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,
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ISBN-13
978-0-8247-4196-9 (9780824741969)
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Schweitzer Klassifikation
Dimensional Analysis and Scale-Up in Theory and Industrial Application. Parenteral Drug Scale-Up. Nonparenteral Liquids and Semisolids. Scale-Up Considerations for Biotechnology-Derived Products. Batch Size Increase in Dry Blending and Mixing. Powder Handling. Scale-Up in the Field of Granulation and Drying. Batch Size Increase in Fluid Bed Granulation. Scale-Up of the Compaction and Tableting Process. Practical Aspects of Tableting Scale-Up. Dimensional Analysis of the Tableting Process. Scale-Up of Film Coating. Engineering Aspects of Process Scale-Up and Pilot Plant Design. A Collaborative Search for Efficient Methods of Ensuring Unchanged Product Quality and Performance During Scale-Up of Immediate Release Solid Oral Dosage Forms. APPENDIXES: GUIDANCE FOR INDUSTRY. Index.