EGR

MANUF LAB (PRELIMS)

PREPARATION 4,5,6
POWDERS
mixture of finely divided drugs &/or chemicals in
drug form
may be finely subdivided, coarsely comminuted
product or product of intermediate particle size
used internally or externally
Advantages:
flexibility of compounding
good chemical stability
rapid dispersion of ingredients
Disadvantages
Time consuming
inaccuracy of dose
unsuitability for many unpleasant tasting,
hygroscopic and deliquescent drugs
Packaging & Dispensing
Bulk Powder
Divided Powder

Sieve Size: All

Particles
Pass
Through

Very Coarse (No. 8)

20

Coarse (No.20)

20

Moderately
(No.40)

Coarse

USP Descriptive Terms

Sieve Size: All

Particles
Pass
Through

20

Coarse (No.20)
Moderately
(No.40)

Coarse

40

Fineness
Nmt 60% through a no.40
sieve
Nmt 60% through a no.60
sieve

Fine (No.180)

180

No Limit

Very Fine (No.120)

120

No limit

Manufacturing Procedures
Triturate
Weigh
Blend
Sieve
Blend
Tumble
Pack
Weigh
PREPARATION 4: Oral Rehydration Salts

Characteristics
Homogenously blended
Methods of Blending
a.) Small Scale
Spatulation
Trituration
Geometric dilution
Sifting
b) Large Scale
Tumbling
Must be of the most advantageous particle size
Comminution techniques
a) Small Scale
Trituration
Levigation
Pulverization by intervention
b) Large Scale
Various mills
Pulverizers
USP Standards for Powders of Animal & Vegetable drugs
USP Descriptive Terms

USP Standards for Powder of Chemicals

40

Fine (No.60)

60

Very Fine (No.80)

80

NaCl......................................... 1.6 g
KCl............................................ 1.5 g
`
NaHCO3................................... 1.5 g
Anhydrous Glucose............. 36.4 g
For 1 L soln
*Each subgroup prepared for 200 mL soln
Guidelines in labeling
Electrolytes for ORT must be expressed in mEq
Quantities of electrolytes administered to patients
Prep of Label
ORAL REHYDRATION SALTS
Provides 200 mL Soln
Sodium.................................................... ___meq
Potassium.............................................. ___meq
Chloride................................................. ___meq
Bicarbonate........................................... ___meq
Anhydrous Glucose............................ ___meq

Fineness

Not more than (nmt) 20%

through a no.60 sieve

Nmt 40% through a no.80

sieve
Nmt 40% through a no.80
sieve
Nmt 40% through a no.100
sieve
No limit to greater fineness

Direction for reconstitution must be indicated in the

labelling materials
Dispensing: Each dose should be dissolved in sufficient,
freshly boiled and cooled water to make 200 mL solution
taking hygiene and precaution.
Storage:
Powders: ______________
After reconstitution: Unused soln must be
discarded after 1 hour
Refrigerated: may be kept for 12 - 24 hrs

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SUSPENSION
Preparation containing finely divided drug particles
distributed uniformly throughout a vehicle
2 phase systems
dispersed medium can be oily or aqueous
dispersed phase is usually greater than 0.5
Preparation = GELOMAMI
Purpose: Sustaining Effect
Stability
Taste
Base Solubility
Properties of Ideal Suspension
uniform particle size
no particle interaction
no sedimentation or slow sedimentation rate
other properties:
redisposable, chemically stable, acceptable to
consume
Components
Active Ingredient
Wetting Agt
-make them more soluble to solvent
-Alcohol, PPG, Sorbitol, Surfactant
Floculating Agt
-avoid aggregates
-electrolytes < 1% of KCl & NaCl
Viscosity Agt
-increases viscosity, hydrophillic colloids
-clays, gums
Buffer
Preservative
Flavorant
Colorant
Solvent
2 Forms of Suspension
Ready to use
- oral suspension
- no reconstitution needed
Dry Powders/ Dry Granules for Oral Suspension
-reconstitution required
-contains "for oral suspension"
PREPARATION 5: Aluminum Magnesium Hydroxide
Al(OH)3......................................................7% (Active Ing)
Mg(OH)2....................................................3% (Active Ing)
CMC Na....................................................2.5 % (Viscosity Agt)
Peppermint................................................0.1% (Flavorant)
Na Saccharin..............................................0.1% (Sweetener)
Na Benzoate...............................................0.1% (Preservative)
Sorbitol Soln...............................................20% (Wetting Agt)
Purified H2O qs ad.....................................100%

Procedures:
Place Mg(OH)2 in a blender
Add Sorbitol Soln
Add purified water (1/3)
Blend the mixture 5 mins
Add Al(OH)3 gel blend for 5 mins
Place CMC in a mortar & triturate with 50 mL
water until paste is formed
Add CMC paste to the blender
In a separate container, heat water to 500C &
dissolve saccharin solution & Sodium benzoate.
Cool the soln to 400C. Charge into blender &
blend for 10 mins

Add Peppermint oil

Homogenize the suspension
QS H2O. Blend for 1-2 mins
GRANULES
Prepared agglomerates of smaller particles
Irregularly shaped and behave as single larger
particles
uses sieve #4 -12 for particles size classification
Granulation
Pharmaceutical process that attempts to convert
produced materials into aggregates
Large Scale
- granulating machine on granulation
Small Scale
powder + water => moist mass =>sieve #4-12
=>net granules =>(drying) Dry granules
Advantages

flow well composed to powder

more stable physically and chemically than

powders

Easily wetted
PREPARATION 6: Phenoxymethyl Penicillin
Phenoxymethyl Penicillin............................ 25g
CMC................................................................ 25g
Sucrose............................................................125g
Na benzoate...................................................9 g
Citric Acid......................................................5g
Cone strawberry powder ..........................1g
Lactose...........................................................30g

EGR

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Procedures:
Mix the powders & blend for 15 mins using
titration
Prepare 20 mL colorant solution & spray into
powder mixtures with continuous trituration until
a moist mass is formed
Pass the moist mass through sieves #12 & receive
net granules in a tray
Oven dry granules a temp not exceeding 400C -1
hour
Dry the granules until 1 nmt 2% moisture is
present. Check the moisture content every 30
mins weigh & pack the divided granules

EGR