Levin Pharmaceutical Process Scale-Up

Erscheinungsjahr 2001
ISBN: 978-0-8247-4196-9
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 584 Seiten

Reihe: Drugs and the Pharmaceutical Sciences

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.

Autoren/Hrsg.

Levin, Michael

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie Industrielle Biotechnologie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie Biotechnologie: Mikrotechnologie, Nanobiotechnologie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie Medizinische Biotechnologie
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie

Inhaltsverzeichnis

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