samedan logo
 
 
 
spacer
home > pmps > summer 2002 > options in materials for liquid-filled capsules
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Options in Materials for Liquid-Filled Capsules

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.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
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.

spacer
William Bowtle
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Bachem is now expanding into Oligonucleotides

The global market for oligonucleotide therapeutics is expanding rapidly. What is Bachem’s strategy in entering this competitive environment? Dr. Torsten Wöhr*: I think it is important for our customers to understand that the decision by Bachem leadership to enter the field of oligonucleotide manufacturing was well-prepared and ultimately taken in line with the company’s long-term growth plan. We are operative since 2019 and are gradually expanding our expert resource pool, capabilities and capacity for oligonucleotides.
More info >>

White Papers

Challenges of Analytical Method Transfer in the Pharmaceutical Industry

RSSL

The development and validation of suitable analytical methods is a critical part of the overall drug-development life-cycle. For the majority of products, particularly those that are clinically successful, the transfer of the analytical method between laboratories will be required. This process is designed to verify that a given laboratory is capable of performing a test method for its intended purpose. This can be performed either internally (at the same company), or, with the on-going increasing trend in outsourcing, to an external Contract Research or Development organisation (CRO or CDO).
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement