Development and evaluation of a dimensionless mechanistic pan coating model for the prediction of coated tablet appearance

- A mechanistic model of a pharmaceutical tablet pan coating process to predict coated tablet appearance quality is developed.
- Prediction of tablet appearance prior to experiment or production.
- Characterisation of tablet coating process using dimensionless quantities - dimensionless spray flux and Niblett Number.
- Dimensionless regime map for tablet film coating created and evaluated - over-wetting defect region identified.
- The Niblett Number differentiates processes based on droplet drying thermodynamics and kinetics.

A mathematical, mechanistic tablet film-coating model has been developed for pharmaceutical pan coating systems based on the mechanisms of atomisation, tablet bed movement and droplet drying with the main purpose of predicting tablet appearance quality. Two dimensionless quantities were used to characterise the product properties and operating parameters: the dimensionless Spray Flux (relating to area coverage of the spray droplets) and the Niblett Number (relating to the time available for drying of coating droplets). The Niblett Number is the ratio between the time a droplet needs to dry under given thermodynamic conditions and the time available for the droplet while on the surface of the tablet bed. The time available for drying on the tablet bed surface is critical for appearance quality. These two dimensionless quantities were used to select process parameters for a set of 22 coating experiments, performed over a wide range of multivariate process parameters. The dimensionless Regime Map created can be used to visualise the effect of interacting process parameters on overall tablet appearance quality and defects such as picking and logo bridging.

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