Capsules are solid dosage forms in which medicinal agents are enclosed in a small shell. Depending on the composition capsules may be hard or soft. Hard gelatin capsules are made from gelatin (Gelatin is a translucent, colorless, brittle (when dry), flavorless solid substance, derived from the collagen- an animal protein).Empty Hard Gelatin Capsules contain 12 - 16% moisture. But the moisture content can vary up on the storage conditions.
Recommended Storage conditions for Hard Gelatin Capsules
• Store capsules away from direct sunlight (e.g. windows and skylights)
• Store capsules away from hot water/air radiators, hot water pipes and steam pipes.
• Store capsules on pallets off the ground.
• Store capsules away from potential sources of water condensation e.g. under water pipes.
• Do not store empty capsules in freezers.
Hard gelatin capsules shall be stored between 15-25oC (68-75oF) and 45-55% relative humidity to maintain the 12-16% moisture content of capsules. It is important that this moisture content is maintained and exposure to high temperatures or cycling between high/low temperatures is avoided. When humidity is low capsules become brittle, if stored at high humidity, the capsules become flaccid and the excess moisture content can interact with encapsulated product and can cause stability problems.
If capsules stored at high temperature following defects can occur
1. Stucking of capsules together in lumps and do not come apart.
2. Brittle or shatter capsules.
3. Capsules with distorted shape.
4. Stucking of capsule cap to body and resists separation.
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