The Solubilization of Drug and Excipient Into a Hydroxypropyl Methylcellulose (HPMC)-Based Film Coating as a Function for the Coating Parameters in a 24” Accela-Cota®

Abstract

During the aqueous film coating of tablets, components of tablets tend to migrate to the film coating. This migration is enhanced if a component is soluble in the coating solution and also depends on the spray condition used during the coating operation. In this study, a 2³ orthogonal factorial design was used to study the migration of drug and stearic acid from a tablet to an aqueous-based cellulose coating solution. The independent variables evaluated were atomization air pressure, inlet air temperature, and spray rate. Differential scanning calorimetry was used to quantitate the presence of guaifenesin and stearic acid in the film coating. In the 24″ Accela Cota that was used on our experiment, only spray rate and inlet air temperature influenced the migration of drug and stearic acid the film coating.