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This review explores tablet film coating, focusing on mixing, spraying, and evaporation. Integrating experimental and model-based methods is key for robust, quality-driven control of coating processes.

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Area of Science:

  • Pharmaceutical Technology
  • Chemical Engineering

Background:

  • Tablet film coating involves complex phenomena: tablet mixing, spray coating, and liquid evaporation.
  • These phenomena critically influence the final product's critical quality attributes (CQAs).

Purpose of the Study:

  • To review how coater design, process parameters, and quality control impact coating variability.
  • To evaluate experimental and model-based approaches for process optimization.

Main Methods:

  • Design of Experiments (DoE) and Process Analytical Technology (PAT) for empirical insights.
  • Thermodynamic, spray-dynamics, and particle-dynamics modeling for mechanistic understanding.

Main Results:

  • Coater design, process parameters, and QC strategies significantly affect coating uniformity.
  • Experimental and modeling approaches offer complementary insights into heat/mass transfer and droplet dynamics.

Conclusions:

  • A comprehensive predictive model for the entire coating process is currently lacking.
  • Future advancements necessitate integrating experimental and model-based methodologies for predictive control.