Thursday, 22 March 2012

Why Empty Hard Gelatin Capsules are stored in Temperature & Humidity controlled area

Empty Hard Gelatin Capsules



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. 



20 comments:

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  2. Unlike today’s modern gelatin capsules , in previous decades, pharmaceutical companies that produced medications for oral ingestion were only able to offer their products in tablet form. Essentially, the medication to be used in the tablet would be mixed with binding agents and hardened, producing a solid pill. These medications, although effective, often took long periods of time to digest, meaning the time needed for the medication to be absorbed was longer, and they were often hard to swallow. In 1834, however, the pharmaceutical company Mothes and Dublanc began producing a different type of capsule made using gelatin.

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  3. I had no idea that this was why they always are so careful about how gelatin capsules are stored. Thanks so much for sharing this. I think I'm pretty much an expert now.

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  4. I didnt know this so thanks for posting this. I hadnt really heard about gelatin capsules untill a friend told me about the. So thanks again for posting this information.

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  5. Thank you for sharing I found this post to be very informative and helpful. I just purchased temperature controlled storage in MA and can’t wait to start using it!

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  8. Dear thanks for the enriched information, kindly can you inform me by the reference of the storage conditions of EHGC if it is present in WHO etc

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  13. Firstly I would like to thanks for shared useful information I really appreciate with your website I have heard about of the Gelatin Capsules basically there are two types of Gelatin Capsules one is the soft and 2nd hard Capsules.

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  15. Great article! That is a very neatly written article. Gelatin is one of those items which are intentionally or unintentionally are included in our daily routines. This is considered the daily supplement for our body which helps us to avail some those benefits which are not told to us before. Thanks for great share.

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  17. If this post interests you, then head straight to this blogger from California who has been in the business for 20 years now. He makes and sells empty caps of all sizes and varieties.

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  18. Thanks so much for your information! I am doing stability test for hard gelatin capsule but the storage conditions are not the same with your recommendation. For long term stability: temperature: 30C ± 2; humidity: 75%± 5%. For accelerated: temperature: 40C ± 2; humidity: 75%± 5%. These extremely affect appearance of capsule. Would you share me reference for stability test for empty and filled hard gelatin capsule? Many thanks!

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