Abstract
This chapter describes several Accelerated Stability Assessment Program (ASAP) case studies for some uncommon small-molecule formulations, such as suspension, liquid, lyophilized, and matrix controlled-release formulations. A simple in-house experimental setup was described that permitted conducting multiple ASAP studies concurrently with small equipment footprint. In the lyophilized formulation case study, multiple analytical tools were employed to monitor not only degradation rates, but also moisture content and water activity changes. The ASAP predictions from those studies matched long-term stability data quite well. Data from these ASAP studies enabled project teams to make quick science-based decisions with regard to expected shelf life of new formulations, and to gain better understanding of degradation pathways.
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