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Precision and low content variability of unit dose

Low manufacturing cost
Simple to identify
Easy to swallow
Appropriate for special release forms
Best suited to large scale production
Most stable of all oral dosage forms (essentially
Some drugs resist compression into tablets
Some drugs may be difficult to formulate to provide
adequate bioavailability
Some drugs require encapsulation / entrapment
before compression
Free of defects (example: chips, cracks,
discoloration, contamination)
Strong enough to withstand the mechanical stresses
of production FRIABILATOR
Chemically and physically stable over time
Capable of releasing medicinal agents in a
predictable and reproducible manner
o Partial / Complete separation of the top /
bottom crown from the main body of the
o Separation of tablet into two or more
distinct layer
o Removal of the surface material of a tablet
by a punch
o Adhesion of tablet material to a die wall
o Film cracks across the crown of the tablet
o Unequal distribution of color, with light or
dark areas standing out on an otherwise
uniform surface
Tablet formula (Active Ingredient)
has different color than excipient
External environment factors
(temperature, pressure, heat)
Colorant added
o The coating of the tablet peels
Orange Peel Roughness
o A surface defect resulting in the film being
rough and non glossy
Logo Bridging
o The logo of the tablets transfer to other

o Tablets stick together
Logo Infilling
o Renders the distinctness
Core Erosion
o The core of the tablet wears away
o A defect whereby pits occurs in the surface
of a tablet core without any visible
disruption of the film coating
o A defect of film coating whereby volcanic
like craters appears exposing the tablet
o Defect where coating becomes dull
immediately or after prolonged storage at
high temperatures
o Whitish specks / haziness in the film
o Local detachment of film from the substrate
forming blister
Double Impression
o Involves only those punches, which have a
monogram or other engraving on them
o Imprinted with a mark below the surface
o Imprinted with a mark raised above the
o Imprinted with a code that is cut into the
surface during production
In addition to the apparent features of tablets, tablets
must meet other physical specifications and quality
standards. These include criteria for weight, weight
variation, content uniformity, thickness, hardness,
disintegration and dissolution
Tablet Thickness
o Determined by the diameter of the die, the
amount of fill permitted to enter the die,
the compaction characteristics of the fill
material, and the force or pressure applied
during compression
o May be measured by hand gauge during
production or by automated equipment
o Vernier Caliper
Tablet Hardness and Friability
o In general, tablets should be sufficiently
hard to resist breaking during normal
handling and yet soft enough to
disintegrate properly after swallowing
o A friabilator determines the tablets
friability, or tendency to crumble, by
allowing it to roll and fall within the drum
o A maximum weight loss of not more than
1% generally is considered acceptable for
most products
Content Uniformity
o The requirements for content uniformity
are met if the amount of the active
ingredient in each dosage unit lies within
the range of 85% to 115% of the label claim
and standard deviation is less than 6%
Tablet Disintegration
o Important for tablets containing medicinal
agents (such as antacids and antidiarrheals)
that are not intended to be absorbed but
rather to act locally within the
gastrointestinal tract
o Provides drug particles with an increased
surface area for activity within the
gastrointestinal tract
Tablet Dissolution
o It guides formulation and product
development toward product optimization
o Manufacturing may be monitored by
dissolution testing as a component of the
overall quality assurance program
o Consistent in vitro dissolution testing
ensures bioequivalence from batch to batch
o It is a requirement for regulatory approval
of marketing for products registered with
the FD and regulatory agencies of other
o Its goal is to provide insofar as is possible a
reasonable prediction of or correlation with
the products in vivo bioavailability
I High Solubility and
High Permeability
II Low Solubility and
High Permeability
III High Solubility
and Low
IV Low Solubility and
Low Permeability
Weight Variation
o Can be made by compression / molding
o Made using a tablet machine and large, flat
o Available for self care drugs, including
benzocaine, dextromethorphan,
phenylpropanolamine, and zinc, to treat self
limiting cough and cold symptoms and
minor sore throat
o Fentanyl Actiq (Cephalon) is a sugar based
lozenge on a stick and contains fentanyl
o Actiq is the first product specifically
designed to aid in controlling breakthrough
pain in cancer patients
o Indicated only for the management of
breakthrough cancer pain in patients with
malignancies who are already taking and
are tolerant to opioids
o Provides almost immediate relief as the
drug starts being absorbed in the mouth
and starts to work within minutes
o Its effect lasts only for 15 minutes, but that
is usually long enough to relieve the
breakthrough pain
o Small, round solid dosage form containing a
medicinal agent and intended to be
administered orally
Based on route of administration
Based on drug delivery
Based on forms and method of manufacture
Designed to be swallowed intact with the exception
of chewable tablets
Reasons for Coating:
o Mask the taste, color and odor of the drug
o Control drug release
Allowed to dissolve in the mouth
Buccal Tablets and Sublingual Tablets
Dissolved in water before administration
Diluents / Fillers / Bulking Agents
o Designed to make up the required bulk of
the tablet when drug dosage amount is
o May also improve cohesion, permit direct
compression, promote flow
o Factors to Consider in Selection of Diluents:
Should be biocompatible with the
active ingredient
Moisture Content
o Examples: Kaolin (grayish brown), Lactose
(very expensive, with sweet taste for
chewable tablet), Mannitol (expensive, with
sweet taste), Starch (for soft tablets),
Microcrystalline Cellulose (stable yet
expensive), Powdered Sugar, Calcium
Binders / Adhesives
o Added in either dry or liquid form to
promote granulation or to promote
cohesive compacts during compression
o Liquid Binder: if the active ingredient is not
affected in the presence of water
o Dry Binder: if the active ingredient is
affected in the presence of water
o 10% - 20% aqueous preparation of
cornstarch, 25% - 50% glucose solution,
molasses, various natural gums, cellulose
derivatives, gelatin and povidone
Disintegrants / Disintegrating Agents
o Examples: Magnesium Oxide, magnesium
Flavoring agents
o Limited to chewable tablets or tablets that
are intended to dissolve in the mouth
o Soluble flavors usually have poor stability.
For this reason, flavor oils or dry powders
are typically used
o 0.5% to 0.75%
Artificial sweeteners
o Some sweetness may come from diluents
o Saccharin has an unpleasant aftertaste
o Aspartame is not stable in the presence of
moisture and heat
o Typically used only with chewable tablets or
tablets that are intended to dissolve in the
Compressed Tablets
o Round, oblong, or unique in shape; thick or
thin; large or small in diameter; flat or
convex; unscored or scored in halves,
thirds, or quadrants; engraved or imprinted
with an identifying symbol and / or code
number; coated or uncoated; colored or
uncolored; one, two, or three layered
Multiple Compressed Tablets
o Layered Tablets are prepared by initial
compaction of a portion of fill material in a
die followed by additional fill material and
compression to form two layered or three
layered tablets
o Compression Coated Tablets / Dry Coated
o Example: Norgesic Tablets
Repeat Action Tablets
Delayed Action Tablets / Enteric Coated Tablets
o Have delayed release features
o Designed to pass unchanged through the
stomach to the intestines
o Examples: Ecotrin Tablets and Caplets
Sugarcoated Tablets and Chocolate Coated Tablets
o May be coated with a colored or an
uncolored sugar layer
o The sugarcoat protects the enclosed drug
from the environment and provides a
barrier to objectionable taste or odor
o Disadvantages include the time and
expertise required for the process and the
increase in tablet size and weight
o May be 50% larger and heavier than the
original tablets
o 8 hours minimum
Film Coated Tablets
o 2% - 3% increase in weight
o Usually contain a film polymer capable of
producing smooth, thin films reproducible
under conventional coating conditions and
applicable to a variety of tablet shapes, an
alloying substance provides water
solubility or permeability to the film to
ensure penetration by body fluids and
therapeutic availability of the drug, a
plasticizer produces flexibility and
elasticity of the coating and thus provide
durability, a surfactant enhances
spreadability of the film during application,
opaquants and colorants make the
appearance of the coated tablets handsome
and distinctive, sweeteners, flavors and
aromas enhance the acceptability of the
tablet by the patient, a glossant provides
luster to the tablets without a separate
polishing operation, and a volatile solvent
allows the spread of the other components
over the tablets while allowing rapid
evaporation to permit an effective yet
speedy operation
Air Suspension Coated Tablets
o Fed into a vertical cylinder and supported
by a column of air that enters from the
bottom of the cylinder
o As the coating solution enters the system, it
is rapidly applied to the suspended, rotating
solids (Wurster Process)
o Less than 1 hour
Chewable Tablets
o Have a smooth disintegration when chewed
or allowed to dissolve in the mouth
o Have a creamy base usually of specially
flavored and colored mannitol
o Especially useful for administration of large
tablets to children and adults who have
difficulty swallowing solid dosage forms
o Examples: multivitamin tablets, Pepcid
Chewable Tablets, Rolaids Chewable Tablets
Buccal Tablets and Sublingual Tablets
o Flat, oval tablets intended to be dissolved in
the buccal pouch (Buccal Tablets) or
beneath the tongue (Sublingual Tablets) for
absorption through the oral mucosa
o Enable oral absorption of drugs that are
destroyed by the gastric juices and / or are
poorly absorbed from the gastrointestinal
o Lozenges or Troches
Disc shaped solid dosage forms
containing a medicinal agent and
generally have a flavoring
substance in a hard candy or sugar
Intended to be slowly dissolved in
the oral cavity, usually for local
effects, although some are
formulated for systemic absorption
Example: Mycelex Troches
Effervescent Tablets
o Prepared by compressing granular
effervescent salts that release gas when in
contact with water
o bubble action
o Commercial alkalinizing analgesic tablets
are often made to effervescence to
encourage rapid dissolution
o Examples: Alka Seltzer Original and Extra
Strength Tablets and Zantac EFFERdose
Molded Tablets
o Tablet Triturates
Small, usually cylindrical, molded
or compressed tablets containing
small amounts of usually potent
o Hypodermic Tablets
Originally used by physicians in
extemporaneous preparation of
parenteral solutions
o Dispensing Tablets
Termed compounding tablets
because the pharmacist used them
to compound prescriptions
o Resultant tablets are very soft and soluble
and are designed for rapid dissolution
Vaginal Tablets
o tablet insert
o Uncoated, bullet shaped, or ovoid tablets
inserted into the vagina for local effects
o Prepared by compression and shaped to fit
snugly on plastic inserter devices that
accompany the product
o Contain antibacterials for the treatment of
nonspecific vaginitis caused by Haemophilus
vaginalis or antifungals for the treatment of
vulvovaginits candidiasis caused by Candida
albicans and related species
Immediate Release Tablets
o Designed to disintegrate and release their
medication with no special rate
controlling features , such as special
coatings and other techniques
Extended Release Tablets
o Sometimes called controlled release
o Designed to release their medication in a
predetermined manner over an extended
Wet Granulation
o A widely employed method for the
production of compressed tablets
Traditional method for many drugs
since it imparts compressibility
Useful for fluffy powders (do not
flow or mix well), thermo labile
compounds, powders generating
static charge
Has a wide range of available
Some drugs are heat sensitive
Dry Granulation
Especially applicable to materials
degraded by moisture or elevated
temperature during drying
Not subjected to heating
o The powder mixture is compacted in large
pieces and subsequently broken down or
sized into granules
o Either the active ingredient or the diluents
must have cohesive properties
o Slugging
o Roller Compaction
Use of powder compactors to
increase the density of a powder
by pressing it between rollers at 1
to 6 tons of pressure
Direct Compression
o Some granular chemicals, like potassium
chloride, possess free flowing and
cohesive properties that enable them to be
compressed directly in a tablet machine
without any need of granulation. Special
pharmaceutical excipients may be used to
impart the necessary qualities for the
production of tablets by direct compression
Stored in tight containers, in places of low humidity,
and protected from extremes in temperature
Products that are prone to decomposition by
moisture generally are packaged with a desiccant
Drugs that are adversely affected by light are
packaged in light resistant containers
With a few exceptions, tablets that are properly
stored will remain stable for several years or more