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 INDICE: 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 NewmanAppendix 1..Xia Lu, Robert Wenslow, and Ann NewmanAppendix 2: Marketed Products..Ann Newman
- ISBN: 978-1-118-45520-3
- Editorial: Wiley–Blackwell
- Encuadernacion: Cartoné
- Páginas: 504
- Fecha Publicación: 20/02/2015
- Nº Volúmenes: 1
- Idioma: Inglés