Developing Solid Oral Dosage Forms: Pharmaceutical Theory & Practice

by Yihong Qiu

"This unique reference provides systematic coverage of the fundamental pharmaceutical theories, and the most updated technologies and practices essential to the rational development of solid oral dosage forms." "Building on the basic principles of physical pharmacy, biopharmaceutics and industrial pharmacy, this book delves into the application of these principles to every stage of dosage form development, from drug molecules to commercial products. Topics covered range from physicochemical, mechanical and biopharmaceutical characterization of APIs, excipients and formulations; design, development, scale-up and optimization of dosage forms and manufacturing processes to in vitro dissolution, oral absorption, IVIVC and in vivo evaluations. Regulatory and registration requirements, intellectual property, and management of product development and lifecycle are discussed as well." This is the first comprehensive book that encompasses scientific principles, the state of the art developments of various techniques, approaches and practices as applied to product and process understanding for ensuring product quality objectives under the new paradigm of pharmaceutical quality by design (QbD). This book will be an important reference for professionals engaged in all facets of drug product development including preformulation, formulation, manufacturing, regulation and intellectual property as well as for graduate level courses.

Hardcover

First published December 1, 2008