Saturday, 24 June 2017

Cellulose-based capsules to replace gelatin capsules

Cellulose-based capsules to replace gelatin capsules Capsules are a very widely used dosage form. They are easy to administer, mask the odor and taste of drugs, which may be unpleasant to some patients. Due to rapid disintegration, the drug is rapidly released in the stomach. Hence, they are a necessary form of drug. However, one aspect that is of concern is their storage. Capsules should be stored in airtight containers and in a cool and dry place to avoid degradation. They need to be protected from light and moisture. Gelatin has been commonly used to manufacture capsules, which is derived from animal sources, including bones. But now, the Govt has recommended a proposal to replace gelatin capsules with vegetable capsules. The sources of these vegetable capsules are plant in origin. In March this year, an Expert Committee was constituted to address all technical issues pertaining to the replacement of gelatin (non-vegetable) capsules with cellulose-based capsules. According to notice from the Directorate General of Health Services (DGHS) office dated June 2, 2017, the proposal is open to suggestions/comments within 21 days. The Bureau of Indian Standards (BIS) has formulated Draft Indian Standards for cellulose based vegetable capsule shells. Hydroxypropyl methyl cellulose (HPMC), most commonly known as hypromellose, is used in the manufacturing of the cellulose-based capsule shell. India is a land of diverse religious and cultural beliefs and traditions. A vegetable alternative should be available. On account of religious and cultural sentiments, patients may prefer the cellulose-based capsules over gelatin capsules. Additionally, personal preferences may influence the choice of the vegetable capsules. We have to respect these choices. Patients should be conveyed that the capsule is non-vegetable. In addition their safety and stability, the most important concern to be addressed is affordability to the patient. If the cost comes out to be the same as gelatin capsules, then the gelatin capsules can be replaced with cellulose-based capsules. But, if these capsules would cost more than the gelatin capsules, then both the options should be made available, leaving it to the patient to choose his preference. Another issue that comes up is the manufacturing capacity. More than a billion capsules are manufactured in India every year. Do we have the production capacity to match and then meet the growing demands? How do we differentiate the vegetable capsules from gelatin capsules? Will they be identified by the green and maroon circles in a square as used on food items? A maroon dot indicates the presence of non-vegetarian ingredients, while a green dot identifies vegetarian food. In May last year, the Drugs Technical Advisory Board (DTAB) had rejected the proposal to label the cellulose-based capsule with green dot to indicate its vegetarian origin to differentiate them from the normally available gelatin-based capsules stating that “unlike food, drugs are not taken by choice but are prescribed by the doctors to save lives and marking them vegetarian or non-vegetarian origin is not desirable”. DCGI is the regulatory authority, which provides the standards and quality of manufacturing, selling, import and distribution of drugs in India. Any drug approved by the Drugs Controller General of India (DCGI) is safe and a quality drug. But, there are issues that need to be addressed. Dr KK Aggarwal National President IMA & HCFI

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