Amorphous drug substances can exhibit enhanced solubility over a crystalline form. However, the amorphous form may be unstable to recrystallisation during the shelf life of a product unless it is stabilised as an amorphous solid dispersion.
Using our formufastTM platform, we can rapidly identify the most suitable polymers at the correct concentration for further development. Prototypes are generated by solvent casting, co-melting, freeze drying or spray drying, fully characterised and their stability assessed.
Nonetheless, a crystalline form of a drug substance is usually the preferred amorphous form, as hygroscopicity, physical/chemical stability, isolation, drying, compaction and flowability may be adversely affected by a lack of crystallinity. In addition, a route to a crystalline form may be desired as a means of purification and/or structure determination of the compound.
If your API has not been observed in a crystalline state to date, our crystallisation screening service incorporates tried and tested techniques, polymer templates and hetero-nucleants. The scope will be tailored to your needs, development phase and budget.