Cutaneous Leishmaniasis (CL) is the most common type of Leishmaniasis which annually affects 1.5 million people worldwide. About 90% of cases are reported from countries such as Iran, Afghanistan, Pakistan, Iraq, and Saudi Arabia. The purpose of the present study was to fabricate transdermal patches of Nigella sativa (NS), characterize and to check its in vitro in vivo anti-Lieshmanial activity. Hydroalcohlic extract was analyzed for preliminary phytochemicals. Five formulations of transdermal patches (NS1, NS2, NS3, NS4 and NS5) were prepared by solvent evaporation method. The optimized formulation NS5 was characterized for FTIR, smoothness, brittleness, clarity, thickness, folding endurance, uniformity of weight, percent moisture content, in-vitro drug release, release kinetics, ex vivo drug permeation and invitro anti-Lieshmanial activity. In vivo anti-Lieshmanial activity was assessed in 30 patients (n = 30) suffering from CL. The FTIR studies showed no incompatibility among the active extract and polymers. In vitro anti-Lieshmanial assay was 194.6 ± 1.88 % as compared to standard drug (p > 0.05) and in vivo anti-Lieshmanial activity was 75 %. The drug release after 24 hours was 87.0 ± 0.94% in NS5 which showed non-Fickian diffusion mechanism while drug permeation across rabbit skin after 24 hours was up to 80.0 ± 0.91%. The results concluded that problems related to the medications parenterally used for Lieshmanial treatment can be managed by applying extract of Nigella sativa seeds in the form of transdermal patch. parasitic, anti-in ammatory, anti-cancer, antibacterial and antifungal activity. 15 Based on the above justi cation, the present study was designed with the aim to formulate and characterize transdermal patches of Nigella sativa extract for possible anti Lieshmanial activity in vitro and in vivo.
Materials And MethodsMethanol, HPMC, Ethyl Cellulose, PVP, PVA (polymers), Propylene glycol, Tween-80, DMSO were purchased from Sigma Aldrich, Germany. Nigella sativa seeds Extract were purchased from local market of D. I. Khan, Pakistan. Benedict's reagent & Wagner's reagent (Iodine Reagent), Chloroform and Distilled Water were obtained from