Cover image for Pharmaceutical process scale-up
Title:
Pharmaceutical process scale-up
Series:
Drugs and pharmaceutical sciences 118
Publication Information:
New York : M Dekker, 2002
ISBN:
9780824706258
Added Author:

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Material Type
Item Category 1
Status
CEPP Resource Center 30000005206135 RS192 P464 2002 Open Access Book
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Summary

Summary

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.


Author Notes

Albert W. Alexander Department of Chemical and Biochemical Engineering, Rutgers University, Piscataway, New Jersey
Lawrence H. Block Division of Pharmaceutical Sciences, Duquesne University, Pittsburgh, Pennsylvania
Marco A. Cacciuttolo Cell Culture Development, Biopharmaceutical Production, Medarex, Inc., Bloomsbury, New Jersey
Adolfo L. Gomez I.D.E.A.S., Inc., Wilson, North Carolina
Igor Gorsky Department of Technical Services, Alpharma, Baltimore, Maryland
Ajaz S. Hussain Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland
Roy Kimura Onyx Pharmaceuticals, Inc., Richmond, California
Hans Leuenberger Institute of Pharmaceutical Technology, University of Basel, Switzerland
Michael Levin Metropolitan Computing Corporation, East Hanover, New Jersey
Fernando J. Muzzio Department of Chemical and Biochemical Engineering, Rutgers University, Piscataway, New Jersey
Cynthia Oliver Process Biochemistry, MedImmune, Inc., Gaithersburg, Maryland
Dilip M. Parikh APACE Pharma Inc., Westminster, Maryland
Stuart C. Porter Pharmaceutical Technologies International, Inc., Belle Mead, New Jersey
James K. Prescott Jenike & Johanson, Inc., Westford, Massachusetts
Joseph B. Schwartz Philadelphia College of Pharmacy, Philadelphia, Pennsylvania
Erica Shane Process Biochemistry, MedImmune, Inc., Gaithersburg, Maryland
Walter A. Strathy I.D.E.A.S., Inc., Wilson, North Carolina
Eric Tsao Process Cell Culture, MedImmune, Inc., Gaithersburg, Maryland
Marko Zlokarnik Graz, Austria


Table of Contents

Marko ZlokarnikIgor GorskyLawrence H. BlockMarco A. Cacciuttolo and Erica Shane and Roy Kimura and Cynthia Oliver and Eric TsaoAlbert W. Alexander and Fernando J. MuzzioJames K. PrescottHans LeuenbergerDilip M. ParikhJoseph B. SchwartzWalter A. Strathy and Adolfo L. GomezMichael Levin and Marko ZlokarnikStuart C. PorterAdolfo L. Gomez and Walter A. StrathyAjaz S. Hussain
Prefacep. v
Introductionp. vii
Contributorsp. xv
1. Dimensional Analysis and Scale-Up in Theory and Industrial Applicationp. 1
2. Parenteral Drug Scale-Upp. 43
3. Nonparenteral Liquids and Semisolidsp. 57
4. Scale-Up Considerations for Biotechnology-Derived Productsp. 95
5 (1). Batch Size Increase in Dry Blending and Mixingp. 115
5 (2). Powder Handlingp. 133
6. Scale-Up in the Field of Granulation and Dryingp. 151
7. Batch Size Increase in Fluid Bed Granulationp. 171
8 (1). Scale-Up of the Compaction and Tableting Processp. 221
8 (2). Practical Aspects of Tableting Scale-Upp. 239
8 (3). Dimensional Analysis of the Tableting Processp. 253
9. Scale-Up of Film Coatingp. 259
10. Engineering Aspects of Process Scale-Up and Pilot Plant Designp. 311
11. A Collaborative Search for Efficient Methods of Ensuring Unchanged Product Quality and Performance During Scale-Up of Immediate-Release Solid Oral Dosage Formsp. 325
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 Documentationp. 353
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 Documentationp. 373
C. SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms--Manufacturing Equipment Addendump. 415
D. Extended Release Oral Dosage Forms--Development, Evaluation, and Application of In Vitro/In Vivo Correlationsp. 447
E. Nonsterile Semisolid Dosage Forms--Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation SUPAC-SSp. 469
F. SUPAC-SS: Nonsterile Semisolid Dosage Forms--Manufacturing Equipment Addendump. 499
G. Changes to an Approved NDA or ANDAp. 517
H. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification Systemp. 551
Indexp. 565