Leishmanicidal Activity of Films Containing Paromomycin and Gentamicin Sulfate both in Vitro and in Vivo

Background: based on the efficacy of paromomycin ointment and recent ongoing clinical trials of combination of paromomycin and gentamicin, a new physical form of films of the paromomy- cin and gentamicin was prepared and anti-leishmania activities of the prepared films were as- sessed in vitro and in vivo. methods: paromomycin 15% and gentamicin 0.5% was incorporated in a film using ethyl cellu- lose and hpmc (hydroxyl propyl methyl cellulose). in order to assess the drug release and anti- leishmania activities of the preparation, a clone l. major parasite was established using a set of modified nnn medium without overlay liquid layer. therapeutic effects of the films were evalu-ated using balb/c mice model. the mice were inoculated with 2×10^6 l. major promastigotes (mrho/ir/75/er) and then when the lesions developed the mice were randomly divided in 3 groups, 10 mice per group, and treated with either perpetrated films or placebo for 28 days or left untreated. results: growth inhibition of cloned promastigotes showed that the films have enough releasing capacity and in vivo system, the films containing paromomycin and gentamicin was able to re- duce the lesion size and induced complete cure in 80% of the mice but relapse was seen in 60% of the cured mice and overall 50% cure rate was seen during 20 weeks period of the study. conclusion: it seems that the prepared films might be further used in human clinical trials.