Experimental and Modeling-Based Approaches for Mechanistic Understanding of Pan Coating Process-A Detailed Review.

Tablet film coating is governed by three interrelated phenomena, namely, tablet mixing, coating-liquid spraying, and liquid evaporation, which dominate the critical quality attributes (CQAs) of the final product. This review examines how differences in coater design, key process parameters, and quality control strategies impact these phenomena and ultimately affect inter-tablet and intra-tablet coating variability. Two complementary approaches for understanding and optimizing the process are evaluated. The experimental approach, involving Design of Experiments (DoE), retrospective data analysis, and advanced Process Analytical Technology (PAT), provides empirical insight into factor-response relationships and enables real-time quality assurance. Simultaneously, model-based approaches, including thermodynamic, spray-dynamics, and particle-dynamics modelling, offer mechanistic understanding of heat and mass transfer, droplet deposition patterns, and tablet motion. Although these sub-models have advanced considerably over the years, a predictive model that treats the coating process in its entirety is still missing. Overall, this review underscores that future advancements will require integrating experimental and model-based methodologies to achieve robust, quality-driven, and predictive control of tablet film coating processes.