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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…mehr
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
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.
Inhaltsangabe
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
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
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
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
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