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.
Table of Contents:
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
About the Author :
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.
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