Developing a non-crystalline API is an approach that can improve the apparent solubility and oral bioavailability of a poorly water-soluble API. In order to stabilise an amorphous form, the API is combined in a single-phase amorphous mixture, amorphous dispersion, with a polymer to inhibit crystallisation over the shelf life of the drug product.
- Increased solubility and bioavailability
- Stabilised amorphous forms
- Controlled particle size distribution