Encyclopedia of Pharmaceutical Technology, Third Edition

4372 Pages·2006·59.715 MB·English

by  James Swarbrick

Volume 1 Volume 2 (Continued)
21CFRPart11Revisited / 1 DrugDelivery:LiquidCrystalsin / 1115
AbsorptionEnhancers / 13 DrugDelivery:MonoclonalAntibodies / 1132
AbsorptionofDrugs / 19 DrugDelivery:MonoclonalAntibodiesinImagingandTherapy / 1149
AdsorptionatSolidSurfaces:PharmaceuticalApplications / 34 DrugDelivery:MucoadhesiveHydrogels / 1169
AdverseDrugReactions / 46 DrugDelivery:Nanoparticles / 1183
AdvertisingandPromotionofPrescriptionandOver-the-Counter DrugDelivery:NasalRoute / 1201
DrugProducts / 57 DrugDelivery:Needle-FreeSystems / 1209
AlternativeMedicines / 66 DrugDelivery:OphthalmicRoute / 1220
AmorphousPharmaceuticalSystems / 83 DrugDelivery:OralColon-Specific / 1228
AnalyticalProcedures:Validation / 92 DrugDelivery:OralRoute / 1242
AnimalsinDrugDevelopment / 114 DrugDelivery:ParenteralRoute / 1266
AsepticProcessing:Validation / 127 DrugDelivery:PulmonaryDelivery / 1279
AutoxidationandAntioxidants / 139 DrugDelivery:PulsatileSystems / 1287
BioabsorbablePolymers / 155 DrugDelivery:RectalRoute / 1298
BioavailabilityofDrugsandBioequivalence / 164 DrugDelivery:TopicalandTransdermalRoutes / 1311
BiodegradablePolymersasDrugCarriers / 176 DrugDelivery:Tumor-TargetedSystems / 1326
BiologicFluids:Analysis / 194 DrugDelivery:VaginalRoute / 1339
Biopharmaceutics / 208 DrugDesign:BasicPrinciplesandApplications / 1362
BiosynthesisofDrugs / 228 DrugDevelopmentManagement / 1370
BiotechnologyandBiologicalPreparations / 258 DrugInformationSystems / 1385
Biotechnology-DerivedDrugProducts:FormulationDevelopment / 281 DrugInteractions / 1392
Biotechnology-DerivedDrugProducts:StabilityTesting, DrugMasterFiles / 1401
Filling,andPackaging / 302 DrugSafetyEvaluation / 1406
BiotransformationofDrugs / 310 DryPowderAerosols:EmergingTechnologies / 1428
Bio-ValidationofSteamSterilization / 325
BloodSubstitutes:FluorocarbonApproach / 335
BloodSubstitutes:Hemoglobin-BasedOxygenCarriers / 353
Blow-Fill-Seal:AdvancedAsepticProcessing / 378
Buffers,BufferingAgents,andIonicEquilibria / 385
CalorimetryinPharmaceuticalResearchandDevelopment / 393
Capsules,Hard / 406 Volume 3
Capsules,Soft / 419 DryingandDryers / 1435
CarcinogenicityTesting:Past,Present,andFuture / 431 EconomicCharacteristicsoftheR&DIntensivePharmaceutical
ChiropticalAnalyticalMethods / 445 Industry / 1450
ChromatographicMethodsofAnalysis:GasChromatography / 463 EffervescentPharmaceuticals / 1454
ChromatographicMethodsofAnalysis:HighPerformanceLiquid ElastomericComponentsforthePharmaceuticalIndustry / 1466
Chromatography / 526 ElectricalPowerSystemsforPharmaceuticalEquipment / 1482
ChromatographicMethodsofAnalysis:ThinLayerChromatography / 538 ElectroanalyticalMethodsofAnalysis:PolarographyandVoltammetry / 1490
ClinicalDataManagementSystems / 551 ElectroanalyticalMethodsofAnalysis:Potentiometry / 1502
ClinicalEvaluationofDrugs / 560 ElectrochemicalDetectionforPharmaceuticalAnalysis / 1516
ClinicalPharmacokineticsandPharmacodynamics / 572 ElectrostaticChargeinPharmaceuticalSystems / 1535
ClinicalSuppliesManufacture:GMPConsiderations / 591 EmulsionsandMicroemulsions / 1548
CoacervationandPhaseSeparation / 600 EnzymeImmunoassayandRelatedBioanalyticalMethods / 1566
Cocrystals:Design,PropertiesandFormationMechanisms / 615 EquipmentCleaning / 1580
ColloidsandColloidDrugDeliverySystem / 636 EuropeanAgencyfortheEvaluationofMedicinalProducts(EMEA) / 1593
ColoringAgentsforUseinPharmaceuticals / 648 EvaporationandEvaporators / 1600
ExcipientsforPharmaceuticalDosageForms / 1609
Excipients:ParenteralDosageFormsandTheirRole / 1622
Excipients:PowdersandSolidDosageForms / 1646
Excipients:SafetyTesting / 1656
ExpertSystemsinPharmaceuticalProductDevelopment / 1663
ExpirationDating / 1685
ExtractablesandLeachablesinDrugsandPackaging / 1693
Volume 2 ExtrusionandExtruders / 1712
Complexation:Cyclodextrins / 671 FilmCoatingofOralSolidDosageForms / 1729
Complexation:Non-Cyclodextrins / 697 FiltersandFiltration / 1748
ComputerSystemsValidation / 707 FlamePhotometry / 1759
Computer-AssistedDrugDesign / 714 FlavorsandFlavorModifiers / 1763
ComputersinPharmaceuticalTechnology / 732 FluidBedProcessesforFormingFunctionalParticles / 1773
ContinuousProcessingofPharmaceuticals / 743 FoodandDrugAdministration:RoleinDrugRegulation / 1779
ContractManufacturing / 750 FractalGeometryinPharmaceuticalandBiologicalApplications / 1791
CoolingProcessesandCongealing / 761 FreezeDrying / 1807
CoprecipitatesandMelts / 774 FreezeDrying,Scale-UpConsiderations / 1834
CorrosionofPharmaceuticalEquipment / 782 Gastro-RetentiveSystems / 1850
CosmeticsandTheirRelationtoDrugs / 798 Gelatin-ContainingFormulations:ChangesinDissolution
CosolventsandCosolvency / 806 Characteristics / 1861
CrystalHabitChangesandDosageFormPerformance / 820 GelsandJellies / 1875
Crystallization:GeneralPrinciplesandSignificanceonProduct GenericDrugsandGenericEquivalency / 1891
Development / 834 GeneticAspectsofDrugDevelopment / 1897
Crystallization:ParticleSizeControl / 858 GeriatricDosingandDosageForms / 1905
Dendrimers / 872 GoodClinicalPractices(GCPs):AnOverview / 1925
DentalProducts / 891 GoodLaboratoryPractices(GLPs):AnOverview / 1931
DissolutionandDissolutionTesting / 908 GoodManufacturingPractices(GMPs):AnOverview / 1941
DNAProbesfortheIdentificationofMicrobes / 929 HandlingHazardousChemicalsandPharmaceuticals / 1948
DosageFormDesign:APhysicochemicalApproach / 939 HarmonizationofPharmacopeialStandards / 1955
DosageFormsandBasicPreparations:History / 948 HeadspaceOxygenAnalysisinPharmaceuticalProducts / 1967
DosageForms:LipidExcipients / 975 HealthCareSystems:OutsidetheUnitedStates / 1977
DosageForms:Non-Parenterals / 988 HealthCareSystems:WithintheUnitedStates / 1985
DosageForms:Parenterals / 1001 HomogenizationandHomogenizers / 1996
DosageRegimensandDose-Response / 1012 Hot-MeltExtrusionTechnology / 2004
DressingsinWoundManagement / 1023 Hydrogels / 2021
DrugAbuse / 1038 HydrolysisofDrugs / 2040
DrugDeliverySystems:NeutronScatteringStudies / 1049 Immunoassay / 2048
DrugDelivery:BuccalRoute / 1071 InVitro–InVivoCorrelation / 2062
DrugDelivery:ControlledRelease / 1082 Inhalation:DryPowder / 2077
DrugDelivery:Fast-DissolveSystems / 1104 Inhalation:Liquids / 2092
Encyclopedia of
PHARMACEUTICAL
TECHNOLOGY
Third Edition
VOLUME 1
DK9650_C000.indd 1 08/24/2006 2:59:20 PM
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 [phone] (Intl.)
E-Mail [email protected]
DK9650_C000.indd 2 08/24/2006 2:59:20 PM
Encyclopedia of
PHAR MACE UTICAL
TECH NOLOGY
Third Edition
VOLUME 1
edited by
James Swarbrick
PharmaceuTech, Inc.
Pinehurst, North Carolinia, USA
New York London
DK9650_C000.indd 3 08/24/2006 2:59:21 PM
Informa Healthcare USA, Inc.
270 Madison Avenue
New York, NY 10016
© 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
10 9 8 7 6 5 4 3 2 1
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)
International Standard Book Number‑10: 0‑8493‑9393‑0 (Hardcover: Volume 4)
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
indicated. A wide variety of references are listed. Reasonable efforts have been made to publish reliable data and information, but the author and the
publisher cannot assume responsibility for the validity of all materials or for the consequences of their use.
No part of this book may be reprinted, reproduced, transmitted, or utilized in any form by any electronic, mechanical, or other means, now known or
hereafter invented, including photocopying, microfilming, and recording, or in any information storage or retrieval system, without written permission
from the publishers.
For permission to photocopy or use material electronically from this work, please access www.copyright.com (http://www.copyright.com/) or contact
the Copyright Clearance Center, Inc. (CCC) 222 Rosewood Drive, Danvers, MA 01923, 978‑750‑8400. CCC is a not‑for‑profit organization that provides
licenses and registration for a variety of users. For organizations that have been granted a photocopy license by the CCC, a separate system of payment
has been arranged.
Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation with‑
out intent to infringe.
Visit the Informa Web site at
www.informa.com
and the Informa Healthcare Web site at
www.informahealthcare.com
DK9650_C000.indd 4 08/24/2006 2:59:21 PM
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