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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
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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 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
• 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
Produktdetails
- Produktdetails
- Verlag: John Wiley & Sons
- Erscheinungstermin: 27. Februar 2015
- Englisch
- ISBN-13: 9781118901380
- Artikelnr.: 42507504
- Verlag: John Wiley & Sons
- Erscheinungstermin: 27. Februar 2015
- Englisch
- ISBN-13: 9781118901380
- Artikelnr.: 42507504
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.
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
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
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
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
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