Resumen

The invention relates to a novel method of obtaining water-dispersible albumin microspheres containing amphotericin B. The invention is based on the atomisation of the albumin with the drug that is to be microencapsulated. The inventive method does not require the pre-formation of an emulsion and is, therefore, of great interest in the industrial field, since the use of oils and organic solvents can be avoided. The aforementioned atomisation is a quick and continuous process which can be performed under aseptic conditions, such that products suitable for parenteral administration can be obtained. The microspheres obtained have a small particle size (generally less than 5 micrometers) and can be dispersed in water, thereby enabling same to be administered intravenously. Studies carried out on test animals have shown that the novel amphotericin B formulation is less toxic than that currently sold as Fungizona(R) and is more effective for the treatment of experimental leishmaniasis in hamsters.