Miniaturization of the dry Granulation Process to Accelerate the NCE Drug Development

3/22/2022 16:05 - 16:35

The terminology amorphous solid dispersion (ASD) was coined about 40 years ago to specifically describe solid pharmaceutical formulations in which the active pharmaceutical ingredient (API) is amorphously embedded in a polymer matrix. ASD as a formulation strategy, enables an increase in the apparent solubility and bioavailability of poorly-water soluble APIs, typically those in the Biopharmaceutics Classification System (BCS) II and IV. Over the last decades, significant scientific progress has been made to mechanistically understand ASDs and to address the challenges associated with their manufacturability, stability, and performance. In this presentation, an overview of recent progress made on the formulation and process modeling front to address these challenges will be discussed. Furthermore, emerging modeling techniques to address current deficiencies or gaps will be highlighted.

Corentin Larcy, NCE Drug Product Expert, UCB