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.
1. Dimensional Analysis and Scale-Up in Theory and Industrial Application
- Marko Zlokarnik (Graz, Austria)
2. Engineering Approaches for Pharmaceutical Process Scale-up, Validation, Optimization, and Control in the PAT Era - Fernando Muzzio (Rutgers University)
3. Understanding Scale Up and Quality Risks on the interface between Primary and Secondary Development - Frans L. Muller, Kathryn A. Gray and Graham E. Robinson (AstraZeneca)
4. Scale-up and Process Validation - Steven Ostrove (Ostrove Associates)
5. Parenteral Drug Scale-Up - Igor Gorsky (Shire)
6. Non-Parenteral Liquids and Semisolids - Lawrence H. Block (Duquesne University)
7. Scale-Up Considerations for Biotechnology-Derived Products - Marco A. Cacciuttolo, John Chon, Greg Zarbis-Papastoitsis (Percivia)
8. Powder Handling - James K. Prescott (Jenike & Johanson)
9-1. Batch Size Increase in Dry Blending and Mixing - Albert W. Alexander and Fernando J. Muzzio (Rutgers University)
9-2. Scale Up Of Continuous Blending - Aditya U. Vanarase, Yijie Gao, Atul Dubey, Marianthi G. Ierapetritou, and Fernando J. Muzzio (Rutgers University)
10. Scale-Up in the Field of Granulation and Drying - Hans Leuenberger (Ifiip GmbH) and Gabriele Betz (University of Basel)
11. Batch Size Increase in Fluid Bed Granulation - Dilip M. Parikh (DPharma Group
12. Roller Compaction Scale-Up - Ronald Miller (Miller Pharmaceutical Technology Consulting)
13. Scale-Up of Extrusion and Spheronization - Raman Iyer, Harpreet K. Sandhu and Navnit Shah (Hoffman-LaRoche
14-1. Scale-Up of Compaction and the Tableting Process - Matthew P. Mullarney and Jeffrey Moriarty (Pfizer)
14-2. Dimensional Analysis of the Tableting Process - Michael Levin (Milev Pharmaceutical Technology Consulting) and Marko Zlokarnik (Graz, Austria)
15. Practical Considerations in the Scale-Up of Powder-Filled Hard Shell Capsule Formulations - Larry Augsburger (University of Maryland)
16. Scale-Up of the Film-Coating - Stuart Porter (International Specialty Products)
17. Virtual scale-up of manufacturing solid dosage forms - Hans Leuenberger (Ifiip GmbH), Michael N. Leuenberger (2AMIFICAS, Inc.) and Maxim Puchkov (CINCAP GmbH)
Appendix A: Relevant FDA Guidance for Industry – Internet link addresses
Appendix B: Relevant EU Directives, Regulations, and Gudelines – Internet link addresses
Appendix C: Relevant ICH Documents - International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use – Internet link addresses
Michael Levin has over 25 years of experience in the field of pharmaceutical scale-up, instrumentation and process optimization. He currently runs his own company Milev Pharmaceutical Technology Consulting. A former teacher of courses on wet granulation and tableting. Mike has a PhD. in BioMathematics (1980) from the University of Washington in Seattle and completed his Post Doctorate at the University of Houston, Department of Mechanical Engineering.