Pharmaceutical Process Scale-Up

Voorkant
Michael Levin
CRC Press, 12 dec. 2001 - 584 pagina's
Focusing on scientific and practical aspects of process scale-up, this resource details the theory and practice of transferring pharmaceutical processes from laboratory scale to the pilot plant and production scale. It covers parenteral and nonparenterel liquids and semi-solids, products derived from biotechnology, dry blending and powder handling, granulation and drying, fluid bed applications, compaction and tableting, and film coating and regulatory requirements for scale-up and postapproval changes. Drawing on the experience of twenty contributing researchers, the book employs dimensional analysis as a unified scientific approach to quantify similar processes on different scales.
 

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Inhoudsopgave

Dimensional Analysis and ScaleUp in Theory and Industrial Application
1
Parenteral Drug ScaleUp
43
Nonparenteral Liquids and Semisolids
57
ScaleUp Considerations for BiotechnologyDerived Products
95
Batch Size Increase in Dry Blending and Mixing
115
Powder Handling
133
ScaleUp in the Field of Granulation and Drying
151
Batch Size Increase in Fluid Bed Granulation
171
Engineering Aspects of Process ScaleUp and Pilot Plant Design
311
A Collaborative Search for Efficient Methods of Ensuring Unchanged Product Quality and Performance During ScaleUp of Immediate Release Solid ...
325
Appendix A
353
Appendix B
373
Appendix C
415
Appendix D
447
Appendix E
469
Appendix F
499

ScaleUp of the Compaction and Tableting Process
221
Practical Aspects of Tableting ScaleUp
239
Dimensional Analysis of the Tableting Process
253
ScaleUp of Film Coating
259
Appendix G
517
Appendix H
551
Back Cover
565
Copyright

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Over de auteur (2001)

Michael Levin, born 1943, is lecturer of History of Art & Architecture, Holon Academic Institute of Technology, Arts & Sciences, Faculty of Architecture, Technion, Israel Institute of Technology, Haifa, & Bezalel Academy of Arts & Design, Jerusalem, Dept. of Industrial Design.

Bibliografische gegevens