Pharmaceutical Process Scale-Up / Edition 3

by Michael Levin

Overview

The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes:

• New material on tableting scale-up and compaction.
• Regulatory appendices that cover FDA and EU Guidelines.
• New chapters on risk evaluation and validation as related to scale-up.
• Practical advice on scale-up solutions from world renowned experts in the field.

Pharmaceutical Process Scale-Up, Third Edition will provide an excellent insight in to the practical aspects of the process scale-up and will be an invaluable source of information on batch enlargement techniques for formulators, process engineers, validation specialists and quality assurance personnel, as well as production managers. It will also provide interesting reading material for anyone involved in Process Analytical Technology (PAT), technology transfer and product globalization.

Product Details

ISBN-13:	9781616310011
Publisher:	Taylor & Francis
Publication date:	02/02/2011
Series:	Drugs and the Pharmaceutical Sciences
Edition description:	3rd ed.
Pages:	548
Product dimensions:	6.10(w) x 9.00(h) x 1.40(d)

About the Author

Levin, Michael

Table of Contents

Dimensional Analysis and Scale-Up in Theory and Industrial Application. Engineering Approaches for Pharmaceutical Process Scale-up, Validation, Optimization, and Control in the PAT Era. Understanding Scale Up and Quality Risks on the interface between Primary and Secondary Development. Scale-up and Process Validation. Parenteral Drug Scale-Up. Non-Parenteral Liquids and Semisolids. Scale-Up Considerations for Biotechnology-Derived Products. Powder Handling. Batch Size Increase in Dry Blending and Mixing . Scale Up Of Continuous Blending. Scale-Up in the Field of Granulation and Drying. Batch Size Increase in Fluid Bed Granulation. Roller Compaction Scale-Up. Scale-Up of Extrusion and Spheronization. Scale-Up of Compaction and the Tableting Process. Dimensional Analysis of the Tableting Process. Practical Considerations in the Scale-Up of Powder-Filled Hard Shell Capsule Formulations. Scale-Up of the Film-Coating. Virtual scale-up of manufacturing solid dosage forms. Appendix A: Relevant FDA Guidance for Industry. Appendix B: Relevant EU Directives, Regulations, and Gudelines . Appendix C: Relevant ICH Documents - International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use. Internet link addresses.

Editorial Reviews

Praise for the Previous Edition

"…the text include[s] comprehensive coverage of many of the significant aspects of pharmaceutical scale-up, realistic case studies for nearly each process, and extensive reference lists"
—Pharmaceutical Research

From the Publisher