Description
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 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. 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
