Investigation and scale-up of hot-melt coating of pharmaceuticals in fluidized beds

This study was performed to investigate and scale-up the hot-melt coating process in fluidized beds. A series of well-designed experiments was carried out in a pilot scale unit with 20 kg product capacity to investigate the effects of process variables on the efficiency of the coating of Cefuroxime Axetil with stearic acid. Results showed that the efficiency is at the highest when the fluidization air flow rate is adjusted by considering the changes in the amount of materials present in the unit as well as the changes in the terminal velocities of particles during the process. With the objective to scale-up the hot-melt coating process from pilot to production scale, a dynamic thermodynamic model based on conservation equations of mass and energy was developed. Predictive accuracy of the model was assessed by applying it to the pilot scale unit and comparing its predictions with the online measurements taken on the same unit. Results showed that the predictions of the model agree well with the measurements. Utilizing this model and taking several experiments performed in the pilot scale unit as a basis, scaling up of the hot-melt coating process was carried out. Comparisons of the model predictions with the measurements taken on the production scale unit (200 kg product capacity) revealed that the model is able to reproduce the product attributes and the outlet air temperatures across scales. Therefore, it proves to be a promising tool that can be used in the scale-up of the hot-melt coating processes in fluidized beds. (C) 2010 Elsevier B.V. All rights reserved.