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Stable Amorphous Formulations

Thermodynamically, the amorphous state shows the greatest solubility, however it has also the largest propensity to re-crystallise on storage. Further, the lack of a crystal lattice can cause increased degradation. Amorphous forms can be readily stabilized by producing a molecular /solid dispersion, hot melt extrusion technology is a simple, fast and effective method of preparing amorphous materials as solid dispersions.
The IPI CIC  offers a phase approach to identifying and preparing the most stable amorphous of your active.

Phase 1-Solid dispersion screen- using a range of polymers

Phase 2-Small scale hot melt extrusion trial and 30 day stability study

Phase-3 Preparation of a formulated product for preclinical studies