(509b) Key Considerations to Achieve Manufacture Excellence in Continuous Manufacturing Using Hot Melt Extrusion

Key Considerations to Achieve Manufacture Excellence in Continuous Manufacturing Using Hot Melt Extrusion

Hot melt extrusion is one of the most important enabling processing technology for manufacturing amorphous solid dispersions (ASDs)  to enhance oral drug absorption.  The extrusion process is inherently continuous.  Back-to-back extrusion runs without shutdown have been demonstrated successfully in commercial manufacturing over the past decade with improved manufacture efficiency and flexible batch size to meet dynamic market supply needs.  Manufacturing excellence is ensured through fundamental understanding of formulation degradation mechanism  and impact of process/formulation variability on product quality as well as implementation of a robust quality control strategy including but not limited to PAT tools.  Best practices to achieve manufacture excellence in continuous manufacturing using hot melt extrusion will be shared through a case study.  Techniques and control strategies to enable fully continuous operation and real-time release will be reviewed and discussed.