Formulation and physico-technical evaluation of a fixed dose combination of amlodipine and spironolactone in the management of hypertension

A fixed dose combination (FDC) product is the resulting product of a combination of more than one active pharmaceutical ingredients from different classes combined into a single dosage form. A total of 3 batches of amlodipine (ADB) and spironolactone (SPRN) have been formulated employing various excipients at different concentrations. Pre-compression studies such as angle of repose, bulk and tapped density, and post- compression evaluation such as: weight variation, hardness, friability. In-vitro release study were similarly evaluated using standard procedures. All the evaluation parameters such as weight variation, hardness, friability and in-vitro release study were within the official acceptable limits. The release of ADB was 58 % (2 % binder), 55.58 % (4 % binder) and 55.78 % (6 % binder) after 10 min and gradually increased to 100 % drug release before 30 min of study; while release of SPRN was 48.64 % (2 % binder), 52.83 % (4 % binder) and 33.32 % (6 % binder) after initial 10 min and achieved 100 % release after 20 min of study. The FDC formulation of ADB/SPRN into an oral solid dosage form (tablet) was successful. The results of the physicochemical properties evaluated show a promising novel formulation for possible fixed dose combination of these molecules in the management of hypertension.