Abstract: Excipient Compatibility as Predicted by ASAP: A Case Study

Excipient Compatibility as Predicted by ASAP: A Case Study


With the advent of the Accelerated Stability Assessment Program (ASAP), a novel approach to excipient compatibility testing is now possible. Formulation development begins with the process of selecting excipients that do not adversely affect the chemical stability of the drug substance. Traditionally, excipient compatibility studies have been a time consuming process as each potential excipient was evaluated by preparing an API-excipient binary mixture at 1:1 ratios and stored at accelerated conditions. The blends were then tested over multiple weeks and often generating results that require investigation thus further prolonging entry into formulation development.

Alternatively, testing multiple prototype formulations within the ASAP platform can be accomplished in a matter of weeks with greater understanding of critical excipient compatibilities, final product storage conditions, and degradation formation. Following rapid ASAP excipient compatibility studies CMC scientists are more informed and prepared to quickly enter into full formulation development. Chromatographic analytical methods can be a rate limiting step in the application of ASAP to early excipient capability studies.

An alternative approach to sample analysis paired with ASAP should be investigated further decreasing cost and product timelines.   This presentation will discuss a case study investigating three prototype formulations each containing unique fillers with the potential for incompatibilities.   The prototype samples were additionally analyzed by an alternate analytical technique and results inputted into ASAP to determine when compared to a traditional chromatographic method would the same incompatibilities be predicted.

Excipient Compatibility as Predicted by ASAP: A Case Study
Jerusha Thompson,
Upsher-Smith, Maple Grove, Minnesota