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 worldContents
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 Xuli