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PharmaceuticalProcess Scale-Upedited byMichael LevinMetropolitan Computing CorporationEast Hanover, New JerseyMarcel Dekker, Inc.New York BaselTMCopyright 2001 by Marcel Dekker, Inc. All Rights Reserved.

ISBN: 0-8247-0625-0This 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 offers discounts on this book when ordered in bulk quantities. For more information, write to Special Sales/Professional Marketing at the headquarters addressabove.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 anymeans, electronic or mechanical, including photocopying, microfilming, and recording, orby any information storage and retrieval system, without permission in writing from thepublisher.Current printing (last digit):10 9 8 7 6 5 4 3 2 1PRINTED IN THE UNITED STATES OF AMERICA

DRUGS AND THE PHARMACEUTICAL SCIENCESExecutive EditorJames SwarbrickPharmaceuTech, Inc.Pinehurst, North CarolinaAdvisory BoardLarry L. AugsburgerUniversity of MarylandBaltimore, MarylandDouwe D. BreimerGorlaeus LaboratoriesLeiden, The NetherlandsDavid E. NicholsPurdue UniversityWest Lafayette, IndianaStephen 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, France

DRUGS AND THE PHARMACEUTICAL SCIENCESA Series of Textbooks and Monographs1. Pharmacokinetics, Milo Gibaldi and Donald Perrier2. Good Manufacturing Practices for Pharmaceuticals: A Plan for TotalQuality Control, Sidney H. Willig, Murray M. Tuckerman, and WilliamS. Hitchings IV3. Microencapsulation, edited by J. R. Nixon4. Drug Metabolism: Chemical and Biochemical Aspects, Bernard Testaand Peter Jenner5. New Drugs: Discovery and Development, edited by Alan A. Rubin6. Sustained and Controlled Release Drug Delivery Systems, edited byJoseph R. Robinson7. Modern Pharmaceutics, edited by Gilbert S. Banker and ChristopherT. Rhodes8. Prescription Drugs in Short Supply: Case Histories, Michael A.Schwartz9. Activated Charcoal: Antidotal and Other Medical Uses, David O.Cooney10. Concepts in Drug Metabolism (in two parts), edited by Peter Jennerand Bernard Testa11. Pharmaceutical Analysis: Modern Methods (in two parts), edited byJames W. Munson12. Techniques of Solubilization of Drugs, edited by Samuel H. Yalkowsky13. Orphan Drugs, edited by Fred E. Karch14. Novel Drug Delivery Systems: Fundamentals, Developmental Concepts, Biomedical Assessments, Yie W. Chien15. Pharmacokinetics: Second Edition, Revised and Expanded, MiloGibaldi and Donald Perrier16. Good Manufacturing Practices for Pharmaceuticals: A Plan for TotalQuality Control, Second Edition, Revised and Expanded, Sidney H.Willig, Murray M. Tuckerman, and William S. Hitchings IV17. Formulation of Veterinary Dosage Forms, edited by Jack Blodinger18. Dermatological Formulations: Percutaneous Absorption, Brian W.Barry19. The Clinical Research Process in the Pharmaceutical Industry, editedby Gary M. Matoren20. Microencapsulation and Related Drug Processes, Patrick B. Deasy21. Drugs and Nutrients: The Interactive Effects, edited by Daphne A.Roe and T. Colin Campbell22. Biotechnology of Industrial Antibiotics, Erick J. Vandamme23. Pharmaceutical Process Validation, edited by Bernard T. Loftus andRobert A. Nash

24. Anticancer and Interferon Agents: Synthesis and Properties, edited byRaphael M. Ottenbrite and George B. Butler25. Pharmaceutical Statistics: Practical and Clinical Applications, SanfordBolton26. Drug Dynamics for Analytical, Clinical, and Biological Chemists,Benjamin J. Gudzinowicz, Burrows T. Younkin, Jr., and Michael J.Gudzinowicz27. Modern Analysis of Antibiotics, edited by Adjoran Aszalos28. Solubility and Related Properties, Kenneth C. James29. Controlled Drug Delivery: Fundamentals and Applications, SecondEdition, Revised and Expanded, edited by Joseph R. Robinson andVincent H. Lee30. New Drug Approval Process: Clinical and Regulatory Management,edited by Richard A. Guarino31. Transdermal Controlled Systemic Medications, edited by Yie W.Chien32. Drug Delivery Devices: Fundamentals and Applications, edited byPraveen Tyle33. Pharmacokinetics: Regulatory · Industrial · Academic Perspectives,edited by Peter G. Welling and Francis L. S. Tse34. Clinical Drug Trials and Tribulations, edited by Allen E. Cato35. Transdermal Drug Delivery: Developmental Issues and Research Initiatives, edited by Jonathan Hadgraft and Richard H. Guy36. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms,edited by James W. McGinity37. Pharmaceutical Pelletization Technology, edited by Isaac GhebreSellassie38. Good Laboratory Practice Regulations, edited by Allen F. Hirsch39. Nasal Systemic Drug Delivery, Yie W. Chien, Kenneth S. E. Su, andShyi-Feu Chang40. Modern Pharmaceutics: Second Edition, Revised and Expanded,edited by Gilbert S. Banker and Christopher T. Rhodes41. Specialized Drug Delivery Systems: Manufacturing and ProductionTechnology, edited by Praveen Tyle42. Topical Drug Delivery Formulations, edited by David W. Osborne andAnton H. Amann43. Drug Stability: Principles and Practices, Jens T. Carstensen44. Pharmaceutical Statistics: Practical and Clinical Applications, SecondEdition, Revised and Expanded, Sanford Bolton45. Biodegradable Polymers as Drug Delivery Systems, edited by MarkChasin and Robert Langer46. Preclinical Drug Disposition: A Laboratory Handbook, Francis L. S.Tse and James J. Jaffe47. HPLC in the Pharmaceutical Industry, edited by Godwin W. Fong andStanley K. Lam48. Pharmaceutical Bioequivalence, edited by Peter G. Welling, Francis L.S. Tse, and Shrikant V. Dinghe49. Pharmaceutical Dissolution Testing, Umesh V. Banakar

50. Novel Drug Delivery Systems: Second Edition, Revised andExpanded, Yie W. Chien51. Managing the Clinical Drug Development Process, David M. Cocchetto and Ronald V. Nardi52. Good Manufacturing Practices for Pharmaceuticals: A Plan for TotalQuality Control, Third Edition, edited by Sidney H. Willig and JamesR. Stoker53. Prodrugs: Topical and Ocular Drug Delivery, edited by Kenneth B.Sloan54. Pharmaceutical Inhalation Aerosol Technology, edited by Anthony J.Hickey55. Radiopharmaceuticals: Chemistry and Pharmacology, edited byAdrian D. Nunn56. New Drug Approval Process: Second Edition, Revised and Expanded,edited by Richard A. Guarino57. Pharmaceutical Process Validation: Second Edition, Revised and Expanded, edited by Ira R. Berry and Robert A. Nash58. Ophthalmic Drug Delivery Systems, edited by Ashim K. Mitra59. Pharmaceutical Skin Penetration Enhancement, edited by Kenneth A.Walters and Jonathan Hadgraft60. Colonic Drug Absorption and Metabolism, edited by Peter R. Bieck61. Pharmaceutical Particulate Carriers: Therapeutic Applications, editedby Alain Rolland62. Drug Permeation Enhancement: Theory and Applications, edited byDean S. Hsieh63. Glycopeptide Antibiotics, edited by Ramakrishnan Nagarajan64. Achieving Sterility in Medical and Pharmaceutical Products, Nigel A.Halls65. Multiparticulate Oral Drug Delivery, edited by Isaac Ghebre-Sellassie66. Colloidal Drug Delivery Systems, edited by Jörg Kreuter67. Pharmacokinetics: Regulatory · Industrial · Academic Perspectives,Second Edition, edited by Peter G. Welling and Francis L. S. Tse68. Drug Stability: Principles and Practices, Second Edition, Revised andExpanded, Jens T. Carstensen69. Good Laboratory Practice Regulations: Second Edition, Revised andExpanded, edited by Sandy Weinberg70. Physical Characterization of Pharmaceutical Solids, edited by HarryG. Brittain71. Pharmaceutical Powder Compaction Technology, edited by Göran Alderborn and Christer Nyström72. Modern Pharmaceutics: Third Edition, Revised and Expanded, editedby Gilbert S. Banker and Christopher T. Rhodes73. Microencapsulation: Methods and Industrial Applications, edited bySimon Benita74. Oral Mucosal Drug Delivery, edited by Michael J. Rathbone75. Clinical Research in Pharmaceutical Development, edited by BarryBleidt and Michael Montagne

76. The Drug Development Process: Increasing Efficiency and Cost Effectiveness, edited by Peter G. Welling, Louis Lasagna, and UmeshV. Banakar77. Microparticulate Systems for the Delivery of Proteins and Vaccines,edited by Smadar Cohen and Howard Bernstein78. Good Manufacturing Practices for Pharmaceuticals: A Plan for TotalQuality Control, Fourth Edition, Revised and Expanded, Sidney H.Willig and James R. Stoker79. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms:Second Edition, Revised and Expanded, edited by James W.McGinity80. Pharmaceutical Statistics: Practical and Clinical Applications, ThirdEdition, Sanford Bolton81. Handbook of Pharmaceutical Granulation Technology, edited by DilipM. Parikh82. Biotechnology of Antibiotics: Second Edition, Revised and Expanded,edited by William R. Strohl83. Mechanisms of Transdermal Drug Delivery, edited by Russell O. Pottsand Richard H. Guy84. Pharmaceutical Enzymes, edited by Albert Lauwers and SimonScharpé85. Development of Biopharmaceutical Parenteral Dosage Forms, editedby John A. Bontempo86. Pharmaceutical Project Management, edited by Tony Kennedy87. Drug Products for Clinical Trials: An International Guide to Formulation · Production · Quality Control, edited by Donald C. Monkhouseand Christopher T. Rhodes88. Development and Formulation of Veterinary Dosage Forms: SecondEdition, Revised and Expanded, edited by Gregory E. Hardee and J.Desmond Baggot89. Receptor-Based Drug Design, edited by Paul Leff90. Automation and Validation of Information in Pharmaceutical Processing, edited by Joseph F. deSpautz91. Dermal Absorption and Toxicity Assessment, edited by Michael S.Roberts and Kenneth A. Walters92. Pharmaceutical Experimental Design, Gareth A. Lewis, DidierMathieu, and Roger Phan-Tan-Luu93. Preparing for FDA Pre-Approval Inspections, edited by Martin D.Hynes III94. Pharmaceutical Excipients: Characterization by IR, Raman, and NMRSpectroscopy, David E. Bugay and W. Paul Findlay95. Polymorphism in Pharmaceutical Solids, edited by Harry G. Brittain96. Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, edited by Louis Rey and Joan C. May97. Percutaneous Absorption: Drugs–Cosmetics–Mechanisms–Methodology, Third Edition, Revised and Expanded, edited by Robert L.Bronaugh and Howard I. Maibach

98. Bioadhesive Drug Delivery Systems: Fundamentals, Novel Approaches, and Development, edited by Edith Mathiowitz, Donald E.Chickering III, and Claus-Michael Lehr99. Protein Formulation and Delivery, edited by Eugene J. McNally100. New Drug Approval Process: Third Edition, The Global Challenge,edited by Richard A. Guarino101. Peptide and Protein Drug Analysis, edited by Ronald E. Reid102. Transport Processes in Pharmaceutical Systems, edited by Gordon L.Amidon, Ping I. Lee, and Elizabeth M. Topp103. Excipient Toxicity and Safety, edited by Myra L. Weiner and Lois A.Kotkoskie104. The Clinical Audit in Pharmaceutical Development, edited by MichaelR. Hamrell105. Pharmaceutical Emulsions and Suspensions, edited by FrancoiseNielloud and Gilberte Marti-Mestres106. Oral Drug Absorption: Prediction and Assessment, edited by JenniferB. Dressman and Hans Lennernäs107. Drug Stability: Principles and Practices, Third Edition, Revised andExpanded, edited by Jens T. Carstensen and C. T. Rhodes108. Containment in the Pharmaceutical Industry, edited by James P.Wood109. Good Manufacturing Practices for Pharmaceuticals: A Plan for TotalQuality Control from Manufacturer to Consumer, Fifth Edition, Revisedand Expanded, Sidney H. Willig110. Advanced Pharmaceutical Solids, Jens T. Carstensen111. Endotoxins: Pyrogens, LAL Testing, and Depyrogenation, SecondEdition, Revised and Expanded, Kevin L. Williams112. Pharmaceutical Process Engineering, Anthony J. Hickey and DavidGanderton113. Pharmacogenomics, edited by Werner Kalow, Urs A. Meyer, and Rachel F. Tyndale114. Handbook of Drug Screening, edited by Ramakrishna Seethala andPrabhavathi B. Fernandes115. Drug Targeting Technology: Physical Chemical Biological Methods,edited by Hans Schreier116. Drug–Drug Interactions, edited by A. David Rodrigues117. Handbook of Pharmaceutical Analysis, edited by Lena Ohannesianand Anthony J. Streeter118. Pharmaceutical Process Scale-Up, edited by Michael Levin119. Dermatological and Transdermal Formulations, edited by Kenneth A.Walters120. Clinical Drug Trials and Tribulations: Second Edition, Revised andExpanded, edited by Allen Cato, Lynda Sutton, and Allen Cato III121. Modern Pharmaceutics: Fourth Edition, Revised and Expanded, edited by Gilbert S. Banker and Christopher T. Rhodes122. Surfactants and Polymers in Drug Delivery, Martin Malmsten123. Transdermal Drug Delivery: Second Edition, Revised and Expanded,edited by Richard H. Guy and Jonathan Hadgraft

124. Good Laboratory Practice Regulations: Second Edition, Revised andExpanded, edited by Sandy Weinberg125. Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing: Third Edition, Revised and Expanded, MichaelJ. Akers, Daniel S. Larrimore, and Dana Morton Guazzo126. Modified-Release Drug Delivery Technology, edited by Michael J.Rathbone, Jonathan Hadgraft, and Michael S. Roberts127. Simulation for Designing Clinical Trials: A Pharmacokinetic-Pharmacodynamic Modeling Perspective, edited by Hui C. Kimko