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Pharmaceutical Manufacturing and Packing Sourcer
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This article describes the current status of some potential substitutes for gelatine two-piece capsules, with particular reference to their suitability for liquid products. Animal gelatine presents a number of issues, including technical, regulatory, commercial and consumer acceptability aspects. The use of possible substitutes - 'fish gelatine', starch and hydroxypropyl methylcellulose (HPMC) - is discussed. Particular reference is made to progress in the suitability of HPMC capsules for commercial manufacture (including filling and sealing). The article will also include relevant comment on their current regulatory status.
Hard (or 'two-piece') capsules have been used in medicines for many years, and are also being used in increasing quantities in nutraceuticals. The commercial manufacturing process for the capsule shell itself was first established for gelatine in 1913. It led to the development of major automatic machines which form the basis of current shell manufacture worldwide.
The raw material gelatine, however, is derived from animal material and has presented a wide range of issues (technical, regulatory, commercial, limits to consumer selection according to religious or dietary needs) and there have been many investigations and commercial efforts to identify possible substitutes (1). In recent years, safety concerns about transmissible spongiform encephalopathies (TSE) and other animal diseases have increased the need for such materials. This paper describes the current status of a) gelatine derived from fish, b) starch and c) hydroxypropyl methylcellulose (HPMC) as potential substitutes for current gelatine two-piece capsules, including assessment of their suitability for liquid products.
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By William Bowtle, Technical Director at MW Encap Ltd, UK William Bowtle, Technical Director at MW Encap, is one of the leading scientists in liquid filling of hard gelatine capsules. After graduating with a first class honours degree in Pharmacy from Strathclyde University in Glasgow, Scotland, he continued his research work while assuming the post of Lecturer in Pharmaceutics, and was awarded a Pfizer Research Prize.
He later moved into industry and worked for 13 years with Eli Lilly, where, as Head of Pharmaceutical Development, he was responsible for the development of a range of oral and parenteral products for international markets. During that time he developed the 'semi-solid matrix' capsule technology. In his position as Technical Director at MW Encap, Bill is responsible for the co-ordination of all technical aspects of new products.
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7th Annual Pharma Packaging and Labelling conference
17 September - 18 October 2008, Barcelona
7th Annual Pharma Packaging and Labelling conference will bring
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News and Press Releases |
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Azopharma Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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