Page 59 - Pharmaceutics III_ 02-06-01304_Fall 2025_ Pharm D_Electronic book
P. 59
• At least 80 % of drug should dissolve within specified time.
Moisture Permeation Test:
Capsules packed with desiccant and stored under high humidity; weight gain indicates
permeation rate.
Stability Testing of Capsules:
Same conditions as tablets.
Parameters monitored: appearance, moisture content, disintegration, dissolution, assay.
Packaging of Capsules:
1. Blister packs:
o PVC or PVDC base with aluminum foil lidding.
o Protects from moisture and oxygen.
2. Strip packs:
o Two heat-sealed foil layers.
3. Bulk bottles:
o Amber glass or HDPE plastic; desiccant added.
Storage:
Store in a cool, dry place below 25 °C and < 50 % RH.
Avoid excessive heat or moisture which causes deformation of gelatin.
Applications of Capsules:
• To enclose unpleasant-tasting or irritant drugs.
• To separate incompatible ingredients.
• To prepare sustained-release dosage forms.
• To deliver liquid or semisolid drugs.
Pharmaceutical Quality System for Tablets and Capsules:
Key components:
1. Raw material control (identification, purity, particle size).
2. In-process control (blend uniformity, compression parameters).
58
