Optimisation of polyherbal gels for vaginal drug delivery by Box-Behnken statistical design.

The present research work aimed at development and optimisation of mucoadhesive polyherbal gels (MPG) for vaginal drug delivery. As the rheological and mucoadhesive properties of the gels correlate well to each other the prepared MPGs were optimised for maximum mucoadhesion using a relationship between the storage modulus (G') and Gel Index (GI), by employing a 3-factor, 3-level Box-Behnken statistical design. Independent variables studied were the polymer concentration (X(1)), honey concentration (X(2)) and aerosil concentration (X(3)). Aerosil has been investigated for the first time to improve the consistency of gels. The dependent variables studied were the elastic modulus, G'(Y(1)), gel index (Y(2)), and maximum detachment force (Y(3)) with applied constraints of 500<or=Y(1)<or=700 and 4<or=Y(2)<or=5. Response surface plots were drawn, statistical validity of the polynomials was established and optimised formulations was selected by feasibility and grid search. Three types of Carbopol studied were Carbopol 934P, Carbopol 974P and Polycarbophil. In vitro release studies were carried out for the optimised formulations and the data were fitted to release kinetics equations. Validation of the optimisation study with 8 confirmatory runs indicated high degree of prognostic ability of response surface methodology. Gels showed a gradual sustained release by a non-Fickian diffusion process. Incorporation of aerosil to gels was found to improve the rheological and mucoadhesion properties by about 50-54% and 7-11%, respectively. The Box-Behnken design facilitated the optimisation of polyherbal gel formulations for enhanced vaginal drug delivery by optimum mucoadhesion and longer retention.