William H. Chandler

Automated Integrated Forced Degradation and Drug-Excipient Compatibility Studies

An integrated high-throughput tool for forced degradation studies during pharmaceutical development is described. A series of experiments are conducted with the Symyx Technologies (Santa Clara, CA) Automated Forced Degradation System. The hardware and software of the workflow are described. Degradation libraries of stressed samples of liquid formulations of drug A were created, analyzed for room temperature solubility, and then replicates of each library were heated and sampled over time at 55, 70, and 85 °C to monitor for parent product degradation. Library arrays of first-order kinetic plots were generated, and predictions of room temperature stability were made. Several viable solution formulations were identified. (JALA 2005;10:374–80)