By Zhejiang Zhenxiong Fiber Technology Co., Ltd.
I. Current Development Situation of New Vacant Capsules
International development of vacant capsules
Standards for new vacant capsules are being gradually set and improved, with application of new materials of vacant capsules and people’s understanding of characteristics of the new vacant capsules.
The USP issued a draft for comment for HPMC vacant capsules in 2016, with comment deadline of September 30, 2016, mainly including articles on identification, loss on drying, disintegration time, microbes, and storage conditions, etc.
The Japanese Pharmacopoeia, 17th Edition adds quality standards for HPMC vacant capsules and Pullulan vacant capsules.
Development of vacant capsules in China
The Chinese Pharmacopoeia 2015 Edition has added the quality standard for hydroxypropyl starch vacant capsules. The Chinese Pharmacopoeia 2015 Edition supplement plans to add quality standards for HPMC vacant capsules and Pullulan vacant capsules, and the Pharmaceutical Capsule Committee of China National Pharmaceutical Packaging Association is currently drafting the association standards for HPMC vacant capsules and Pullulan vacant capsules.
Development trend in China
Seen from the world, China, a big producer and consumer of TCM and health products, is a big demander for capsule products. Seen from the category, the HPMC vegetarian capsules especially will have bright market prospects.
For pharmaceutical and functional food enterprises, having vegetarian capsules enter the Chinese pharmaceutical product and functional food markets will not only improve the brand value of products in China, and more importantly, accelerate the internationalization of Chinese-produced preparations. Manufacturers ranking high in the Chinese capsule industry have competed to start vegetarian capsule development and production, besides production of gelatin capsules.
II. Comparison between Vegetarian Capsules and Gelatin Capsules
The hydroxypropyl methylcellulose (HPMC) in vegetarian capsules has stable chemical properties, and has no chemical reaction with air and water; the cellulose therein has metabolic inertness, and is not absorbed in vivo but directly excreted from the body; microbes are not liable to grow in vegetarian capsules, therefore, there will be no decomposition and deterioration when they are placed under normal conditions for a long time.
Compared to the traditional vacant gelatin capsules, vegetarian capsules have advantages such as wide adaptability, no risk of crosslinking reaction, and high stability; vegetarian capsules have relatively stable drug release rate and small individual difference, and are not absorbed after disintegration in vivo and can be excreted from the body with the excrement. Regarding storage conditions, numerous experiments show that vegetarian capsules are not friable under low humidity, their shell characters are still stable under high humidity, and various indicators of the HPMC vacant capsules are not affected under extreme storage conditions, while vacant gelatin capsules easily become adhesive under high humidity, lose water and harden or become friable under low humidity, and strongly depend on the storage environment temperature and humidity, and packaging materials.
The main ingredient of the traditional vacant gelatin capsules is protein, therefore, the dividing bacilli and microbes are liable to grow, and preservative shall be added during the production, leading to the possibility that a small amount of preservative remains on capsules; ethylene oxide shall be used for sterilization during product packaging, to guarantee the control indicator of capsule microbes. Chloroethanol is an indicator that shall be strictly controlled for vacant gelatin capsules. However, the vegetarian capsules require no preservative during the production, or ethylene oxide for sterilization, which fundamentally solves the chloroethanol residue problem.
<...Read More
(All Rights Reserved)