OR WAIT 15 SECS
© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Arvind K. Bansal is an associate professor at the National Institute of Pharmaceutical Education and Research, Sector-67, Phase-X, S.A.S. Nagar, Punjab 160062, India, tel 191 0 172 2214682 87, fax 191 0 172 2214692.
June 01, 2006
Bioequivalence with the reference product is the only reliable measure of demonstrating the therapeutic equivalence of a generic product to the innovator product. Systematic and comprehensive innovator product characterization can be used to make generic product development easier. This involves characterization of API and quantification of the critical excipients. The latter contributes towards performance of the final dosage form. This article describes the capsule formulation of a poorly water-soluble drug, celecoxib, which contains sodium lauryl sulphate as a critical excipient. The importance of a decoding process aimed at developing a generic product that matches the innovator formulation in a discriminating dissolution method is demonstrated.
April 20, 2006
Being the first to gain the most is a fundamental principle in the generics business because several companies compete to create generics of successful products going off patent. For a generics company to maintain revenue growth in a market in which product prices continue to fall, it must secure a continuous flow of new products, with quality and speed to market being key drivers. Thus, generics companies must be highly skilled in product and process development (1), the generics business, and achieving bioequivalence-the most critical development area.
August 02, 2005
January 02, 2004
The authors examine the development and performance of coprocessed excipients, including testing them for flowability, compressibility, amd dilution potential.