Modified-Release Drug Delivery Technology: Volume 2 PDF
Preview Modified-Release Drug Delivery Technology: Volume 2
Pharmaceutical Science and Technology 184 DRUGS AND THE PHARMACEUTICAL SCIENCES VOLUME 184 about the book… This two volume Second Edition describes the anatomical, physiological, pharmaceutical, and technological aspects of delivery routes, found in areas like: • Oral • Ocular • Dermal and transdermal • Vaginal M • Colonic • Oral mucosal • Nasal • Pulmonary Modified-Release o Providing insight and critical assessment of the many available and emerging modified release drug d delivery systems for their current and future value, topics include: i • modified drug release landscape; academic, regulatory, and intellectual property viewpoints fi • I-vation Sustained Release Intravitreal System e d • ViaNase Intranasal Device and controlled particle dispersion technology Platform Drug Delivery Technology - • Microneedles for drug delivery, PassPort system, Dot-Matrix technology, ultrasound, R iontophoretic and technologies e • DiretcHaler Nasal technology l e • intravaginal ring systems, Supravail, Vagisite, C-Vad™ Vaginal Insert, and ‘Smart’ Vaginal a Delivery Systems Ss Second Edition • the AERx® Pulmonary Drug Delivery System ece • AAD-Adaptive aerosol delivery technology on • nebulizer technologies and dry powder inhaler systems d EdDr Volume 2 about the editors... itu iog Ma IDCiHviAsiEoLn J.o fR ADTEHCB OInNteEr nisa tDioirneaclt oNr,Z RLeismeaitrecdh, aHnadm Diletovnel,o Npmewen Zt,e aanladn dG. eDner.r aRl aMthabnoangee rr eocfe Iinvetedr Ahgis, n, V D TES: o O Ph.D. in Pharmaceutical Science from the University of Aston, Birmingham, England, and has lue N ichniaansloi zevedaditt.ee dDd rmo. rRa canotyh- enbdooivnteeeld mh tahosrd ewiefir eibtdtoe-ornek lsoe aavsneerd d 3nr5uu mgp eedererol-iurvesev rsiyep wesycesidatel amisrstsui,c elsese svo,e fh rjaaolsu orlifnc waelnhs.sicehd hfiavvee U bSe epna tceonmtsm aenrd- me 2live XXXX JONATHAN HADGRAFT is Professor of Biophysical Chemistry, University of London, United Kingdom. ry ED: Dr. Hadgraft received his D.Phil. in Chemistry and his D.Sc. in Medicine from the University of S T VI Oxford, United Kingdom. His major research interests are in the application of physical chemistry to e E R drug delivery, with special reference to the skin. He has been elected to Fellowships of the Royal c E Society of Chemistry and the American Association of Pharmaceutical Scientists, and has contributed h T A to over 500 publications. He has contributed numerous book chapters and has co-edited several n D books. He serves on a number of editorial boards of pharmaceutical science journals. o X l X MICHAEL S. ROBERTS is Professor, School of Medicine, University of Queensland, Brisbane, Australia; o XX Senior Principal Research Fellow, National Health and Research Council; Director Therapeutics g X Research Unit, Princess Alexandra Hospital, Queensland Australia; Adjunct Professor, University of y D: E Canberra, Australia; and Visiting Professor, University of Lyon, France. Dr. Roberts received his Ph.D. T A and D.Sc. from the University of Sydney, Australia, and his M.B.A. from the University of Queensland. E R Dr. Roberts has also written over 280 peer-reviewed articles, 36 chapters, and has edited or co-edited C five books. Rathbone TE • A MAJELLA E. LANE is a lecturer in Pharmaceutics in the School of Pharmacy, University of London, D United Kingdom. She received her Ph.D. from Trinity College, Dublin, Ireland, and spent a sabbatical Hadgraft X X period at the University of Michigan, Ann Arbor, where she holds a Visiting Associate Scientist • X edited by X appointment. Her current research interests include development of vaccine dosage forms, Roberts X formulation of peptides, transdermal drug delivery and mucosal drug delivery, and modeling of • E: M absorption processes across epithelial barriers. H5355 Lane Michael J. Rathbone NA Printed in the United States of America E Jonathan Hadgraft FIL Michael S. Roberts X X R: Majella E. Lane E N G SI E D Rathbone_978-1420053555.indd 1 4/28/08 12:59:14 PM PANTONE 202 C Modified-Release Drug Delivery Technology DRUGS AND THE PHARMACEUTICAL SCIENCES A Series of Textbooks and Monographs Executive Editor James Swarbrick PharmaceuTech, Inc. Pinehurst, North Carolina Advisory Board Larry L. Augsburger Harry G. Brittain UniversityofMaryland CenterforPharmaceuticalPhysics Milford,NewJersey Baltimore,Maryland Robert Gurny Jennifer B. Dressman UniversitedeGeneve UniversityofFrankfurtInstituteof Geneve,Switzerland PharmaceuticalTechnology Frankfurt,Germany Jeffrey A. Hughes UniversityofFloridaCollege Anthony J. Hickey ofPharmacy UniversityofNorthCarolina Gainesville,Florida SchoolofPharmacy Vincent H. L. Lee ChapelHill,NorthCarolina USFDACenterforDrug Ajaz Hussain EvaluationandResearch Sandoz LosAngeles,California Princeton,NewJersey Kinam Park PurdueUniversity Joseph W. Polli WestLafayette,Indiana GlaxoSmithKlineResearchTriangle ParkNorthCarolina Jerome P. Skelly Alexandria,Virginia Stephen G. Schulman UniversityofFlorida Elizabeth M. Topp Gainesville,Florida UniversityofKansas Lawrence,Kansas Yuichi Sugiyama Peter York UniversityofTokyo,Tokyo,Japan UniversityofBradfordSchoolof Geoffrey T. Tucker Pharmacy UniversityofSheffield Bradford,UnitedKingdom RoyalHallamshireHospital Sheffield,UnitedKingdom 1. Pharmacokinetics,Milo Gibaldi and DonaldPerrier 2. GoodManufacturing Practices forPharmaceuticals: APlanfor Total QualityControl, SidneyH. Willig, MurrayM.Tuckerman, and William S. Hitchings IV 3. Microencapsulation, editedbyJ.R. Nixon 4. DrugMetabolism: Chemicaland Biochemical Aspects,Bernard Testa and Peter Jenner 5. NewDrugs:DiscoveryandDevelopment,editedbyAlanA. Rubin 6. Sustained andControlled ReleaseDrugDelivery Systems,editedby JosephR. Robinson 7. ModernPharmaceutics, editedbyGilbertS.Banker and Christopher T.Rhodes 8. Prescription Drugs inShortSupply: CaseHistories,Michael A.Schwartz 9. Activated Charcoal:Antidotal andOtherMedical Uses, DavidO. Cooney 10. ConceptsinDrugMetabolism(intwoparts),editedbyPeter Jennerand BernardTesta 11. PharmaceuticalAnalysis:ModernMethods(intwoparts),editedby JamesW.Munson 12. TechniquesofSolubilizationofDrugs,editedbySamuel H.Yalkowsky 13. OrphanDrugs,editedbyFredE. Karch 14. Novel Drug Delivery Systems: Fundamentals, Developmental Concepts, BiomedicalAssessments,YieW.Chien 15. Pharmacokinetics:SecondEdition,Revisedand Expanded, Milo Gibaldiand DonaldPerrier 16. GoodManufacturingPracticesforPharmaceuticals:APlanforTotalQuality Control,SecondEdition, RevisedandExpanded,Sidney H. Willig, MurrayM.Tuckerman,and William S. Hitchings IV 17. FormulationofVeterinaryDosageForms,editedby JackBlodinger 18. Dermatological Formulations:PercutaneousAbsorption,Brian W.Barry 19. TheClinicalResearchProcessinthePharmaceuticalIndustry,editedby GaryM.Matoren 20. MicroencapsulationandRelatedDrugProcesses,PatrickB. Deasy 21. DrugsandNutrients: TheInteractiveEffects,editedbyDaphneA. Roe andT. ColinCampbell 22. BiotechnologyofIndustrial Antibiotics,ErickJ. Vandamme 23. PharmaceuticalProcessValidation, editedby BernardT. Loftusand RobertA. Nash 24. Anticancer and Interferon Agents: Synthesis and Properties, edited by RaphaelM.Ottenbriteand GeorgeB. Butler 25. PharmaceuticalStatistics:PracticalandClinicalApplications, SanfordBolton 26. DrugDynamicsforAnalytical,Clinical,andBiological Chemists, BenjaminJ.Gudzinowicz, Burrows T.Younkin, Jr.,and MichaelJ.Gudzinowicz 27. ModernAnalysisofAntibiotics,editedbyAdjoran Aszalos 28. SolubilityandRelatedProperties,KennethC. James 29. Controlled Drug Delivery: Fundamentals and Applications, Second Edition, RevisedandExpanded,editedbyJosephR. Robinsonand VincentH. Lee 30. NewDrugApprovalProcess:ClinicalandRegulatoryManagement, editedbyRichardA. Guarino 31. TransdermalControlledSystemicMedications,editedbyYieW.Chien 32. DrugDeliveryDevices:FundamentalsandApplications,editedby PraveenTyle 33. Pharmacokinetics:Regulatory(cid:1)Industrial(cid:1) AcademicPerspectives, editedbyPeter G.Welling andFrancis L. S.Tse 34. ClinicalDrugTrials andTribulations,editedbyAllen E. Cato 35. TransdermalDrugDelivery:DevelopmentalIssuesandResearchInitiatives, editedbyJonathanHadgraftandRichard H. Guy 36. AqueousPolymericCoatingsforPharmaceuticalDosageForms, editedbyJamesW.McGinity 37. PharmaceuticalPelletizationTechnology,editedbyIsaacGhebre-Sellassie 38. GoodLaboratoryPracticeRegulations,editedbyAllen F.Hirsch 39. NasalSystemicDrugDelivery,YieW.Chien,KennethS. E.Su, andShyi-Feu Chang 40. ModernPharmaceutics:SecondEdition,RevisedandExpanded,editedby GilbertS.Banker and ChristopherT. Rhodes 41. SpecializedDrugDeliverySystems:Manufacturingand ProductionTechnology,editedbyPraveenTyle 42. TopicalDrugDeliveryFormulations,editedby DavidW.Osborneand AntonH. Amann 43. DrugStability:Principles andPractices,JensT.Carstensen 44. PharmaceuticalStatistics:PracticalandClinicalApplications, SecondEdition, RevisedandExpanded,Sanford Bolton 45. BiodegradablePolymersasDrugDeliverySystems,editedby MarkChasin and RobertLanger 46. PreclinicalDrugDisposition:ALaboratory Handbook, FrancisL. S. TseandJames J.Jaffe 47. HPLCinthePharmaceuticalIndustry,editedbyGodwinW. Fong andStanleyK. Lam 48. PharmaceuticalBioequivalence,editedbyPeter G.Welling, FrancisL. S. Tse,and Shrikant V.Dinghe 49. PharmaceuticalDissolution Testing,Umesh V. Banakar 50. NovelDrugDeliverySystems:SecondEdition, RevisedandExpanded, YieW.Chien 51. ManagingtheClinicalDrugDevelopmentProcess,DavidM.Cocchettoand RonaldV.Nardi 52. GoodManufacturingPracticesforPharmaceuticals:APlanforTotalQuality Control,ThirdEdition,editedby SidneyH. Willig and JamesR. Stoker 53. Prodrugs: TopicalandOcularDrugDelivery,editedbyKennethB. Sloan 54. PharmaceuticalInhalationAerosolTechnology,editedby AnthonyJ. Hickey 55. Radiopharmaceuticals: ChemistryandPharmacology,editedby AdrianD. Nunn 56. New Drug Approval Process: Second Edition, Revised and Expanded, editedbyRichardA. Guarino 57. PharmaceuticalProcessValidation:SecondEdition,RevisedandExpanded, editedbyIraR. Berry andRobert A.Nash 58. OphthalmicDrugDeliverySystems,editedbyAshim K. Mitra 59. PharmaceuticalSkinPenetrationEnhancement,editedby KennethA.Walters and JonathanHadgraft 60. ColonicDrugAbsorption andMetabolism,editedbyPeter R. Bieck 61. PharmaceuticalParticulateCarriers:TherapeuticApplications,editedby AlainRolland 62. DrugPermeationEnhancement:TheoryandApplications,editedby DeanS.Hsieh 63. Glycopeptide Antibiotics,editedbyRamakrishnanNagarajan 64. AchievingSterilityin MedicalandPharmaceuticalProducts,NigelA. Halls 65. MultiparticulateOralDrugDelivery,editedbyIsaacGhebre-Sellassie 66. ColloidalDrugDeliverySystems,editedbyJo¨rg Kreuter 67. Pharmacokinetics:Regulatory(cid:1)Industrial(cid:1)AcademicPerspectives,Second Edition,editedbyPeter G. Wellingand Francis L.S. Tse 68. DrugStability:Principles andPractices,SecondEdition,Revisedand Expanded,JensT.Carstensen 69. GoodLaboratoryPracticeRegulations: SecondEdition,Revised andExpanded,editedbySandyWeinberg 70. Physical CharacterizationofPharmaceuticalSolids,editedby HarryG.Brittain 71. PharmaceuticalPowderCompactionTechnology,editedbyGo¨ranAlderborn andChrister Nystro¨m 72. ModernPharmaceutics:ThirdEdition, RevisedandExpanded,editedby GilbertS.Banker and ChristopherT. Rhodes 73. Microencapsulation:MethodsandIndustrial Applications,editedby SimonBenita 74. OralMucosalDrugDelivery,editedbyMichael J.Rathbone 75. ClinicalResearchinPharmaceuticalDevelopment,editedby BarryBleidt andMichael Montagne 76. TheDrugDevelopmentProcess:IncreasingEfficiencyand CostEffectiveness,editedby PeterG. Welling, LouisLasagna, andUmesh V. Banakar 77. Microparticulate Systems for the Delivery of Proteins and Vaccines, edited bySmadarCohen andHoward Bernstein 78. GoodManufacturingPracticesforPharmaceuticals:APlanforTotalQuality Control,FourthEdition, RevisedandExpanded,Sidney H.Willig and JamesR. Stoker 79. AqueousPolymericCoatingsforPharmaceuticalDosageForms: SecondEdition, RevisedandExpanded,editedbyJames W.McGinity 80. PharmaceuticalStatistics:PracticalandClinicalApplications,ThirdEdition, SanfordBolton 81. HandbookofPharmaceuticalGranulationTechnology,editedby DilipM.Parikh 82. BiotechnologyofAntibiotics:SecondEdition, RevisedandExpanded, editedbyWilliam R.Strohl 83. Mechanisms of Transdermal Drug Delivery, edited by Russell O. Potts and RichardH.Guy 84. PharmaceuticalEnzymes,editedbyAlbert Lauwersand SimonScharpe´ 85. Development of Biopharmaceutical Parenteral Dosage Forms, edited by JohnA. Bontempo 86. PharmaceuticalProjectManagement,editedbyTony Kennedy 87. DrugProductsforClinicalTrials:AnInternationalGuidetoFormulation(cid:1) Production(cid:1)QualityControl,editedbyDonaldC. Monkhouseand ChristopherT.Rhodes 88. DevelopmentandFormulationofVeterinaryDosageForms:SecondEdition, RevisedandExpanded,editedbyGregoryE. Hardeeand J.Desmond Baggot 89. Receptor-Based DrugDesign,editedbyPaulLeff 90. Automation and Validation of Information in Pharmaceutical Processing, editedbyJosephF.deSpautz 91. Dermal Absorption and Toxicity Assessment, edited by Michael S. Roberts andKennethA. Walters 92. PharmaceuticalExperimentalDesign,GarethA.Lewis,DidierMathieu,and RogerPhan-Tan-Luu 93. PreparingforFDAPre-ApprovalInspections,editedbyMartin D. HynesIII 94. PharmaceuticalExcipients:CharacterizationbyIR,Raman,and NMRSpectroscopy,David E.Bugayand W.PaulFindlay 95. PolymorphisminPharmaceuticalSolids,editedbyHarryG. Brittain 96. Freeze-Drying/LyophilizationofPharmaceuticalandBiologicalProducts, editedbyLouisRey andJoan C.May 97. Percutaneous Absorption: Drugs–Cosmetics–Mechanisms–Methodology, ThirdEdition,RevisedandExpanded,editedbyRobertL. Bronaughand HowardI. Maibach 98. BioadhesiveDrugDeliverySystems:Fundamentals,NovelApproaches,and Development,editedbyEdith Mathiowitz, DonaldE.Chickering III,and Claus-Michael Lehr 99. ProteinFormulationandDelivery,editedbyEugeneJ. McNally 100. NewDrugApproval Process:ThirdEdition, TheGlobalChallenge, editedbyRichardA. Guarino 101. PeptideandProteinDrugAnalysis,editedbyRonaldE. Reid 102. TransportProcessesinPharmaceuticalSystems,editedby GordonL.Amidon, Ping I.Lee,and Elizabeth M.Topp 103. ExcipientToxicityandSafety,editedbyMyraL. Weinerand LoisA.Kotkoskie 104. TheClinicalAuditinPharmaceuticalDevelopment,editedby MichaelR. Hamrell 105. Pharmaceutical Emulsions and Suspensions, edited by Francoise Nielloud andGilberte Marti-Mestres 106. OralDrugAbsorption:PredictionandAssessment,editedby Jennifer B.Dressman and HansLennerna¨s 107. DrugStability: PrinciplesandPractices,ThirdEdition, Revised andExpanded,editedbyJensT. CarstensenandC. T. Rhodes 108. ContainmentinthePharmaceuticalIndustry,editedbyJamesP. Wood 109. GoodManufacturingPracticesforPharmaceuticals:APlanforTotalQuality ControlfromManufacturer toConsumer,Fifth Edition,Revisedand Expanded,SidneyH. Willig 110. AdvancedPharmaceuticalSolids,JensT.Carstensen 111. Endotoxins:Pyrogens,LALTesting,andDepyrogenation, SecondEdition,Revisedand Expanded,Kevin L.Williams 112. PharmaceuticalProcessEngineering, AnthonyJ. Hickeyand DavidGanderton 113. Pharmacogenomics,editedbyWerner Kalow,UrsA. Meyer and Rachel F.Tyndale 114. HandbookofDrugScreening,editedbyRamakrishnaSeethala andPrabhavathi B. Fernandes 115. DrugTargetingTechnology:Physical(cid:1)Chemical(cid:1)Biological Methods, editedbyHansSchreier 116. Drug–DrugInteractions,editedbyA. DavidRodrigues 117. HandbookofPharmaceuticalAnalysis,editedby LenaOhannesian andAnthony J.Streeter 118. PharmaceuticalProcessScale-Up,editedbyMichael Levin 119. Dermatological andTransdermalFormulations,editedby KennethA.Walters 120. ClinicalDrugTrials andTribulations:SecondEdition, Revisedand Expanded,editedbyAllen Cato, LyndaSutton,and Allen CatoIII 121. ModernPharmaceutics:FourthEdition, RevisedandExpanded, editedbyGilbertS. Bankerand ChristopherT. Rhodes 122. SurfactantsandPolymersinDrugDelivery,Martin Malmsten 123. TransdermalDrugDelivery:SecondEdition,RevisedandExpanded,edited byRichardH. Guy and JonathanHadgraft 124. GoodLaboratoryPracticeRegulations:SecondEdition,Revised andExpanded,editedbySandyWeinberg 125. Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package IntegrityTesting:ThirdEdition, RevisedandExpanded,Michael J.Akers, DanielS. Larrimore, andDana MortonGuazzo 126. Modified-ReleaseDrugDeliveryTechnology,editedbyMichaelJ.Rathbone, JonathanHadgraft, andMichael S.Roberts 127. SimulationforDesigningClinicalTrials: APharmacokinetic-PharmacodynamicModelingPerspective, editedbyHuiC. Kimko andStephenB. Duffull 128. Affinity Capillary Electrophoresis in Pharmaceutics and Biopharmaceutics, editedbyReinhardH. H. Neubertand Hans-Hermann Ru€ttinger 129. Pharmaceutical Process Validation: An International Third Edition, Revised andExpanded,editedbyRobertA. Nashand AlfredH. Wachter 130. OphthalmicDrugDeliverySystems:SecondEdition, Revisedand Expanded,editedbyAshim K.Mitra 131. PharmaceuticalGeneDeliverySystems,editedbyAlain Rolland and SeanM.Sullivan 132. BiomarkersinClinicalDrugDevelopment,editedbyJohnC. Bloom andRobert A.Dean 133. PharmaceuticalExtrusionTechnology,editedbyIsaacGhebre-Sellassieand CharlesMartin 134. PharmaceuticalInhalationAerosolTechnology:SecondEdition, RevisedandExpanded,editedbyAnthony J.Hickey 135. PharmaceuticalStatistics:PracticalandClinicalApplications,FourthEdition, SanfordBoltonand Charles Bon 136. ComplianceHandbookforPharmaceuticals,MedicalDevices,andBiologics, editedbyCarmen Medina 137. Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products: SecondEdition,Revisedand Expanded,editedby LouisRey and JoanC. May 138. Supercritical Fluid Technology for Drug Product Development, edited by Peter York,UdayB. Kompella, andBoris Y. Shekunov 139. NewDrugApproval Process:FourthEdition,Accelerating GlobalRegistrations,editedbyRichardA. Guarino 140. MicrobialContaminationControlinParenteralManufacturing, editedbyKevinL. Williams 141. New Drug Development: Regulatory Paradigms for Clinical Pharmacology andBiopharmaceutics,editedbyChandrahasG. Sahajwalla 142. MicrobialContaminationControlinthe PharmaceuticalIndustry, editedbyLuisJimenez 143. GenericDrugProductDevelopment:Solid OralDosageForms, editedbyLeonShargeland IsadoreKanfer 144. IntroductiontothePharmaceuticalRegulatoryProcess,edited byIraR. Berry 145. DrugDeliverytotheOral Cavity:MoleculestoMarket,editedby TapashK. GhoshandWilliam R. Pfister 146. GoodDesign PracticesforGMPPharmaceuticalFacilities,editedby AndrewSignore andTerry Jacobs 147. DrugProductsforClinicalTrials,SecondEdition,editedby DonaldMonkhouse,CharlesCarney, and JimClark 148. PolymericDrugDeliverySystems,editedbyGlenS. Kwon 149. InjectableDispersedSystems:Formulation,Processing,and Performance,editedbyDiane J.Burgess 150. LaboratoryAuditingforQualityandRegulatoryCompliance,DonaldSinger, Raluca-IoanaStefan, andJacobusvan Staden 151. ActivePharmaceuticalIngredients:Development,Manufacturing, andRegulation, editedbyStanleyNusim 152. PreclinicalDrugDevelopment,editedbyMark C. Roggeand David R.Taft 153. PharmaceuticalStress Testing:Predicting DrugDegradation, editedbyStevenW.Baertschi 154. HandbookofPharmaceuticalGranulationTechnology: SecondEdition,editedbyDilip M.Parikh 155. Percutaneous Absorption: Drugs–Cosmetics–Mechanisms–Methodology, FourthEdition, editedbyRobertL. Bronaughand Howard I.Maibach 156. Pharmacogenomics:SecondEdition, editedbyWerner Kalow, UrsA.Meyer and Rachel F.Tyndale 157. PharmaceuticalProcessScale-Up,SecondEdition,editedbyMichaelLevin 158. Microencapsulation: Methods and Industrial Applications, Second Edition, editedbySimonBenita
The list of books you might like
