• Mulugeta Bezabeh Andhra University



Objective: The objective of the present investigation was to formulate and evaluate combination of amphotericin B and miltefosine loaded nanovesicles  to be used in the treatment of visceral leishmaniasis.
Method: Amphotericin B (AmB) and miltefosine (MTF) combination loaded nanovesicles were prepared by ethanol injection method. Formulations of nanovesicles were evaluated at varying conditions of stirring rate,  composition of  lipids, drug loading and ethanol/ aqueous ratio on response variables of drug entrapment efficiency (DEE) and particle size.
Results: The study revealed that especially DEE was significantly affected (p < 0.01) by the effects of composition of lipids,  drug loading ,  ethanol /water ratio,  and stirring rate. Particle size of the nanovesicles was significantly affected (p < 0.05) by drug loading and stirring rate. An optimal formulation of AmB/MTF nanovesicles was prepared at selected values of formulation variables-  phosphatidylcholine (PC) /Cholesterol/Stearic acid 20/4/1, drug/ lipid 1:8, AmB/MTF 1:1;  and ethanol /water 1:4 ratios,  and stirring rate 1000 rpm. This  nano vesicular formulation  of AmB/MTF 1:1 combination showed particle size of 145.6 nm, poly dispersity index (PDI) 0.19, zeta potential -27.3 mV and DEE 87 %.
Conclusion: Evaluation of the AmB/MTF 1:1 nanovesicles showed a successful  formulation with very good compatibility, extended drug release, convenient particle size  and high drug entrapment efficiency. To conclude, AmB/MTF nanovesicular formulations could be a safe and reliable therapeutic option over conventional AmB/MTF combination therapy.
Keywords: Key words: Nanovesicles; AmB/MTF; Ethanol injection method; Leishmaniasis.


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