Abstract:
The present study was conducted to formulate and evaluate microemulsion based
vaginal gel of Econazole nitrate. The solubility of Econazole nitrate in various oils,
surfactants and co-surfactants was evaluated to identify components of
microemulsion. Pseudoternary phase diagrams were constructed using oleic acid as
the oil, Tween 80 as the surfactant and PEG 200 as the co-surfactant for the
formulation of microemulsion. For optimization, 32 factorial design was applied to
investigate the combine effect of dependant variables/factors as amount of oil
concentration and Surfactant:Co-surfactant (S:CoS) concentration and globule size, %
drug release and Zeta potential selected as dependant Variables/responses. The
prepared batches of Microemulsion were evaluated for various parameters such as
transparency, dilutability, pH, globule size, zeta potential, drug content and % drug
release. Various gelling agents were evaluated for their gelling capacity to incorporate
them into microemulsion. Carbopol 934 P was selected as gelling agent to formulate
microemulsion based gel (MBG). MBG was evaluated by checking its pH, viscosity, spreadability, gelling strength, and in vitro drug release studies. The Bioadhesive
potential and antifungal activity of Econazole nitrate MBG was determined and
compared with marketed cream. The vaginal irritation potential of Econazole nitrate
MBG was evaluated in female rabbits. Econazole nitrate MBG showed good in vitro
bioadhesion and antifungal activity. The Econazole nitrate MBG did not show any
signs of vaginal irritation in rabbits. The MBG followed korsmeyer-peppas model for
in vitro drug release and gave extended release from Econazole nitrate MBG.
