Encyclopaedia of Pharmaceutical Technology, 2nd edition Edited by J

Although the work of Pisano at Harvard Business School is referred to, his important book, The Development Factory, is not referenced. Overall, this c...
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Organic Process Research & Development 2003, 7, 613

Encyclopaedia of Pharmaceutical Technology, 2nd edition. Edited by J. Swarbrick and J. C. Boylan. 2002, Marcel Dekker: New York. 2002. 3 Volumes. 3032 + 64 pp. ISBN 0-8247-2822-X (Vol. 1), 0-8247-2823-8 (Vol. 2), 0-8247-2824-6 (Vol. 3), 0-8247-2825-4 (Prepack), 0-82472825-4 (Online). Encyclopaedias are always valuable as a first port of call when researching a new area. Thus, for the chemist/chemical engineer Kirk Othmer and Ullmann provide valuable insight into selected topics, with a strong industrial bias. Encyclopaedia of Pharmaceutical Technology provides the same service for the pharmaceutical industry, and the previous edition was well-received. The first edition’s first volume was published in 1988, and the last, volume 20, in 2000, the whole work encompassing 9000 pages. The second edition, at 3000 pages, is much more condensed and focuses on a list of topics relevant to the discovery, development, regulation, manufacture, and commercialisation of drugs and dosage forms. The second edition has tried to match the breadth of coverage of the previous edition, but with a consistent format and style, difficult for a multi-author work. Over 300 chapter-authors have been used. A chapter in an encyclopaedia should give a comprehensive, but short, review of the topic, with a good list of references to key works so that the reader can explore further if he/she wishes to have more in-depth knowledge. Most of the chapters do this very well. For example, chapters of interest to process chemists in Volume 1 include Calorimetry in Pharmaceutical R & D, Chiroptical Analytical Methods, Chromatographic Methods of Analysis, Contract Manufacturing, Crystallisation, Design of Drugs, and Drying and Dryers. As one would expect, the authors concentrate more on dosage forms rather than on the bulk-active (e.g., in Drying and Dryers), but nevertheless, these are useful chapters for the process chemist. Each chapter is approximately 10-20 pages long with 5-80 references at the end. References tend to be to U.S. books and literaturesfor example, the chapter on Drying and Dryers does not mention the key book by van’t Land on this topic. Chapters in volume 2 which may be of interest include Equipment Cleaning, Evaporation and Evaporators, Excipients (four chapters), European Agency for the Evaluation of Medicines (EMEA), Filters and Filtration, FDA, FreezeDrying, Good Manufacturing Practices - An Overview, Harmonisation of Pharmacopeial Standards, Hydrolysis of Drugs, Optimisation Methods, Particle Size Characterisation, and Patents (both international and U.S.A. perspectives). The latter chapter has useful discussion on process patents and is an excellent example of how to summarise an extremely complex subject in only 12 pages. In contrast the six-page

10.1021/op0340356 CCC: $25.00 © 2003 American Chemical Society Published on Web 04/09/2003

chapter on Generic Drugs and Generic Equivalency barely covers the surface, and in common with many other chapters, takes a U.S. view rather than examining the international scene. Volume 3 includes sections on Pharmacopeial Standards (European, Japanese, and U.S.A.), Polymorphism-Pharmaceutical Aspects, Process Chemistry in the Pharmaceutical Industry, Scale Up and Post approval Changes, Spectroscopic Methods of Analysis (six chapters), Thermal Analysis of Drugs and Drug Products, and X-ray Powder Diffractometry. The chapter on Polymorphism is by Harry Brittain, author of many books on the subject, and is an excellent summary and is well referenced. It has a number of typos, however, and, in a list of solvents, quotes the boiling point of NMP as 80°! The chapter on Process Chemistry in the Pharmaceutical Industry is a great disappointmentswhat an opportunity lost! A stimulating chapter on this subject would have emphasised to other disciplines the importance and value of process chemistry. However, the 14 pages are virtually a quick summary of one author’s book of the same name. Of the 23 refs five are to chapters from this book. No mention is made of Lee and Robinson’s book, Anderson’s excellent and more recent monograph on Process Development, or even our journal, Organic Process Research & DeVelopment (OPRD). The authors briefly discuss biotransformations, polymorphism, and automation, all of which have had recent special issues in this journal, without any reference to OPRD. If the authors had read these special issues, their chapter would have been more up to date. The chapter also fails to direct the reader to the important reviews of process R & D published elsewhere. On the subject of enzyme catalysis, the key works of Patel, Faber, Roberts, etc. are not referenced. Although the work of Pisano at Harvard Business School is referred to, his important book, The DeVelopment Factory, is not referenced. Overall, this chapter fails to impart the importance of process chemistry in the pharmaceutical industry and the way it interfaces with other disciplines. With a compendium of such size, one would expect some variability in quality, and the above criticism should not deter readers and potential purchasers. Overall, the quality of the individual chapters is good, and the value of the encyclopaedia is in its tremendous breadth, so that it can be a first port of callsalong with the first editionswhen needing knowledge of some new aspect of pharmaceutical technology. The encyclopaedia, which has an excellent 64-page index, is highly recommended and should be in the library of any company or institution involved in pharmaceuticals. OP0340356 10.1021/op0340356

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