Table Of ContentEncyclopedia of
PHARMACEUTICAL
TECHNOLOGY
Third Edition
VOLUME 6
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Drugs and the Pharmaceutical Sciences
A comprehensive series of more than 160 volumes on all aspects of pharmaceutical science
Series Executive Editor: James Swarbrick
Herbal Supplements-Drug Interactions: Scientific Introduction to the Pharmaceutical Regulatory Surfactants and Polymers in Drug Delivery
and Regulatory Perspectives Process Martin Malmsten
Edited by: Y.W. Francis Lam, Shiew-Mei Huang and Edited by: Ira R. Berry ISBN: 0-8247-0804-0
Stephen D. Hall ISBN: 0-8247-5464-6
ISBN: 0-8247-2538-7 Modern Pharmaceutics, Fourth Edition
New Drug Development: Regulatory Paradigms for Edited by: Gilbert S. Banker and
Dose Optimization In Drug Development Clinical Pharmacology and Biopharmaceutics Christopher T. Rhodes
Edited by: Rajesh Krishna Edited by: Chandrah Sahajwalla ISBN: 0-8247-0674-9
ISBN: 1-5744-4808-0 ISBN: 0-8247-5465-4
Handbook of Pharmaceutical Analysis
Spectroscopy of Pharmaceutical Solids Freeze-Drying/Lyophilization of Pharmaceutical Edited by: Lena Ohannesian
Edited by: Harry G. Brittain and Biological Products, Second Edition ISBN: 0-8247-0462-2
ISBN: 1-5744-4893-5 Edited by: Louis Rey and Joan C. May
ISBN: 0-8247-4868-9 Drug-Drug Interactions
Nanoparticle Technology for Drug Delivery Edited by: A. David Rodrigues
Edited by: Ram B. Gupta and Uday B. Kompella Pharmaceutical Statistics, Fourth Edition ISBN: 0-8247-0283-2
ISBN: 1-5744-4857-9 Sanford Bolton and Charles Bon
ISBN: 0-8247-4695-3 Handbook of Drug Screening
Microencapsulation: Methods and Industrial Edited by: Ramakrishn Seethala
Applications, Second Edition Pharmaceutical Inhalation Aerosol Technology, ISBN: 0-8247-0562-9
Edited by: Simon Benita Second Edition
ISBN: 0-8247-2317-1 Edited by: Anthony J. Hickey Pharmaceutical Process Engineering
ISBN: 0-8247-4253-2 Edited by: Anthony J. Hickey
Pharmaceutical Process Scale-Up, Second Edition ISBN: 0-8247-0298-0
Edited by: Michael Levin Biomarkers in Clinical Drug Development
ISBN: 1-5744-4876-5 Edited by: John C. Bloom and Richard A. Dean Drug Stability, Third Edition, Revised, and
ISBN: 0-8247-4026-2 Expanded: Principles and Practices
Pharmacogenomics, Second Edition Edited by: Jens T. Carstensen
Edited by: Werner Kalow, Urs B. Meyer, and Rachel F. Pharmaceutical Extrusion Technology ISBN: 0-8247-0376-6
Tyndale Edited by: Isa Ghebre-Selassie and Charles Martin
ISBN: 1-5744-4878-1 ISBN: 0-8247-4050-5 Coming Soon!
November 2006
Handbook of Pharmaceutical Granulation Pharmaceutical Gene Delivery Systems
Environmental Monitoring for Cleanrooms and
Technology, Second Edition Edited by: Alain Rolland and Sean M. Sullivan
Controlled Environments
Edited by: Dilip M. Parikh ISBN: 0-8247-4235-4
Edited by: Anne Marie Dixon
ISBN: 0-8247-2647-2
ISBN: 0-8247-2359-7
Pharmaceutical Process Validation:
Preclinical Drug Development An International Third Edition
Pharmaceutical Photostability and Stabilization
Edited by: Mark C. Rogge Edited by: Robert A. Nash and Alfred H. Wachter
Technology
ISBN: 1-5744-4882-X ISBN: 0-8247-0838-5
Edited by: Joseph T. Piechocki
ISBN: 0-8247-5924-9
Percutaneous Absorption: Drugs, Cosmetics, Ophthalmic Drug Delivery Systems, Second
Mechanisms, Methods, Fourth Edition Edition
December 2006
Edited by: Robert L. Bronaugh and Howard I. Maibach Edited by: Ashim K. Mitra
Good Manufacturing Practices for
ISBN: 1-5744-4869-2 ISBN: 0-8247-4124-2
Pharmaceuticals: A Plan for Total Quality
Control from Manufacturer to Consumer, Sixth
Pharmaceutical Stress Testing: Predicting Drug Affinity Capillary Electrophoresis in Pharmaceutics
Edited by: Joseph Nally
Degradation and Biopharmaceutics
ISBN: 0-8493-3972-3
Edited by: Steven W. Baertschi Edited by: Reinhard Neubert
ISBN: 0-8247-4021-1 ISBN: 0-8247-0951-9
February 2007
Pharmaceutical Product Development: In Vitro-In
Active Pharmaceutical Ingredients: Development, Parenteral Quality Control: Sterility, Pyrogen,
Vivo Correlation
Manufacturing, and Regulation Particulate, and Package Integrity Testing:
Edited by: Dakshina Chilukuri
Edited by: Stanley Nusim Third Edition
ISBN: 0-8493-3827-1
ISBN: 0-8247-0293-X Michael K. Akers, Daniel S. Larrimore, and Dana
Morton Guazzo
Endotoxins: Pyrogens, LAL Testing and
Injectable Dispersed Systems: Formulation, ISBN: 0-8247-0885-7
Depyrogenation, Third Edition
Processing and Performance
Kevin L. Williams
Edited by: Diane J. Burgess Modified-Release Drug Delivery Technology
ISBN: 0-8493-9372-8
ISBN: 0-8493-3699-6 Edited by: Michael J. Rathbone
ISBN: 0-8247-0869-5
April 2007
Polymeric Drug Delivery Systems
Good Laboratory Practice Regulations,
Edited by: Glen S. Kwon Simulation for Designing Clinical Trials: A
Fourth Edition
ISBN: 0-8247-2532-8 Pharmacokinetic-Pharmacodynamic Modeling
Edited by: Sandy Weinberg
Perspective
ISBN: 0-8493-7583-5
Drug Delivery to the Oral Cavity Edited by: Hui Kimko
Edited by: Tapash K. Ghosh and William Pfister ISBN: 0-8247-0862-8
June 2007
ISBN: 0-8247-8293-3
Filtration and Purification in the Biopharmaceutical
Transdermal Drug Delivery
Industry, Second Edition
Generic Drug Development: Solid Oral Dosage Forms Second Edition Edited by: Theodore H. Meltzer and Maik Jornitz
Edited by: Leon Shargel Edited by: Jonathan Hadgraft
ISBN: 0-8493-7953-9
ISBN: 0-8247-5460-3 ISBN: 0-8247-0861-X
To order, call 1-800-634-7064 (North America) or +44 (0) 1264 343071 (Intl.)
E-Mail [email protected]
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Encyclopedia of
PHAR MACE UTICAL
TECH NOLOGY
Third Edition
VOLUME 6
edited by
James Swarbrick
PharmaceuTech, Inc.
Pinehurst, North Carolinia, USA
New York London
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Informa Healthcare USA, Inc.
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© 2007 by Informa Healthcare USA, Inc.
Informa Healthcare is an Informa business
No claim to original U.S. Government works
Printed in the United States of America on acid‑free paper
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International Standard Book Number‑10: 0‑8493‑9399‑X (Hardcover: Set)
International Standard Book Number‑10: 0‑8493‑9396‑5 (Hardcover: Volume 1)
International Standard Book Number‑10: 0‑8493‑9395‑7 (Hardcover: Volume 2)
International Standard Book Number‑10: 0‑8493‑9394‑9 (Hardcover: Volume 3)
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International Standard Book Number‑10: 0‑8493‑9392‑2 (Hardcover: Volume 5)
International Standard Book Number‑10: 0‑8493‑9391‑4 (Hardcover: Volume 6)
International Standard Book Number‑13: 978‑0‑8493‑9399‑0 (Hardcover: Set)
International Standard Book Number‑13: 978‑0‑8493‑9396‑9 (Hardcover: Volume 1)
International Standard Book Number‑13: 978‑0‑8493‑9395‑2 (Hardcover: Volume 2)
International Standard Book Number‑13: 978‑0‑8493‑9394‑5 (Hardcover: Volume 3)
International Standard Book Number‑13: 978‑0‑8493‑9393‑8 (Hardcover: Volume 4)
International Standard Book Number‑13: 978‑0‑8493‑9392‑1 (Hardcover: Volume 5)
International Standard Book Number‑13: 978‑0‑8493‑9391‑4 (Hardcover: Volume 6)
This book contains information obtained from authentic and highly regarded sources. Reprinted material is quoted with permission, and sources are
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To James C. Boylan
Co-Editor of the First and Second Editions
A great colleague and friend.
Editorial Advisory Board
Jean-Marc Aiache Igor Gonda
Biopharmaceutics Department, University of Clermont Acrux Limited, West Melbourne,
Ferrand, Clermont Ferrand, France Victoria, Australia
David Attwood Anthony J. Hickey
School of Pharmacy & Pharmaceutical Sciences, Department of Pharmaceutics, School of Pharmacy,
University of Manchester, Manchester, U.K. University of North Carolina at Chapel Hill,
Chapel Hill, North Carolina, U.S.A.
Larry L. Augsburger
Department of Pharmaceutics, University of Maryland Hideki Ichikawa
at Baltimore, Baltimore, Maryland, U.S.A. Faculty of Pharmaceutical Sciences,
Kobe Gakuin University, Kobe, Japan
Roland A. Bodmeier
College of Pharmacy, Freie Universita¨t Berlin, Brian E. Jones
Berlin, Germany Qualicaps, S.A., Penarth, U.K.
J. Phillip Bowen James C. McElnay
Center for Biomolecular Structure and Dynamics, Faculty of Science and Agriculture, Queen’s University
Department of Chemistry, University of Georgia, Belfast, Belfast, U.K.
Athens, Georgia, U.S.A.
Iain J. McGilveray
Gayle A. Brazeau McGilveray Pharmacon Inc., Nepean,
School of Pharmacy, State University of New York at Ontario, Canada
Buffalo, Amherst, New York, U.S.A.
Kinam Park
Harry G. Brittain School of Pharmacy and Pharmacal Sciences, Purdue
Center for Pharmaceutical Physics, Milford, University, West Lafayette, Indiana, U.S.A.
New Jersey, U.S.A.
Michael J. Pikal
Les F. Chasseaud School of Pharmacy, University of Connecticut, Storrs,
Drug Metabolism and Pharmacokinetics (DMPK), Connecticut, U.S.A.
Cambridge, U.K.
Na´ır Rodr´ıguez-Hornedo
Yie W. Chien Department of Pharmaceutical Sciences, College of
Research and Development, Kaohsiung Medical Pharmacy, University of Michigan, Ann Arbor,
University, Kaohsiung, Taiwan Michigan, U.S.A.
Bradley A. Clark Stephen G. Schulman
Solvay Pharmaceuticals, Marietta, Georgia, U.S.A. Department of Medicinal Chemistry, College of
Pharmacy, University of Florida, Gainesville,
Owen I. Corrigan Florida, U.S.A.
Department of Pharmaceutics, School of Pharmacy,
University of Dublin, Trinity College, Dublin, Ireland Jerome P. Skelly
Pharmaceutical Consultant, Alexandria,
Gillian M. Eccleston Virginia, U.S.A.
Department of Pharmaceutical Sciences, University of
Strathclyde, Glasgow, Scotland, U.K. Clive G. Wilson
Department of Pharmaceutical Sciences,
James L. Ford Strathclyde Institute for Biomedical Sciences (SIBS),
School of Pharmacy and Chemistry, Liverpool John University of Strathclyde,
Moores University, Liverpool, U.K. Glasgow, U.K.
vii
Contributors
Ragheb Abu-Rmaileh = School of Pharmacy and Pharmaceutical Sciences, University of Manchester,
Manchester, U.K.
Phillip M. Achey = Department of Microbiology and Cell Science, Institute of Food and
Agricultural Sciences, University of Florida, Gainesville, Florida, U.S.A.
James P. Agalloco = Agalloco and Associates Inc., Belle Mead, New Jersey, U.S.A.
Vikas Agarwal = CIMA Labs, Inc., Brooklyn Park, Minnesota, U.S.A.
Alaa M. Ahmad = Department of Clinical Pharmacology, Vertex Pharmaceuticals, Inc.,
Cambridge, Massachusetts, U.S.A.
Jean-Marc Aiache = Biopharmaceutics Department, University of Clermont-Ferrand,
Clermont Ferrand, France
James E. Akers = Akers Kennedy and Associates, Kansas City, Missouri, U.S.A.
Michael J. Akers = Martinsville, Indiana, U.S.A.
Hemant H. Alur = Division of Pharmaceutical Sciences, School of Pharmacy,
University of Missouri-Kansas City, Kansas City, Missouri, U.S.A.
David G. Allison = School of Pharmacy and Pharmaceutical Sciences, University of Manchester,
Manchester, U.K.
Norman Anthony Armstrong = Welsh School of Pharmacy, Cardiff University, Cardiff, U.K.
Agne`s Artiges = European Directorate for the Quality of Medicines (EDQM),
Strasbourg Cedex, France
Carolyn H. Asbury = Department of Medicine, University of Pennsylvania Health System,
Philadelphia, Pennsylvania, U.S.A.
C. K. Atterwill = Biosciences Division, Huntingdon Life Sciences, Cambridgeshire, U.K.
David Attwood = School of Pharmacy and Pharmaceutical Sciences, University of Manchester,
Manchester, U.K.
Larry L. Augsburger = Department of Pharmaceutics, University of Maryland at Baltimore,
Baltimore, Maryland, U.S.A.
J. Desmond Baggot = School of Veterinary Medicine, St. George’s University, Grenada, West Indies
Mark L. Balboni = KMI, A Division of PAREXEL International, LLC, Waltham,
Massachusetts, U.S.A.
Paul Baldrick = Covance Laboratories, Ltd., North Yorkshire, U.K.
Samuel B. Balik = GlaxoSmithKline, Research Triangle Park, North Carolina, U.S.A.
David J. Barlow = Molecular Biophysics Group, Pharmaceutical Science Research Division,
King’s College London, College London, London, U.K.
Debra Barnes = Roche Global Development, Palo Alto, California, U.S.A.
Onkaram Basavapathruni = Pharmacia, Skokie, Illinois, U.S.A.
Annette Bauer-Brandl = Institute of Pharmacy, Department of Pharmaceutics and Biopharmaceutics,
The University of Tromsø, Tromsø, Norway
G.J.P.J. Beernink = Amsterdam, The Netherlands
Leslie Z. Benet = Department of Biopharmaceutical Sciences, University of California
San Francisco, San Francisco, California, U.S.A.
David H. Bergstrom = Cardinal Health Pharmaceutical Development, Somerset, New Jersey, U.S.A.
Ira R. Berry = International Regulatory Business Consultants, LLC, Maplewood, New Jersey, U.S.A.
ix
