Catalogue


Formulation and analytical development for low-dose oral drug products [electronic resource] /
edited by Jack Zheng.
imprint
Hoboken, N.J. : John Wiley & Sons, c2009.
description
xxiii, 461 p. : ill. ; 25 cm.
ISBN
0470056096 (cloth), 9780470056097 (cloth)
format(s)
Book
More Details
added author
imprint
Hoboken, N.J. : John Wiley & Sons, c2009.
isbn
0470056096 (cloth)
9780470056097 (cloth)
restrictions
Licensed for access by U. of T. users.
contents note
An overview / Jack Y. Zheng -- Challenges and strategies in formulation development of oral solid low-dose drug products / Jack Y. Zheng -- Particle size of drug substance and product content uniformity: theoretical considerations / Kevin C. Johnson -- Development of low-dose formulations using fluidized bed granulation / J. Joe Zhou, and Ralph Lipp -- Development of low-dose solid oral formulations using wet granulation / Ahmad Almaya -- Challenges in development and scale-up of low dose drug products by dry granulation: a case study / Mary T. Am Ende ... [et al.] -- Development of low-dose solid oral tablets using direct compression / Jack Y. Zheng and Robert L. Ternik -- Reduction of particle size of drug substance for low-dose drug products / Christopher L. Burcham ... [et al.] -- Function, quality, and regulations of pharmaceutical excipients for oral solid dosage forms / Jack Y. Zheng --
Analytical method development: challenges and solutions for low-dose oral dosage forms / Beverly Nickerson ... [et al.] -- In vitro dissolution testing and method development / Vivian A. Gray, Jack Y. Zheng, and Norman N. Sesi -- Analysis of physical transformation of API during manufacture and storage / Gregory A. Stephenson -- Physical characterization tests for drug substances used in low-dose formulations / Ronald G. Lacocca -- An excipient library approach to analytical development for low-dose, solid oral dosage form drug products / Qing Chang ... [et al.] -- Cleaning verification for highly potent compounds / Brian W. Pack -- Containment challenges and strategies for potent compounds in the pharmaceutical industry / Victoria Cathcart, Sarah Jones, Beverly Nickerson -- Sample handling and containment in analytical testing laboratories / David Pattavina, Nancy Sage, Beverly Nickerson -- Regulatory considerations in the development of low-dose solid oral drug products / Ravi S. Harapanhalli.
catalogue key
7924029
 
Includes bibliographical references and index.
A Look Inside
About the Author
Author Affiliation
Jack Zheng, PhD, is Research Advisor and Team Leader in the Pharmaceutical Sciences RD Division of Eli Lilly and Company and Adjunct Professor at Beijing University. Dr. Zheng is the author of more than thirty articles and several book chapters. He has been invited to present his work at numerous national and international scientific meetings. He was involved in more than ten new drug product development and regulatory filing with the Food and Drug Administration.
Reviews
This item was reviewed in:
Doody's Reviews, August 2009
To find out how to look for other reviews, please see our guides to finding book reviews in the Sciences or Social Sciences and Humanities.
Summaries
Back Cover Copy
Tested-and-proven strategies for developing and manufacturing low-dose oral drug products Developing and commercializing a low-dose oral drug product presents a number of hurdles that can quickly offset the drug's benefits. Written by a team of leading scientists in drug development, this book collects and synthesizes the knowledge, techniques, and strategies needed for developing low-dose drugs successfully. With this book's practical support, readers can overcome the hurdles at all stages in drug development, from formulation to manufacturing and control to regulatory compliance. Following an overview of the drug discovery and development process, the book is divided into four parts: Part One examines formulation and process development of low-dose drugs, including theoretical considerations concerning the particle size of the drug substance and content uniformity, micronization of the drug substance, and manufacturing platform technologies. Part Two focuses on challenges in analytical method development, including analytical control strategy, physical characterization of the micronized powder and the solid state of the active pharmaceutical ingredient in dosage forms, and cleaning verification of manufacturing equipment. Part Three investigates containment technologies used in analytical laboratories and manufacturing plants. Part Four deals with important regulatory considerations. Readers learn how a variety of analytical methodologies are used in low-dose drug development, including dissolution testing, NMR, HPLC, and X-ray diffraction. Moreover, the book explains several possible manufacturing techniques, such as wet granulation, roller compaction, and direct compression alongside containment technologies for highly potent drugs. Case studies throughout the book demonstrate how particular strategies and techniques are applied in practice. Pharmaceutical scientists as well as students will find overcoming the obstacles in developing low-dose drug products much easier when they have this book on hand to consult at all stages in the drug development and manufacturing process.
Back Cover Copy
Tested-and-proven strategies for developing and manufacturing low-dose oral drug productsDeveloping and commercializing a low-dose oral drug product presents a number of hurdles that can quickly offset the drug's benefits. Written by a team of leading scientists in drug development, this book collects and synthesizes the knowledge, techniques, and strategies needed for developing low-dose drugs successfully. With this book's practical support, readers can overcome the hurdles at all stages in drug development, from formulation to manufacturing and control to regulatory compliance.Following an overview of the drug discovery and development process, the book is divided into four parts:Part One examines formulation and process development of low-dose drugs, including theoretical considerations concerning the particle size of the drug substance and content uniformity, micronization of the drug substance, and manufacturing platform technologies.Part Two focuses on challenges in analytical method development, including analytical control strategy, physical characterization of the micronized powder and the solid state of the active pharmaceutical ingredient in dosage forms, and cleaning verification of manufacturing equipment.Part Three investigates containment technologies used in analytical laboratories and manufacturing plants.Part Four deals with important regulatory considerations.Readers learn how a variety of analytical methodologies are used in low-dose drug development, including dissolution testing, NMR, HPLC, and X-ray diffraction. Moreover, the book explains several possible manufacturing techniques, such as wet granulation, roller compaction, and direct compression alongside containment technologies for highly potent drugs. Case studies throughout the book demonstrate how particular strategies and techniques are applied in practice.Pharmaceutical scientists as well as students will find overcoming the obstacles in developing low-dose drug products much easier when they have this book on hand to consult at all stages in the drug development and manufacturing process.
Bowker Data Service Summary
There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialised field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book.
Main Description
There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.
Table of Contents
Prefacep. xv
Forewordp. xix
Contributorsp. xxi
An Overviewp. 1
The Drug Discovery and Development Processp. 2
Challenges and Strategies in Development of Low-Dose Drug Productsp. 10
Summaryp. 20
Acknowledgmentsp. 20
Referencesp. 20
Challenges and Strategies in Formulation Development of Oral Low-Dose Drug Productsp. 23
Challenges and Strategies in Formulation Development of Oral Solid Low-Dose Drug Productsp. 25
Introductionp. 25
Current Regulatory Environment and its Impact on New Drug Product Developmentp. 28
Challenges in Developing Low-Dose Formulationsp. 31
Manufacturing Platforms for Low-Dose Drug Productsp. 38
Use of Experimental Design in Formulation and Process Developmentp. 42
Containmentsp. 44
Summaryp. 45
Acknowledgmentsp. 46
Referencesp. 46
Particle Size of Drug Substance and Product Content Uniformity - Theoretical Considerationsp. 49
Introductionp. 49
Concept of Ideal Mixingp. 50
Ideal Mixing Model Comparison with the Yalkowsky and Bolton Approachp. 56
Experimental Support of Model Assumptionsp. 59
Analytical and Practical Considerationsp. 61
Referencesp. 62
Development of Low-Dose Formulations Using Fluidized Bed Granulationp. 63
Introductionp. 63
Granulation Fundamentalsp. 66
Theory of Fluidizationp. 68
Formulation Developmentp. 72
Process Developmentp. 77
Summaryp. 86
Referencesp. 86
Development of Low-Dose Solid Oral Formulations Using Wet Granulationp. 89
Introductionp. 89
Granulation Mechanismsp. 91
General Considerations on Wet Granulationp. 93
Advantages and Disadvantages of Wet Granulationp. 100
Use of Wet Granulation for Low-Dose Formulationsp. 101
Process-Induced Form Changes in Wet Granulationp. 109
Concluding Remarksp. 111
Referencesp. 112
Challenges in Development and Scale-Up of Low-Dose Drug Products by Dry Granulation: A Case Studyp. 117
Introductionp. 117
Dry Granulation Process-Pros and Consp. 118
Overview of Dry Granulation Processes and Equipment Designp. 119
Challenges for Low-Dose Product Development and their Assessment Methodsp. 125
Case Study: Formulation Challenges for Low-Dose Productsp. 128
Process Challenges During Dry Granulation Optimization for Low-Dose Productsp. 140
Conclusionsp. 154
Acknowledgmentsp. 155
Referencesp. 155
Development of Low-Dose Solid Oral Tablets Using Direct Compressionp. 159
Introductionp. 159
Advantages of Direct Compressionp. 160
Challenges in Low-Dose Tablet Development Using Direct Compressionp. 162
Formulation Development for Low-Dose Drug Products Using Direct Compressionp. 169
Manufacturing Process Development for Low-Dose Drug Productsp. 187
Scale-Up for Blending Operationp. 196
Formulation Examples for Direct Compressionp. 197
Conclusionsp. 199
Acknowledgmentsp. 199
Referencesp. 200
Reduction of Particle Size of Drug Substance for Low-Dose Drug Productsp. 205
Introductionp. 205
Reduction of Particle Size of Drug Substance by Milling Technologiesp. 207
Reduction of Particle Size of Drug Substance Using Crystallization Technologiesp. 216
Scale-Up Considerationsp. 218
Emerging Technologies and Future Directionsp. 219
Acknowledgmentsp. 219
Referencesp. 219
Function, Quality, and Regulations of Pharmaceutical Excipients for Oral Solid Dosage Formsp. 223
Introductionp. 223
Classification of Pharmaceutical Excipients in Solid Dosage Formsp. 224
Physicochemical Attributes of Pharmaceutical Excipientsp. 225
Regulatory Status and Excipient Qualityp. 228
Summaryp. 235
Acknowledgmentsp. 235
Referencesp. 236
Challenges in Analytical Method Development for Oral Low-Dose Drug Productsp. 239
Analytical Method Development: Challenges and Solutions for Low-Dose Oral Dosage Formsp. 241
Introductionp. 241
Case Study 1: Drug Adsorption to Surfacesp. 242
Case Study 2: Challenges Due to Nondrug-Related Impuritiesp. 245
Case Study 3: HPLC Purity Method Development Challenges for a Fixed Combination Product Containing a Low-Dose Active Ingredient and a High-Dose Active Ingredientp. 250
Case Study 4: Small Volume Dissolution Testingp. 255
Summaryp. 261
Acknowledgmentsp. 261
Referencesp. 261
In Vitro Dissolution Testing and Method Developmentp. 265
Introductionp. 265
Overview of Dissolution Testingp. 265
Dissolution Method Developmentp. 271
Dissolution Method Development for Low-Dose Oral Drug Productsp. 275
Summaryp. 279
Referencesp. 280
Analysis of Physical Transformation of Api During Manufacture and Storagep. 283
Introductionp. 283
Discussion of Solid-State Formsp. 284
Monitoring Processing Stepsp. 285
Measuring Transitions and Solid-Form Transformations in the Low-Dose Tabletp. 287
Common Methods Used for Examination of Solid Formsp. 289
Conclusionsp. 305
Referencesp. 306
Physical Characterization Tests for Drug Substances Used in Low-Dose Formulationsp. 309
General Issues in the Physical Characterization of Micronized Powders Used in Low-Dose Formulationsp. 309
Particle Size Analysisp. 309
Specific Surface Area Analysisp. 320
Summaryp. 323
Referencesp. 323
An Excipient Library Approach to Analytical Development for Low-Dose, Solid Oral Dosage form Drug Productsp. 327
Introductionp. 327
Importance of Excipient Absorbance Background to Low-Dose Impurity Analysisp. 328
Factors Affecting Excipient Absorbance Backgroundp. 332
Use of Excipient Libraryp. 339
Conclusionsp. 341
Acknowledgmentsp. 341
Referencesp. 342
Cleaning Verification for Highly Potent Compoundsp. 345
Introductionp. 345
Cleaning Validation vs Cleaning Verificationp. 346
Acceptance Limit Calculationsp. 347
Analytical Method Validationp. 352
General Analytical Techniquesp. 361
Analytical Techniques for Low-Dose Compoundsp. 364
Conclusionsp. 376
Acknowledgmentsp. 377
Referencesp. 377
Containment Techniques for Highly Potent Pharmaceutical Compoundsp. 381
Containment Challenges and Strategies for Potent Compounds in the Pharmaceutical Industryp. 383
Introductionp. 383
Safe Exposure Control Levels-Bands, Limits, and Handling Guidancep. 384
The Hierarchy of Workplace Controlsp. 389
Case Studiesp. 397
Summaryp. 403
Acknowledgmentsp. 403
Referencesp. 403
Sample Handling and Containment in Analytical Testing Laboratoriesp. 405
Introductionp. 405
Sample Handling Considerationsp. 406
Handling Potent Compounds in Standard Analytical Laboratoriesp. 407
Handling Potent Compounds in a Containment Laboratoryp. 411
Additional Considerations for Handling Potent Materialsp. 426
Summaryp. 427
Acknowledgmentsp. 428
Referencesp. 428
Regulatory Considerations in the Development of Low-Dose Drug Productsp. 429
Regulatory Considerations in the Development of Low-Dose Solid Oral Drug Productsp. 431
Introduction and Overviewp. 431
Three-Pronged Approach to Low-Dose Formulationsp. 433
Pharmaceutical Development Reportp. 434
Facility Cosntrols for Highly Potent Drugsp. 451
Conclusionp. 452
Referencesp. 453
Indexp. 455
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