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A.Bharathkumar*, C. Velmurugan, P.R. Logesh Kumar and SK. Shajahan


The main aim of present work is to develop a new topical formulation Tretinoin cream (0.05%) a category of acne products which was prepared by using different concentrations of penetration enhancers by fusion method. All the formulations were evaluated for various physicochemical parameters such as solubility, loss on drying, stability, pH, and in vitro drug release as well as skin irritation test (DRAIZE PATCH TEST) on rabbits. Rabbits were differentiated into five groups each consisting of one. The five formulations containing different percentage of penetration enhancer was applied to the skin and erythema was noted. The Result of skin irritation test shows that F1and F2 formulations does not exhibit any kind if erythema upto 48 hours and F3 reveal light changes (Pink color) in skin color at 36 hours but F4, F5 shows significant changes in 18 and 6 hours of application in rabbit. The in vitro drug release revealed that drug release was increased with increasing of penetration enhancer but among the five formulations, third formulation was shows optimum level of drug release and physiochemical properties were within the specified limit as per standard specification. So the present study shows that the third formulation is the best formulation.

Keywords: Tretinoin, loss on drying, stability, pH, in vitro drug release and Draize patch test.

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