Development and Standardization of Herbal Tablets Containing Withania somnifera (Ashwagandha)

Abstract

The present investigation was aimed at the formulation, standardization, and evaluation of herbal tablets containing hydroalcoholic extract of Withania somnifera (Ashwagandha) roots in order to develop a stable, pharmaceutically acceptable, and therapeutically effective herbal dosage form with improved patient compliance and quality characteristics. Dried roots of Withania somnifera were subjected to hydroalcoholic extraction using maceration technique. The obtained extract was evaluated for organoleptic, physicochemical, and phytochemical characteristics. Preliminary phytochemical screening was carried out to identify the presence of major secondary metabolites. Herbal tablets were formulated by wet granulation method using suitable pharmaceutical excipients including microcrystalline cellulose, starch, talc, and magnesium stearate. The prepared granules were evaluated for pre-compression parameters such as bulk density, tapped density, Carr’s index, Hausner ratio, and angle of repose. The compressed tablets were further evaluated for post-compression parameters including weight variation, hardness, friability, thickness, drug content uniformity, and disintegration time. Accelerated stability studies were performed according to ICH guidelines. The hydroalcoholic extraction process yielded satisfactory quantity of extract rich in biologically active phytoconstituents. Phytochemical screening confirmed the presence of alkaloids, flavonoids, tannins, glycosides, phenolic compounds, steroids, and saponins. Physicochemical evaluation of the crude drug demonstrated acceptable moisture content, ash values, and extractive values. The formulated granules exhibited satisfactory flow properties and compressibility characteristics. The herbal tablets showed acceptable pharmaceutical quality control parameters with uniform weight variation, adequate hardness, low friability, satisfactory drug content, and appropriate disintegration time. The stability studies revealed no significant changes in tablet appearance, hardness, friability, or drug content during the storage period, indicating satisfactory stability of the formulation. The present study successfully demonstrated the development and standardization of herbal tablets containing Withania somnifera root extract. The prepared formulation exhibited satisfactory physicochemical properties, pharmaceutical quality characteristics, and stability profile. The developed herbal tablets may therefore serve as a promising adaptogenic dosage form for stress management and overall wellness.

Keywords: Withania somnifera, Ashwagandha, Herbal tablets, Adaptogen, Standardization, Phytochemical screening, Herbal formulation, Quality control