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Pharmaceutical Amorphous Solid Dispersions

Ann Newman (Edited by), AW Newman (Author)

9781118455203, Wiley

Hardback, published 24 April 2015

512 pages
23.4 x 16 x 3.3 cm, 0.816 kg

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

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 D. Ormes, Jesse L. Kuiper, Allen C. Templeton, and Annette Bak

7 Translational Development of Amorphous Dispersions 259
Patrick R. 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 Copyrighted Material

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 Rahman, and Mansoor A. Khan

13 Patenting Amorphous Solid Dispersions of Pharmaceuticals 415
Jeffrey 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

Subject Areas: Chemistry [PN]
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