Developing Solid Oral Dosage Forms: Pharmaceutical Theory & Practice

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This book is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with:

Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms

Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies

New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development

The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards

It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter

A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

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Product Details

  • ISBN-13: 9780444532428
  • Publisher: Elsevier Science
  • Publication date: 12/19/2008
  • Pages: 978
  • Sales rank: 1,103,523
  • Product dimensions: 8.70 (w) x 10.90 (h) x 1.60 (d)

Table of Contents

Ch 1 Solubility of Pharmaceutical Solids
Ch 2 Crystalline and Amorphous Solids
Ch 3 Analytical Techniques in Solid State Characterization
Ch 4 Salt Screening and Selection: New Challenges and Considerations in the Modern Pharmaceutical R&D Paradigm
Ch 5 Drug Stability and Stability Studies
Ch 6 Excipient Compatibility
Ch 7 Theory of Diffusion and Pharmaceutical Applications
Ch 8 Particle, Powder and Compact Characterization
Ch 9 Polymer Properties and Characterization
Ch 10 Applied Statistics in Product Development
Ch 11 Oral Absorption Basics: Pathways, Physicochemical and Biological Factors, and Methods of Study
Ch 12 Oral Absorption Evaluation and Prediction
Ch 13 Fundamentals of Dissolution
Ch 14 Dissolution Testing of Solid Products
Ch 15 Bioavailability and Bioequivalence
Ch 16 In Vivo Evaluation of Dosage Form Performance
Ch 17 In Vitro-In Vivo Correlations: Fundamentals, Applications and Development Considerations
Ch 18 Integration of physical, chemical, mechanical and biopharmaceutical properties in solid oral dosage form development
Ch 19 Design and Development of Self-Emulsifying Drug Delivery Systems for Enhanced Oral Absorption of Poorly Soluble Compounds
Ch 20 Rational Design of Oral Modified-Release Drug Delivery Systems
Ch 21 Development of Modified-Releas Oral Dosage Forms
Ch 22 Analytical Development and Validation for Solid Oral Dosage Forms
Ch 23 Statistical Design and Analysis of Long Term Stabilty Studies for Drug Products
Ch 24 Packaging selection for solid dosage forms
Ch 25 Clincial Supplies Manufacture
Ch 26 Specification Setting and Manufacturing Process Control for Solid Oral Drug Products
Ch 27 Scale-Up Of Pharmaceutical Manufacturing Operation of Solid Dosage Forms
Ch 28 Process Development, Optimization and Scale-Up: Powder Handling and Segregation Concerns
Ch 29 Process Development and Scale-Up of Wet Granulation by High-Shear Process
Ch 30 Development,Scale-Up and Optimization of Fluid-bed Granulation
Ch 31 Development, Optimization and Scale-Up of Process Parameters: Roller Compaction
Ch 32 Development, Optimization And Scale-Up Of Process Parameters: Compression
Ch 33 Development, Optimization & Scale-Up of Process Parameters: Pan Coating
Ch 34 Development, Optimization And Scale-Up Of Process Parameters: Wurster Coating
Ch 35 Process Analytical Technology
Ch 36 The Product Development Process
Ch 37 Product Registration and Drug Approval Process
Ch 38 Modern Pharmaceutical Development Regulations
Ch 39 Intellectual Property in Pharmaceutical Development
Ch 40 Product Life-Cycle Management

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  • Posted March 5, 2009


    This is a great book that provides both basic theories and practical aspects of developing solid products. It is an "all-in-one" book covering all essential topics including preformulation, biopharmaceutics, formulation and process, scale-up and all the way to regulatory submission of drug product. The book also contains many useful references and good case studies. Its content is organized logically and flows very well. I would definitely recommend this book to anyone in the field of product development who has a keen interest in applying science and systematic approach in his or her work. Last, but not the least, for an all-inclusive 1000-page long book, you can't beat its price!

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  • Posted February 28, 2009

    Must read for pharmaceutical scientists

    This book integrates all relevant aspects for the development of solid pharmaceutical products for human use. It covers in depth the entire spectrum of solid product development from preformulation, formulation, process development and validation, clinical study, regulatory registration, intellectual property, and product life cycle management. It discusses and presents the science supporting the routine works in each area, providing examples for quality by design of pharmaceutical products, and fills the gaps between the current regulatory requirements and the industrial practice. The book is written for practical use without compromising the scientific contents. It is a very useful reference for students and professionals in the field of pharmaceutical science, and for regulatory staff of government agency for drug administration. It can be used as guides for development scientists to develop safe, effective and high quality products for human use.

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