Formulation and evaluation of Amlodipine Besylate orodispersible tablet for the treatment of hypertension

Abstract

The primary aim of this research was to develop and assess orodispersible tablets of Amlodipine besylate for hypertension management. The tablets were formulated using the direct compression technique, incorporating croscarmellose sodium as a superdisintegrant. Various parameters, including friability, hardness, disintegration, wetting time, in vitro drug release, and drug content were evaluated for the tablets. The results for all formulations fell within acceptable limits. Calibration curves of the pure drug were plotted using different solvents such as phosphate buffer pH 6.8 and methanol. Among the formulations F1-F9, this contained varying concentrations of croscarmellose sodium, F7 demonstrated the shortest disintegration time of 37 ± 3 seconds, attributed to the higher superdisintegrant concentration. The in vitro drug release study was conducted in phosphate buffer pH 6.8 at intervals of 5, 10, 15, 20, 25, and 30 minutes revealed that F7 achieved a 98.91% drug release. The findings from this study indicate that orodispersible tablets with an optimal ratio of croscarmellose sodium as a superdisintegrant hold significant potential for the effective treatment of hypertension.