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Abstract
This study was undertaken to develop and evaluate various dermatological formulations with optimum drug release and clinical efficacy. Formulations containing 0.5% of Clotrimazole were developed using HPMC gel, cationic and non-ionic emulsion based vehicles. Penetration enhancers including dimethylsulfoxide (DMSO), polyethylene glycol (PEG) and diethylene glycol monoethyl ether (DGME) at various levels were studied. Diffusion studies were carried out with Franz Diffusion Cells. Using a commercial product as a control, all samples were screened on an equal sample weight basis for the drug release through the cellulose membrane. The formulation with the best release pattern was then compared against the commercial product containing I% of the drug and was evaluated using the human cadaver skin.
The general order of drug release from three different vehicles was observed in this following order: HPMC Gel> Cationic Emulsion> Non-Ionic Emulsion system. Among all samples with 0.5% of clotrimazole, the HPMC Gel with 15% DMSO gave the maximum release, where the sample exhibited 8.07% drug release compared to the 4.93% drug release from the control formulation after 2 hour of study period using the Franz Diffusion Cell. This formulation was then further studied using human cadaver skin as a diffusion barrier over a period of 12 hour against a commercial product. Here, the drug release was observed to be 12.62% from the sample and 4.05% from the brand name formulation. This represents greater than 3 folds increase in the drug release while compared against the marketed formulation. This data was also used to calculate various physicochemical parameters that influence drug diffusion.
