(719b) Exploring the Kinetics of API Degradation Under Hot Melt Extrusion Conditions

An understanding of API degradation in the formulation of drug product is crucial to develop a robust formulation process. This becomes especially challenging for hot melt Hot Melt Extrusion (HME) processes. The complexity is due to axially varying temperature and pressure profiles. Moreover, the transition from solids blending (at the start of HME) to slurry generation to solution (at the end of HME) also needs to be understood to predict thermally induced impurity generation. In this presentation, we will use a combined experimental and modeling framework to predict such impurity generation under conditions relevant to HME. The multivariate interactions between impurity generation kinetics, underlying transport phenomena, and flow patterns in the HME will be elucidated and a consistent modeling framework to predict such impurity generation will be presented.

The work presented here was sponsored by AbbVie. AbbVie contributed to the design, research, and interpretation of data, writing, reviewing, and approving the presentation. All authors are employees of AbbVie.