Page 54 - Pharmaceutics III_ 02-06-01304_Fall 2025_ Pharm D_Electronic book

o Liquid fill injected between them at point of contact.
o Capsules formed, sealed, cut, and dried.
3. Bubble method:
o Gelatin drop formed around fill material by surface tension.

Drying of Softgels:
• Tumble drying for few minutes → tray drying at 20–30°C for 24–48 hours.
• Final moisture content 6–10%.

Storage of Capsules:
• 15–25°C and 35–45% RH.
• Avoid high humidity (softening) or low humidity (brittleness).
• Store in airtight containers.

Quality Control Tests for Capsules:
1. Appearance: uniform color, no cracks, dents, or leaks.
2. Average weight: as per BP (same limits as tablets).
3. Weight variation:
o 20 capsules weighed individually.
o Difference from average ≤10% (for ≤300 mg) or ≤7.5% (for >300 mg).
4. Content uniformity: 85–115% of label claim.
5. Disintegration:
o HGC: ≤30 min in water at 37°C.
o SGC: ≤60 min unless otherwise specified.
6. Dissolution: not less than 80% release in specified time.
7. Moisture content: Karl Fischer or LOD method.

Capsule Defects:
1. Softening or stickiness:
o Due to high humidity; store properly.
2. Brittleness or cracking:

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