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• Non-animal source.
• Lower moisture content.
• Stable over wide humidity range.
Comparison of Hard vs Soft Gelatin Capsules:
Property Hard Gelatin Soft Gelatin
Water content 12–16% 20–30%
Plasticizer None Glycerin, Sorbitol
Fill type Solid/semi-solid Liquid/semi-solid
Manufacturing Two-piece, filled separately One-piece, formed & filled simultaneously
Dissolution Faster Slightly slower
Cost Lower Higher
Evaluation of Capsule Performance:
1. Disintegration test: ensure shell rupture and release.
2. Dissolution profile: compare with reference.
3. Assay: determine content uniformity.
4. Stability: test for changes in appearance, shell integrity, assay, and dissolution.
Storage and Handling Precautions:
• Avoid direct contact with strong light.
• Keep tightly closed.
• Do not refrigerate unless specified.
• Maintain recommended humidity.
Common Capsule Applications:
• Vitamins and nutritional supplements.
• Antibiotics.
• Analgesics.
• Lipophilic drugs in softgels.
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