Predicting the Supersaturation Behavior of Indomethacin in Aqueous Solution

Amorphous formulations of active pharmaceutical ingredients (APIs) represent a valuable tool towards addressing the
ever-existing challenge of bioavailability limitation during administration of poorly water-soluble APIs. Yet, it has often been
observed that formulations with proven long-term stability - even at high relative humidity - only performed superior to their
crystalline counterparts for a much shorter period than expected when subjected to dissolution tests. The mechanisms
at play – dissolution, solution crystallization, and solid-state transformation-, while generally not unknown to the scientific
community, were assessed and combined quantitatively for the first time in this work.