(486e) Developing Predictive Models for Degradation of APIs during Hot Melt Extrusion in Pharmaceutical Processes
AIChE Annual Meeting
Wednesday, November 17, 2021 - 2:30pm to 2:54pm
In this presentation, we will provide a methodology for elucidating the degradation mechanisms and governing factors that control API decomposition to form impurities during HME. Such a methodology begins through generation of 1D models to predict the temperature profile that results from selection of the extruder operating conditions and by heat generation from viscous dissipation. Further, the important role of screw configuration and operating conditions on the residence time distribution of the melt will be discussed. Selection of an appropriate solvent system can then be used to mimic the solvation environment and impurities of common pharmaceutical excipients to deconvolute the intrinsic reaction kinetics. By combining the residence time distribution and temperature profile with the intrinsic reaction kinetics, we will discuss how we have applied this understanding to model API degradation to de-risk the operating space for manufacture of drug products by HME.
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