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