FORMULATION DESIGN, DEVELOPMENT AND EVALUATION OF QUERCUS INFECTORIA GALLS EXTRACT ORAL GELS

The objective of the study is to design, formulate and evaluate an oral gel containing Q. infectoria galls extract for its anti-Candida activity. The gel formulation was designed by using carbapol 940 and xanthan gum as gel forming polymers, propylene glycol, methyl paraben, propyl paraben and required amount of distilled water. The pH  was maintained by drop wise addition of Tri-ethanolamine. Eight different gel formulations (F1 to F8) were prepared by dispersion method, using different concentrations of carbopol 940 for carbopol 940-based oral gels (F1and F2), and combined with xanthan gum as secondary gelling polymer for combined polymer-based formulations (F3-F8) have been prepared to study the individual effect of two polymers as well as polymer concentrations, and they were evaluated using official and non-official experiments including organoleptic properties, pH, spreadability, extrudability and viscosity, in vitro release and drug content uniformity. The stability study for the developed gel formulation was done as per ICH guidelines and antifungal activity was evaluated by paper disc diffusion method. The overall pharmaceutical acceptability were satisfactory for the developed oral gels regarding chemical and physical investigations. The viscosity of oral gels was significantly (P<0.05) affected by both of polymer concentration and polymer type, also the developed oral gel formulations exhibited antifungal activity against C. albicans, it was observed that the biological activity of prepared oral gels significantly (P=0.03) increases with decreasing polymers concentration. The accelerated stability testing indicated that all formulations showed a good stability, thus providing a safe and stable gel delivery system. The pharmaceutical evaluations and in vitro results showed that oral gel formulations can be a potential candidate for the delivery of Q. infectoria galls ethanolic extract to the oral cavity, with better in vitro characteristics, physicochemical properties and pharmacological activity, using carbopol 940 alone and in combination with xanthan gum as drug carriers.