Formulation And In-Vitro Evaluation of Simvastatin Matrix Tablets Using Nelumbo Nucifera Leaf Mucilage as A Release Retardant

Abstract

The present study investigated the formulation and in-vitro evaluation of sustained-release matrix tablets of simvastatin using Nelumbo nucifera leaf mucilage as a natural release-retarding polymer. Six formulations (F1–F6) containing 20 mg simvastatin were prepared by wet granulation, with mucilage concentrations ranging from 5 to 30 mg per 100 mg tablet. Microcrystalline cellulose was used as diluent and magnesium stearate as lubricant. Granules were evaluated for bulk and tapped density, compressibility index, Hausner ratio and angle of repose. Tablets were assessed for weight variation, hardness, thickness and friability. The reported granule data showed bulk density values of 0.42–0.52 g/cm³, tapped density values of 0.52–0.62 g/cm³ and angles of repose of approximately 30.15–33.62°. Tablet friability was reported between 0.12 and 0.35%, while hardness ranged from 6.32 to 7.55 kg/cm². In-vitro dissolution data showed 52.19% release from pure simvastatin at 960 min. Formulation F6 released 91.36% at 960 min, whereas F5 released 98.45% at the same time point. The thesis reports F6 as the formulation with the most prolonged release and describes first-order and Korsmeyer–Peppas models as suitable release models; however, the supplied kinetic table does not fully establish a single best-fit model without additional model details. Overall, the findings suggest that Nelumbo nucifera leaf mucilage may be explored as a matrix-forming release retardant. Data inconsistencies and missing methodological details must be verified against original laboratory records before submission.