The oral solid dosage form of solid lipid nanoparticles (SLN). loaded with Amphotericin B having LD50 of atleast 200mg/kg in mice and process for making the same have been described. The method used for making present composion is a modified nanoprecipitaton process. It essentially requires dissolving Amphotericin B in organic solvent and dispersing Amphotericin B solution, lipid and emulsifler in an aqueous phase. The process of present invention is simple, cost effective and gives a stable product suitable for oral administration. Amphotericin B SLN compositions prepared by the process of the present invention may be administered orally to human beings for the treatment of fungal infections and second line treatment of leishmaniasis with substantially equivalent or greater efficacy and low drug toxicity as compared to the conventional parenteral composition containing Amphotericin B and sodium desoxycholate.
