Impacting the Glass-Forming Ability and Long-Term Stability of Spray-Dried Medicines Maintained in Dry and Humid Settings

Abstract

Our objectives were to examine (i) how different preparation methods affect the evaluation of GFA and GS in compounds, specifically comparing the GFA class of compounds made by spray-drying vs melt-quenching in the DSC, (ii) how amorphous compounds made by spray-drying fare when stored at <5% RH (dry) and 75% RH (humid) for 168 days, and (iii) whether there is a possible correlation between the long-term physical stability and glass forming ability (GFA) and/or physicochemical characteristics. Twenty-six glass-forming compounds (II and III) with a wide range of physicochemical characteristics were chosen based on their prior reporting.

Keywords: physicochemical, prior, stability, forming reporting.