05.16.22 -- A Versatile Formulation Strategy For Poorly Soluble Drugs

Explore how to classify HPAPIs in early development and recommendations for safe product handling, from clinical manufacturing to commercialization, as well as key advantages of using micronization technology for the development and manufacture of HPAPIs.

This expert review presents strategies for selecting a suitable formulation technique for poorly soluble drugs and describes in detail the characteristics of amorphous solid dispersions (ASD), and methods of manufacturing including spray drying and hot melt extrusion.

A biopharmaceutical company needed to develop and manufacture a commercially viable, patient-friendly, stable tablet for a program intended to treat a disease that has unmet medical need. By deploying phase-appropriate technologies, a solution reduced program risks and accelerated timelines.

Experts share a case study that illustrates how to use PBPK modeling, the developability classification system, and the biopharmaceutics drug distribution classification system together to facilitate the development of a molecule.