Apparent Melting: A New Approach To Detecting Drug-Excipient Incompatibility

Drug-excipient incompatibility is a term used to describe the chemical interaction between an active pharmaceutical ingredient (API) and another material (excipient) that is added to perform a specific function in the final dosage form. Typically identified as an inert ingredient, the excipient is expected to have no effect on the chemistry or physical properties of the API. Verifying that the excipient is not affecting the API usually requires months of testing and significant use of resources, such as manpower, oven usage, and analytical time.

Explore a systematic thermal analysis approach for detecting drug-excipient incompatibility. The proposed method uses "apparent melting" and provides a rapid screening protocol that can quickly identify problem excipients and reduce detection of drug-excipient incompatibility to a few days. While this method does not eliminate the need to do long term oven aging and analytical testing of a final candidate dosage form, it should improve the probability of a successful development.