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Related Experiment Video

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Numerical simulation of hot-melt extrusion processes for amorphous solid dispersions using model-based melt

Esther S Bochmann1, Kristina E Steffens1, Andreas Gryczke2

  • 1Department of Pharmaceutical Technology and Biopharmaceutics, University of Bonn, Bonn, Germany.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|December 10, 2017
PubMed
Summary

This study simplifies hot-melt extrusion (HME) simulations for amorphous solid dispersions (ASDs) by using model-based viscosity, reducing experimental effort. This approach ensures similar simulation outcomes to those using full experimental data, aiding rational ASD development.

Keywords:
Amorphous solid dispersionCarbamazepine (PubChem CID: 2554)Copovidone (PubChem CID: 25086-89-9)Dipyridamole (PubChem CID: 3108)Glass transition temperatureHot-melt extrusionIbuprofen (PubChem CID: 3672)Indomethacin (PubChem CID: 3715)Melt rheologyPrediction modelSimulation

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Area of Science:

  • Pharmaceutical Technology
  • Process Engineering
  • Materials Science

Background:

  • Hot-melt extrusion (HME) is crucial for amorphous solid dispersion (ASD) development, but requires extensive parameter input.
  • Experimental determination of melt rheology for ASDs is time-consuming and complex.

Purpose of the Study:

  • To present a simplified procedure for HME simulations of ASDs.
  • To reduce the experimental effort required for HME process simulation.
  • To enable a rational development approach for ASDs using HME.

Main Methods:

  • Utilized commercial 1D simulation software (Ludovic®).
  • Performed HME simulations with full experimental data and with model-based melt viscosity data.
  • Model-based viscosity was calculated using glass transition temperature (Tg) and polymer matrix viscosity.
  • Compared simulation outcomes with experimental HME results, evaluating physical properties and process characteristics.

Main Results:

  • Model-based melt viscosity closely matched measured viscosity in most cases.
  • HME simulations using both data sets yielded similar outcomes.
  • Variations in physical properties and process characteristics were evaluated between simulations and experiments.

Conclusions:

  • The simplified procedure effectively reduces experimental effort for HME simulations.
  • Model-based viscosity provides a reliable alternative to extensive rheological measurements.
  • This method offers a practical starting point for efficient ASD development via HME.