STABILITY OF AMPHOTERICIN-B IN AN EXTEMPORANEOUSLY PREPARED IV FAT EMULSION

Tile stability of amphotericin B in an extemporaneously prepared i.v. fat emulsion was studied. Admixtures of amphotericin B 0.5, 1, and 2 m g/mL were prepared by adding 10, 20, and 40 mt of amphotericin B 5 mg/ mL to 90, SO, and 60 mt, respectively, of 20% fat emulsion. The admixt ures were stored in glass vacuum containers al 20-25 degrees C and exp osed to fluorescent light, 20-25 degrees C and protected from light, o r 4-8 degrees C and protected from light. A sample was withdrawn from each container at 0, 4, 12, and 24 hours and at 2, 4, 7, and 15 days f or analysis of amphotericin B concentration by high-performance liquid chromatography and for visual evaluations; these samples were immedia tely frozen until analyzed. A sample was withdrawn from one container of amphotericin B I and 2 mg/mL for each storage condition at 0, 7, an d 15 days for immediate determination of particle-size distribution wi th a fluorescinated-antibody cell sorter. Amphotericin B 0.5 mg/mL in 20% fat emulsion was stable for one week under all the storage conditi ons. Amphotericin B in the 1- and 2-mg/mL mt admixtures was stable for up to four days at 20-25 degrees C exposed to fluorescent light, and for up to one week at 20-25 degrees C protected from light and at 4-8 degrees C protected from light. There was no visible ev evidence of in compatibility. There were no substantial changes in particle-size dist ribution for the 2-mg/mL admixtures; appreciable changes were detected for the 2-mg/mL admixtures. Amphotericin B 1 and 2 mg/mL was stable i n 20% fat emulsion for four days at 20-25 degrees C exposed to fluores cent Light and for seven days at 20-25 degrees C protected from Light or at 4-8 degrees C; amphotericin B 0.5 mg/mL was stable in 20% fat em ulsion for seven days under the three storage conditions.