Pharmaceutical Process Scale-Up spans the latest research and regulations, technologies, and expert solutions for every significant aspect of pharmaceutical process scale-up.

Features:

• Contains practical trade secrets and hands-on recommendations from seasoned professionals in the field
• Provides completely revised chapters on scale-up theory and the scale-up of parenteral drugs, liquids, and semi-solids; biotechnology products; blending and mixing; granulation and drying; tableting; and FDA perspectives
• Contains entirely new sections on roller compaction, extrusion and spheronizing, encapsulation, and PAT aspects of scale-up engineering
• Addresses the regulatory aspects of scale-up and post-approval changes and lists all references relating to FDA regulations
• Concentrates on the theory and practice of transferring pharmaceutical processes from laboratory scale to the pilot plant and production scale
• Focuses on new directions in industry-showcasing the increasing emphasis on SUPAC and PAT guidelines

Contents

• Dimensional Analysis and Scale-Up in Theory and Industrial Application
• Engineering Approaches for Pharmaceutical Process Scale-up, Validation, Optimization, and Control in the PAT Era
• Parenteral Drug Scale-Up
• Non-Parenteral Liquids and Semi-Solids
• Scale-Up Considerations for Biotechnology Derived Products
• Batch Size Increase in Dry Blending and Mixing
• Batch Size Increase and: Powder Handling
• Scale-Up in the Field of Granulation and Drying
• Scale-Up of Roller Compaction Process
• Batch Size Increase in Fluid Bed Granulation
• Scale-Up of Extrusion and Spheronizing
• Scale-Up of Compaction and Tableting Process
• Practical Considerations in the Scale Up of Powder-Filled Hard Shell Capsule Formulations
• Scale-Up of the Film-Coating Process
• Innovation and Continuous Improvement in Pharmaceutical Manufacturing

Index

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