Accelerated Stability Modeling: Desolvation of a Solvate Drug Product (original) (raw)

Accelerated Predictive Stability, 2018

Abstract

Abstract An APS study conducted on API was used to accurately predict the long-term stability of tablets packaged in HDPE bottles. The API solid form is a 1:1 crystalline solvate and the critical degradation process in this case study is the desolvation process. The representativeness of the API APS study to the long-term stability of the tablets is partly because the DMSO vapor pressures in both systems are maintained at very low levels: in the API APS studies, the presence of saturated salt solutions acts as a sink for the removal of free DMSO, whereas in the tablet long-term stability studies, the excipients, desiccant, and the semipermeable bottles provide the sink conditions for the removal of free DMSO. The desolvation kinetics of the API appear to be similar to those of the drug product and are apparently unaffected by factors such as drug load.

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