Intravaginal administration of metformin HCL loaded nanoemulgel for treatment of PCOS: in-vitro and in-vivo study

Metformin HCL (MET-HCL), is a Biguanide derivative, most effective agent in treatment of PCOS. The focus of the present study was on developing and optimizing a nanoemulsion formulation. of MET-HCL and convert into intravaginal MET-HCL Nanoemulsion Gel (MET-HCLNE GEL) To enhance the therapeutic efficacy in managing PCOS. The nanoemulsion was formulated using water titration method and evaluated for droplet size, zeta potential, polydispersity index (PDI), drug content, viscosity, and morphology. Then incorporated into gel and evaluated for pH, drug content, viscosity, in-vitro release & in-vivo study. The formulation MET-HCLNE 1 showed the desired droplet size (45.60 ± 1.7 nm), PDI (0.198 ± 0.2), zeta potential (22.4 ± 0.3), drug content (89.19 ± 0.2 %) and viscosity (42.85 ± 2.1 cp). In in-vitro release, MET-HCLNEGEL showed significant prolonged release over MET-HCL solution. Intravaginal MET-HCLNE GEL showed significant efficiency against PCOS compared to oral administration in female Wistar rats. No significant changes were found in the values of viscosity, drug content and pH over the period of 120 days. Thus, MET-HCLNE GEL was found to have good potential to function as an Intravaginal formulation & having great PCOS activity and good storage stability.