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.