Formulation Optimization, Preliminary Phytochemical Characterization, and Comparative Quality Evaluation of Gymnema sylvestre (Retz.) R.Br. Extract Tablets

Abstract

Aims: To formulate Meshashringi tablets containing a hydroalcoholic extract of Gymnema sylvestre leaves and to establish a preliminary quality profile using pharmaceutical, physicochemical, phytochemical, spectroscopic, and chromatographic evaluation. Study Design: Laboratory-based formulation development, response-surface optimisation, and comparative quality evaluation. Place and Duration of Study: The study was conducted in the Department of Pharmaceutics and Quality Assurance, Shivaji University, from November 2025 to April 2026. Methodology: Meshashringi tablets were prepared by direct compression. The powder blends were assessed for flow and compressibility, and the tablets were evaluated for weight variation, hardness, friability, thickness, disintegration, and in vitro dissolution. Microcrystalline cellulose and crospovidone were investigated as formulation variables, with hardness, friability, and disintegration time as responses. Preliminary phytochemical screening, Fourier transform infrared spectroscopy, total flavonoid estimation, and high-performance thin-layer chromatography using quercetin as a reference marker were also performed. The optimised laboratory formulation was compared with a marketed Meshashringi tablet. Results: The optimised formulation showed a hardness of 5.91 ± 0.02 kg/cm², friability of 0.45 ± 0.02%, and disintegration time of 4.02 ± 0.5 min. The laboratory and marketed tablets released 88.09 ± 0.27% and 90.41 ± 0.24%, respectively, at the final sampling point. Total flavonoid contents were 4.79 and 5.18 mg quercetin equivalents/g for the laboratory and marketed tablets, respectively. High-performance thin-layer chromatography showed an Rf value of 0.61 for standard quercetin and the laboratory tablet; the marketed tablet value reported in the comparative table was 0.69. The fitted formulation models indicated that microcrystalline cellulose principally increased tablet hardness, whereas crospovidone reduced disintegration time. Conclusion: The study established a preliminary pharmaceutical and phytochemical quality profile for the developed Meshashringi tablet. The formulation showed acceptable mechanical characteristics, rapid disintegration, and a dissolution pattern close to that of the marketed comparator at the sampled time points. The findings support further development of the formulation, while validated marker quantification, stability testing, and biological evaluation remain necessary before therapeutic equivalence, safety, or clinical effectiveness can be inferred.