Oral Controlled Release Formulation Design and Drug Delivery

This book describes the theories, applications, and challenges for different oral controlled release formulations. This book differs from most in its focus on oral controlled release formulation design and process development. It also covers the related areas like preformulation, biopharmaceutics, in vitro-in vivo correlations (IVIVC), quality by design (QbD), and regulatory issues.

HONG WEN, PhD, is a Fellow and Project Leader in the Department of Pharmaceutical Development at Novartis, as well as a core member of the Novartis TRD S&T committee. He has contributed to dozens of INDs/IMPDs in addition to several approved NDAs. His expertise spans from discovery support and preformulation to late-phase development of solid dosage forms. He also specializes in bioavailability enhancement for water insoluble drugs, oral sustained release (SR) formulations, and combination products (FDC). He has written fifteen publications, six presentations, and eight patents in the drug delivery and controlled release fields.

KINAM PARK, PhD, is a Professor in the Department of Pharmaceutics and Showalter Distinguished Professor of Biomedical Engineering at Purdue University. He is also the President of Akina, Inc., specializing in drug delivery. Dr. Park is Editor-in-Chief of the Journal of Controlled Release among other journal and advisory board appointments. The recipient of the Controlled Release Society Founders Award in 2004, Dr. Park has published nine books, more than a hundred chapters, and more than two hundred journal articles, and holds sixteen patents.