Process Validation of Beta-Sitosterol Hair Gel Formulation and Evaluation of 5 Alpha Reductase Inhibition In Vitro for the Treatment of Androgenetic Alopecia

The study aimed to develop a β-sitosterol hair gel using carbopol 940 and evaluate its 5α-reductase inhibitory activity for treating androgenetic alopecia. Three batches of the gel were manufactured and compared with a commercial product and finasteride. The gel showed good appearance, homogeneity, and spreadability, with β-sitosterol content meeting label claims. In vitro tests demonstrated significant 5α-reductase inhibition, with an IC50 value of 118.960±0.634 µg/ml for the gel, compared to 88.854±0.70 µg/ml for standard β-sitosterol and 224.372±3.103 ng/ml for finasteride. The β-sitosterol gel formulation is cost-effective, easy to produce, and a promising candidate for further antiandrogenic studies.