Developing HME-Based Drug Products Using Emerging Science: a Fast-Track Roadmap from Concept to Clinical Batch
This paper presents a rational workflow for growing enabling formulations, similar to amorphous strong dispersions, through hot-melt extrusion in lower than a yr. First, our strategy to an built-in product and course of improvement framework is described, together with state-of-the-art theoretical ideas, modeling, and experimental characterization described within the literature and developed by us. Subsequent, lab-scale extruder setups are designed (processing situations and screw design) […]