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Scale-Up of pharmaceutical Hot-Melt-Extrusion: Process optimization and transfer
Jens Wesholowski1, Kevin Hoppe1, Kathrin Nickel2
1Laboratory of Solids Process Engineering, TU Dortmund University, Dortmund, Germany.
Summary
Scaling up Hot-Melt-Extrusion (HME) requires optimizing load and throughput. The study reveals energy ratio for transport versus mixing is key for successful process transfer across different twin-screw extruder scales.
Area of Science:
- Pharmaceutical Manufacturing
- Chemical Engineering
- Materials Science
Background:
- Hot-Melt-Extrusion (HME) on twin-screw extruders is a standard pharmaceutical processing technique.
- Scaling up HME presents challenges due to integrated unit operations and complex continuous manufacturing conditions.
- Residence time distribution (RTD) is critical for understanding dissolution, mixing, and degradation during HME.
Purpose of the Study:
- To develop and validate a methodology for optimizing HME processes regarding load and throughput across different extruder scales.
- To investigate and compare various literature-based concepts for transferring HME processes to larger scales.
- To analyze the impact of scale-up approaches on residence time distribution (RTD) and identify optimal transfer strategies.
Main Methods:
- Developed an optimization methodology for HME load and throughput, applied across multiple extruder scales.
- Evaluated processing windows and dominant material heating mechanisms at different scales.
- Applied literature concepts for HME process transfer to larger scales, focusing on RTD analysis and modeling.
Main Results:
- Observed deviations in dominant material heating mechanisms across different extruder scales.
- Demonstrated the effectiveness of the developed optimization concept for process transfer constraints.
- Identified a shift in the most suitable scale-up approach for different extruder sizes, impacting RTD characteristics.
Conclusions:
- The ratio of energy applied for transport to mixing is a valuable metric for HME scale-up.
- The developed optimization concept provides a framework for transferring HME processes between scales.
- RTD analysis is crucial for evaluating and comparing different scale-up strategies in continuous pharmaceutical manufacturing.
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