Pharmaceutical Amorphous Solid Dispersions
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
Table of Contents:
Preface ix
Contributors xi
1 Introduction to Amorphous Solid Dispersions 1
George Zografi and Ann Newman
2 Polymers and Surfactants 42
Padma Narayan, William W. Porter III, Meinolf Brackhagen, and Christopher Tucker
3 Amorphous Solid Dispersion Screening 85
Ann Newman
4 Solid state Characterization of Amorphous Dispersions 117
Frederick G. Vogt
5 Physical Stability and Crystallization Inhibition 179
Lynne S. Taylor
6 Solubility and Dissolution Considerations for Amorphous Solid Dispersions 218
Grace A. Ilevbare, Wei Xu, Christopher T. John, James Ormes, Jesse Kuiper, Allen C. Templeton, and Annette Bak
7 Translational Development of Amorphous Dispersions 259
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
8 Preclinical and Clinical Studies 288
Marcus E. Brewster, Geert Verreck, Jan Bevernage, Joachim Brouwers, Guy Van den Mooter, and Patrick Augustijns
9 Spray-Drying and Scale-Up 315
Daniel E. Dobry, Dana M. Settell, and John M. Baumann
10 Hot Melt Extrusion of Amorphous Solid Dispersions 341
Kieran Crowley and Andreas Gryczke
11 Formulation Development of Amorphous Dispersions 364
Tapan Sanghvi, Jeff Katstra, Brian Patrick Quinn, Hayden Thomas, and Patricia Hurter
12 Scientific and Regulatory Considerations in Product Development 398
Abhay Gupta, Ziyaur Rahmna, and Manssor A. Khan
13 Chapter Patenting Amorphous Solid Dispersions of Pharmaceuticals 415
Jeffry A. Lindeman
14 Monographs on Polymers and Surfactants 433
Xia Lu, Robert Wenslow, and Ann Newman
Appendix A: 455
Xia Lu, Robert Wenslow, and Ann Newman
Appendix B: Marketed Products 470
Ann Newman
Index 473
