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Pharmaceutical Amorphous Solid Dispersions

Pharmaceutical Amorphous Solid Dispersions


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About the Book

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:
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

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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Product Details
  • ISBN-13: 9781118455203
  • Publisher: John Wiley & Sons Inc
  • Publisher Imprint: John Wiley & Sons Inc
  • Height: 234 mm
  • No of Pages: 504
  • Returnable: N
  • Weight: 797 gr
  • ISBN-10: 1118455207
  • Publisher Date: 24 Apr 2015
  • Binding: Hardback
  • Language: English
  • Returnable: N
  • Spine Width: 33 mm
  • Width: 160 mm


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