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