Assessment of Mini-Tablets Coating Uniformity as a Function of Fluid Bed Coater Inlet Conditions

Abstract

This study concerned the quality of mini-tablets’ coating uniformity obtained by either the bottom spray chamber with a classical Wurster distributor (CW) or a swirl distributor (SW). Mini-tablets with a diameter of 2.0, 2.5, and 3.0 mm were coated with hypromellose using two different inlet air distributors as well as inlet airflow rates (130 and 156 m3/h). Tartrazine was used as a colorant in the coating layer and the coating uniformity was assessed by spectrophotometric analysis of solutions obtained after disintegration of the mini-tablets (n = 100). Higher uniformity of coating material distribution among the mini-tablets was observed in the case of SW distributor, even for the biggest mini-tablets (d = 3.0 mm), with an RSD no larger than 5.0%. Additionally, coating thickness was evaluated by colorimetric analysis (n = 1000), using a scanner method, and expressed as a hue value. A high correlation (R = 0.993) between inter-tablet variability of hue and UV-Vis results was obtained. Mini-tablets were successfully coated in a fluid bed system using both a classical Wurster distributor as well as a swirl generator. However, regardless of the mini-tablets’ diameter, better film uniformity was achieved in the case of a distributor with a swirl generator.