Optimization of curcumin loaded vaginal in-situ hydrogel by box-behnken statistical design for contraception

Abstract

Sexually transmitted infections and unplanned pregnancies present a great risk to the reproductive health of women. Therefore, female-controlled vaginal products directed toward disease prevention and contraception is needed urgently. The purpose of this investigation was to develop poloxamer based thermo sensitive contraceptive vaginal in situ hydrogel of curcumin, a plant-derived diferuloylmethane compound. Different formulations using different ratio of poloxamer 407/188 and mucoadhesive polymer - HPMC K4M were prepared and optimized by box behnken experimental design (BBD). Formulations were optimized on the basis of gelation temperature (°C), gel strength (gm/cm2), Mucoadhesive strength (dyne/cm2), viscosity (Pa) and % drug release. Optimized formulation was subjected to In Vitro sperm immobilization study on 5 fertile human volunteers’ ejaculate sample. The quantitative effect of independent variables on dependent variables at different levels could be predicted by polynomial equations. From BBD, that batch containing 19.96% Poloxamer 407, 3.83% Poloxamer 188, 0.91% HPMC K4M was optimized. Total 100% Sperm immobilization was achieved within 15 min by optimized formulation for 3.5 ml of dose. Stability study of optimized batch shows no change in physical and chemical characteristics. Curcumin would be successfully formulated as thermo sensitive In Situ gelling mucoadhesive system for contraception.