FORMULATION DEVELOPMENT AND EVALUATION OF AQUEOUS POLYMER DISPERSIONS (PELLETS) FOR EXTENDED RELEASE DOSAGE FORMS OF GALANTAMINE HYDROBROMIDE

Abstract

In this study, a novel approach for compression of matrix pellets into matrix tablets has been studied in an attempt to overcome the issues pertaining to rupture of polymer coat during compression of reservoir type pellets. Extended release matrix pellets were prepared by the extrusion/spheronization technique using commercially available aqueous dispersions of ethyl cellulose, acrylic polymers and sodium alginate at 10 %, 20 % and 30 % w/w levels. Galantamine Hydrobromide was used as the model drug and an in vitro release profile of 12 h was targeted. Tablets containing matrix pellets were prepared by the direct compression process. Acceptance Value, a pharmacopeial test, was applied to study the uniformity of drug distribution. Effect of compression force (2-6 kN), extrusion screen aperture size, diluent blend composition and pellet percentage on drug release and acceptance value were studied. As polymer is uniformly distributed within each pellet, the drug release pattern from uncompressed pellets was comparable to compressed tablets. The pellet segregated from the surface of the tablet was found to be flattened in the direction of applied compression force with minor deformities. In conclusion, matrix pellets can constitute an alternative approach to reservoir-type pellets in obtaining matrix tablets for extended delivery of drugs.