A large majority of active pharmaceutical ingredients (API) currently in development have limited bioavailability due to low solubility and dissolution rates (BCS IIa and IIb). The integrated Capsugel Dosage Form Solutions and Bend Research development team have a full range of established technologies and rigorous selection criteria to address this problem on a per API basis.
In this webinar, hot-melt extrusion (HME) of amorphous solid dispersions is one approach used to address APIs with limited bioavailability due to low solubility and dissolution rates (BCS IIa / IIb). By using an integrated process and formulation approach that balances the target absorption profile, manufacturability, physical and chemical stability, and API availability Capsugel Dosage Form Solutions / Bend Research scientists are able to rapidly develop a progress-able drug intermediate and dosage form for preclinical and clinical manufacture. The bio-enhancement technology selection process will be reviewed along with HME process optimization and representative case studies.