Formulation, Optimization and Evaluation of Clobetasol Propionate Gel

Objective: The present study was aimed to develop topical gel of Clobetasol propionate with the help of carbopol-934 and Hydroxypropyl methylcellulose K4m as gelling agents. Polymers play major role in various characterization parameters of topical gel such as in vitro release and rheological properties. Methods: Gels were prepared with carbopol-934 and Hydroxypropyl methylcellulose K4m as gelling agents. In all the gels formulated, the drug concentration was kept constant at 0.05%. The concentration of propylene glycol and ethanol was kept constant at 15% and 40 % respectively. Propylene glycol served as a co-solvent for drug. The concentration of carbopol-934 and Hydroxypropyl methylcellulose K4m was selected as independent variables and optimised using a 32 full factorial design. The percentage drug release after 8 hours (Q8) and Viscosity were selected as dependent variables. The optimized gel formulation was evaluated for various physical parameters. Mathematical models were applied to predict the mechanism of drug release. Results: The optimized gel passed the evaluation tests. A marked effect of independent variables (concentration of carbopol-934 and Hydroxypropyl methylcellulose K4M) was observed on the values of percentage drug release (Q8) and Viscosity. A drug release of 91.02±0.32 % was achieved after 8 hours. The optimised gel formulation followed first order kinetics. Stability studies indicated no changes in the formulation. Conclusion: The study indicated that the polymer concentration significantly affects the drug release and rheological properties of the gel formulation. The study holds promise for further investigation in the development stable topical gels of clobetasol propionate.