Dissolution, Bioavailablllty and Bioequivalence

BOOK REVIEWS
Dissolution, Bioavailablllty and Bioequivalence. By Ham& dosage forms such as controlled release drug products and
M. Abdou. Mack Publishing Company: Easton, PA, 1989. topical preparations.
xvii + 554 pp. 26 x 18 cm. ISBN 0-912-734-20-5.$69.95. The section on bioequivalence covers the following topics:
Occasionally a book appears that is informative, instruc- methods for determining bioequivalence of drug products and
tive, well organized, written with clarity, and a pleasure to regulatory aspects; critical issues and aspects relating to
read. Such a book is Dr. Hamed Abdou’s Dissolution, Bio- bioequivalence protocols; in vivo-in vitro correlation studies
availability and Bioequivalence. Dr. Abdou has succeeded in and their value in determining meaningful dissolution limits;
his endeavor to provide a comprehensive, coherent, and and some important case histories of bioinequivalence. Each
competent treatment, in one volume, of the most dynamic of the chapters in the sections on bioavailability and bioequiv-
subject in the pharmaceutical sciences. alence is well written with an extensive and up-todate
Professor John Wagner’s Biopharmaceutics and Relevant bibliography and presents an integrated treatment of the
Pharmacokinetics published in 1971, was the first attempt to subject covered.
cover topics which are the subject matter of this text. Disso- “Understanding the complex and interwoven factors that
lution Technology by Drs. Leeson and Carstensen, published may influence the nature and reproducibility of the biologic
in 1974, was the first monograph on the topic, and surveyed response of pharmaceutical dosage forms is the ultimate goal
the theory and methodology of dissolution, influence of for- of this book,” according to the author. Dr. Abdou has admi-
mulation on dissolution rate, and the biological implications rably succeeded in achieving his goal. In addition, extensive
of in vitro dissolution rate. The twin biopharmaceutical citations throughout the book give the student, as Professor
science areas of dissolution and bioavailability have seen Wagner rightly points out in his foreword, a sense of history
tremendous research activity and growth during the last and acquaintance with contributors to the field.
three decades, and the scientific literature in these areas has This book is essential reading for every pharmaceutical and
grown by leaps and bounds during the last twenty years. Dr. medical scientist engaged in development, testing, and man-
Abdou’s volume makes available for the first time a compre- ufacturing of drug products. It belongs on the bookshelves of
hensive and completely updated text totally devoted to the students and teachers in colleges of pharmacy, and scientists
important (albeit controversial) topics of dissolution, bio- and other professionals in drug regulatory bodies of govern-
availability, and bioequivalence. ment agencies and pharmaceutical industry. Clinical phar-
The book is divided into three sections, each covering one of macologists and other health scientists desirous of learning
the major topics. A little over half the book is devoted to the more about the relationships between drug products and their
section on dissolution. This section includes chapters that clinical performance will find this book a rich and welcome
cover the following topics: principles that control dissolution resource.
of pure drug substances; theories of dissolution; effect of Shrikant V. Dighe
physiochemical properties of the drug on dissolution rate; Division of Bioequivalence
formulation and processing factors affecting dissolution of Food and Drug Administration
solid oral dosage forms; official and nonofficial methods of Rockville, MD 20857
determining the dissolution rate of pharmaceutical dosage
forms; principles and methods of measurement of dissolution
of suspensions, suppositories, topical preparations, transder-
ma1 drug delivery systems, and controlled release dosage
forms; and methods to enhance the dissolution rate of drug
products.
The chapters on formulation and processing factors that
affect dissolution rate of solid oral dosage forms, factors Principles and Methods of Toxicology. Second Edition. Edited
relating to dissolution apparatus, and effect of test parame- by A. Wallace Hayes. Raven Press: New York. 1989. xiii +
ters such as dissolution fluid, agitation, the rate of stirring, 929. 22 x 29 cm. ISBN 0-88167-439-7. $79.00.
additives, and temperature will be found useful and instruc- The second edition of Dr. Hayes’ edited text has maintained
tive by practitioners and students of the art and science of and expanded his concept of producing a teaching reference
dissolution. Chapters on the principles and methods of mea- balanced between the practical and the theoretical. The
surement of dissolution of suspensions, suppositories, topical overall organization of the text has been improved by dividing
preparations, and controlled release delivery systems bring the index into three major sections (Toxicologic Principles,
together a wealth of information that should be of particular Testing Methods, and Specific Organ Systems) and by pro-
interest to those engaged in developing and testing these drug viding each chapter with a chapter-specific outline which the
products. The textual material is clearly presented with reviewer found useful. The new edition contains more tables
numerous graphs and illustrations. Important mathematical and illustrations, making it easier to use than the first
equations are included in the text not to awe or impress the edition. The chapter on acute toxicology still contains the
reader but rather to convey the interrelationships of various section on laws related to toxicology and seems misplaced in
parameters that affect dissolution. The section on dissolution its location. A separate chapter or a combination of the
is perhaps the most attractive and appealing feature of this information on laws and the chapter on the regulatory process
book. All you want to know about dissolution-theory as well would be an improvement.
as practice-is competently and authoritatively discussed. The second edition contains several new chapters, some of
The section on bioavailability discusses the following: which are entirely new, while others result from expanding
principles of pharmacokinetics (compartmental and noncom- first-edition chapters to the point where two chapters are
partmental analysis); mechanisms of drug absorption; justified. The most significant additions deal with clinical
sources of variation in drug blood levels and correlations to pathology, the regulatory process (on of the major motivating
biologic response; methods to measure bioavailability and for forces in toxicology), methods for endomyocardial biopsy, and
enhancement of bioavailability; and bioavailability of special the role of metabolism in toxicology. The chapter on organ
.OO/O
OO22-3549/90//04OO-O377$Ol Journal of Pharmaceutical Sciences I 371
0 1990, American Pharmaceutical Association Vol. 79, No. 4, April 1990

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