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Related Experiment Video

Updated: Jul 27, 2025

Formation of Dispersible Taohong Siwu Tablets
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A validation of discrete-element model simulations for predicting tablet coating variability.

Rakulan Sivanesapillai1, Anja Ehrig2, Leon White Nogueira3

  • 1Bayer AG, Chemical and Pharmaceutical Development, Wuppertal, 42117, Germany.

International Journal of Pharmaceutics
|June 9, 2023
PubMed
Summary
This summary is machine-generated.

Computer simulations using Discrete Element Method (DEM) accurately predict tablet coating variability. This approach aids in designing more efficient industrial coating processes by minimizing errors and understanding uncertainties.

Keywords:
Coating variabilityDEM simulationModel-based process designTablet film coating

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Area of Science:

  • Pharmaceutical engineering
  • Computational fluid dynamics
  • Process modeling

Background:

  • Ensuring uniform tablet coating distribution and quantifying variability are significant challenges in pharmaceutical manufacturing.
  • Computer simulations, specifically the Discrete Element Method (DEM), offer a promising approach for predictive design in coating processes.

Purpose of the Study:

  • To evaluate the predictive accuracy of Discrete Element Method (DEM) simulations for tablet coating processes.
  • To assess the impact of experimental and simulation input uncertainties on DEM model predictions.
  • To validate DEM predictions against a comprehensive set of experimental data across different scales and conditions.

Main Methods:

  • Conducted extensive tablet coating experiments across various scales, conditions, and tablet shapes.
  • Developed a water-soluble formulation for rapid UV/VIS spectroscopic analysis of coating amounts.
  • Utilized Discrete Element Method (DEM) simulations to model and predict coating distribution and variability.

Main Results:

  • DEM predictions consistently fell within experimentally determined confidence intervals.
  • Achieved a mean absolute comparison error of 0.54% between DEM predictions and experimental estimates of coating variability.
  • Identified spray area size parameterization as the primary source of simulation error, though smaller than experimental uncertainties at larger scales.

Conclusions:

  • Discrete Element Method (DEM) simulations demonstrate high predictivity for tablet coating processes.
  • DEM is a valuable tool for the model-predictive design of industrial coating operations.
  • Understanding and minimizing simulation input uncertainties, particularly spray area, enhances model accuracy.