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Modeling the coating layer thickness in a pharmaceutical coating process.

S Madlmeir1, T Forgber1, M Trogrlic1

  • 1Research Center Pharmaceutical Engineering, Graz, Austria.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|February 21, 2021
PubMed
Summary
This summary is machine-generated.

This study combines CFD-DEM and Monte Carlo simulations to predict pharmaceutical coating processes. Smaller beads get thicker coatings, and spray rate significantly impacts coating uniformity in Multiple Unit Pellet Systems (MUPS).

Keywords:
CFD-DEMCoating uniformityMUPSMonte-CarloSpray coatingWurster coater

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Area of Science:

  • Pharmaceutical engineering
  • Computational fluid dynamics
  • Discrete element method

Background:

  • Mechanistic simulations offer insights but are limited by process time.
  • Statistical models predict long-term behavior but require accurate probability distributions.
  • Wurster coating of microspheres is crucial for drug delivery systems.

Purpose of the Study:

  • To develop a hybrid simulation approach combining CFD-DEM and Monte Carlo methods.
  • To predict coating mass and thickness distributions over extended process times.
  • To investigate factors influencing coating variability and product non-uniformity in MUPS.

Main Methods:

  • Detailed Computational Fluid Dynamics-Discrete Element Method (CFD-DEM) simulations of Wurster coating.
  • Development and application of a novel Monte Carlo simulation approach.
  • Stochastic modeling to analyze variability contributions in capsule filling.

Main Results:

  • Smaller beads receive thicker coating layers due to proximity to the spray nozzle.
  • Spray rate has a greater impact on inter-particle coating variability than airflow rate.
  • Quantified the relative contributions of coating layer and fill weight variability to MUPS non-uniformity.

Conclusions:

  • The hybrid simulation approach accurately predicts coating distributions over the entire process time.
  • Optimizing spray rate is critical for minimizing coating variability in pharmaceutical processes.
  • Understanding variability sources is essential for improving MUPS product uniformity.