Pharmaceutical Dosage Forms: Tablets, Third edition is a comprehensive treatment of the design, formulation, manufacture, and evaluation of the tablet dosage form.

Volume 3: Manufacture and Process Control ties the other volumes in the Third edition together to show how the information learned in the previous chapters fits together to make tablet on a commercial scale.

Features:

• addresses testing and evaluation of tablets, and setting up specification for manufacture
• focuses on new regulatory policies that address international harmonization
• proposes the use of modern process analyzers or process analytical chemistry tools to achieve real-time control and quality assurance during manufacturing

Contents

1. Tooling for Pharmaceutical Processing
2. Tablet Press Instrumentation in the Research and Development Environment
3. Pharmaceutical Manufacturing: Changes in Paradigms
4. A Forward-Looking Approach to Process Scale-Up for Solid Dose Manufacturing
5. Dissolution and Drug Release
6. Setting Dissolution Specifications
7. Mechanical Strength of Tablets
8. CGMPs for the 21st Century and ICH Quality Initiatives
9. Intellectual Property, Patent and Patenting Process in Pharmaceutical Industry
10. Near-Infrared Chemical Imaging of Pharmaceutical Oral Solid Dosage Forms
11. Surface Area, Porosity and Related Physical Characteristics

Index

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