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OPTIMIZATION STUDY OF AQUEOUS FILM-COATING PROCESS IN THE INDUSTRIAL SCALE USING DESIGN OF EXPERIMENTS

K. TOSHEV 1*, I. ENDEKOVSKA 1, M. TODOROVSKA ACKOVSKA 2, N. ANEVSKA STOJANOVSKA

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Experimental design approach has been used for optimization of film-coating phase of the immediate release tablets manufacturing process in order to evaluate the effects of the potential critical process parameters (CPPs) and define the optimal operating conditions. Optimization was performed during the transfer of the process on a film-coating machine for pilot and industrial scale production. Immediate release ready-to-use coating system Opadry® White was used as the coating. Central Composite Orthogonal design with 17 coating runs of size of 103000 pcs was used for the study. The ranges of film-coating process parameters: inlet air flow, inlet air temperature and spray rate for the spraying stage of the coating process were optimized and the effects on: hardness, disintegration time, coating defects, coating efficiency and coating time were evaluated. The results showed that among the process parameters, the spray rate had the highest significant effect on all responses. The inlet air temperature showed a significant effect on the disintegration time. Interaction effects of the spray rate with the inlet air flow were found to be significant for the coating efficiency and disintegration time. Target values and sweet spot area were set for the parameters of the process in order to gain results with fastest disintegration time, highest coating efficiency, lowest number of coating defects, fastest coating time and hardness within the predetermined acceptance criteria.