A Quality by Design Approach for Coating Process Parameter Optimization

Film coating is a thin polymer layer applied on to a solid dosage form. Quality by design approach was explored to optimize the tablet coating process using Opadry®, an optimized one step film coating system. A central composite design was chosen by considering independent variables as inlet temperature, atomization air pressure, spray rate and dependent variables as weight gain and tablet surface roughness. Non-linear regression models were developed for response variables. The model was used to achieve an optimized response characteristic of weight gain, surface roughness with predicted input variables of inlet air temperature, atomization air pressure and spray rate. With optimized process parameters tablet has been coated and the suitability of the model determined. The results demonstrated the overall reliability and effectiveness of the proposed quality by design approach to the derived model and provides useful tool to help optimize the film coating process.