Preparation of pellets containing highly soluble drug by extrusion/spheronisation and coating with Kollicoat® SR 30D

Abstract

The aim of this study was to prepare and evaluate the pellets, containing a highly soluble drug (ascorbic acid), by the extrusion-spheronization process and coated with a release controlling polymer. The coating (undertaken in a fluid bed) was applied to three batches of the pellets with a dispersion of Kollicoat® SR 30 D, with each batch of pellets receiving a different level of polymer (5.07; 8.26 and 10.35%). The coated pellets were evaluated for sphericity by imaging analysis and comparative dissolution profile with a product commercially available in Brazil. All of the evaluated samples presented adequate physical properties and the dissolution profile of those coated with 5.07% of polymer proved to be similar to that of the commercially available brand name.