Stability of Drugs and Dosage Forms 2000th Edition

Book Reviews: A thorough knowledge of the chemical and physical stability of drugs and dosage forms is critical in the development and evaluation of pharmaceuticals. Although a very large number of studies on the subject of stability have appeared in the primary pharmaceutical literature, books on the subject have not been comprehensive. Therefore, researchers and students have had to rely on individual papers for an in-depth analysis of the subject. The objective of this book is to bring together and analyze, in a systematic fashion, some examples relating to the stability of drugs from the work of others as well as from studies that have been performed in the laboratories of the authors.

This text is organized by first presenting the major mechanisms contributing to chemical instability, followed by discussion of factors affecting degradation based on kinetic theory and of ways in which problematic pharmaceutical products might be stabilized. Predictions of stability are covered, from basic theory to practical solutions.

Unlike earlier books in which chemical stability profiles and the effects of factors such as pH and other catalytic contributions on single substances were described extensively, the present text attempts to take a more global approach. Specifically, analysis of the factors affecting drug stability based on basic kinetic theory allowed for a sound theoretical treatment of available information. Furthermore, the bases for physical degradation kinetics, which have generally been treated empirically, are also covered, and sound bases for the observations are also presented and discussed.

The chemical and physical stability of protein and peptide drugs is considered in a separate chapter of this book. Although some newer texts have comprehensively addressed the difficult subject of protein stability, it was felt that no drug stability text would be complete without this subject.

Drug products are complex mixtures of drug and excipients, and, as such, their chemical and physical stability kinetics are complex. The chemical and physical stability of these complex dosage forms, starting with preformulating studies and continuing through to studies of the final products, including the role of packaging, are discussed. Information on the stability of novel drug delivery systems such as biodegradable microspheres is also included where possible. Issues of quality assurance, the estimation of shelf life, and the relevant regulatory requirements are described. The most recent information on International Harmonized Guidelines for stability testing is also provided, along with a brief discussion on conflicts that exist between the requirements of different countries.

As stated earlier, this book attempts to present a reasonably systematic and comprehensive approach to the subject of chemical and physical drug stability. Efforts have also been made to provide a fairly comprehensive listing of references that could be used by the reader to access the primary literature. Our understanding of the chemical and physical stability of drugs in solid dosage forms is still quite incomplete, and good comprehensive studies on the stability of proteins are only now providing the type of information from which the prediction of physical and chemical stability of proteins might be possible. Additionally, we do not know what the stability problems of the drugs of the future, especially the products of genomic research, will be. Therefore, no book on the subject of drug stability should be considered complete. Opinions and interpretations of any scientific study also differ. The emphases presented here represent the biases of the authors, who welcome constructive comments and criticisms on any of the work presented in this text.

Finally, the authors would like to thank their colleagues for their contributions to the studies presented in this book. They would like to especially thank Drs. Aso and Izutsu, who contributed significantly to a number of the studies presented from Dr. Yoshiokas laboratory. Contributors from Professor Stellas laboratory include various students, technicians (especially Ms. Waugh), and postdoctoral and visiting scientists. The authors would also like to thank Ms. Kawai and Ms. Nakamura of Nankoudo Publishers, who helped with the original Japanese version of this book.

Bibliographical Data of Stability of Drugs and Dosage Forms 2000th Edition

Reference Type: Book
Record Number: xx
Author: Sumie Yoshioka, Valentino J. Stella
Year: 2000
Place Published: New York City
Publisher: Springer
Number of Pages: 270
Edition: 2000th
ISBN -10: 0306464047
ISBN-13: 978-0306464041
Kindle Available: ASIN- B008PMUX34
Buy: Get it on Amazon

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