Oral Controlled Release Formulation Design

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.

Preface
Introduction and Overview of Oral Controlled Release Formulation Design
Evolution of Oral Controlled Release Dosage Forms
Biopharmaceutic Consideration and Assessment for Oral Controlled Release (CR) Formulations
Preformulation Consideration for Drugs in Oral CR Formulation
Polymers used in Oral Modified Release Systems
Oral Extended Release Hydrophilic Matrices: Formulation and Design
Coating Systems for Oral Controlled-Release Formulations
Fluid Bed Coating and Granulation for CR Delivery
Controlled Release using Bilayer Osmotic Tablet Technology: Reducing Theory to Practice
Fast Disintegrating Tablets
Buccal Drug Delivery Systems
Oral Targeted Drug Delivery Systems: Gastric Retention Devices
Oral Targeted Drug Delivery Systems: Enteric Coating
Orally administered drug delivery systems to the colon
Dissolution Testing: In vitro Characterization of Oral Controlled Release Dosage Forms
Challenges and New Technologies of Oral Controlled Release
Oral Controlled Drug Delivery: Quality By Design approach to Drug Development
Oral Controlled Release-Based Products for Lifecycle Management
Generic Oral Controlled Release Product Development - Formulation and Process Considerations
The Science and Regulatory Perspectives of Emerging Controlled Release Dosage Forms
Table of Contents provided by Publisher. All Rights Reserved.

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Oral Controlled Release Formulation Design and Drug Delivery Theory to Practice

Summary

Author Biography

Table of Contents

Supplemental Materials