Pharmaceutical Amorphous Solid Dispersions / Edition 1

by Ann Newman

Overview

Providing a roadmap from early to late stages of drug development, this book overviews amorphous solid dispersion technology – a leading platform to deliver poorly water soluble drugs, a major hurdle in today’s pharmaceutical industry.

• Helps readers understand amorphous solid dispersions and apply techniques to particular pharmaceutical systems
• Covers physical and chemical properties, screening, scale-up, formulation, drug product manufacture, intellectual property, and regulatory considerations
• Has an appendix with structure and property information for polymers commonly used in drug development and with marketed drugs developed using the amorphous sold dispersion approach
• Addresses global regulatory issues including USA regulations, ICH guidelines, and patent concerns around the world

Product Details

ISBN-13:	9781118455203
Publisher:	Wiley
Publication date:	03/09/2015
Pages:	504
Product dimensions:	6.10(w) x 9.30(h) x 1.20(d)

About the Author

Ann Newman is a pharmaceutical consultant with Seventh Street Development Group, where she provides consulting, training, and webcast services on solid-state pharmaceutics and pharmaceutical development. She is also an Adjunct Professor and Lecturer in the Department of Industrial and Physical Pharmacy at Purdue University. A senior pharmaceutical scientist with demonstrated scientific and leadership expertise in the pharmaceutical industry, Dr. Newman has over 25 years of large pharma and contract research experience.

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Table of Contents

Contents

Contributors

Preface

Chapter 1: Introduction to Amorphous Solid Dispersions
George Zografi and Ann Newman

Chapter 2: Polymers and Surfactants
Padma Narayan, William W. Porter III, Meinolf Brackhagen, and Christopher Tucker

Chapter 3: Amorphous Solid Dispersion Screening
Ann Newman

Chapter 4: Solid state Characterization of Amorphous Dispersions
Frederick G. Vogt

Chapter 5: Physical Stability and Crystallization Inhibition
Lynne S. Taylor

Chapter 6: Solubility and Dissolution Considerations for Amorphous Solid Dispersions
Grace A. Ilevbare, Wei Xu, Christopher T. John, James Ormes, Jesse Kuiper, Allen C. Templeton, and Annette Bak

Chapter 7: Translational Development of Amorphous Dispersions
Patrick Connelly, Brian Patrick Quinn, Steve Johnston, Philip Bransford, Praveen Mudunuri, Andrey Peresypkin, Majed Fawaz, Setu Roday, Anuj Kuldipkumar, Hong-Ren Wang, Phillip Snyder, Jeff Katstra, Tapan Sanghvi, Bill Rowe, and Patricia Hurter

Chapter 8: Preclinical and Clinical Studies
Marcus E. Brewster, Geert Verreck, Jan Bevernage, Joachim Brouwers, Guy Van den Mooter, and Patrick Augustijns

Chapter 9: Spray-Drying and Scale-Up
Daniel E. Dobry, Dana M. Settell, and John M. Baumann

Chapter 10: Hot Melt Extrusion of Amorphous Solid Dispersions
Kieran Crowley and Andreas Gryczke

Chapter 11: Formulation Development of Amorphous Dispersions
Tapan Sanghvi, Jeff Katstra, Brian Patrick Quinn, Hayden Thomas, and Patricia Hurter

Chapter 12: Scientific and Regulatory Considerations in Product Development
Abhay Gupta, Ziyaur Rahmna, and Manssor A. Khan

Chapter 13: Chapter Patenting Amorphous Solid Dispersions of Pharmaceuticals
Jeffry A. Lindeman

Chapter 14: Monographs on Polymers and Surfactants
Xia Lu, Robert Wenslow, and Ann Newman

Appendix 1
Xia Lu, Robert Wenslow, and Ann Newman

Appendix 2: Marketed Products
Ann Newman