Formulation Development And In Vitro Characterization of Orally Disintegrating Tablets for Enhanced Antihypertensive Drug Delivery

<p><span>Many individuals—including the elderly, young children, and patients with certain medical conditions—face difficulties in swallowing conventional tablets. Fast-disintegrating tablets (FDTs) provide a convenient and patient-friendly alternative, as they dissolve quickly in the mouth without the need for water, thereby improving patient compliance and adherence to prescribed regimens. This study aimed to formulate and evaluate fast-disintegrating tablets of amlodipine, a widely prescribed antihypertensive medication. Tablets were prepared using the direct compression method, with polyvinyl pyrrolidone (4%) employed as a dry binder. Different formulations were developed by varying the proportions of two super disintegrants: sodium starch glycolate (SSG) and crospovidone. Each formulation underwent comprehensive in-vitro evaluation, including tests for hardness, thickness, friability, weight variation, disintegration time, drug assay, and dissolution profile. The results demonstrated an inverse relationship between the concentration of super disintegrants and disintegration time. Among all formulations, F8 (containing 5% crospovidone) exhibited the shortest disintegration time of 18 seconds, while F1 (containing 2% SSG) had the longest disintegration time of 1 minute and 5 seconds. All evaluated parameters were within acceptable pharmacopoeial limits. FT-IR spectral analysis confirmed the absence of any chemical interaction between amlodipine and the selected excipients, indicating compatibility of the formulation components. In conclusion, this research highlights the successful development of a fast-disintegrating tablet of amlodipine using the direct compression technique. The combination of crospovidone and SSG, particularly at optimized concentrations, significantly enhanced the disintegration </span><span lang="EN-GB">performance, offering a promising strategy for improving the administration of antihypertensive therapy in patients with swallowing difficulties.</span></p>