Close to 90% of drugs coming out of the drug discovery pipeline, have solubility limitations translating to poor bioavailability, which may ultimately result in clinical failures. Amorphous solid dispersions (ASDs) are an established platform to address bioavailability challenges due to low aqueous solubility. The complexity of ASD development, added to the concerns on physical stability, pose as perceived risks, however, the clinical and commercial success of ASD-based formulations stands as driving force: to date, 24 FDA-approved therapies are commercially available
This presentation will address the main challenges in the formulation of ASDs, and highlighting the importance of integrated development and the synergies between pre-formulation and commercial manufacturing expertise. The science-based development platform for ASDs will be presented. This platform relies on the integration between formulation and analytical development, from API to drug product, coupled with the use of computational models, formulation databases and miniaturized high-throughput in vitro techniques.