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.

Preface vii Contributors ix 1 Introduction and Overview of Oral Controlled Release Formulation Design 1 Hong Wen and Kinam Park 2 Evolution of Oral Controlled Release Dosage Forms 21 Ping I. Lee and Jian-Xin li 3 Biopharmaceutic Consideration and Assessment for Oral Controlled Release Formulations 33 Hua Zhang and Jean M. Surian 4 Preformulation Consideration for Drugs in Oral CR Formulation 47 Mannching Sherry Ku 5 Polymers in Oral Modified Release Systems 71 Jiasheng Tu, Yan Shen, Ravichandran Mahalingam, Bhaskara Jasti, and Xiaoling li 6 Oral Extended Release Hydrophilic Matrices: Formulation and Design 89 Xiaoguang Wen, Ali Nokhodchi, and Ali Rajabi-Siahboomi 7 Coating Systems for Oral Controlled Release Formulations 101 Linda A. Felton 8 Fluid Bed Coating and Granulation for CR Delivery 115 Yue Teng and Zhihui Qiu 9 Controlled Release Using Bilayer Osmotic Tablet Technology: Reducing Theory to Practice 129 Sheri L. Shamblin 10 Fast Disintegrating Tablets 155 Seong Hoon Jeong, Jaehwi Lee, and Jong Soo Woo 11 Buccal Drug Delivery Systems 169 John D. Smart and Gemma Keegan 12 Oral Targeted Drug Delivery Systems: Gastric Retention Devices 185 Hossein Omidian and Kinam Park 13 Oral Targeted Drug Delivery Systems: Enteric Coating 205 Wendy Dulin 14 Orally Administered Drug Delivery Systems to the Colon 225 Mirela Nadler Milabuer, Yossi Kam, and Abraham Rubinstein 15 Dissolution Testing: In Vitro Characterization of Oral Controlled Release Dosage Forms 245 Michele Xuemei Guo 16 Challenges and New Technologies of Oral Controlled Release 257 Xiaoming Chen, Hong Wen, and Kinam Park 17 Oral Controlled Drug Delivery: Quality by Design (QbD) Approach to Drug Development 279 Shailesh K. Singh, Thirunellai G. Venkateshwaran, and Stephen P. Simmons 18 Oral Controlled Release-Based Products for Life Cycle Management 305 Nipun Davar and Sangita Ghosh 19 Generic Oral Controlled Release Product Development: Formulation and Process Considerations 321 Salah U. Ahmed and Venkatesh Naini 20 The Science and Regulatory Perspectives of Emerging Controlled Release Dosage Forms 337 Rakhi B. Shah and Mansoor A. Khan Index 351