Manufacture of spherical granules of isosorbide dinitrate with modified release

Abstract

Objective: This study was aimed to obtain spherical matrix pellets of isosorbide dinitrate with different dissolution kinetics to create a multidosage medicinal form with controlled release of the active substance. Material and Method: Spherical matrix granules were obtained by extrusion-spherinization and coated with different amounts of polymer shell. Dissolution profiles of the obtained spheroids were compared with reference drug tablets. Result and Discussion: The results showed that the combination of spherical granules provides an isosorbide dinitrate release profile similar to the dissolution of Cardicet Retard tablets. The target dissolution profile is achieved using a combination of uncoated spherical granules and spheroids with a 10% film coating. The similarity coefficient (f2) is 73.6.