Oral Controlled Release Formulation Design and Drug Delivery

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 viiContributors ix1 Introduction and Overview of Oral Controlled Release Formulation Design 1Hong Wen and Kinam Park2 Evolution of Oral Controlled Release Dosage Forms 21Ping I. Lee and Jian-Xin li3 Biopharmaceutic Consideration and Assessment for Oral Controlled Release Formulations 33Hua Zhang and Jean M. Surian4 Preformulation Consideration for Drugs in Oral CR Formulation 47Mannching Sherry Ku5 Polymers in Oral Modified Release Systems 71Jiasheng Tu, Yan Shen, Ravichandran Mahalingam, Bhaskara Jasti, and Xiaoling li6 Oral Extended Release Hydrophilic Matrices: Formulation and Design 89Xiaoguang Wen, Ali Nokhodchi, and Ali Rajabi-Siahboomi7 Coating Systems for Oral Controlled Release Formulations 101Linda A. Felton8 Fluid Bed Coating and Granulation for CR Delivery 115Yue Teng and Zhihui Qiu9 Controlled Release Using Bilayer Osmotic Tablet Technology: Reducing Theory to Practice 129Sheri L. Shamblin10 Fast Disintegrating Tablets 155Seong Hoon Jeong, Jaehwi Lee, and Jong Soo Woo11 Buccal Drug Delivery Systems 169John D. Smart and Gemma Keegan12 Oral Targeted Drug Delivery Systems: Gastric Retention Devices 185Hossein Omidian and Kinam Park13 Oral Targeted Drug Delivery Systems: Enteric Coating 205Wendy Dulin14 Orally Administered Drug Delivery Systems to the Colon 225Mirela Nadler Milabuer, Yossi Kam, and Abraham Rubinstein15 Dissolution Testing: In Vitro Characterization of Oral Controlled Release Dosage Forms 245Michele Xuemei Guo16 Challenges and New Technologies of Oral Controlled Release 257Xiaoming Chen, Hong Wen, and Kinam Park17 Oral Controlled Drug Delivery: Quality by Design (QbD) Approach to Drug Development 279Shailesh K. Singh, Thirunellai G. Venkateshwaran, and Stephen P. Simmons18 Oral Controlled Release-Based Products for Life Cycle Management 305Nipun Davar and Sangita Ghosh19 Generic Oral Controlled Release Product Development: Formulation and Process Considerations 321Salah U. Ahmed and Venkatesh Naini20 The Science and Regulatory Perspectives of Emerging Controlled Release Dosage Forms 337Rakhi B. Shah and Mansoor A. KhanIndex 351