Tolnaftate is a topically used antifungal agent, having specific and significant fungicidal effect on trichophyton, microsporum and epidermophyton. It has a history of 50 years of usage and still remains one of the most potent drugs for treatment of Tinea Pedis, which affects approximately 10% of the population. Tolnaftate is a BCS class IV drug. It possesses poor water solubility and high hydrophobicity which leads to low permeability. Such drugs pose a challenge in development of topical drug delivery system. Hence, for solubilization of tolnaftate, formulation of emulsion appeared to be a viable approach. Emulsions have gained lot of attention for delivery of hydrophobic agents for local treatment; because of its ability to increase solubility, permeability of drug. In the global market tolnaftate is available in the form of solutions, aerosols, powders and creams (in form of suspension); while no emulgel dosage forms with dissolved tolnaftate are available till date. Thus the present work was done with an objective to formulate tolnaftate (1% w/w) in the form of emulgel, containing emulsion of the drug, with a view to achieve main objective, To design a stable topical dosage form of tolnaftate that will effectively release drug for prolong period time. Tolnaftate emulgel was prepared by dispersing carbopol 934 in purified water with constant stirring at moderate speed, the pH was adjusted to 6-6.5 using tri ethanol amine (TEA). 32 factorial design was applied for the formulation of emulgel. Evaluation of tolnaftate emulgel was carried out for physical appearance, pH, spreadability, Rheological study, drug content, in-vitro release study of all formulation F1-F9. Optimization was done by design expert software trial version 8.0.0.6. % Drug release and viscosity was consider as response for this and according to design expert F3 batch was selected as optimized batch and optimized batch was evaluated for the skin irritation test, antifungal study (zone of inhibition), stability study and fitting result into different kinetic equations was also carried out. From this study it was concluded that optimized batch having good release and no skin irritation on rats skin, drug release follow zero order kinetic and the formulation was stable at room temperature.
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