Pharmaceutical Dosage Forms - Tablets: Manufacture and Process Control

ISBN-13: 9780849390166 / Angielski / Twarda / 2008 / 328 str.

Augsburger L. Augsburger; Larry L. Augsburger; Larry L. Augsburger

Opis

The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients. Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive treatment of the design, formulation, manufacture, and evaluation of the tablet dosage form. With over 700 illustrations, it guides pharmaceutical scientists and engineers through difficult and technical procedures in a simple easy-to-follow format. New to the Third Edition:

• developments in formulation science and technology
• changes in product regulation
• streamlined manufacturing processes for greater efficiency and productivity

Pharmaceutical Dosage Forms: Tablets, Volume Three examines:

• automation in tablet manufacture
• setting dissolution specifications
• testing and evaluating tablets
• specifications for manufacture
• new regulatory policies

Spis treści

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