Evaluating the potential of polyester nanoparticles for per oral delivery of amphotericin B in treating visceral leishmaniasis.

Leishmaniasis is a protozoan disease, which is responsible for response for major epidemics in many parts of the World. Amphotericin B (AMB) is one of the drugs used to treat leishmaniasis but it must be given intravenously and serious side effects such as nephrotoxicity can limit its use. Development of a formulation of AMB, which can be given by a non-invasive route but is still as effective as the conventional formulation, whilst causing minimal adverse side effects, is required. The present study describes a method for scale up production of a per oral nanoparticle formulation of AMB (AMB-NP) and compared its efficacy both in vitro and in vivo against Leishmania donovavni. Prophylactic studies showed that the AMB-NP formulation was significantly more effective (p < 0.05) than the same dose of AMB solution at suppressing parasite numbers compared to controls in bone marrow derived macrophages infected with L. donovani. Per oral treatment with AMB-NP resulted in a significant reduction in liver parasite burdens (p < 0.05) compared to control values and the formulation had a similar antileishmanial activity against parasites with different inherent susceptibilities to sodium stibogluconate.