Pharmaceutical Amorphous Solid Dispersions - by Ann Newman (Hardcover)

About the Book

Includes bibliographical references and index.

Book Synopsis

Pharmaceutical Amorphous Solid Dispersions

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

From the Back Cover

A roadmap to enhance and maximize drug solubility and bioavailability

With an increasing number of poorly soluble or difficult to crystallize drugs entering development, new formulation strategies are required to achieve sufficient bioavailability. Amorphous solid dispersions are an option receiving increased attention in recent years, because they can improve dissolution rates and increase solubility characteristics of drug compounds.

This book highlights and discusses the advances in developing pharmaceutical amorphous solid dispersions. Chapters, written by contributing authors on the frontlines of R & D, provide a roadmap from early to late stages of drug development. They cover topics that include: physical and chemical properties, screening, scale-up, formulation, drug product manufacture, intellectual property, and regulatory considerations.

Pharmaceutical scientists using this book as a guide for formulating their drugs benefit from a number of features, including:

• A comprehensive overview of the amorphous solid dispersion technology, which is a leading technology platform to deliver poorly water soluble drugs - a major hurdle in today's pharmaceutical industry
• How to apply amorphous solid dispersions techniques to particular pharmaceutical systems
• 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
• Global regulatory issues including USA regulations, ICH guidelines, and patent concerns around the world

About the Author

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.