The Pharmaceutical Journal
Vol 278 No 7455 p685
9 June 2007

Comprehensive resource on the use, regulation and approval of excipients

‘Excipient development for pharmaceutical, biotechnology, and drug delivery systems’, edited by Ashok Katdare and Mahesh V. Chaubal. Pp xvii+452. Price £26.95. New York: Informa Healthcare; 2006. ISBN 0 8493 2706 7

The great attention this book offers to excipient development and application in drug-delivery formulations is of interest to those working in the pharmaceutical industry. It is aimed at providing a comprehensive resource on the use, regulation and approval of new or alternative excipients. A good range of formulation types are addressed, from tablets to injections, and there are useful chapters on excipient use within protein formulations and vaccine systems. Throughout the text, good summary tables are provided and there are some helpful case studies.

The book tackles four main areas: global regulatory processes, preclinical testing and development of excipients, excipient interactions, and relevant quality control and assurance issues. It is useful to see all these aspects addressed within one book and thus it makes a helpful addition to current literature. However, the bulk of the text, not surprisingly, focuses on the regulatory issues pertaining to the US Food and Drug Administration. Although the authors have compiled this book for various people working within the pharmaceutical industry, which operates mainly under FDA regulatory guidelines, widening the scope of the text to a more global outlook would have added further value to this book particularly for use within undergraduate teaching programmes.

Yvonne Perrie
(senior lecturer in pharmaceutics at the school of life and health sciences, Aston University)