Changing landscape of dosage forms: Industry needs and science challenges

YCC 15

Sue Wollowitz, Medivation Inc, 55 Hawthorne St, Suite 610, San Francisco, CA 94105
Chemistry in the pharmaceutical industry has been largely looked at in the domain of drug substances. But formulation science is chemistry at the interface of material science, biology, physics and engineering.

Formulation options have exploded in the last 20 years due to the need to deliver highly unsoluble or unstable drug substances and to increase patient compliance. In addition, directed delivery of highly potent compounds has broadened the routes of administration. Coupled with this, the pharmaceutical industry is trying to catch up with 21st century manufacturing practices and better understand the science behind the performance characteristics of the resulting drug products.

This presentation will discuss how the drug substance constraints as well as manufacturing and market demands coalesce to drive formulation development. We will give some examples, from a chemistry perspective, of formulations developed to meet the needs and how an understanding of the materials on the microscopic scale lead to better macroscopic performance.