Page 38 - Pharmaceutics III_ 02-06-01304_Fall 2025_ Pharm D_Electronic book

Moisture Content:
Measured by Karl Fischer titration or loss on drying method.
Excess moisture affects stability, hardness, and disintegration.

Packaging of Tablets:
Purpose: to protect from environmental factors such as moisture, light, oxygen, and mechanical
damage.
Types:

1. Blister packs: individual cavities sealed with aluminum foil.
o Protect from moisture and contamination.
o Improve patient compliance.

2. Strip packs: similar to blister but tablets sealed between two layers of foil.
3. Bulk packaging: bottles of glass or HDPE plastic with desiccant.

Storage:
• Temperature: 15–30°C.
• Humidity: <50% RH.
• Avoid exposure to sunlight and air.

Stability Testing:
Purpose: to determine shelf-life and establish recommended storage conditions.
Types:

1. Accelerated stability testing (40°C ± 2°C / 75% ± 5% RH for 6 months).
2. Long-term stability testing (25°C ± 2°C / 60% ± 5% RH for 12 months).
Parameters monitored: appearance, hardness, disintegration, dissolution, assay, degradation
products.

Evaluation of Film-Coated Tablets:
1. Visual inspection: uniformity, gloss, color.
2. Thickness: measured by micrometer.
3. Adhesion: test for film peeling or cracking.
4. Disintegration and dissolution: as per official tests.

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