Pharmaceutical Process Scale-Up
Published on 15. January 2002
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584 pages
978-0-203-90821-1 (ISBN)
Description
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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Michael Levin
Pharmaceutical Process Scale-Up
Book
12/2001
1st Edition
Marcel Dekker Inc
€152.27
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Content
Dimensional Analysis and Scale-Up in Theory and Industrial Application, M. Zlokarnik
Parenteral Drug Scale-Up, I. Gorsky
Nonparenteral Liquids and Semisolids. L. Block
Scale-Up Considerations for Biotechnology-Derived Products, M.A. Cacciuttolo, E. Shane, R. Kimura, C. Oliver, and E. Tsao
Batch Size Increase in Dry Blending and Mixing, A.W. Alexander and F.J. Muzzio
Powder Handling, J.K. Prescott
Scale-Up in the Field of Granulation and Drying, H. Leuenberger
Batch Size Increase in Fluid Bed Granulation, D.M. Parikh
Scale-Up of the Compaction and Tableting Process, J.B. Schwartz
Practical Aspects of Tableting Scale-Up, W.A. Strathy and A.L. Gomez
Dimensional Analysis of the Tableting Process, M. Levin and M. Zlokarnik
Scale-Up of Film Coating, S.C. Porter
Engineering Aspects of Process Scale-Up and Pilot Plant Design, A.L. Gomez and W.A. Strathy
A Collaborative Search for Efficient Methods of Ensuring Unchanged Product Quality and Performance During Scale-Up of Immediate Release Solid Oral Dosage Forms, A.S. Hussain
APPENDIXES: GUIDANCE FOR INDUSTRY
A. Immediate Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
B. SUPAC-MR: Modified Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation
C. SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum
D. Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations
E. Nonsterile Semisolid Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation SUPAC-SS
F. SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum
G. Changes to an Approved NDA or ANDA
H. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
Index
Parenteral Drug Scale-Up, I. Gorsky
Nonparenteral Liquids and Semisolids. L. Block
Scale-Up Considerations for Biotechnology-Derived Products, M.A. Cacciuttolo, E. Shane, R. Kimura, C. Oliver, and E. Tsao
Batch Size Increase in Dry Blending and Mixing, A.W. Alexander and F.J. Muzzio
Powder Handling, J.K. Prescott
Scale-Up in the Field of Granulation and Drying, H. Leuenberger
Batch Size Increase in Fluid Bed Granulation, D.M. Parikh
Scale-Up of the Compaction and Tableting Process, J.B. Schwartz
Practical Aspects of Tableting Scale-Up, W.A. Strathy and A.L. Gomez
Dimensional Analysis of the Tableting Process, M. Levin and M. Zlokarnik
Scale-Up of Film Coating, S.C. Porter
Engineering Aspects of Process Scale-Up and Pilot Plant Design, A.L. Gomez and W.A. Strathy
A Collaborative Search for Efficient Methods of Ensuring Unchanged Product Quality and Performance During Scale-Up of Immediate Release Solid Oral Dosage Forms, A.S. Hussain
APPENDIXES: GUIDANCE FOR INDUSTRY
A. Immediate Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
B. SUPAC-MR: Modified Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation
C. SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum
D. Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations
E. Nonsterile Semisolid Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation SUPAC-SS
F. SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum
G. Changes to an Approved NDA or ANDA
H. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System
Index