Currently available gels like hydrogel and other have their physical stability issues as the polymers tend to coagulate or degrade during storage in high temperature countries. It is also not practical advisable to store such external preparations in refrigerator. Gels prepared with fumed silica are thermally independent as such these gels do not change their rheological properties even at high temperature. Gel formulations of fluconazole for topical application were prepared by using different percentages of Aerosil 200 Pharma (colloidal silicon dioxide) as a gelling agent. The poor water solubility of fluconazole was overcome by cosolvency approach using 10:10:15 ratio of water, propylene glycol and polyethylene glycol, respectively. FTIR studies revealed that there was no interaction between fluconazole and gelling agent. The formulated fluconazole gels were evaluated for physical appearance, drug content, pH, spreadability, extrudability, viscosity, in-vitro antifungal studies and found satisfactory. In-vitro release studies were carried out by Franz diffusion cell using phosphate buffer, pH 7.4 at 50 rpm. The cumulative drug released from formulation F-6 (9% of Aerosil 200 pharma) was found to be 99.98% after 90 minutes. Stability studies were conducted for the optimized formulation F6 as per ICH guidelines for a period of 90 days by storing at different temperatures (4 ± 2 °C, room temperature and 40±2 °C) and results showed that formulation was stable. A simple, accurate and precise stability indicating HPLC and TLC analytical method was developed for the analysis of Fluconazole gel formulations. Fluconozole gels prepared with Aerosil 200 pharma performed better than marketed gel, leading to improved thermal stability and efficacy.
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