Developing HME-Based Drug Products Using Emerging Science: a Fast-Track Roadmap from Concept to Clinical Batch

Josip Matic, Amrit Paudel*, Hannes Bauer, Raymar Andreina Lara Garcia, Kinga Biedrzycka, Johannes G. Khinast*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

Abstract

This paper presents a rational workflow for developing enabling formulations, such as amorphous solid dispersions, via hot-melt extrusion in less than a year. First, our approach to an integrated product and process development framework is described, including state-of-the-art theoretical concepts, modeling, and experimental characterization described in the literature and developed by us. Next, lab-scale extruder setups are designed (processing conditions and screw design) based on a rational, model-based framework that takes into account the thermal load required, the mixing capabilities, and the thermo-mechanical degradation. The predicted optimal process setup can be validated quickly in the pilot plant. Lastly, a transfer of the process to any GMP-certified manufacturing site can be performed in silico for any extruder based on our validated computational framework. In summary, the proposed workflow massively reduces the risk in product and process development and shortens the drug-to-market time for enabling formulations.

Original languageEnglish
Article number176
JournalAAPS PharmSciTech
Volume21
Issue number5
DOIs
Publication statusPublished - 22 Jun 2020

Keywords

  • rational formulation development
  • hot melt extrusion
  • amorphous solid dispersions
  • process and product modeling

ASJC Scopus subject areas

  • Pharmaceutical Science

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