Journal
AAPS PHARMSCITECH
Volume 21, Issue 5, Pages -Publisher
SPRINGER
DOI: 10.1208/s12249-020-01713-0
Keywords
rational formulation development; hot melt extrusion; amorphous solid dispersions; process and product modeling
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Funding
- Graz University of Technology
- Austrian COMET Program under Austrian Federal Ministry of Transport, Innovation and Technology (bmvit)
- Austrian Federal Ministry of Economy, Family and Youth (bmwfj)
- State of Styria (Styrian Funding Agency SFG)
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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 performedin silicofor 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.
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