To Optimize Therapeutic Outcomes

edited by

Robert O.Williams III

David R. Taft Jason T. McConville informa healthcare

Advanced Drug Formulation Design to Optimize Therapeutic Outcomes

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

University of Maryland Baltimore, Maryland

Jennifer B. Dressman

Johann Wolfgang Goethe University Frankfurt, Germany

Jeffrey A. Hughes

University of Florida College of Pharmacy Gainesville, Florida

Trevor M. Jones

The Association of the British Pharmaceutical Industry London, United Kingdom

Vincent H. L. Lee

University of Southern California Los Angeles, California

Jerome P. Skelly

Alexandria, Virginia

Geoffrey T. Tucker

University of Sheffield Royal Hallamshire Hospital Sheffield, United Kingdom

Harry G. Brittain

Center for Pharmaceutical Physics Milford, New Jersey

Anthony J. Hickey

University of North Carolina School of Pharmacy

Chapel Hill, North Carolina Ajaz Hussain

Sandoz

Princeton, New Jersey

Stephen G. Schulman

University of Florida Gainesville, Florida

Elizabeth M. Topp

University of Kansas School of

Pharmacy

Lawrence, Kansas

Peter York

University of Bradford School of Pharmacy

Bradford, United Kingdom

1. Pharmacokinetics, Milo Gibaldi and Donald Perrier

2. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control, Sidney H. Willig, Murray M. Tuckerman, and William S. Hitchings IV

3. Microencapsulation, edited by J. R. Nixon

4. Drug Metabolism: Chemical and Biochemical Aspects, Bernard Testa and Peter Jenner

5. New Drugs: Discovery and Development, edited by Alan A. Rubin

6. Sustained and Controlled Release Drug Delivery Systems, edited by Joseph R. Robinson

7. Modern Pharmaceutics, edited by Gilbert S. Banker and Christopher T. Rhodes

8. Prescription Drugs in Short Supply: Case Histories, Michael A. Schwartz

9. Activated Charcoal: Antidotal and Other Medical Uses, David O. Cooney

10. Concepts in Drug Metabolism (in two parts), edited by Peter Jenner and Bernard Testa

11. Pharmaceutical Analysis: Modern Methods (in two parts), edited by James W. Munson

12. Techniques of Solubilization of Drugs, edited by Samuel H. Yalkowsky

13. Orphan Drugs, edited by Fred E. Karch

14. Novel Drug Delivery Systems: Fundamentals, Developmental Concepts, Biomedical Assessments, Yie W. Chien

15. Pharmacokinetics: Second Edition, Revised and Expanded, Milo Gibaldi and Donald Perrier

16. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control, Second Edition, Revised and Expanded, Sidney H. Willig, Murray M. Tuckerman, and William S. Hitchings IV

17. Formulation of Veterinary Dosage Forms, edited by Jack Blodinger

18. Dermatological Formulations: Percutaneous Absorption, Brian W. Barry

19. The Clinical Research Process in the Pharmaceutical Industry, edited by Gary M. Matoren

20. Microencapsulation and Related Drug Processes, Patrick B. Deasy

21. Drugs and Nutrients: The Interactive Effects, edited by Daphne A. Roe and T. Colin Campbell

22. Biotechnology of Industrial Antibiotics, Erick J. Vandamme

23. Pharmaceutical Process Validation, edited by Bernard T. Loftus and Robert A. Nash

24. Anticancer and Interferon Agents: Synthesis and Properties, edited by Raphael M. Ottenbrite and George B. Butler

25. Pharmaceutical Statistics: Practical and Clinical Applications, Sanford Bolton

26. Drug Dynamics for Analytical, Clinical, and Biological Chemists, Benjamin J. Gudzinowicz, Burrows T. Younkin, Jr., and Michael J. Gudzinowicz

27. Modern Analysis of Antibiotics, edited by Adjoran Aszalos

28. Solubility and Related Properties, Kenneth C. James

29. Controlled Drug Delivery: Fundamentals and Applications, Second Edition, Revised and Expanded, edited by Joseph R. Robinson and

Vincent H. Lee

30. New Drug Approval Process: Clinical and Regulatory Management, edited by Richard A. Guarino

31. Transdermal Controlled Systemic Medications, edited by Yie W. Chien

32. Drug Delivery Devices: Fundamentals and Applications, edited by Praveen Tyle

33. Pharmacokinetics: Regulatory o Industrial o Academic Perspectives, edited by Peter G. Welling and Francis L. S. Tse

34. Clinical Drug Trials and Tribulations, edited by Allen E. Cato

35. Transdermal Drug Delivery: Developmental Issues and Research Initiatives, edited by Jonathan Hadgraft and Richard H. Guy

36. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, edited by James W. McGinity

37. Pharmaceutical Pelletization Technology, edited by Isaac Ghebre-Sellassie

38. Good Laboratory Practice Regulations, edited by Allen F. Hirsch

39. Nasal Systemic Drug Delivery, Yie W. Chien, Kenneth S. E. Su, and Shyi-Feu Chang

40. Modern Pharmaceutics: Second Edition, Revised and Expanded, edited by Gilbert S. Banker and Christopher T. Rhodes

41. Specialized Drug Delivery Systems: Manufacturing and Production Technology, edited by Praveen Tyle

42. Topical Drug Delivery Formulations, edited by David W. Osborne and Anton H. Amann

43. Drug Stability: Principles and Practices, Jens T. Carstensen

44. Pharmaceutical Statistics: Practical and Clinical Applications, Second Edition, Revised and Expanded, Sanford Bolton

45. Biodegradable Polymers as Drug Delivery Systems, edited by Mark Chasin and Robert Langer

46. Preclinical Drug Disposition: A Laboratory Handbook, Francis L. S. Tse and James J. Jaffe

47. HPLC in the Pharmaceutical Industry, edited by Godwin W. Fong and Stanley K. Lam

48. Pharmaceutical Bioequivalence, edited by Peter G. Welling, Francis L. S. Tse, and Shrikant V. Dinghe

49. Pharmaceutical Dissolution Testing, Umesh V. Banakar

50. Novel Drug Delivery Systems: Second Edition, Revised and Expanded, Yie W. Chien

51. Managing the Clinical Drug Development Process, David M. Cocchetto and Ronald V. Nardi

52. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control, Third Edition, edited by Sidney H. Willig and James

R. Stoker

53. Prodrugs: Topical and Ocular Drug Delivery, edited by Kenneth B. Sloan

54. Pharmaceutical Inhalation Aerosol Technology, edited by Anthony J. Hickey

55. Radiopharmaceuticals: Chemistry and Pharmacology, edited by Adrian D. Nunn

56. New Drug Approval Process: Second Edition, Revised and Expanded, edited by Richard A. Guarino

57. Pharmaceutical Process Validation: Second Edition, Revised and Expanded, edited by Ira R. Berry and Robert A. Nash

58. Ophthalmic Drug Delivery Systems, edited by Ashim K. Mitra

59. Pharmaceutical Skin Penetration Enhancement, edited by Kenneth A. Walters and Jonathan Hadgraft

60. Colonic Drug Absorption and Metabolism, edited by Peter R. Bieck

61. Pharmaceutical Particulate Carriers: Therapeutic Applications, edited by Alain Rolland

62. Drug Permeation Enhancement: Theory and Applications, edited by Dean S. Hsieh

63. Glycopeptide Antibiotics, edited by Ramakrishnan Nagarajan

64. Achieving Sterility in Medical and Pharmaceutical Products, Nigel A. Halls

65. Multiparticulate Oral Drug Delivery, edited by Isaac Ghebre-Sellassie

66. Colloidal Drug Delivery Systems, edited by Jorg Kreuter

67. Pharmacokinetics: Regulatory o Industrial o Academic Perspectives, Second Edition, edited by Peter G. Welling and Francis L. S. Tse

68. Drug Stability: Principles and Practices, Second Edition, Revised and Expanded, Jens T. Carstensen

69. Good Laboratory Practice Regulations: Second Edition, Revised and Expanded, edited by Sandy Weinberg

70. Physical Characterization of Pharmaceutical Solids, edited by Harry G. Brittain

71. Pharmaceutical Powder Compaction Technology, edited by Goran Alderborn and Christer Nystrom

72. Modern Pharmaceutics: Third Edition, Revised and Expanded, edited by Gilbert S. Banker and Christopher T. Rhodes

73. Microencapsulation: Methods and Industrial Applications, edited by Simon Benita

74. Oral Mucosal Drug Delivery, edited by Michael J. Rathbone

75. Clinical Research in Pharmaceutical Development, edited by Barry Bleidt and Michael Montagne

76. The Drug Development Process: Increasing Efficiency and Cost Effectiveness, edited by Peter G. Welling, Louis Lasagna, and Umesh V. Banakar

77. Microparticulate Systems for the Delivery of Proteins and Vaccines, edited by Smadar Cohen and Howard Bernstein

78. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control, Fourth Edition, Revised and Expanded, Sidney H. Willig and James R. Stoker

79. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms: Second Edition, Revised and Expanded, edited by James W. McGinity

80. Pharmaceutical Statistics: Practical and Clinical Applications, Third Edition, Sanford Bolton

81. Handbook of Pharmaceutical Granulation Technology, edited by Dilip M. Parikh

82. Biotechnology of Antibiotics: Second Edition, Revised and Expanded, edited by William R. Strohl

83. Mechanisms of Transdermal Drug Delivery, edited by Russell O. Potts and Richard H. Guy

84. Pharmaceutical Enzymes, edited by Albert Lauwers and Simon Scharpe

85. Development of Biopharmaceutical Parenteral Dosage Forms, edited by John A. Bontempo

86. Pharmaceutical Project Management, edited byTony Kennedy

87. Drug Products for Clinical Trials: An International Guide to Formulation Production o Quality Control, edited by Donald C. Monkhouse and Christopher T. Rhodes

88. Development and Formulation of Veterinary Dosage Forms: Second Edition, Revised and Expanded, edited by Gregory E. Hardee and J. Desmond Baggot

89. Receptor-Based Drug Design, edited by Paul Leff

90. Automation and Validation of Information in Pharmaceutical Processing, edited by Joseph F. deSpautz

91. Dermal Absorption and Toxicity Assessment, edited by Michael S. Roberts and Kenneth A. Walters

92. Pharmaceutical Experimental Design, Gareth A. Lewis, Didier Mathieu, and Roger Phan-Tan-Luu

93. Preparing for FDA Pre-Approval Inspections, edited by Martin D. Hynes III

94. Pharmaceutical Excipients: Characterization by IR, Raman, and NMR Spectroscopy, David E. Bugay and W. Paul Findlay

95. Polymorphism in Pharmaceutical Solids, edited by Harry G. Brittain

96. Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, edited by Louis Rey and Joan C.May

97. 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 Lehr

99. Protein Formulation and Delivery, edited by Eugene J. McNally

100. New Drug Approval Process: Third Edition, The Global Challenge, edited by Richard A. Guarino

101. Peptide and Protein Drug Analysis, edited by Ronald E. Reid

102. Transport Processes in Pharmaceutical Systems, edited by Gordon L. Amidon, Ping I. Lee, and Elizabeth M. Topp

103. Excipient Toxicity and Safety, edited by Myra L. Weiner and Lois A. Kotkoskie

104. The Clinical Audit in Pharmaceutical Development, edited by Michael R. Hamrell

105. Pharmaceutical Emulsions and Suspensions, edited by Francoise Nielloud and Gilberte Marti-Mestres

106. Oral Drug Absorption: Prediction and Assessment, edited by Jennifer B. Dressman and Hans Lennernas

107. Drug Stability: Principles and Practices, Third Edition, Revised and Expanded, edited by Jens T. Carstensen and C. T. Rhodes

108. Containment in the Pharmaceutical Industry, edited by James P. Wood

109. Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer, Fifth Edition, Revised and Expanded, Sidney H. Willig

110. Advanced Pharmaceutical Solids, Jens T. Carstensen

111. Endotoxins: Pyrogens, LAL Testing, and Depyrogenation, Second Edition, Revised and Expanded, Kevin L. Williams

112. Pharmaceutical Process Engineering, Anthony J. Hickey and David Ganderton

113. Pharmacogenomics, edited by Werner Kalow, Urs A. Meyer and Rachel F. Tyndale

114. Handbook of Drug Screening, edited by Ramakrishna Seethala and Prabhavathi B. Fernandes

115. Drug Targeting Technology: Physical o Chemical o Biological Methods, edited by Hans Schreier

116. Drug-Drug Interactions, edited by A. David Rodrigues

117. Handbook of Pharmaceutical Analysis, edited by Lena Ohannesian and Anthony J. Streeter

118. Pharmaceutical Process Scale-Up, edited by Michael Levin

119. Dermatological and Transdermal Formulations, edited by Kenneth A. Walters

120. Clinical Drug Trials and Tribulations: Second Edition, Revised and Expanded, edited by Allen Cato, Lynda Sutton, and Allen Cato III

121. Modern Pharmaceutics: Fourth Edition, Revised and Expanded, edited by Gilbert S. Banker and Christopher T. Rhodes

122. Surfactants and Polymers in Drug Delivery, Martin Malmsten

123. Transdermal Drug Delivery: Second Edition, Revised and Expanded, edited by Richard H. Guy and Jonathan Hadgraft

124. Good Laboratory Practice Regulations: Second Edition, Revised and Expanded, edited by Sandy Weinberg

125. Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing: Third Edition, Revised and Expanded, Michael J. Akers, Daniel S. Larrimore, and Dana Morton Guazzo

126. Modified-Release Drug Delivery Technology, edited by Michael J. Rathbone, Jonathan Hadgraft, and Michael S. Roberts

127. Simulation for Designing Clinical Trials:

A Pharmacokinetic-Pharmacodynamic Modeling Perspective, edited by Hui C. Kimko and Stephen B. Duffull

128. Affinity Capillary Electrophoresis in Pharmaceutics and Biopharmaceutics, editedby Reinhard H. H. Neubert and Hans-Hermann Ruttinger

129. Pharmaceutical Process Validation: An International Third Edition, Revised and Expanded, edited by Robert A. Nash and Alfred H. Wachter

130. Ophthalmic Drug Delivery Systems: Second Edition, Revised and Expanded, edited by Ashim K. Mitra

131. Pharmaceutical Gene Delivery Systems, edited by Alain Rolland and Sean M. Sullivan

132. Biomarkers in Clinical Drug Development, edited by John C. Bloom and Robert A. Dean

133. Pharmaceutical Extrusion Technology, edited by Isaac Ghebre-Sellassie and Charles Martin

134. Pharmaceutical Inhalation Aerosol Technology: Second Edition, Revised and Expanded, edited by Anthony J. Hickey

135. Pharmaceutical Statistics: Practical and Clinical Applications, Fourth Edition, Sanford Bolton and Charles Bon

136. Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics, edited by Carmen Medina

137. Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products: Second Edition, Revised and Expanded, edited by Louis Rey and

Joan C. May

138. Supercritical Fluid Technology for Drug Product Development, edited by Peter York, Uday B. Kompella, and Boris Y. Shekunov

139. New Drug Approval Process: Fourth Edition, Accelerating Global Registrations, edited by Richard A. Guarino

140. Microbial Contamination Control in Parenteral Manufacturing, edited by Kevin L. Williams

141. New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics, edited by Chandrahas G. Sahajwalla

142. Microbial Contamination Control in the Pharmaceutical Industry, edited by Luis Jimenez

143. Generic Drug Product Development: Solid Oral Dosage Forms, edited by Leon Shargel and Izzy Kanfer

144. Introduction to the Pharmaceutical Regulatory Process, edited by Ira R. Berry

145. Drug Delivery to the Oral Cavity: Molecules to Market, edited by Tapash K. Ghosh and William R. Pfister

146. Good Design Practices for GMP Pharmaceutical Facilities, edited by Andrew Signore and Terry Jacobs

147. Drug Products for Clinical Trials, Second Edition, edited by Donald Monkhouse, Charles Carney, and Jim Clark

148. Polymeric Drug Delivery Systems, edited by Glen S. Kwon

149. Injectable Dispersed Systems: Formulation, Processing, and Performance, edited by Diane J. Burgess

150. Laboratory Auditing for Quality and Regulatory Compliance, Donald Singer, Raluca-Ioana Stefan, and Jacobus van Staden

151. Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation, edited by Stanley Nusim

152. Preclinical Drug Development, edited by Mark C. Rogge and David R. Taft

153. Pharmaceutical Stress Testing: Predicting Drug Degradation, edited by Steven W. Baertschi

154. Handbook of Pharmaceutical Granulation Technology: Second Edition, edited by Dilip M. Parikh

155. Percutaneous Absorption: Drugs-Cosmetics-Mechanisms-Methodology, Fourth Edition, edited by Robert L. Bronaugh and Howard I. Maibach

156. Pharmacogenomics: Second Edition, edited by Werner Kalow, Urs A. Meyer and Rachel F. Tyndale

157. Pharmaceutical Process Scale-Up, Second Edition, edited by Michael Levin

158. Microencapsulation: Methods and Industrial Applications, Second Edition, edited by Simon Benita

159. Nanoparticle Technology for Drug Delivery, edited by Ram B. Gupta and Uday B. Kompella

160. Spectroscopy of Pharmaceutical Solids, edited by Harry G. Brittain

161. Dose Optimization in Drug Development, edited by Rajesh Krishna

162. Herbal Supplements-Drug Interactions: Scientific and

Regulatory Perspectives, edited by Y. W. Francis Lam, Shiew-Mei Huang, and Stephen D. Hall

163. Pharmaceutical Photostability and Stabilization Technology, edited by Joseph T.Piechocki and Karl Thoma

164. Environmental Monitoring for Cleanrooms and Controlled Environments, edited by Anne Marie Dixon

165. Pharmaceutical Product Development: In Vitro-In Vivo Correlation, edited by Dakshina Murthy Chilukuri, Gangadhar Sunkara, and David Young

166. Nanoparticulate Drug Delivery Systems, edited by Deepak Thassu, Michel Deleers, and Yashwant Pathak

167. Endotoxins: Pyrogens, LAL Testing and Depyrogenation, Third Edition, edited by Kevin L. Williams

168. Good Laboratory Practice Regulations, Fourth Edition, edited by Anne Sandy Weinberg

169. Good Manufacturing Practices for Pharmaceuticals, Sixth Edition, edited by Joseph D. Nally

170. Oral Lipid-based Formulations: Enhancing the Bioavailability of Poorly Water-soluble Drugs, edited by David J. Hauss

171. Handbook of Bioequivalence Testing, edited by Sarfaraz K. Niazi

172. Advanced Drug Formulation Design to Optimize Therapeutic Outcomes, edited by Robert O. Williams III, David R. Taft, and Jason T. McConville

Advanced Drug Formulation Design to Optimize Therapeutic Outcomes

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