Pharmaceutical Dosage Forms: Tablets, Third Edition (Volume 3) Manufacture and Process Control

"Pharmaceutical Dosage Forms: Tablets, Third Edition"is acomprehensive treatment of the design, formulation, manufacture, and evaluation of the tablet dosage form. "Volume 3" 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.

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

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.

LARRY L. AUGSBURGER is Professor Emeritus, University of Maryland School of Pharmacy, Baltimore, and a member of the Scientific Advisory Committee, International Pharmaceutical Excipients Council of the Americas (IPEC). Dr. Augsburger received his Ph.D. in Pharmaceutical Science from the University of Maryland, Baltimore. The focus of his research covers the design and optimization of immediate release and extended release oral solid dosage forms, the instrumentation of automatic capsule filling machines, tablet presses and other pharmaceutical processing equipment, and the product quality and performance of nutraceuticals (dietary supplements). Dr. Augsburger has also published over 115 papers and three books, including Pharmaceutical Excipients Towards the 21st Century published by Informa Healthcare. STEPHEN W. HOAG is Associate Professor, School of Pharmacy, University of Maryland, Baltimore. Dr. Hoag received his Ph.D. in Pharmaceutical Science from the University of Minnesota, Minneapolis. The focus of his research covers Tablet Formulation and Material, Characterization, Process Analytical Technology (PAT), Near Infrared (NIR) Analysis of Solid Oral Dosage Forms, Controlled Release Polymer Characterization, Powder Flow, Thermal Analysis of Polymers, Mass Transfer and Controlled Release Gels. Dr. Hoag has also published over 40 papers, has licensed four patents, and has written more than five books, including Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, Third Edition and Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems, both published by Informa Healthcare.