RESUMEN
BACKGROUND: Continuous film coating processes are recognized for their high production rates but have had slow acceptance for pharmaceutical production because of perceived high product losses during start-up and shut-down. In this article, the recent improvements in continuous coater designs were evaluated with respect to coating uniformity and reduction in product losses. Two separate studies represent trials conducted in newly redesigned continuous coating pans from two different coating pan manufacturers. METHOD: Multivitamin tablets were coated with Opadry((R)) II, high performance film coating system, in both batch and continuous modes in the continuous coater. Tablet samples collected throughout all phases of the process were tested for color development and uniformity. Soft gelatin capsules were coated with a delayed release coating formulation, Nutrateric((R)), nutritional enteric coating system. Samples of the soft gelatin capsules were taken throughout the process and tested for resistance to simulated gastric fluid as a measure of coating uniformity and delayed release functionality performance. CONCLUSIONS: The results from both the immediate release and delayed release case studies support the assertion that continuous coating processes are capable of applying aqueous film coatings with significant improvements in coating uniformity and reduction in product loss.