02232nas a2200205 4500008004100000245011000041210006900151260001400220300001200234490000700246520151100253653007901764100002801843700001801871700002601889700002501915700002601940700002401966856003601990 2025 eng d00aFormulation Strategy and Excipient Selection for Tribulus terrestris L. Tablets: A Quality-Based Approach0 aFormulation Strategy and Excipient Selection for Tribulus terres cJune 2025 a370-3770 v173 a

Background: To develop and evaluate a tablet formulation containing standardized dry extract of Tribulus terrestris L.—a plant traditionally used in Mongolian medicine—by focusing on excipient optimization and pharmaceutical quality assessment. Methods: Tablets were manufactured using the wet granulation method, incorporating an extract standardized to 54.45% dioscin. Various excipient ratios were investigated to determine the optimal formulation. Dioscin content was quantified using UV-visible spectrophotometry. Results: The optimized formulation comprised 25% dry extract, 34% lactose, 34% microcrystalline cellulose, 6% PVPP, 0.5% magnesium stearate, 0.5% talc, and 4.5% HPMC. The tablets demonstrated acceptable pharmaceutical characteristics, including an average weight of 0.113 ± 0.001 g, hardness of 0.83 ± 0.23 MPa, friability of 98.17 ± 0.65%, and disintegration time of 7.30 minutes. The dioscin content was 13.50 ± 0.50 mg/g, with an assay recovery of 95.51%. Dissolution exceeded 83% in both media within 45 minutes. The similarity factor (f₂) confirmed equivalent dissolution profiles. Conclusion: The developed T. terrestris tablet formulation met pharmacopoeial standards and exhibited consistent physical, chemical, and biopharmaceutical performance, supporting its potential as a standardized herbal medicinal product for clinical and commercial application.

10aTribulus Terrestre’s L.; tablet; excipients; saponins; spectrophotometer1 aDovchinsuren, Baigalmaa1 aHu, Wang, Qin1 aDambiinyam, Jambaninj1 aMukhtar, Yerkyebulan1 aDamdinjav, Davaadagva1 aDorjbal, Enkhjargal uhttps://phcogj.com/article/2512