides the production monographs, quality control standards and procedures, but sub-contracts, the manufacture of such product to a
licensed manufacturer. In addition, a trader may also engage in distribution, and/or marketing of its products.
Drug Distributor/Importer means any establishment that imports raw materials, active ingredients and/or finished products for its own use or for
wholesale distribution to other drug establishments or outlets.
Drug Distributor/Exporter means any drug establishment that exports raw materials, active ingredients and/or finished products to another country.
Drug Distributor/Wholesaler means any drug establishment that exports raw materials, active ingredients and/or finished products from local
establishments for local distribution on wholesale basis.
General Requirements
Application – any person desiring to operate or establishment a drug establishment shall file with the BFAD an application supported by the following
documents:
A standard petition form containing among others the name, age, citizenship and a passport size picture (5x5) of the petitioner
1. Proof of registration as an establishment, i.e.:
a) For single proprietorship an authenticated photocopy of the certificate of Business Name Registration issued by the Bureau
of Domestic Trade (BDT) of the Department of Trade and Industry.
b) For partnership, corporations and other juridical persons authenticated photocopies of the Certificate of Registration
issued by the Securities and Exchange Commission (SEC) and the Articles of Incorporation of Partnership.
2. A valid Certificate of Registration of the Establishment’s Filipino Pharmacist issued by the Professional Regulation Commission (PRC).
3. A Certificate of attendance to a BFAD – sponsored /accredited seminar on Licensing of Drug Establishments.
4. An affidavit of Undertaking providing that the applicant shall:
a) change the establishment's name if there is already a validly registered name similar to it.
b) display the duly approved LTO in a conspicuous place within the establishment.
c) notify BFAD in case of any change in the circumstances described in the application such as: change of location, change of
pharmacist, change in drug products.
5. List of products to be manufactured or distributed identified by their generic names and brand names if any.
6. An authenticated photocopy of contract of Lease for the space to be occupied if the applicant does not own it.
A certificate of continuing compliance with specific technical requirements (to be specified by BFAD according to section 2.2 below).
A Batch Distribution Record Book duly registered with BFAD.
A contingency plan or procedure for a systematic, effective and prompt recall in case any of its products is found violative and ordered recalled
from the market by the BFAD.
An orderly and secure system of filling up to date invoices from suppliers and buyers
Renewal of License to Operate (LTO)
The License to Operate shall have the following validities for all categories of drug establishments:
▪Initial Period (Initial Application) 1 year
▪Subsequent Period (Renewal Application) 2 years
At least one month prior to the expiration of the LTO, drug establishments shall apply to renew their license.
In considering the renewal application, BFAD shall ascertain the continued compliance by the establishment
The following grounds shall be Basis for Non-Renewal of LTO:
▪Failure to comply with BFAD standards and requirements.
▪Serious, repeated or rampant violation of existing laws, rules and regulations.
▪Persistent shortenings in demonstrating a capacity to perform in a manner that satisfactorily assures the safety, efficacy
and quality of its drug products.
Administrative Sanctions
Grounds for Revocation of LTO
▪Misrepresentation of any material fact in the application for LTO and in any documentation used as a basis for issuing the LTO.
▪For manufacturer and traders: any deficiency in GMP that is likely to result in adulterated, misbranded, substandard or unsafe products as
determined by BFAD. This includes among others, grossly inadequate premises, lack of key technical and professional personnel, lack of
key equipment in production or quality control, poor or inadequate process control and inadequate or improper documentation of the
production process.
▪For distributors: distribution of fake, misbranded, adulterated or unsafe drug products.
▪Violation of BFAD standards of quality, efficacy, purity and safety of drug products.
▪Sale or distribution of antibiotic products without batch certification by BFAD.
▪Failure to take adequate remedial or corrective measures for deficiencies identified in accordance with requirements of BFAD.
▪Failure to keep up to date, secure, orderly, and easily inspected records that would indicate continued compliance with standards.
Grounds for Suspension of LTO
▪Minor deficiencies in GMP or material management that need to be corrected but are not immediately or likely to result in adulterated,
misbranded, substandard or unsafe products as determined by BFAD. This includes, among others, poor housekeeping, inadequate
storage facilities, lack of minor equipment or requirement and other minor shortcomings.
▪Lapses in record keeping of invoices, receipts or distribution records.
Re-application after Revocation
No establishment whose LTO was revoked may apply for an LTO within 5 years after the revocation of its license.
DRUG OUTLETS  means drugstore, pharmacy and other business establishment w/c sells drugs or medicine

Types of Drug Outlets

Drugstores, Pharmacy or Botica, including Hospital Pharmacy/Dispensary means a drug outlet where registered drugs, chemical products, active
principles, proprietary medicines or pharmaceutical specialties and dental medicinal, galenical or veterinary
preparations are compounded and/or dispensed.
Retail outlet for non-prescription drugs including non-traditional outlets such as supermarkets and stores, means a drug outlet where registered non-
prescription or Over-the-Counter (OTC) drugs are sold in their original packages, bottles or containers or in
smaller quantities not in their original containers.
Specific Requirements:
Drugstore, Pharmacy or Botica
A. Premises
▪ A signboard in front of the place of business bearing the registered
name of the drugstore.
▪ A well-ventilated area not less than 15 sq. m. in floor area with
concrete, tile or wooden flooring.
▪ A place suitable for compounding prescription and for washing and
sterilizing bottles (compulsory only for hospital pharmacy)
▪ A suitable and proper place for the adequate storage of drugs and
biological products as specification in the label.
▪ A suitable cabinet for hanging poisons and/or dangerous drugs.
B. Reference Books and Documents
▪ Philippine National Drug Formulary (when available)
▪ United States Pharmacopoeia/National Formulary (USP-NF) (latest
edition)
▪ R.A. 3720, otherwise known as the Food, Drugs, and Devices and
Cosmetics Act as amended and relevant implementing rules and
regulations.
▪ R.A. 6675, Generic Act of 1988 and relevant implementing rules
and regulations.
▪ R.A. 5921 Pharmacy Law, as amended and relevant rules and
regulations
▪ Remington’s Pharmaceutical Sciences (latest edition)
▪Goodman and Gillman Pharmacological Basis of Therapeutics
(Latest Edition)
C. Record Books Duly Registered with the BFAD
▪ Prescription
▪ Dangerous Drug Book
▪ Exempt Preparation Book
▪ Poison Books
▪ Record Book for Selected Non-Prescription Drugs, subject to abuse
as determined by BFAD and/or Dangerous Drugs Board (DDB)
D. Utensils, Apparatus and Other Equipment
▪ For all drugstores including hospital pharmacies, refrigerator for
biologicals and other drug products needing refrigeration.
▪ For hospital pharmacy only:
-Prescription balance of one centigram sensitivity and a set of
weights.
-Glass volumetric measures a set of not less than six pieces from
15 ml to 1000 ml capacity.
-Mortar and pestle - a set of not less than three in assorted
sizes.
E. A full-time validly registered pharmacist physically present while the
drugstore is open to business.
F. Other additional Requirements
▪ Invoices indicating the lot number or batch number of the
manufacturer's stock pursuant to BFAD Memo. Circular No. 001
s. 1983.
▪ File of prescriptions filled consecutively numbered
▪ Dry Seal or rubber Stamp containing the name and address of the
drug outlet.
▪ Red and White labels indicating name and address of drugstore.
Retail Outlets for Non-Prescription Drugs
A. Premises
▪ A signboard in front of the place of business bearing the registered
name of retail outlet and the symbol non-Rx or equivalent.
2.2.2.1.2. An adequate, well ventilated area with concrete, tile, or
wooden flooring.
▪ A suitable and proper place for the adequate storage of
nonprescription drugs. When there are products sold other than
drugs, area exclusively for drug products shall be allocated within
the premises.
B. Reference Books and Documents
▪ Philippine National Drug Formulary (when available)
▪ R.A. 5921 Pharmacy Law and implementing rules and regulations
▪ R.A. 6675, Generics Act of 1988 and relevant implementing rules
and regulations.
▪ R.A. 3720, as amended or Food, Drugs, and Devices and Cosmetics
Act as amended and relevant implementing rules and regulations
C. Record Book as required by BFAD for selected non-prescription drugs
subject to abuse as determined by BFAD and/or DDB.
D. A full-time validly registered pharmacist physically present while the
retail outlets is open for business.
E. Other Additional Requirements
▪ Invoiced indicating the lot number or batch number of the
manufacturer's stock pursuant to BFAD Memo Circular No.
001 s. 1988
▪ Dry Seal or Rubber Stamp containing the name and address of the
drug outlet.
F. Renewal of License to Operate (LTO)
▪In case of renewal of LTO the drug outlet must have a history of
satisfactory performance, consistent with BFAD standards and
requirements, without any cases of serious violation of laws, rules
and regulations.
G. Administrative Sanctions
▪ Temporary Closure
-Absence of pharmacist on three (3) inspections by BFAD
inspector.
▪ Suspension of License to Operate
-Failure to produce invoices and receipts together with1st
numbers, expiry dates for the drugs in stock.
-Failure to properly record and keep a file of all prescriptions
filled in the last two years.
-Refusal to allow entry of BFAD inspectors.
▪ Revocation of License to Operate
-Sale or offer for sale of adulterated, misbranded, sub-
standard, unregistered expired and/or unsafe drugs or
products marked
"Not for Sale". 4.3.2. Failure to properly record
dangerous drugs as determined by DDB.
-Lack of pharmacist.
-Failure to take necessary remedial or corrective measures
within the prescribed period
ADMINISTRATIVE ORDER No. 67 s. 1989
Subject REVISED RULES AND REGULATIONS ON REGISTRATION OF PHARMACEUTICAL PRODUCTS
DEFINITION OF TERMS
1.1. "Registration" means the process of approval for the manufacture, importation, exportation, sale, offer for sale, distribution or transfer of
pharmaceutical products containing active ingredients) of known chemical structure and properties determined to be safe,
efficacious and of good quality according to standards of BFAD.
1.2. "Pharmaceutical Product" means any pharmaceutical or biological product containing active ingredients responsible for its desired effect intended
for use in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or function of the
body of man or animal.
1.3. “Drug for General Use" is a drug approved for sale to the general public without restriction other than the usual.
1.4. “Drug for Restricted use" is a drug approved for sale to the general public under certain conditions.
GENERAL STANDARDS (Requirement for product registration)
CLASSIFICATION
All pharmaceutical products shall be evaluated and registered on the basis of specific requirements and standards pertinent to such classification of
such products. All registered drug products shall be classified in terms of each of the following six categorizations:
3.1. Number of Active Ingredients
3.1.1. Single Ingredient
3.1.2. Fixed-dose combination of two or more ingredients
3.2. Available scientific evidence and experience on the drug's use
"Investigational Drug" refers to a new chemical or structural modification of a Tried and Tested or Established Drug proposed to be used
for a specific therapeutic indication. An investigational drug needs further clinical pharmacology studies (Phase I, II
or III) to determine its safety and efficacy, and meets the requirements of a new drug.
"New Drug" refers to a new chemical or structural modification of a Tried and Tested or Established Drug proposed to be used for a
specific therapeutic indication, which has undergone adequate clinical pharmacology Phase I, II and III studies but which
needs further Phase IV Clinical Pharmacology studies before it can be given regular registration.
"Tried and Tested Drug" is a drug which has been used for at least five (5) years and involving at least 5,000 patients.
"Established Drug" is a drug the safety and efficacy of which has been demonstrated through long years of general use and can be found
in current official USP-NF, and other internationally-recognized pharmacopoeia.
3.3. Pharmacologic/therapeutic category as specified in the Philippine National Drug Formulary
3.4. Source or circumstances of drug production
3.4.1. Imported as finished
3.4.2. Locally manufactured from imported materials
3.4.3. Locally manufactured from local materials
3.5. Brand identification and patent protection of the drug
3.5.1. Branded and patented
3.5.2. Branded and off patent
3.5.3. Unbranded and off-patent (generic drug)
3.6. Prescribing and dispensing regulations applicable
3.6.1. Over-the-counter (OTC) Drug or Non-Prescription
3.6.2. Ethical or Prescription Drug
3.6.3. Dangerous Drugs (List-A Drugs)
3.6.4. Drugs requiring strict precaution in prescribing and dispensing (List-B Drugs)
REQUIREMENTS AND STANDARDS FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS
Human Studies:
1. Clinical pharmacology
Phase I (tolerance and safety)
Phase II (safety and efficacy)
Phase III (controlled clinical trials)
Phase IV (provisional monitored release/post-marketing surveillance)
2. Bioavailability
3. Bioequivalence
ADMINISTRATIVE ORDER No. 42 s. 1982
Subject REGULATION PART C-10: DRUG REGISTRATION OF HERBAL AND/OR TRADITIONAL DRUGS BOTH LOCAL AND IMPORTED
Herbal and/or traditional drug means:
1. Articles recognized in the Philippine National Formulary
2. Articles intended for use in the diagnosis, cure mitigation, treatment or prevention of disease in man.
3. Articles (other than food) intended to affect the structure or any function of the body of man.
4. Articles intended for use as a component of any article specified in clause (1) (2) or (3).
The application for registration of herbal and/or traditional drug both local and importer shall be accompanied by the following requirements:
For locally manufactured herbal and/or traditional drug.
1. Application letter from the manufacturer
2. Full list and amount of all ingredients used as component of the finished product.
3. Technical specification of all the ingredients used as component.
4. Technical specification of description of the finished drug product.
5. Labels, labeling materials, package insert, brochures and other advertising materials to be used with the drug product.
6. Sufficient sample for laboratory analysis.
For foreign manufactured herbal and/or traditional drug product.
1. Application letter from importer attesting importation of the drug product.
2. Government certificate of clearance, acceptance or registry and free sale from the country of origin and duly authenticated by the territorial
Philippine Consulate.
3. Government certificate attesting the status of the manufacturer, competency and reliability of the personnel and facilities and duly
authenticated by territorial Philippine Consulate.
4. Some requirements enumerated in locally manufactured herbal and/or traditional drug product.
Quality Control Requirements (FDA Analysis):
1. Tests for the presence of synthetic drugs: 4. Analysis for impurities
a) Aspirin 5. Tablets
b) Acetaminophen a) Weight variation
c) Dipyrone b) Disintegration
d) Phenylbutazone c) Dissolution for pure active ingredient
e) Pyrazolone d) Content uniformity
f) Corticosteroid e) Hardness
g) Anabolic steroids 6. Liquids, suspensions, or syrups
h) Gonadal hormones a) Suspendibility
2. Test for the presence of heavy metals b) Homogeniety
a) lead c) Viscosity
b) mercury d) Standard plate count
c) arsenic e) Coliform count
d) cadmium f) Yeast count and mold count
3. Test for alcohol content – should not be more than 10% 7. Ointments, creams and other Semi-solid preparation
a) Impalpability
b) Homogeniety
c) Melting point
d) Sterility for ophthalmic preparations
8. Suppositories and pessaries melting point.
ADMINISTRATIVE ORDER No. 47-a , series of 2001
Subject RULES AND REGULATIONS ON THE REGISTRATION, INCLUDING APPROVAL AND CONDUCT OF CLINICAL TRIALS, AND LOT OR BATCH
RELEASE CERTIFICATION OF VACCINES AND BIOLOGIC PRODUCTS
DEFINITION OF TERMS (The following definitions are adopted) :
1.1. “Biologic” or “Biologic Product” means any attenuated or inactivated virus or bacteria, or sub-components attached to adjuvants, toxoids,
hyperimmune serum, and analogous products applicable to diagnosis, prevention, treatment or cure of disease or
injuries to man, obtained or derived from living matter - animals, plants or microorganisms, or parts thereof. It
includes preparations primarily designed to develop a type of immunity or preparations that are concerned with
immunity.
1.2. “Certificate of Product Registration (CPR)” is a document issued by the Bureau of Food and Drugs (BFAD) for the purpose of marketing, use or free
distribution of a product in the Philippines.
1.3. “Permit for Clinical Investigational Use (PCIU)” is a registration document issued by the BFAD for the purpose of allowing the conduct of Phase I,
Phase II and Phase III clinical trials of developmental or investigational biologic products in the
country.
1.4. “Developmental or Investigational Vaccine or Biologic” refers to a vaccine or biologic product that needs or is undergoing pre-clinical and clinical
studies to determine its safety, potency, efficacy, and therapeutic/prophylactic value. It
refers to a vaccine or biologic product which has never been registered or licensed by any
National Regulatory Authorities.
1.5. “National Regulatory Authority (NRA)” is the designated national control authority of vaccines and biological products of the exporting country or
country of origin that meets the criteria established by the World Health Organization (WHO), such as having
a documented licensing system and GMP guidelines, GMP inspectors, and the administrative capacity to
validate and issue the required certificates to other national regulatory authorities. It sets the standards and
requirements to which all manufacturers of vaccines and biological products are required to conform.
1.6. “New Vaccine or Biologic” refers to a vaccine or biologic product which has undergone adequate Phases I, II, and III clinical studies, but which
requires a Phase IV 2 clinical studies. It refers to a vaccine or biologic product which has never been registered or
licensed by any NRA for general use.
1.7. “Established Vaccine or Biologic” refers to a vaccine or biologic product which has undergone adequate Phase I, II, III and IV clinical studies. In
addition, it has been reviewed by the WHO Expert Committee on Biological Standardization and has
recommended sets of general and specific guidelines and requirements for the manufacture, control, and product
evaluation for registration or licensing by a national regulatory authority.
1.8. “Shared Product” refers to a finished product whose final phase of production, including labeling, is done by a local manufacturer using biological
materials, including naked or bulk biologic products, produced by another manufacturer. It also refers to a finished product
whereby some of the active components, as in mixed vaccines, were processed by another manufacturer or laboratory. A shared
product is a locally produced or manufactured biologic product.
1.9. “Specifications of Product” are the values and conditions of a product based on submitted documents and information that have been accepted by
the BFAD.
1.10. “Locally Manufactured Product” refers to biologic products, as bulk or finished products that were produced or manufactured in the Philippines.
1.11. “Reevaluation” means the reexamination of the quality, efficacy, safety, therapeutic/prophylactic value, and rational use of all vaccines and
biological products during the renewal of the CPR.
1.12. "Applicant for Clinical Trial Protocol Approval" –shall mean the sponsor of the clinical trial as defined by the International Committee on
Harmonization (ICH) or the WHO Code of GCP.
1.13. "Good Laboratory Practice (GLP)" –are standards and procedures whereby the laboratory achieves a defined, consistent and reliable standard in
performing laboratory test and activities.
1.14. "Good Manufacturing Practice (GMP) –is that part of quality assurance which ensures that products, including vaccines and biologics, are
consistently produced and controlled to the quality standards appropriate for their intended use, including
all phases of vaccine clinical trials, and as required by registration and marketing authorization.
1.15. "Good Clinical Practice (GCP)" –are standards and procedures for clinical trials that encompass the design, protocol approval, conduct, monitoring,
termination, audit, analyses, reporting, and documentation of human studies. It defines the responsibilities and
activities of the sponsor, principal investigator and monitor involved in clinical trials. The Code of GCP ensures that
the studies are scientifically and ethically sound, and all the clinical properties of the product under investigation
are properly documented.
1.16. "Phase I Clinical Vaccine Trial" –an initial test of investigational vaccine in healthy adult volunteers and, occasionally, in actual patients. The number
of subject is small. Safety evaluation, tolerability, immune response and dose findings are the primary objectives,
and attempt is made to establish the approximate levels of patient tolerance for single or multiple dosing. The
trial is done in 3 the country of origin of the product. A comparison group may receive the adjuvant as a placebo.
1.17. "Phase II Clinical Vaccine Trial" –is a study designed to evaluate the efficacy and safety based on dose/response, tolerability and acceptance of the
investigational vaccine or combination vaccine in a small number of a selected population for whom the vaccine or
combined vaccine is intended. The trial consists of two parts. The first part, known as Phase II a, consists of a
selected population that is artificially challenged. The second part, known as Phase II b, consists of a selected
population that harbors natural infection. A larger subject is enrolled in the second part. The studies are
randomized double-blind placebo-controlled.
1.18. "Phase III Clinical Vaccine Trial" is a study for the population at risk. The primary objective is to evaluate the efficacy, safety, tolerability, and
acceptance in a larger target population (community in situ) while monitoring for rare side effects or adverse
events. Different clinical endpoints shall be determined and established. The number of subject required may
vary, but are usually of larger sample size. An Extended Phase III Clinical Vaccine Trial may be considered. This
involves larger number of participants and under normal conditions of use (open population). Assessment of
additional endpoints to determine immune response vs. protection, efficacy in different subgroups, effects on
mortality, efficacy under controlled trials vs. effectiveness under routine use, required information to
recommend vaccination on a routine basis, logistics for mass vaccination and evaluation for alternatives, effects
on severity relapses, rare side effects or events, and establish the duration of protection are usually undertaken.
1.19. "Phase IV Clinical Vaccine Trial" –is a mandatory PMS study of newly registered biologic products or combined vaccines for a period of five years.
The primary objective is to determine and establish the public health impact of the vaccine or combined vaccine
– epidemiological impact on infectious and non-infectious disease(s) and the impact in terms of acceptance. In a
Phase IV Clinical Vaccine Trial, which may include the extended phase III clinical trial as part of it, the following
are some of the specific objectives: to determine and establish the efficacy of different vaccination schedules
(doses and intervals), long-term antibody kinetics vs. protection, evaluation under different conditions,
prediction/modeling in transmission/protection social acceptability if repeated vaccination is required, and
surveillance strategies (e.g. before-after trend analysis vs. stepped wedge design).
1.20. "Institutional Ethics Committee (IEC)" or “Institutional Ethics Review Board (IERB)” shall refer to the body formed by an establishment or institute
which ensures that the activities of the researchers and support staff engaged in the conduct of research
involving humans subjects are ethically and scientifically sound. The Department of Science and Technology
has a national ethics committee or ethics review board.
1.21. "Deviation Report" –is a written document prepared by the principal investigator and submitted to the monitor, sponsor, IEC and the BFAD which
details departures from protocol parameters which affect the results or outcome of a clinical trial or from the elements of GCP.
1.22. "Incident Report" –is a written document prepared by the principal investigator submitted to the monitor, sponsor, IEC and BFAD which details any
unforeseen, unexpected, rare, unusual, and life-threatening adverse reactions or adverse events, or process and procedures
performed incorrectly, such as injection of vaccines, which may affect the health of the subject or put the health of the subject
at risk.
1.23. "Amendment of Protocol" –means any changes in the protocol as approved by the BFAD, such as procedures, personnel, steps, process, equipment,
facility, clinical trial site, and subject.
1.24. “Summary Lot or Batch Protocol” is a document for each lot or batch of biologic and vaccine product that contains the following:
a) the summary information on the final lot or batch,
b) the detailed information of manufacture and control,
c) the manufacturer's certification to release the lot or batch, and
d) the Certificate of Lot or Batch Release issued by the National Regulatory Authority (NRA).
1.25. “Batch” or “Lot” is a defined quantity of starting materials or product manufactured in a single process or series of processes into a final dispensed
product having identical risks of contamination and expected to be homogenous.

MEMORANDUM CIRCULAR No. 19-A s. 1992

To ALL COSMETIC ESTABLISHMENTS AND PARTIES CONCERNED
Subject SPECIFIC STANDARDS AND REQUIREMENTS
Definition of Terms
a) Label - means a display of written, printed or graphic matter upon any article or any of its containers or wrappers or attached to or accompanying such
articles.
b) Principal display panel - means the part of the label that is most likely to be displayed, presented, shown or examined under customary conditions of
display for retail sale. This shall be large enough to accommodate all the mandatory label information required to be placed thereon with
clarity and conspicuousness and without obscuring designs, vignettes, or crowding.
c) Immediate container - means any form of packaging materials which enclose the articles.
d) Labeling - means all labels and other written, printed or graphic matter
(1) upon any article or any of its containers or wrappers, or
(2) accompanying such articles.
e) Inner label - means the label on or affixed to an immediate container.
f) Outer label - means all items used or attached to bind, enclose or contain the preparation in the final form for market presentation of the product.
g) Packaging material - means all items used or attached to bind, enclose or contain the preparation in the final form for market presentation of the
product.
MEMORANDUM CIRCULAR No. 4-A s. 1991
To Regional Health/Bureau/Service Directors, Chiefs of Hospitals and Medical Centers, Supply Officers, COA Auditors/ Importers/
Distributors/ Manufacturers of Medical Devices and Diagnostic Reagents
Subject AMENDING LIST 1-A AND LIST II OF MEMORANDUM CIRCULAR NO. 1 S. 1991 DATED 03 JANUARY 1991SUBJECT: REGISTRATION OF
MEDICAL DEVICES AND DIAGNOSTIC REAGENTS
LIST I-A. MEDICAL DEVICES REQUIRED TO BE REGISTERED
1. Absorbable Collagen Hemostatic Felt 25. Endotracheal Tube 50. Porcine Heart Valve51. Implantable
2. Absorbent Cotton, sterile & non-sterile 26. Exchange Transfusion Tray Prostheses
3. Arterial Venous Fistula Needle Set 27. Feeding Tube 52. Rectal Catheter
4. Elastic Bandage 28. Filter Set 53. Rectal Tube
5. Bandages with Plaster of Paris 29. Fluor Alloy Amalgam 54. Removable Skin Staple
6. Band-Aid Plastic Strip Plain Pad 30. Gauze Pads, sterile 55. Rotahalers
7. Bone Wax 31. Humidifier Mask 56. Scalp Vein Infusion Set
8. Blood Transfusion Set 32. Hypo-Allergenic Paper Tape 57. Scissors Skin Retractors
9. Catheters 33. Implantable Staple 58. Skin Traction Kit
10. Cervical Collar 34. Infusion Administration Set 59. Spinal Anesthesia Tray
11. Collagen 35. Intraocular Lenses 60. Stoma Bag
12. Condom 36. Intrauterine Device (IUD) 61. Stomach Tube
13. Contact Lenses (hard and soft and 37. I.V. Catheter Needles 62. Suction Catheter
disposable) 38. Ligating Clip Device 63. Surgical Blades, Disposable
14. Corset Cast 39. Lubricating Jelly 64. Surgical Gloves (Sterile & Unsterile)
15. Cosmetic Puffs Cotton 40. Lumbar Puncture Tray 65. Sutures
16. Cotton Buds 41. Nasal Oxygen Cannula 66. Suturing Needles
17. Cotton Swabs 42. Nebulizer with Aerosol Mask 67. Synthetic Cast Padding
18. Dental Filling Alloy 43. Orthoplast Cervical Collar 68. Syringes
19. Disposable Needles 44. Ostotomy set 69. Thermometers
20. Disposable Skin Stapler and Staples 45. Oxygen Catheter 70. Transfusion Set
21. Disposable Tissue Measuring Device 46. Oxygen Mask 71. Urethral Catheter
22. Drainage Pouches 47. Peridontal Bone Grafting Implant 72. Urinary Drainage Tube
23. Duodenal Tube 48. Peritoneal Dialysis Administration Set 73. Urine Collecting Bag
24. Earpiercing Device 49. Plaster
LIST I-B. DIAGNOSTIC REAGENTS REQUIRED LIST II PRODUCTS THAT ARE NOT REQUIRED TO
TO BE REGISTERED BE REGISTERED
1. HIV Testing Kits 1. Plastic Bags for Blood Transfusion 15. Surgical Instruments (e.g. scissors, foreceps,
2. Hepatitis B Testing Kits 2. Non-sterile Surgical Facemasks blade-holder, needle holder, clamps,
3. Blood Typing Seva 3. Surgical Caps (non-sterile) biopsy punches, retractors, scopes, etc.)
4. Pregnancy Test Kits 4. Tounge Depressors 16. Toothbrushes
5. Non-sterile Applicator Sticks 17. Dental Floss
6. Gauze (in bolts) 18. Heat Solution19. Mortuary Refrigerator
7. Anti Embolism Stocking 20. Abdominal Binder
8. Undercast Padding 21. Weighing Scale
9. Sputum Caps 22. Ice Bags
10. Rubber Stoppers 23. Urinal/Receptacles
11. Aluminum Seals 24. Splints
12. Vials (50, 10, 5 cc) 25. Plaster of Paris
13. Ampules (5, 10 mL amber/white) 26. Abdominal Pads
14. Laboratory Glasswares 27. Centrifuges & equipment
28. Anaerobic Generating System
29. X-Ray Films and Chemicals
30. Surgical Face Mask
REPUBLIC ACT NO. 8203 – SPECIAL LAW ON COUNTERFEIT DRUGS
Title AN ACT OF PROHIBITING COUNTERFEIT DRUGS, PROVIDING PENALTIES FOR VIOLATIONS AND APPROPRIATING FUNDS THEREFOR
Counterfeit drug/medicine refers to
 Medicinal products with the correct ingredients but not in the amounts as provided
 Wrong ingredients,
 Without active ingredients,
 With sufficient quantity of active ingredient, which results in the reduction of the drug’s safety, efficacy, quality, strength or purity
 Deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic
products
 Container or labeling bearing without authorization the trademark, trade name or other identification mark or imprint or any likeness to that which is
owned or registered in the bureau of patent, trademark and technology transfer (bpttt) in the name of another natural or juridical person;
 Drug product refilled in containers by unauthorized persons if the legitimate labels or marks are used;
 An unregistered imported drug product, except drugs brought in the country for personal use as confirmed and justified by accompanying medical
records;
 A drug which contains no amount of or a different active ingredient or less than eighty percent (80%) of the active ingredient it purports to possess
as distinguished from an adulterated drug including reduction or loss or efficacy due to expiration.

Brokering  shall refer to any act of facilitating the disposal or sale or counterfeit drugs, including acts of agency.
Business Establishment  shall refer to any entity, whether a single proprietorship, partnership, or corporation engaged in or doing business in the
Philippines
Owner  shall refer to a person or group of persons who is the unregistered owner of a license to operate a business undertaking in the Philippines or
the branch manager or operator, licensee, franchisee, or any person acting on behalf of he corporate entity.
Residence  shall refer to a private dwelling or abode where a person lives, either as owner or lessee
Additional to the Terms
(a) "Bureau or BFAD" shall refer to the Bureau of Food and Drugs
(b) "Constructive Knowledge" as here applied shall mean, that by exercise of reasonable care, one would have known the fact or suspect that the drug product he
or she has sold or in possession of is counterfeit, such as but not limited to the knowledge that the drug was not covered by any
sales invoice or evidence of delivery of purchase from a BFAD license drug establishment.
(c) "FDRO" shall mean Food and Drug Regulation Officer
(d) "LICD" shall mean Legal, Information and Compliance Division of the BFAD
(e) "Life saving drugs" shall refer to drug products indicated for life threatening condition(s)
(f) "LSD" shall mean Laboratory Services Division of BFAD
(g) "PSD" shall mean Product Services Division of BFAD
(h) "Unregistered imported drug product" as distinguished from counterfeit drug defined under Section 3 of R.A., shall refer to unregistered imported drug
product without a registered counterpart brand in the Philippines. If the unregistered imported drug product has a
registered counterpart brand in the Philippines, their product shall be considered counterfeit.
Prohibited Acts:
1. The manufacture, sale, or offering for sale, donation, distribution, trafficking, brokering, exportation, or importation of counterfeit drugs.
2. Possession of any such counterfeit drugs.
3. Forging, counterfeiting, simulating or falsely representing, or without proper authority
4. Photocopying, duplicating, altering, printing, transferring, obliterating or removing the approved label
5. Making, selling, or concealing any punch, dye or plate or any other equipment or instrument designed to print, imprint, or reproduce the trademark.
Parties Liable - The following persons shall be liable for violation(s) of this Act:
a) the manufacturer, exporter or importer of the counterfeit drugs and their agents:
b) the seller, distributor, trafficker, broker or donor and their agents
c) the possessor of counterfeit drugs
d) the manager, operator or lessee of the laboratory or laboratory facilities used in the manufacture of counterfeit drugs;
e) the owner, proprietor, administrator or manager of the drugstore, hospital pharmacy or dispensary, laboratory or other outlets or premises
where the counterfeit drug is found who induces, causes or allows the commission of any act herein prohibited;
f) the registered pharmacist of the outlet where the counterfeit drug is sold or found,
g) should the offense be committed by a juridical person the president, general manager, the managing partner, chief operating officer or the
person who directly induces, causes or knowingly allows the commission of the offense shall be penalized.
ADMINISTRATIVE SANCTIONS
Minimum Penalty: NLT 100,000, but NMT 500,000 pesos
 when the counterfeit drug products subject of the case are not life saving drugs and the volume of the said products is not worth
more than (PHP 100,000.00); or the number of drug product subject of the case it not more than three brands or generic products.
Medium Penalty: NLT 100,000, but NMT 300,000 pesos and permanent closure of establishment as well as the revocation of its license to do business shall
be the medium administrative penalty
 when the counterfeit drug products subject of the case are not life saving drugs and the volume of the said products is not worth (PHP
100,000.00) but not exceeding One Million Pesos (PHP 1,000,000.00) or the number of counterfeit drug products is more than three
brands or generic products.
Maximum Penalty: NLT 300,000 but NMT 500, 000 pesos and permanent closure of establishment concerned as well as the revocation of its license to do
business shall be the maximum administrative penalty
 when the counterfeit drug products are life saving drugs regardless of the volume; or the volume of the counterfeit drug products is
worth more than One Million Pesos (PHP 1,000,000.00)
Accessory Penalties:
Forfeiture
Confiscation
Destruction of product found to be counterfeit and the equipment, instrument and other articles used in violation of R.A. 820
Permanent disqualification
 If the seized drug was found to be counterfeit the business establishment must be directed for preventive closure for a period of 30 days.
REPUBLIC ACT NO. 6425 –THE DANGEROUS DRUG ACT
Definition of terms
(a) "Administer" refers to the act of introducing any dangerous drug into the body of any person, with or without his knowledge, by injection, ingestion or
other means or of committing any act of indispensable assistance to a person in administering a dangerous drug to himself;
(b) "Board" refers to the Dangerous Drugs Board created under Section 35, Article VIII of this Act;
(c) "Centers" refers to any of the treatment and rehabilitation centers for drug dependents referred to in Section 34, Article VII of this Act;
(d) "Cultivate or culture" means the act of knowingly planting, growing, raising or permitting the planting, growing or raising of any plant which is the
source of a prohibited drug;
(e) "Dangerous drugs" refers to either:
(1) "Prohibited drug," which includes opium and its active components and derivatives, such as heroin and morphine; coca leaf and its
derivatives, principally cocaine; alpha and beta eucaine; hallucinogenic drugs, such as mescaline, lysergic acid
diethylamide (LSD) and other substances producing similar effects; Indian hemp and its derivates; all preparations
made from any of the foregoing; and other drugs, whether natural or synthetic, with the physiological effects of a
narcotic drug;
(2) "Regulated drug," which includes self-inducing sedatives, such as secobarbital, phenobarbital, pentobarbital, barbital, amobarbital and any
other drug which contains a salt or a derivative of a salt of barbituric acid; any salt, isomer or salt of an isomer, of
amphetamine, such as benzedrine or dexedrine, or any drug which produces a physiological action similar to
amphetamine; and hypnotic drugs, such as methaqualone or any other compound producing similar physiological
effects;
(3) “Exempt Dangerous Drug Preparation” is any dangerous drug preparation which is compounded in such a way that it presents no or a
negligible risk of abuse & the dangerous drug it contains cannot be recovered by readily applicable means in quantity
liable to abuse so that the preparation does not give risk to public health or social problem & has therapeutic value, a
wide use for legitimate purposes & is much needed medicine required to be easily available to the public in medical
need thereof.
(f) "Deliver" refers to a person's act of knowingly passing a dangerous drug to another, personally or otherwise, and by any means, with or without
consideration;
(g) "Drug dependence" means a state of psychic or physical dependence, or both, on a dangerous drug, arising in a person following administration or use
of that drug on a periodic or continuous basis;
(h) "Employee" of a prohibited drug den, dive or resort includes the caretaker, helper, watchman, lookout and other persons employed by the operator of
a prohibited drug den, dive or resort where any prohibited drug is administered, delivered, distributed, sold or used, with or without
compensation, in connection with the operation thereof;
(i) "Indian hemp," otherwise known as "Marijuana," embraces every kind and class of the plant Cannabis sativa L. from which the resin has not been
extracted, including Cannabis Americana, Hashish, Bhang, Guaza, Churrus & Ganjah, and embraces every kind, class and character of
Indian hemp, whether dried or fresh, flowering or fruiting tops of the pistillate plant, and all its geographic varieties, whether as a
reefer, resin, extract, tincture or in any form whatsoever;
(j) "Manufacture" means the production, preparation, compounding or processing of a dangerous drug either directly or indirectly or by extraction from
substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical
synthesis, and shall include any packaging or repackaging of such substance or labeling or relabelling of its container; except that such
term does not include the preparation, compounding, packaging, or labeling of a drug or other substance by a duly authorized
practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice;
(k) "Narcotic drug" refers to any drug which produces insensibility, stupor, melancholy or dullness of mind with delusions and which may be habit-forming,
and shall include opium, opium derivatives and synthetic opiates;
(l) "Opium" refers to the coagulated juice of the opium poppy (papaver somniferum) and embraces every kind and class of opium, whether crude or
prepared; the ashes or refuse of the same; narcotic preparations thereof or therefrom; morphine or any alkaloid of opium; preparations in
which opium, morphine or any alkaloid of opium enters as an ingredient; opium poppy straw; and leaves or wrappings of opium leaves,
whether prepared for use or not;
(m) "Pusher" refers to any person who sells, administers, delivers, or gives away to another, on any terms whatsoever, or distributes, dispatches in transit
or transports any dangerous drug or who acts as a broker in any of such transactions, in violation of this Act;
(n) "School" includes any university, college, or institution of learning, regardless of the course or courses it offers;
(o) "Sell" means the act of giving a dangerous drug, whether for money or any other material consideration;
(p) "Use" refers to the act of injecting, intravenously or intramuscularly, or of consuming, either by chewing, smoking, sniffing, eating, swallowing, drinking,
or otherwise introducing into the physiological system of the body, any of the dangerous drugs.
Records Required Every pharmacist dealing in dangerous drugs shall maintain and keep an original record of sales, purchases, acquisitions and
of Pharmacists deliveries of dangerous drugs, indicating therein the license number and address of the pharmacist; the name, address and license
of the manufacturer, importer or wholesaler from whom dangerous drugs have been purchased; the quantity and name of the
dangerous drugs so purchased or acquired; the date of acquisition or purchase; the name, address and class A residence certificate
number of the buyer; the serial number of the prescription and the name of the doctor, dentist, veterinarian
or practitioner issuing the same; the quantity and name of the dangerous drug so sold or delivered; and the date of sale or delivery.

A certified true copy of such record covering a period of three calendar months, duly signed by the pharmacist or the owner of the
drug store or pharmacy, shall be forwarded to the city or municipal health officer within fifteen days following the last day of every
quarter of each year.
Composition of the (a) DOH Secretary or representative
Dangerous Drug (b) DOH Undersecretary or representative
(c) Executive Director of the Dangerous Drugs Board
Board (d) DOJ Secretary or representative Two regular members:
(e) Department of National Defense or representative
(f) DepEd Secretary or representative -President of Integrated Bar of the Philippines
(g) Department of Finance Secretary or representative -Chairman / President of a Non-Government Organization
(h) DSWD Secretary representative

 The Director of the National Bureau of Investigation shall be the permanent consultant of the Board.
Powers and Duties (a) Promulgate such rules and regulations as may be necessary to carry out the purposes of this Act, including the manner of
of the Board safekeeping, disposition, burning or condemnation of dangerous drugs under its charge and custody, and prescribe
administrative remedies or sanctions for the violation of such rules and regulations;
(b) Take charge and custody of all dangerous drugs seized, confiscated by or surrendered to any national, provincial or local law
enforcement agency, if no longer needed for purposes of evidence in court;
(c) Develop educational programs based on factual information and disseminate the same to the general public, for which purpose
the Board shall endeavor to make the general public aware of the hazards of dangerous drugs by providing, among others,
literature, films, displays or advertisements, and by coordinating with all institutions of learning as well as with all national and
local law enforcement agencies in planning and conducting its educational campaign programs;
(d) Provide law enforcement officers, school authorities and personnel of centers with special training in dangerous drugs control;
(e) Conduct scientific, clinical, social, psychological, physical and biological researches on dangerous drugs;
(f) Draw up, in consultation and in coordination with the various agencies involved in drugs control, treatment and rehabilitation,
both public and private, a national treatment and rehabilitation program for drug dependents; and call upon any department,
office, bureau, institution or agency of the Government to render such assistance as it may require, or coordinate with it or with
other such entities, to carry out such program as well as such other activities as it may undertake pursuant to the provisions of
this Act;
(g) Receive all donations for the purpose of carrying out the objectives of this Act;
(h) Subject to the civil service law and the rules and regulations issued thereunder, appoint such technical, administrative and other
personnel as may be necessary for the effective implementation of this Act;
(i) Receive, gather, collate and evaluate all information on the importation, exportation, production, manufacture, sale, stocks,
seizures of and the estimated need for dangerous drugs, for which purpose of the Board may require from any official,
instrumentality or agency of the Government or any private persons or enterprises dealing in, or engaged in activities having to
do with, dangerous drugs such data or information as it may need to implement this Act;
(j) Relay information regarding any violation of this Act to law enforcement agencies to effect the apprehension of offenders and the
confiscation of dangerous drugs and transmit evidence to the proper court;
(k) Conduct eradication programs to destroy wild or illicit growth of plants from which dangerous drugs may be extracted;
(l) Authorize, pursuant to the provisions of this Act, the importation, distribution, prescription dispensing and sale of, and other
lawful acts in connection with, dangerous drugs of such kind and quantity as it may deem necessary according to the medical
and research needs of the country, which authorization shall be required by the Commissioner of Internal Revenue as a basis for
the issuance of licenses and permits for such purposes in accordance with Republic Act No. 953;
(m) Encourage, assist and accredit private centers, promulgating rules and regulations setting minimum standards for their
accreditation to assure their competence, integrity and stability;
(n) Prescribe and promulgate rules and regulations governing the establishment of such centers as it may deem necessary, after
conducting a feasibility study thereof;
(o) Provide appropriate rewards to informers who are instrumental in the discovery and seizure of dangerous drugs and in the
apprehension of violators of this Act;
(p) Gather and prepare detailed statistics on the importation, exportation, manufacture, stocks, seizures of and estimated need for
dangerous drugs and such other statistical data on said drugs as may be periodically required by the United Nations Narcotics
Drug Commission, the World Health Organization and other international organizations in consonance with international
commitments.
REPUBLIC ACT NO. 9165 – COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002
Title AN ACT INSTITUTING THE COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002, REPEALING REPUBLIC ACT NO. 6425, OTHERWISE
KNOWN AS THE DANGEROUS DRUGS ACT OF 1972, AS AMENDED, PROVIDING FUNDS THEREFOR, AND FOR OTHER PURPOSES
Definition of terms
(a) Administer. – Any act of introducing any dangerous drug into the body of any person, with or without his/her knowledge, by injection, inhalation,
ingestion or other means, or of committing any act of indispensable assistance to a person in administering a dangerous drug to
himself/herself unless administered by a duly licensed practitioner for purposes of medication.
(b) Board. - Refers to the Dangerous Drugs Board under Section 77, Article IX of this Act.
(c) Centers. - Any of the treatment and rehabilitation centers for drug dependents referred to in Section 34, Article VIII of this Act.
(d) Chemical Diversion. – The sale, distribution, supply or transport of legitimately imported, in-transit, manufactured or procured controlled precursors
and essential chemicals, in diluted, mixtures or in concentrated form, to any person or entity engaged in the manufacture of any
dangerous drug, and shall include packaging, repackaging, labeling, relabeling or concealment of such transaction through fraud,
destruction of documents, fraudulent use of permits, misdeclaration, use of front companies or mail fraud.
(e) Clandestine Laboratory. – Any facility used for the illegal manufacture of any dangerous drug and/or controlled precursor and essential chemical.
(f) Confirmatory Test. – An analytical test using a device, tool or equipment with a different chemical or physical principle that is more specific which will
validate and confirm the result of the screening test.
(g) Controlled Delivery. – The investigative technique of allowing an unlawful or suspect consignment of any dangerous drug and/or controlled precursor
and essential chemical, equipment or paraphernalia, or property believed to be derived directly or indirectly from any offense,
to pass into, through or out of the country under the supervision of an authorized officer, with a view to gathering evidence to
identify any person involved in any dangerous drugs related offense, or to facilitate prosecution of that offense.
(h) Controlled Precursors and Essential Chemicals. – Include those listed in Tables I and II of the 1988 UN Convention Against Illicit Traffic in Narcotic Drugs
and Psychotropic Substances as enumerated in the attached annex, which is an integral part of this Act.
(i) Cultivate or Culture. – Any act of knowingly planting, growing, raising, or permitting the planting, growing or raising of any plant which is the source of a
dangerous drug.
(j) Dangerous Drugs. – Include those listed in the Schedules annexed to the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol,
and in the Schedules annexed to the 1971 Single Convention on Psychotropic Substances as enumerated in the attached annex
which is an integral part of this Act.
(k) Deliver. – Any act of knowingly passing a dangerous drug to another, personally or otherwise, and by any means, with or without consideration.
(l) Den, Dive or Resort. – A place where any dangerous drug and/or controlled precursor and essential chemical is administered, delivered, stored for
illegal purposes, distributed, sold or used in any form.
(m) Dispense. – Any act of giving away, selling or distributing medicine or any dangerous drug with or without the use of prescription.
(n) Drug Dependence. – As based on the World Health Organization definition, it is a cluster of physiological, behavioral and cognitive phenomena of
variable intensity, in which the use of psychoactive drug takes on a high priority thereby involving, among others, a strong desire
or a sense of compulsion to take the substance and the difficulties in controlling substance-taking behavior in terms of its onset,
termination, or levels of use.
(o) Drug Syndicate. – Any organized group of two (2) or more persons forming or joining together with the intention of committing any offense prescribed
under this Act.
(p) Employee of Den, Dive or Resort. – The caretaker, helper, watchman, lookout, and other persons working in the den, dive or resort, employed by the
maintainer, owner and/or operator where any dangerous drug and/or controlled precursor and essential chemical
is administered, delivered, distributed, sold or used, with or without compensation, in connection with the
operation thereof.
(q) Financier. – Any person who pays for, raises or supplies money for, or underwrites any of the illegal activities prescribed under this Act.
(r) Illegal Trafficking. – The illegal cultivation, culture, delivery, administration, dispensation, manufacture, sale, trading, transportation, distribution,
importation, exportation and possession of any dangerous drug and/or controlled precursor and essential chemical.
(s) Instrument. – Any thing that is used in or intended to be used in any manner in the commission of illegal drug trafficking or related offenses.
(t) Laboratory Equipment. – The paraphernalia, apparatus, materials or appliances when used, intended for use or designed for use in the manufacture of
any dangerous drug and/or controlled precursor and essential chemical, such as reaction vessel, preparative/purifying
equipment, fermentors, separatory funnel, flask, heating mantle, gas generator, or their substitute.
(u) Manufacture. – The production, preparation, compounding or processing of any dangerous drug and/or controlled precursor and essential chemical,
either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a
combination of extraction and chemical synthesis, and shall include any packaging or repackaging of such substances, design or
configuration of its form, or labeling or relabeling of its container; except that such terms do not include the preparation,
compounding, packaging or labeling of a drug or other substances by a duly authorized practitioner as an incident to his/her
administration or dispensation of such drug or substance in the course of his/her professional practice including research, teaching and
chemical analysis of dangerous drugs or such substances that are not intended for sale or for any other purpose.
(v) Cannabis or commonly known as "Marijuana" or "Indian Hemp" or by its any other name. – Embraces every kind, class, genus, or specie of the
plant Cannabis sativa L. including, but not limited to, Cannabis americana,hashish, bhang, guaza, churrus and ganjab, and embraces every
kind, class and character of marijuana, whether dried or fresh and flowering, flowering or fruiting tops, or any part or portion of the plant
and seeds thereof, and all its geographic varieties, whether as a reefer, resin, extract, tincture or in any form whatsoever.
(w) Methylenedioxymethamphetamine (MDMA) or commonly known as "Ecstasy", or by its any other name. – Refers to the drug having such chemical
composition, including any of its isomers or derivatives in any form.
(x) Methamphetamine Hydrochloride or commonly known as "Shabu", "Ice", "Meth", or by its any other name. – Refers to the drug having such chemical
composition, including any of its isomers or derivatives in any form.
(y) Opium. – Refers to the coagulated juice of the opium poppy (Papaver somniferum L.) and embraces every kind, class and character of opium, whether
crude or prepared; the ashes or refuse of the same; narcotic preparations thereof or therefrom; morphine or any alkaloid of opium;
preparations in which opium, morphine or any alkaloid of opium enters as an ingredient; opium poppy; opium poppy straw; and leaves
or wrappings of opium leaves, whether prepared for use or not.
(z) Opium Poppy. – Refers to any part of the plant of the species Papaver somniferum L., Papaver setigerum DC, Papaver orientale, Papaver bracteatum
and Papaver rhoeas, which includes the seeds, straws, branches, leaves or any part thereof, or substances derived therefrom, even for
floral, decorative and culinary purposes.
 (aa) PDEA. – Refers to the Philippine Drug Enforcement Agency (implementing arm of DDB)
 shall take charge & have the custody of all dangerous dugs that are confiscated, seized, & surrender (issued within 24 hours)
(bb) Person. – Any entity, natural or juridical, including among others, a corporation, partnership, trust or estate, joint stock company, association,
syndicate, joint venture or other unincorporated organization or group capable of acquiring rights or entering into obligations.
(cc) Planting of Evidence. – The willful act by any person of maliciously and surreptitiously inserting, placing, adding or attaching directly or indirectly,
through any overt or covert act, whatever quantity of any dangerous drug and/or controlled precursor and essential chemical in the
person, house, effects or in the immediate vicinity of an innocent individual for the purpose of implicating, incriminating or imputing the
commission of any violation of this Act.
(dd) Practitioner. – Any person who is a licensed physician, dentist, chemist, medical technologist, nurse, midwife, veterinarian or pharmacist in the
Philippines.
(ee) Protector/Coddler – Any person who knowingly and willfully consents to the unlawful acts provided for in this Act and uses his/her influence, power
or position in shielding, harboring, screening or facilitating the escape of any person he/she knows, or has reasonable grounds to
believe on or suspects, has violated the provisions of this Act in order to prevent the arrest, prosecution and conviction of the
violator.
 penalty of 12 years & 1 day to 20 years of imprisonment & a fine of 100,000 pesos to 500,000 pesos
(ff) Pusher. – Any person who sells, trades, administers, dispenses, delivers or gives away to another, on any terms whatsoever, or distributes, dispatches
in transit or transports dangerous drugs or who acts as a broker in any of such transactions, in violation of this Act.
(gg) School. – Any educational institution, private or public, undertaking educational operation for pupils/students pursuing certain studies at defined
levels, receiving instructions from teachers, usually located in a building or a group of buildings in a particular physical or cyber site.
(hh) Screening Test. – A rapid test performed to establish potential/presumptive positive result.
(ii) Sell. – Any act of giving away any dangerous drug and/or controlled precursor and essential chemical whether for money or any other consideration.
(jj) Trading. – Transactions involving the illegal trafficking of dangerous drugs and/or controlled precursors and essential chemicals using electronic devices
such as, but not limited to, text messages, email, mobile or landlines, two-way radios, internet, instant messengers and chat rooms or
acting as a broker in any of such transactions whether for money or any other consideration in violation of this Act.
(kk) Use. – Any act of injecting, intravenously or intramuscularly, of consuming, either by chewing, smoking, sniffing, eating, swallowing, drinking or
otherwise introducing into the physiological system of the body, and of the dangerous drugs.
Possession of The penalty of life imprisonment to death and a fine ranging from Five hundred thousand pesos (P500,000.00) to Ten million pesos
Dangerous Drugs (P10,000,000.00) shall be imposed upon any person, who, unless authorized by law, shall possess any dangerous drug in the
following quantities, regardless of the degree of purity thereof:
(1) 10 grams or more of opium; 10 grams: Opium
(2) 10 grams or more of morphine; Morphine
Heroin
(3) 10 grams or more of heroin; Cocaine
(4) 10 grams or more of cocaine or cocaine hydrochloride; Marijuana Resin/ Oil
(5) 50 grams or more of methamphetamine hydrochloride or "shabu"; Ecstacy
(6) 10 grams or more of marijuana resin or marijuana resin oil; LSD
PMA
(7) 500 grams or more of marijuana; and TMA
(8) 10 grams or more of other dangerous drugs such as, but not limited to, GHB
methylenedioxymethamphetamine (MDA) or "ecstasy", 50 grams: Shabu
paramethoxyamphetamine (PMA), trimethoxyamphetamine (TMA), lysergic acid 500 grams: Marijuana
diethylamine (LSD), gamma hydroxyamphetamine (GHB), and those similarly
designed or newly introduced drugs and their derivatives, without having any therapeutic value or if the quantity
possessed is far beyond therapeutic requirements, as determined and promulgated by the Board in accordance to
Section 93, Article XI of this Act.
S licenses issued by S1 For persons dealing in exempt dangerous drug preparation
the DDB authorizing S2 For MD, DMD, VetMD to prescribe dangerous drug renewable very 3 calendar years
individual S3 For retail dealers of dangerous drugs
establishment to S4 For wholesaler of dangerous drugs
deal w/ Dangerous S5-I For importers of dangerous drugs
Drug Preparations S5-C For compounds, producers, & manufacturer
S6 For persons not registered as importer, manufacturer producer or compounder but lawfully entitled to obtain & use in a
laboratory dangerous drugs for purpose of research, instruction or analysis
S7 For importers & compounds, RM (1.0peso/100g) FG (1.5peso/100g)

 The original copy of the prescription of dangerous drugs is retained by the Pharmacist for a period of 5 years from the date of sale or delivery of such drugs
 Head of PDEA: Director General
 Permanent Consultant of DDB: NBI Director & PNP Chief
 Reporting to DDB record sales of dangerous drugs is done every 6 months.
 Any person who shall import or bring into the Philippines any dangerous drug (including Opium poppy), regardless of the quantity & purity shall have the
penalty of Life imprisonment to death & Fine of 500,000 pesos to 10M pesos.
 Any Person who shall import Controlled precursor & Essential Chemical, unless authorized by law, shall be punished by
imprisonment from 12 years & 1 day to 20 years & a fine of 100,000 pesos.
Maximum Penalty  shall be imposed on anyone who shall import into the Philippines any dangerous drugs &/or controlled precursor & Essential chemical
through the use of a diplomatic passport.
 shall be imposed if the sale, trading, administration, delivery or distribution of dangerous drugs &/or controlled precursor & essential
chemical transpires within 100 meters from the school.
 Penalty of Unlawful Prescription of Dangerous Drugs & Person who imports Prohibited Drugs: Life imprisonment to Death & Fine of 500,000 to 10M pesos
Hazardous Substances (PD 881)
 Strong Sensitizer  means any substance which will cause on normal living tissue, allergy or photodynamic quality of hypersensitivity which becomes evident
on reapplication of the substance
 Corrosive  any substance which on contact w/ living tissue will cause destruction of tissue by chemical action
 Irritant  any substance not corrosive which on immediate, prolonged or repeated contact w/ normal living tissue will induce a local inflammatory reaction
 Toxic  any substance which can cause injury or illness or death to man through ingestion, inhalation or absorption through any body surface
 Radioactive  any substance which emits ionizing radiation
REPUBLIC ACT NO. 6675 – GENERICS ACT
Title AN ACT TO PROMOTE, REQUIRE AND ENSURE THE PRODUCTION OF AN ADEQUATE SUPPLY, DISTRIBUTION, USE AND ACCEPTANCE
OF DRUGS AND MEDICINES IDENTIFIED BY THEIR GENERIC NAMES
Statement of  To promote, encourage and require the use of generic terminology in the importation, manufacture, distribution, marketing,
Policy advertising and promotion, prescription and dispensing of drugs
 To ensure the adequate supply of drugs with generic names at the lowest possible cost and endeavor to make them available for
free to indigent patients;
 To encourage the extensive use of drugs with generic names through a rational system or procurement and distribution;
 To emphasize the scientific basis for the use of drugs, in order that health professionals may become more aware and cognizant
of their therapeutic effectiveness, and
 To promote drug safety by minimizing duplication medications and/or use of drugs with potentially adverse drug interactions.
Components of the (a) Quality Assurance of Drugs
National Drug (b) Rational Use of Drugs by Health Professionals & Consumers
Policy (c) National Self-sufficiency in Pharmaceuticals
(d) Rationalization of the DOH’s Procurement Program
Penalty for 1. For the first conviction, he shall suffer the penalty of reprimand which shall be officially recorded in the appropriate books of the
Medical Professional Regulation Commission.
Practitioner 2. For the second conviction, the penalty of fine in the amount of NLTP 2,000.00 but NMT P 5,000.00
3. For the third conviction, the penalty of fine in the amount of NLT P 5,000.00 but NMT P 10,000.00 and suspension of his license to
practice his profession for thirty (30) days at the discretion of the court.
4. For the fourth and subsequent convictions, the penalty of fine of NLT P 10,000.00 and suspension of his license to practice his
processions for one year or no longer at the discretion of the court.
Violations on the  Imposing a particular brand or product on the buyer
part of dispensers  Inaccurate dispensing
(Pharmacist) &  Failure to post or make accessible the required up-to-date information on drug products
outlets  Failure to adequately inform the buyer on available products that met the prescription
 Failure to indicate the generic name/ official name designated by BFAD
 Failure to report to the nearest DOH office cases of Violative, Erroneous, &/ or wrong prescriptions w/in three months after
receipt of such prescription

ADMINISTRATIVE ORDER NO. 62

Series of 1989
SUBJECT RULES AND REGULATIONS TO IMPLEMENT PRESCRIBING REQUIREMENTS UNDER THE GENERICS ACT OF 1988 (R.A. 6675)
Definition of Terms
1.1 “Prescription” is the written order and instruction of a validly registered physician, dentists or veterinarian for the use of a specific drug product for a
specific patient. For the purpose of these Rules and Regulations, the doctor’s order on the patient’s chart for the use of specific drug(s)
shall be considered a prescription.
1.2 “Generic Prescribing” is prescribing of drugs or medicines using their generic name(s) or generic terminology.
1.3 “Dispensing” is the act by a validly-registered pharmacist of filling a prescription or doctor's order on the patient's chart.
1.4 “Generic Dispensing” means dispensing the patient's/buyer's choice from among generic equivalents, i.e., finished pharmaceutical products having
the same active ingredient(s), same dosage form and same strength as the prescribed drug.
1.5 “Generic name or generic terminology” is the identification of drugs and medicines by their scientifically and internationally recognized active
ingredients or by their official name as
1.6 Drugs means (1) “articles recognized in the current official United States Pharmacopoeia-National Drug Formulary (USP-NF), official Homeopathic
Pharmacopoeia of the United States, Official Philippine National Drug Formulary, or any supplement to any of them, and (2) articles
intended for use to diagnosis, cure, mitigation, treatment or prevention of disease in man or animals; and (3) articles (other than
food) intended to affect the structure or function of the body of man or animals; and (4) articles intended for use as a component of
any articles specified in clauses (1), (2) or (3) but do not include devices or their components, parts or accessories.
1.7 Drug product or medicine is the finished form that contains the active ingredient(s), generally, but not necessarily in association with inactive
ingredients
1.7.1 Prescription or ethical drugs are pharmaceutical products or drug preparation that are to be dispensed only upon written order of
a validly-registered licensed physician, dentist or veterinarian for the management or treatment of a
condition or disease.
1.7.2 Non-prescription or over-the-counter drugs are pharmaceutical products or drug preparations that can be dispensed even without
the written order of a validly registered licensed physician, dentist or veterinarian, for the use of
consumers for the prevention or symptomatic relief of minor or self-limiting ailments.
Guidelines On 2.1. Prescription or Ethical Drugs
Dispensing Based These drugs can only be dispensed upon a written order of a validly-registered physician, dentist or veterinarian.
on Prior Laws 2.2 Non-Prescription or Over-the-Counter (OTC) Drugs
These drugs may be dispensed even without a written order of a validly-registered physician, dentist or veterinarian in
duly licensed drug outlets. When dispensing OTC drugs without a doctor's prescription, the pharmacist shall give the
necessary information and direction for use of the drug.
2.3. All prescriptions dispensed in the drugstore, botica or hospital pharmacy shall be kept in file for two years and recorded in a
prescription book duly-registered by BFAD which shall be open for inspection to Food and Drug Inspectors at any time during
business hours of the outlet. . This prescription book shall be kept for two years after the last entry.
Erroneous, Violative and Impossible Prescriptions

Erroneous Prescriptions
 Where the brand name precedes the generic name
 Where the generic name is the one in parenthesis
 Where the brand name is not in parentheses
 Where more than one drug product is prescribed on one prescription form.
What to do with erroneous prescriptions
 Erroneous prescriptions shall be filed.
 Shall also be kept and reported by the pharmacist of the drug outlet or any other interested party to the nearest DOH office for appropriate action.
 Pharmacist shall advice the prescriber of the problem &/or instruct the customer to get a proper prescription.

Violative Prescriptions
 Where generic name is not written
 Where the generic name is not legible and a brand name which is legible is written
 When the brand name is indicated and instructions added (such as the phrase " no substitution") which tend to obstruct, hinder or prevent
proper generic dispensing.
What to do with violative prescriptions
 Violative prescriptions shall not be filed.
 They are kept and reported by the pharmacist of drug outlet or any other interested party to the nearest DOH office for appropriate action.
 The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription.

Impossible Prescriptions
 When only the generic name is written but it is not legible.
 When the generic name does not correspond to the brand name
 When both the generic name and the brand name are not legible
 When the drug product prescribed is not registered with FDA
What to do with impossible prescriptions
 Impossible prescription shall not be filed.
 They shall be and reported by the pharmacistof drug outlet or any other interested party to the nearest DOH office for appropriate action.
 The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription.

ADMINISTRATIVE ORDER NO. 63

Series of 1989
SUBJECT Rules and Regulations to Implement Dispensing Requirements under the Generics Act of 1988 (R.A. No. 6675)
Definition of Terms
1.1 “Dispensing” is the act by a validly-registered pharmacist of filling a prescription or doctor's order on the patient's chart.
1.2 “Generic Dispensing” means dispensing the patient's/buyer's choice from among generic equivalents, i.e., finished pharmaceutical products having the
same active ingredient(s), same dosage form and same strength as the prescribed drug.
1.3 “Partial filling of prescription" means dispensing less than the total number of units prescribed.
1.4 “Drug Outlet” means drugstore, pharmacy and other business establishment which sells drugs or medicines.

ADMINISTRATIVE ORDER NO. 65

Series of 1989
SUBJECT Guidelines on Advertisement and Promotions to Implement The Generics Act Of 1988
Definition of Terms
1.1 “Advertisement” includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any
pharmaceutical product.
1.2 “Promotion” means the practice of giving temporary additional value to a brand, product, or service to achieve specific marketing objectives.
“Promotion” includes the distribution of free/sample pharmaceutical products.
1.3 “Pharmaceutical product” means any pharmaceutical or biological product intended for use in the diagnosis, cure, mitigation, treatment, or prevention
of disease or to affect the structure or any function of the body of man or animals.
1.4 “Prescription or Ethical Drugs” are pharmaceutical products or drug preparations that are to be dispensed only upon written order of a duly licensed
physician, dentist, or veterinarian for the treatment of a condition or a diagnosed disease of man or animals.
1.5 “Non-prescription Drugs” or “Over-the-Counter Drugs” are pharmaceutical products or drug preparations that can be dispensed even without the
written order of a duly-licensed physician, dentist, or veterinarian, for the use of consumers for the prevention of symptomatic relief
of minor or self-limiting ailments.
1.6 “Mass Media” means any publication, book, notice, handbill, poster, circular, pamphlet, letter, billboard, print media, radio, television, cinema, mobile
audiovisual units or any other widespread medium of information directed to the lay public.

ADMINISTRATIVE ORDER NO. 90

Series of 1990
SUBJECT Amendment to A.O. 62 s. 1989 re: Rules and Regulations to Implement Prescribing Requirements
Generic Dispensing Flow Chart

If prescription is fully filled, retain prescription and file for 2 years.

If prescription is partially filled, indicate the number dispensed in prescription and return it to the patient.
REPUBLIC ACT NO. 7432 – SENIOR CITIZEN ACT
Title AN ACT TO MAXIMIZE THE CONTRIBUTION OF SENIOR CITIZENS TO NATION BUILDING. GRAND BENEFITS AND SPECIAL PRIVILEGES
AND FOR OTHER PURPOSES.
Declaration of a) to motivate and encourage the senior citizens to contribute to nation building;
Policies and b) to encourage their families and the communities they live with to reaffirm the valued Filipino tradition of caring for the senior
Objectives citizens.
In accordance with these policies, this Act aims to:
1) establish mechanisms whereby the contribution of the senior citizens are maximized;
2) adopt measures whereby our senior citizens are assisted and appreciated by the community as a whole;
3) establish a program beneficial to the se
Definition of Terms. -
“Senior Citizen” shall mean any resident citizen of the Philippines at least sixty (60) years old, including those who have retired from both government
officer and private enterprises, and has an income of not more than Sixty thousand pesos (P60,000.00 per annum subject to review by the
National Economic and Development Authority (NEDA) every three (3) years. 2
“Benefactor” shall mean any person whether related to the senior citizen or not who takes care of him/her as a dependent.
“Head of the Family” shall mean any person so defined in the National Internal Revenue Code

REPUBLIC ACT NO. 9257 – EXPANDED SENIOR CITIZENS ACT OF 2003

Title AN ACT GRANTING ADDITIONAL BENEFITS AND PRIVILEGES TO SENIOR CITIZENS AMENDING FOR THE PURPOSE REPUBLIC ACT NO.
7432, OTHERWISE KNOWN AS "AN ACT TO MAXIMIZE THE CONTRIBUTION OF SENIOR CITIZENS TO NATION BUILDING, GRANT
BENEFITS AND SPECIAL PRIVILEGES AND FOR OTHER PURPOSES"

REPUBLIC ACT NO. 9994 – EXPANDED SENIOR CITIZENS ACT OF 20010

Title AN ACT GRANTING ADDITIONAL BENEFITS AND PRIVILEGES TO SENIOR CITIZENS, FURTHER AMENDING REPUBLIC ACT NO. 7432, AS
AMENDED, OTHERWISE KNOWN AS "AN ACT TO MAXIMIZE THE CONTRIBUTION OF SENIOR CITIZENS TO NATION BUILDING, GRANT
BENEFITS AND SPECIAL PRIVILEGES AND FOR OTHER PURPOSES"
Declaration of Consistent with these constitutional principles, this Act shall serve the following objectives:
Policies and (a) To recognize the rights of senior citizens to take their proper place in society and make it a concern of the family, community,
Objectives and government;
(b) To give full support to the improvement of the total well-being of the elderly and their full participation in society, considering
that senior citizens are integral part of Philippine society;
(c) To motivate and encourage the senior citizens to contribute to nation building;
(d) To encourage their families and the communities they live with to reaffirm the valued Filipino tradition of caring for the senior
citizens;
(e) To provide a comprehensive health care and rehabilitation system for disabled senior citizens to foster their capacity to attain a
more meaningful and productive ageing; and
(f) To recognize the important role of the private sector in the improvement of the welfare of senior citizens and to actively seek
their partnership.

In accordance with these objectives, this Act shall:

(1) establish mechanisms whereby the contributions of the senior citizens are maximized;
(2) adopt measures whereby our senior citizens are assisted and appreciated by the community as a whole;
(3) establish a program beneficial to the senior citizens, their families and the rest of the community they serve: and
(4) establish community-based health and rehabilitation programs for senior citizens in every political unit of society."
Definition of terms. - For purposes of this Act, these terms are defined as follows:
(a) Senior citizen or elderly refers to any resident citizen of the Philippines at least sixty (60) years old;
(b) Geriatrics refer to the branch of medical science devoted to the study of the biological and physical changes and the diseases of old age;
Gerontology  is the scientific study of the biological, psychological, & sociological phenomena associated w/ old age & ageing & in determining
answers about the normal aging process rather than the disease
(c) Lodging establishment refers to a building, edifice, structure, apartment or house including tourist inn, apartelle, motorist hotel, and pension house
engaged in catering, leasing or providing facilities to transients, tourists or travelers;
(d) Medical Services refer to hospital services, professional services of physicians and other health care professionals and diagnostics and laboratory tests
that the necessary for the diagnosis or treatment of an illness or injury;
(e) Dental services to oral examination, cleaning, permanent and temporary filling, extractions and gum treatments, restoration, replacement or
repositioning of teeth, or alteration of the alveolar or periodont
ium process of the maxilla and the mandible that are necessary for the diagnosis or treatment of an illness or injury;
(f) Nearest surviving relative refers to the legal spouse who survives the deceased senior citizen: Provided, That where no spouse survives the decedent,
this shall be limited to relatives in the following order of degree of kinship: children, parents, siblings, grandparents, grandchildren,
uncles and aunts;
(g) Home health care service refers to health or supportive care provided to the senior citizen patient at home by licensed health care professionals to
include, but not limited to, physicians, nurses, midwives, physical therapist and caregivers; and
(h) Indigent senior citizen, refers to any elderly who is frail, sickly or with disability, and without pension or permanent source of income, compensation or
financial assistance from his/her relatives to support his/her basic needs, as determined by the Department of Social Welfare and
development (DSWD) in consultation with the National Coordinating and Monitoring Board.
Privileges for the Senior Citizens
The senior citizens shall be entitled to the following:
(a) the grant of twenty percent (20%) discount and exemption from the value -added tax (VAT), if applicable, on the sale of the following goods and
services from all establishments, for the exclusive use and enjoyment or availment of the senior citizen
(1) on the purchase of medicines, including the purchase of influenza and pneumococcal vaccines, and such other essential medical supplies,
accessories and equipment to be determined by the Department of Health (DOH).
The DOH shall establish guidelines and mechanism of compulsory rebates in the sharing of burden of discounts among retailers,
manufacturers and distributors, taking into consideration their respective margins;
(2) on the professional fees of attending physician/s in all private hospitals, medical facilities, outpatient clinics and home health care
services;
(3) on the professional fees of licensed professional health providing home health care services as endorsed by private hospitals or employed
through home health care employment agencies;
(4) on medical and dental services, diagnostic and laboratory fees in all private hospitals, medical facilities, outpatient clinics, and home
health care services, in accordance with the rules and regulations to be issued by the DOH, in coordination with the Philippine Health
Insurance Corporation (PhilHealth);
(5) in actual fare for land transportation travel in public utility buses (PUBs), public utility jeepneys (PUJs), taxis, Asian utility vehicles (AUVs),
shuttle services and public railways, including Light Rail Transit (LRT), Mass Rail Transit (MRT), and Philippine National Railways (PNR);
(6) in actual transportation fare for domestic air transport services and sea shipping vessels and the like, based on the actual fare and
advanced booking;
(7) on the utilization of services in hotels and similar lodging establishments, restaurants and recreation centers;
(8) on admission fees charged by theaters, cinema houses and concert halls, circuses, leisure and amusement; and
(9) on funeral and burial services for the death of senior citizens;
(b) exemption from the payment of individual income taxes of senior citizens who are considered to be minimum wage earners in accordance with
Republic Act No. 9504;
(c) the grant of a minimum of five percent (5%) discount relative to the monthly utilization of water and electricity supplied by the public
utilities: Provided, That the individual meters for the foregoing utilities are registered in the name of the senior citizen residing therein: Provided,
further, That the monthly consumption does not exceed one hundred kilowatt hours (100 kWh) of electricity and thirty cubic meters (30 m3) of
water: Provided, furthermore, That the privilege is granted per household regardless of the number of senior citizens residing therein;
(d) exemption from training fees for socioeconomic programs;
(e) free medical and dental services, diagnostic and laboratory fees such as, but not limited to, x-rays, computerized tomography scans and blood tests, in
all government facilities, subject to the guidelines to be issued by the DOH in coordination with the PhilHealth;
(f) the DOH shall administer free vaccination against the influenza virus and pneumococcal disease for indigent senior citizen patients;
(g) educational assistance to senior citizens to pursue pot secondary, tertiary, post tertiary, vocational and technical education, as well as short-term
courses for retooling in both public and private schools through provision of scholarships, grants, financial aids, subsides and other incentives to
qualified senior citizens, including support for books, learning materials, and uniform allowances, to the extent feasible: Provided, That senior
citizens shall meet minimum admission requirements;
(h) to the extent practicable and feasible, the continuance of the same benefits and privileges given by the Government Service Insurance System (GSIS),
the Social Security System (SSS) and the PAG-IBIG, as the case may be, as are enjoyed by those in actual service;
(i) retirement benefits of retirees from both the government and the private sector shall be regularly reviewed to ensure their continuing responsiveness
and sustainability, and to the extent practicable and feasible, shall be upgraded to be at par with the current scale enjoyed by those in actual
service;
(j) to the extent possible, the government may grant special discounts in special programs for senior citizens on purchase of basic commodities, subject to
the guidelines to be issued for the purpose by the Department of Trade and Industry (DTI) and the Department of Agriculture (DA);
(k) provision of express lanes for senior citizens in all commercial and government establishments; in the absence thereof, priority shall be given to them;
and
(l) death benefit assistance of a minimum of Two thousand pesos (Php2, 000.00) shall be given to the nearest surviving relative of a deceased senior citizen
which amount shall be subject to adjustments due to inflation in accordance with the guidelines to be issued by the DSWD.1avvphi1

In the availment of the privileges mentioned above, the senior citizen, or his/her duly authorized representative, may submit as proof of his/her
entitled thereto any of the following:
(1) an identification card issued by the Office of the Senior Citizen Affairs (OSCA) of the place where the senior citizen resides: Provided, That the
identification card issued by the particular OSCA shall be honored nationwide;
(2) the passport of the senior citizen concerned; and
(3) other documents that establish that the senior citizen is a citizen of the Republic and is at least sixty (60) years of age as further provided in the
implementing rules and regulations.

In the purchase of goods and services which are on promotional discount, the senior citizen can avail of the promotional discount or the discount
provided herein, whichever is higher.
The establishment may claim the discounts granted under subsections (a) and (c) of this section as tax deduction based on the cost of the goods
sold or services rendered: Provided, That the cost of the discount shall be allowed as deduction from gross income for the same taxable year that
the discount is granted: Provided, further, That the total amount of the claimed tax deduction net of VAT, if applicable, shall be included in their
gross sales receipts for tax purposes and shall be subject to proper documentation and to the provisions of the National Internal Revenue Code
(NICR), as amended."
Government Assistance. - The government shall provide the following:
(a) Employment
(b) Education
(c) Health
(d) Social Services At least fifty percent (50%) discount shall be granted on the consumption of electricity, water, and telephone by the senior citizens
center and residential care/group homes
(1) "self and social enhancement services" which provide senior citizens opportunities for socializing, organizing, creative expression, and self-
improvement;
(2) "after care and follow-up services" for citizens who are discharged from the homes or institutions for the aged, especially those who have
problems of reintegration with family and community, wherein both the senior citizens and their families are provided
with counseling;
(3) "neighborhood support services" wherein the community or family members provide caregiving services to their frail, sick, or bedridden
senior citizens; and
(4) "substitute family care " in the form of residential care or group homes for the abandoned, neglected, unattached or homeless senior
citizens and those incapable of self-care.
(e) Housing
(f) Access to Public Transport
(g) Incentive for Foster Care
(1) realty tax holiday for the first five (5) years starting from the first year of operation; and
(2) priority in the construction or maintenance of provincial or municipal roads leading to the aforesaid home, residential community or
retirement village.
(h) Additional Government Assistance
(1) Social Pension Indigent senior citizens shall be entitled to a monthly stipend amounting to Five hundred pesos (Php500.00) to augment the daily
subsistence and other medical needs of senior citizens, subject to a review every two (2) years by Congress, in consultation with
the DSWD.
(2) Mandatory PhilHealth Coverage
(3) Social Safety Nets

Office for Senior Citizens Affairs (OSCA)

Functions:
(a) To plan, implement and monitor yearly work programs in pursuance of the objectives of this Act;
(b) To draw up a list of available and required services which can be provided by the senior citizens;
(c) To maintain and regularly update on a quarterly basis the list of senior citizens and to issue national individual identification cards, free of charge,
which shall be valid anywhere in the country;
(d) To serve as a general information and liaison center for senior citizens;
(e) To monitor compliance of the provisions of this Act particularly the grant of special discounts and privileges to senior citizens;
(f) To report to the mayor, any individual, establishments, business entity, institutions or agency found violating any provision of this Act; and
(g) To assist the senior citizens in filing complaints or charges against any individual, establishments, business entity, institution, or agency refusing to
comply with the privileges under this Act before the Department of Justice (DOJ), the Provincial Prosecutor's Office, the regional or the municipal
trial court, the municipal trial court in cities, or the municipal circuit trial court.
REPUBLIC ACT NO. 7581 – THE PRICE ACT
Title AN ACT PROVIDING PROTECTION TO CONSUMERS BY STABILIZING THE PRICES OF BASIC NECESSITIES AND PRIME COMMODITIES
AND BY PRESCRIBING MEASURES AGAINST UNDUE PRICE INCREASES DURING EMERGENCY SITUATIONS AND LIKE OCCASIONS
Definition of Terms
(1) "Basic necessities" includes: rice; corn; bread; fresh, dried and canned fish and other marine products, fresh pork, beef and poultry meal; fresh eggs;
fresh and processed milk; fresh vegetables; root crops; coffee; sugar; cooking oil; salt; laundry soap; detergents; firewood;
charcoal; candles; and drugs classified as essential by the Department of Health;
(2) "Butter fund" means a contingent fund in the budget of the implementing agency which shall not be used in its normal or regular operations but only
for purposes provided for in this Act;
(3) "Implementing agency" means the department, agency or office of the Government which has jurisdiction over a basic necessity or prime commodity
as defined in this Act, which shall be:
(a) The Department of Agriculture, with reference to agricultural crops, fish and other marine products, fresh meat, fresh poultry and dairy
products, fertilizers, and other farm inputs;
(b) The Department of Health, with reference to drugs;
(c) The Department of Environment and Natural Resources, with reference to wood and other forest products; and
(d) The Department of Trade and Industry, with reference to all other basic necessities and prime commodities.
(4) "Panic-buying" is the abnormal phenomenon where consumers buy basic necessities and prime commodities grossly in excess of their
normal requirement resulting in undue shortages of such goods to the prejudice of less privileged consumers;
(5) "Person" means a natural person or juridical person;
(6) "Prevailing price" means the average price at which any basic necessity has been sold in a given time within a month from the occurrence of any of the
conditions enumerated under Section 6 of this Act;
(7) "Price ceiling" means the maximum price at which any basic necessity or prime commodity may be sold to the general public; and
(8) "Prime commodities" include fresh fruits; flour; dried processed and canned pork; beef and poultry meat; dairy products not falling under basic
necessities; noodles; onions; garlic; vinegar; patis; soy sauce; toilet soap; fertilizer; pesticides; herbicides; poultry; swine and
cattle feeds; veterinary products for poultry, swine and cattle; paper; school supplies; nipa shingles; sawali; cement; clinker; GI
sheets; hollow blocks; plywood; plyboard; construction nails; batteries; electrical supplies; light bulbs; steel wire; and all drugs
not classified as essential drugs by the Department of Health.
Illegal Acts of Price (1) Hoarding, which is the undue accumulation by a person or combination of persons of any basic commodity beyond his or their
Manipulation normal inventory levels or the unreasonable limitation or refusal to dispose of, sell or distribute the stocks of any basic
necessity of prime commodity to the general public or the unjustified taking out of any basic necessity or prime
commodity from the channels of reproduction, trade, commerce and industry.
(2) Profiteering, which is the sale or offering for sale of any basic necessity or prime commodity at a price grossly in excess of its
true worth. prima facie evidence of profiteering
(a) has no price tag;
(b) is misrepresented as to its weight or measurement;
(c) is adulterated or dilluted; or
(d) whenever a person raises the price by more than ten percent (10%)
(3) Cartel, which is any combination of or agreement between two (2) or more persons engaged in the production, manufacture,
processing, storage, supply, distribution, marketing, sale or disposition of any basic necessity or prime commodity
designed to artificially and unreasonably increase or manipulate its price.

Automatic Price (1) That area is proclaimed or declared a disaster area or under a state of calamity;
Control (2) That area is declared under an emergency;
(3) The privilege of the writ of habeas corpus is suspended in that area;
(4) That area is placed under martial law;
(5) That area is declared to be in a state of rebellion; or
(6) A state of war is declared in that area.
RA 9502  amended the following three acts:
RA 8293
RA 6675
RA 5921

AO 90 s. 1990  amended AO 62 s. 1989 in response to the request

of prescribing doctors to allow them to write
the name of more than one drug product on
the same page of a prescription form for a
particular patient.

RA 9211 (Tobacco Regulation Act of 2003)

 The electronic cigarette is not a proven nicotine replacement
therapy & WHO has no scientific evidence to confirm the
product’s safety & efficacy.
RATIONAL DRUG USE
A component of the Philippine national Drug Policy that attempts
to correct and limit inappropriate and wasteful utilization of
pharmaceuticals in the community through thorough legislation and
strategies (public education program) that tries to reach prescribers,
dispensers and the consumers so they can use drugs properly,
correctly and sanely. The goal of this pillar is fulfillment the SANE
criteria in drug use: safety, affordability need and efficacy
The rational use of drugs means that patients receive medicines
appropriate for their clinical needs, in doses that meet their individual
requirements, for an adequate period of time, and at the lowest cost to
them and their community. Irrational drug use by prescribers and
consumers is a very complex problem, which calls for the
implementation of many different interventions at the same time.
Efforts to promote rational drug use should also cover the use of
traditional and herbal medicines. Key policy issues are:
 development of evidence-based clinical, as the basis for
training, prescribing, drug utilization review, drug supply
and drug reimbursement;
 establishment and support of drugs and therapeutics
committees;
 promotion of the concepts of essential drugs, rational drug
use and generic prescribing in basic and in-service training
of health professionals;
 the need and potential for training informal drug sellers;
 continuing education of health care providers and
independent, unbiased drug information;
 consumer education, and ways to deliver it;
 financial incentives to promote rational drug use;
 regulatory and managerial strategies to promote rational
drug use
General Guidelines for proper drug use
The essential drugs concept is central to a national drug policy
because it promotes equity and helps to set priorities for the health
care system. The core of the concept is that use of a limited number of
carefully selected drugs based on agreed clinical leads to a better
supply of drugs, to more rational prescribing and to lower costs.
The reasons are clear. Essential drugs that is selected on the basis of
safe and cost-effective clinical, give better quality of care and better
value for money. The procurement of fewer items in larger quantities
results in more price competition and economies of scale. Quality
assurance, procurement, storage, distribution and dispensing are all
easier with a reduced number of drugs. Training of health workers and
drug information in general can be more focused, and prescribers gain
more experience with fewer drugs and are more likely to recognize
drug interactions and adverse reactions.
PHILIPPINE NATIONAL DRUG FORMULARY
The Philippine National Drug Formulary is an integral component
of the National Drug Policy (NDP). It is a major strategy in the
promotion of rational drug use, by assuring the availability and
accessibility of essential drugs of proven efficacy, safety and quality at
affordable cost. It is formulated by the Department of Health through
the National Formulary Committee (NFC), mandated by the R.A. 6675
also known as the Generics Act of 1988.
It was formulated utilizing submitted evidence tables,
documentations and a series of deliberation meetings with a panel of
experts and resource persons consisting of representatives from
medical schools, Philippine Medical Association (PMA), academic,
specialty and sub-specialty societies, drug industry, government and
private hospitals, and other stakeholders.
In 1993, by virtue of Executive Order No. 49 s.1993 and the
Philippine Health Insurance Act of 1995, the PNDF was officially
adopted as the basis for procurement of drug products within the
entire DOH.
General Guidelines for Establishing the Philippine National Drug
Formulary
Drug selection for the Philippine National Drug Formulary must be based
on the following:
1. Relevance to disease which is indicated in the treatment of
prevalent diseases.
2. Efficacy and safety objectively obtained on pharmacologic
studies, which includes at least expanded Phase II clinical trials
and/or additional Phase III studies among Filipinos.
3. Quality control standards, including stability, and when
necessary, bioavailability have to be met. The suppliers of
pharmaceutical products must provide documentation of the
product’s compliance with the requested specifications.
4. Cost of the treatment regimen.
5. Appropriateness to the capability of health workers at different
level of health care must be considered.
6. Local health problems, the prevalent diseases or conditions on
pharmacokinetic and pharmacodynamic parameters modifying
therapeutic response have to be considered.
7. Most favorable benefit/risk ratio is selected when several drugs
are available for the same therapeutic indication.
8. Preferential factors for evaluating therapeutically equivalent
drugs:
a. Drug with best understood beneficial properties and
limitations
b. Drug with clinical utility for treating more than one
condition
c. Drug with most favorable pharmacokinetic
properties
d. Drugs in a dosage form easily dispensed by health
staff or safely administered to the patient
e. Drugs with greater acceptability
f. Drugs with favorable stability
g. Drugs for which local reliable manufacturing
facilities exist for its production
9. Formulation as single compounds and fixed-ratio combinations
are acceptable only when:
a. Use of more than one drug is clinically documented
b. Its therapeutic benefit is greater than the sum of
each individual component
c. It is safer than the use of a single compound drug
d. It is cheaper or does not exceed the cost of the sum
of individual products
e. Patient compliance is improved
f. Satisfaction of majority of the population is
maintained
10. Period review of significant new therapeutic advances and
information is necessary.
11. International Non-propriety Names for drugs should be used.
The PNDF is a component of the National Drug Policy which seeks to
bring about the availability of safe, efficacious, and quality drugs at
affordable cost. Through the Essential Drug Concept, it is a step to
rationalize drug production, distribution, procurement and
consumption.
Philippine National Drug Formulary (PNDF)
 Is the Essential Drug List for the Philippines prepared by
the National Drug Committee (NDC) with consultation to
different experts in the field of pharmaceutics, which is
updated every year, consisting of:
a. Core List – drugs that are essential and are needed
by the majority of the population and should be
available at all times in appropriate dosage forms and
in sufficient quantities.
b. Complimentary List – drugs that are needed for
treating rare disorders, drugs with special
pharmaceutical properties and alternative drugs to be
used when there is no response in medicating Core
list drugs or when Core list drugs cannot be
administered for a reason or situation.
Corazon C. Aquino declared publicly the Philippine National Drug
Policy (PNDP)
Five Pillars of PNDP are
(1) assurance of the safety, efficacy and usefulness of drug
products through quality control
(2) promotion of the rational use of drugs by health professionals
and the general public
(3) development of self reliance in local pharmaceutical industry
(4) targeted procurement of drugs by government and
(5) people empowerment.
Code of Ethics For Pharmacists
Preamble
Pharmacists are health professionals who help
individuals protect themselves against diseases,
maintain good health and make the best use of
their medication. The pharmacists ensure the
provision of safe, effective and quality drugs,
for improved patient care and quality of life.
This Code, prepared and supported by
pharmacists, is intended to state publicly the
principles that form the fundamental basis of
their roles and responsibilities which are based
on moral obligations and virtues and to guide
pharmacists in their relationship with patients,
health professionals and society.

1. A pharmacist places the well being of the patient

at the center of professional practice.
2. A pharmacist promotes the welfare of each
individual in a caring and compassionate manner.
3. A pharmacist serves the needs of the individual,
community and society and provides health for all.
4. A pharmacist respects the rights of patient and
upholds confidentiality of patient records.
5. A pharmacist acts with honesty, integrity and
professionalism in relationship with the patient
and other health professionals.
6. A pharmacist respects the abilities, values and
contributions of colleagues and other health
professionals and work with the closely to ensure
better patient care.
7. A pharmacist is committed to continuously
enhance professional competence.
8. A pharmacist, in coordination with the
government and other health professionals helps
in the formulation and implementation of health
care policies, standards and programs designed for
the benefit of society.