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TMMar cel Dekker , Inc. New Yor k Baseledit ed byGilber t S. BankerUniversity of IowaIowa City, IowaChrist opher T. RhodesUniversity of Rhode IslandKingston, Rhode IslandModer nPhar maceut i csFour t h Edi t i on, Revi sed and ExpandedCopyright 2002 by Marcel Dekker, Inc. All Rights Reserved.Copyright 2002 Marcel Dekker, Inc.ISBN: 0-8247-0674-9This book is printed on acid-free paper.HeadquartersMarcel Dekker, Inc.270 Madison Avenue, New York, NY 10016tel: 212-696-9000; fax: 212-685-4540Eastern Hemisphere DistributionMarcel Dekker AGHutgasse 4, Postfach 812, CH-4001 Basel, Switzerlandtel: 41-61-261-8482; fax: 41-61-261-8896World Wide Webhttp:==www.dekker.comThe publisher oers discounts on this book when ordered in bulk quantities. For more information, write to Special Sales=Professional Marketing at the headquarters address above.Copyright # 2002 by Marcel Dekker, Inc. All Rights Reserved.Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical,including photocopying, microlming, and recording, or by any information storage and retrieval system, without permission inwriting from the publisher.Current printing (last digit):10 9 8 7 6 5 4 3 2 1PRINTED IN THE UNITED STATES OF AMERICACopyright 2002 Marcel Dekker, Inc.DRUGS AND THE PHARMACEUTICAL SCIENCESExecutive EditorJames SwarbrickPharmaceuTech, Inc.Pinehurst, North CarolinaAdvisory BoardLarry L. AugsburgerUniversity of MarylandBaltimore, MarylandDavid E. NicholsPurdue UniversityWest Lafayette, IndianaDouwe D. BreimerGorlaeus LaboratoriesLeiden, The NetherlandsStephen G. SchulmanUniversity of FloridaGainesville, FloridaTrevor M. JonesThe Association of theBritish Pharmaceutical IndustryLondon, United KingdomJerome P. SkellyAlexandria, VirginiaHans E. JungingerLeiden/Amsterdam Centerfor Drug ResearchLeiden, The NetherlandsFelix TheeuwesAlza CorporationPalo Alto, CaliforniaVincent H. L. LeeUniversity of Southern CaliforniaLos Angeles, CaliforniaGeoffrey T. TuckerUniversity of SheffieldRoyal Hallamshire HospitalSheffield, United KingdomPeter G. WellingInstitut de Recherche JouveinalFresnes, FranceCopyright 2002 Marcel Dekker, Inc.PrefaceThe rst edition of Modern Pharmaceutics was published in 1980, the second in 1989, and the third in 1995. Duringthe more than 20 years since we developed the concept of this text we have been privileged to work with many of themost notable pharmaceutical scientists as chapter authors. Some of our original rst edition team are still with us.Others, for a variety of reasonsincluding change of career focus, retirement, and deathare no longer with us orable to cooperate in this endeavor. We place on record our gratitude to all our colleagues who have so unselshlyassisted us in any or all of our four editions.We are also grateful to all those readers of our book who have provided comments on their perceptions of thevalue of Modern Pharmaceutics and suggested to us ways in which the book might be improved. We have mostcarefully considered all such ideas and some of the changes that we have implemented in this edition derive fromadvice given to us by industrial pharmaceutical scientists, university faculty, and students.The fourth edition of Modern Pharmaceutics follows the same format and has the same goals as previous edi-tions. Chapter 1 sets the stage by reviewing the role of drugs and drug products in treating and preventing disease,while also summarizing their primary quality features. Chapters 2 through 6 provide background that is funda-mental to an understanding of drug action and the design of drug products. Chapter 7, on preformulation, isanother fundamentals chapter, describing the manner in which drugs are characterized for their physical, chemical,and pharmacokinetic properties to provide a rational and scientic basis for drug product design.Chapters 8 through 16 describe drug products and dosage forms, together with the routes of administration bywhich they are given. Chapters 17 through 28 also treat topics critical to drug product quality such as packaging,optimization, and food and drug laws, in addition to examining more specialized product classes and introducingseveral new chapters. As in previous editions, this book once again ends with a view to the future.In the planning of this edition, we identied certain areas of recent growth that seemed to merit increasedattention in this text, while attempting to further recognize pharmacy's international character. Also, we gaveattention to topics that are of relatively more importance than previously. Overall the book has grown in sizebecause there are a number of critical areas that justify signicant additional coverage. We have been fortunate inobtaining the services of a number of distinguished individuals to cover topics not allocated whole chapters inprevious editions.The growing importance of botanicals and other natural products has been recognized by devoting one of ournew chapters to this topic. Also, we have a new chapter on managed care since this is an area of great importanceand impacts all facets of pharmacy. Further, we expect this topic to gain additional recognition in parts of the worldwhere at present the implications of this discipline are not fully recognized. Also, appreciating the growing im-portance of generic products, especially in North America and the European Union, we have included in this editionCopyright 2002 Marcel Dekker, Inc.a chapter focused on bioequivalence. Finally, recognizing the impact of the information revolution, catalyzed bycomputers and the Internet, we have included a new chapter on drug information.With one exception, all the chapters from the third edition of Modern Pharmaceutics that appear in the fourthedition have been revised and updated. Many chapters were extensively updated, and some, such as the rst and lastchapters, were extensively rewritten. Due to the illness of Dr. Robinson, the chapter on sustained and controlledrelease drug delivery systems was updated with the assistance of Gil Banker, with Dr. Robinson's approval.Although Modern Pharmaceutics continues to evolve, our basic goals remain those which we developed in the1970s when we rst delineated the concept of this comprehensive and integrated treatment of pharmaceutics, with afocus on drug product quality and performance. We are committed to producing an up-to-date, authoritative,multiauthored treatise on pharmaceutics, which can be used by both students and practitioners.Gilbert S. BankerChristopher T. RhodesCopyright 2002 Marcel Dekker, Inc.ContentsPrefaceContributors1. Drug Products: Their Role in the Treatment of Disease, Their Quality, andTheir Status and Future as Drug-Delivery SystemsGilbert S. Banker2. Principles of Drug AbsorptionMichael Mayersohn3. PharmacokineticsDavid W. A. Bourne4. Factors Inuencing Drug Absorption and Drug AvailabilityBetty-ann Hoener and Leslie Z. Benet5. The Eect of Route of Administration and Distribution on Drug ActionSvein ie and Leslie Z. Benet6. Chemical Kinetics and Drug StabilityJ. Keith Guillory and Rolland I. Poust7. PreformulationJens T. Carstensen8. Cutaneous and Transdermal DeliveryProcesses and Systems of DeliveryGordon L. Flynn9. Disperse SystemsWandee Im-Emsap, Ornlaksana Paeratakul, and Juergen SiepmannCopyright 2002 Marcel Dekker, Inc.10. Tablet Dosage FormMary J. Kottke and Edward M. Rudnic11. Hard and Soft Shell CapsulesLarry L. Augsburger12. Parenteral ProductsJames C. Boylan and Steven L. Nail13. Design and Evaluation of Ophthalmic Pharmaceutical ProductsJohn C. Lang, Robert E. Roehrs, Denise P. Rodeheaver, Paul J. Missel, Rajni Jani, andMasood A. Chowhan14. Delivery of Drugs by the Pulmonary RouteAnthony J. Hickey15. Sustained- and Controlled-Release Drug Delivery SystemsGwen M. Jantzen and Joseph R. Robinson16. Target-Oriented Drug-Delivery SystemsVijay Kumar and Gilbert S. Banker17. Packaging of Pharmaceutical Dosage FormsThomas J. Ambrosio18. Optimization Techniques in Pharmaceutical Formulation and ProcessingJoseph B. Schwartz, Robert E. O'Connor, and Roger L. Schnaare19. Food and Drug Laws that Aect Drug Product Design, Manufacture, andDistributionGarnet E. Peck and Roland Poust20. European Aspects of the Regulation of Drug Products with Particular Referenceto Development PharmaceuticsBrian R. Matthews21. Pediatric and Geriatric Aspects of PharmaceuticsMichelle Danish and Mary Kathryn Kottke22. Biotechnology-Based PharmaceuticalsPaul R. Dal Monte, S. Kathy Edmond Rouan, and Narendra B. Bam23. The Pharmacist and Veterinary Pharmaceutical Dosage FormsJ. Patrick McDonnell and Lisa Blair Banker24. Dietary SupplementsTeresa Bailey Klepser25. BioequivalencyChristopher T. RhodesCopyright 2002 Marcel Dekker, Inc.26. Drug InformationHazel H. Seaba27. Managed Care and Pharmacotherapy ManagementJulie M. Ganther and William R. Doucette28. A View to the FutureGilbert S. Banker and Christopher T. RhodesCopyright 2002 Marcel Dekker, Inc.ContributorsThomas J. Ambrosio,