MANUF LAB (PRELIMS) EGR 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
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
Sieve Size: All
Particles Pass
Through
Fineness
Very Coarse (No. 8) 20 Not more than (nmt) 20%
through a no.60 sieve
Coarse (No.20) 20 Nmt 40% through a no.80
sieve
Moderately Coarse (No.40)
40 Nmt 40% through a no.80
sieve
Fine (No.60) 60 Nmt 40% through a no.100
sieve
Very Fine (No.80) 80 No limit to greater fineness
USP Standards for Powder of Chemicals USP Descriptive Terms
Sieve Size: All
Particles Pass
Through
Fineness
Coarse (No.20) 20 Nmt 60% through a no.40
sieve
Moderately Coarse (No.40)
40 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
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
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
ORAL REHYDRATION SALTS
Provides 200 mL Soln
Sodium.................................................... ___meq
Potassium.............................................. ___meq
Chloride................................................. ___meq
Bicarbonate........................................... ___meq
Anhydrous Glucose............................ ___meq
2
EGR
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
