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.
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
Frans L. Muller, Kathryn A. Gray, and Graham E. Robinson
Scale-up and Process Validation
Parenteral Drug Scale-Up
Non-Parenteral Liquids and Semisolids
Lawrence H. Block
Scale-Up Considerations for Biotechnology-Derived Products
Marco A. Cacciuttolo, John Chon, and Greg Zarbis-Papastoitsis
James K. Prescott
Batch Size Increase in Dry Blending and Mixing
Albert W. Alexander and Fernando J. Muzzio
Scale Up Of Continuous Blending
Aditya U. Vanarase, Yijie Gao, Atul Dubey, Marianthi G. Ierapetritou, and Fernando J. Muzzio
Scale-Up in the Field of Granulation and Drying
Hans Leuenberger and Gabriele Betz
Batch Size Increase in Fluid Bed Granulation
Dilip M. Parikh
Roller Compaction Scale-Up
Scale-Up of Extrusion and Spheronization
Raman Iyer, Harpreet K. Sandhu and Navnit Shah
Scale-Up of Compaction and the Tableting Process
Matthew P. Mullarney and Jeffrey Moriarty
Dimensional Analysis of the Tableting Process
Michael Levin and Marko Zlokarnik
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
Hans Leuenberger, Michael N. Leuenberger, and Maxim Puchkov
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
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"