Effect of Formulation Ingredients on Spironolactone 5% Emulgel

Background and Hirsutism, the growing unwanted terminal hair, is one of the disorders which affect life style. Spironolactone is one of the common drugs used in treatment of hirsutism. Topical preparation has been focused in many researches due to side effects after oral administration. In this study, the effect of formulation ingredients on spironolactone emulgel characteristics was evaluated. Carbopol TR2 was used as polymer in this study. The effects of aqueous and oily phase ingredients were also investigated. Physical properties of emulgels were studied for two months. Dissolution of drug was evaluated using USP apparatus No. II dissolution tester. Then the prepared material was filled in membrane sac (27 Kd) and drug release was studied for 24 hours. Diffusion cell and mice skin were used for percutaneous absorption evaluation. The drug release was determined by UV spectrophotometer method. The drug release and percutaneous absorption data were fitted in zero order, first order, and Higuchi model for kinetic evaluation. The results showed that emulgels containing glycerin were not stable. We also observed the effects of polymer content on the quality of prepared material. The drug release was decreased by increase in polymer content (P<0.01). The pH of final preparations was near to skin pH value. The percutaneous absorption study showed that the dug was 39.61% ± 4.2 absorbed during 24 hours. This study showed polymer, type and amount of vehicle effect on spironolactone emulgel characteristics. The dissolution and transdermal absorption showed that this product could be used as suitable topical preparation.