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Continuous mixing technology: Validation of a DEM model.

Peter Toson1, Pankaj Doshi2, Marko Matic1

  • 1Research Center Pharmaceutical Engineering, Inffeldgasse 13, 8010 Graz, Austria.

International Journal of Pharmaceutics
|September 4, 2021
PubMed
Summary
This summary is machine-generated.

Discrete Element Method (DEM) simulations accurately predict powder mixing in continuous manufacturing, reducing experimental needs. This validated DEM model for the CMT device can replace costly tracer experiments for process control.

Keywords:
Continuous processingMixingPhysical characterizationPowder technologyResidence timeSimulationSolid dosage form

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Area of Science:

  • Pharmaceutical Engineering
  • Powder Technology
  • Computational Fluid Dynamics (CFD) and Discrete Element Method (DEM)

Background:

  • Continuous powder mixing is vital for solid oral dosage form manufacturing.
  • Critical quality attributes depend heavily on mixing efficiency.
  • Experimental analysis of continuous mixing is time-consuming and costly.

Purpose of the Study:

  • To develop and validate a Discrete Element Method (DEM) model for a vertical continuous mixing device (CMT).
  • To assess the suitability of DEM simulations for replacing experimental runs in process development.
  • To investigate the model's capability in predicting blend properties and process dynamics.

Main Methods:

  • Cohesive contact model calibration using compression and shear cell tests.
  • DEM simulations of the CMT device to determine residence time distribution (RTD).
  • Validation against tracer spike experiments under various throughputs, hold-up masses, and impeller speeds.

Main Results:

  • A validated DEM model for the CMT device was established.
  • DEM simulations accurately predicted the residence time distribution (RTD).
  • DEM and experimental data showed excellent agreement in predicting fluctuation damping and control strategy funnels.

Conclusions:

  • DEM simulations are a powerful, cost-effective tool for analyzing continuous powder mixing.
  • Validated DEM models can reliably replace process-scale tracer spike experiments for RTD determination.
  • This approach supports efficient product development and manufacturing of solid oral dosage forms.