Page 58 - Pharmaceutics III_ 02-06-01304_Fall 2025_ Pharm D_Electronic book

Novel Capsule Technologies:
1. Capsugel Licaps®: liquid-filled hard gelatin capsules using nitrogen flushing.
2. Pellet-filled capsules: multiple release profiles in single capsule.
3. Capsule-in-capsule (dual release): separation of incompatible drugs.
4. Enteric liquid capsules: enteric-coated shells for liquid fills.
5. Dry powder inhalation capsules: contain drug for pulmonary delivery (pierced before
inhalation).

Evaluation Tests for Capsules (continued):
Uniformity of Weight:

• Twenty capsules selected at random.
• Each weighed individually and compared to the average.
• Deviations must not exceed limits prescribed by pharmacopeia.

Average weight % Deviation allowed

<300 mg ±10 %

≥300 mg ±7.5 %

Content Uniformity:
Ten capsules assayed individually.
Each capsule should contain 85 – 115 % of the label amount.

Disintegration Test for Capsules:

• Apparatus: six-tube basket rack assembly (same as tablets).

• Medium: water at 37 ± 2 °C.

• For HGC → ≤ 30 min; for SGC → ≤ 60 min unless otherwise specified.
If enteric-coated → must resist 0.1 N HCl for 2 h, then disintegrate within 60 min in
phosphate buffer pH 6.8.

Dissolution Test for Capsules:
• Purpose: determine rate of drug release.
• Apparatus I (basket) or II (paddle) used.
• 900 mL medium, 37 ± 0.5 °C, 50 – 100 rpm.

57