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
- 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
Table of Contents
ContentsContributors
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
