Page 53 - Pharmaceutics III_ 02-06-01304_Fall 2025_ Pharm D_Electronic book

Composition of Shell:
• Gelatin (30–45%)
• Plasticizer (glycerin, sorbitol)
• Water (20–30%)
• Colorants, opacifiers, flavoring agents

Plasticizer ratio:
• Glycerin:sorbitol = 1:1 to 1:2
• Determines elasticity of shell.

Filling Materials for Softgels:
• Non-aqueous liquids (vegetable oils, PEG, propylene glycol).
• Suspensions of solids in liquid vehicles.
• Volatile liquids not suitable (evaporate, cause leakage).

Advantages of Softgels:
1. Improved bioavailability of poorly soluble drugs.
2. Mask unpleasant taste/odor.
3. Accurate dosing of liquids.
4. Elegant appearance.
5. Easy to swallow.

Disadvantages:
1. Moisture sensitivity (soft shells).
2. Incompatibility with water or alcohol.
3. Higher manufacturing cost.

Manufacturing of Softgels:
1. Plate process:
o Warm gelatin sheets placed between plates.
o Liquid fill introduced, plates pressed to seal.
2. Rotary die process (most common):
o Two ribbons of gelatin continuously formed.

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