Development and Evaluation of Eprosartan Immediate Release Tablet Physical Characterization and in Vitro Drug Release Studies

Abstract

A chronic cardiovascular disease, hypertension is one of the main causes of morbidity and death globally. Although eprosartan mesylate, a selective angiotensin II receptor blocker (ARB), is frequently recommended to treat hypertension, its low oral bioavailability (about 13%) and poor water solubility limit its clinical efficacy. Eprosartan mesylate immediate-release mouth dissolving tablets (MDTs) were developed and evaluated in this study in order to increase the drug's rate of dissolution, boost its bioavailability, and guarantee a prompt commencement of therapeutic activity. The suitability of drug–excipient combinations was confirmed by preformulation tests that included organoleptic characteristics, melting point, and solubility, loss on drying, partition coefficient, UV spectroscopic analysis, calibration curve development, and FTIR compatibility investigations. Using crospovidone as a superdisintegrant in different doses, MDTs were created using the direct compression approach. Mannitol, microcrystalline cellulose, sodium saccharin, HPMC, talc, and magnesium stearate were also used. While the prepared tablets were assessed for hardness, thickness, friability, weight variation, drug content uniformity, wetting time, water absorption ratio, and in vitro drug release, the powder blends were subjected to precompression parameters like angle of repose, bulk density, tapped density, Carr's index, and Hausner's ratio. When compared to traditional dose forms, optimised formulations demonstrated much better dissolving behaviour and quick disintegration within 30 seconds. While stability experiments carried out in accordance with ICH recommendations showed that the formulations were stable without any discernible changes in physicochemical attributes, FTIR analysis verified that there were no significant drug–excipient interactions. According to the study's findings, eprosartan mesylate mouth-dissolving tablets present a viable substitute for traditional tablets, enhancing patient adherence, treatment effectiveness, and the general control of hypertension.