Formulation and Evaluation of Controlled Release Matrix Tablets of Sotalol

Abstract

The present study aimed at Formulation Development and Evaluation of controlled release tablets for the programmed release of sotalol hydrochloride for the treatment of Arrhythmia. The matrix tablets of sotalol hydrochloride were prepared using wet granulation. Physical characterization of tablet and powder blends used to form the matrix tablet was under taken using a range of experimental techniques. Instacoat EN II was used as enteric coat polymer for coating the matrix tablet. Dissolution studies of sotalol hydrochloride controlled release tablets in media with different dissolution media 0.1 N HCl, pH (7.4) as per US Pharmacopeia. The study showed that, drug release in 2hr was highly affected by the coating level. The dissolution data revealed that the % of coating, ratio of polymers and concentration of Compritol 888 ATO are very important to achieve a optimum formulation. Dissolution shows that the drug release from F12 is very similar to Marketed brand (Sotalar). Stability study of the optimized formulation indicates no significant difference in release profile after a period of one month.