title: Stability of amphotericin B in an extemporaneously prepared i.v. fat emulsion.
abstract: The stability of amphotericin B in an extemporaneously prepared i.v. fat emulsion was studied. Admixtures of amphotericin B 0.5, 1, and 2 mg/mL were prepared by adding 10, 20, and 40 mL of amphotericin B 5 mg/mL to 90, 80, and 60 mL, respectively, of 20% fat emulsion. The admixtures were stored in glass vacuum containers at 20-25 degrees C and exposed to fluorescent light, 20-25 degrees C and protected from light, or 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 A sample was withdrawn from each container at 0, 4, 12, and 24 hours and at 2, 4, 7, and 15 days for analysis of amphotericin B concentration by high-performance liquid chromatography and for visual evaluations; these samples were immediately frozen until analyzed. A sample was withdrawn from one container of amphotericin B 1 and 2 mg/mL for each storage condition at 0, 7, and 15 days for immediate determination of particle-size distribution with a fluorescinated-antibody cell sorter. Amphotericin B 0.5 mg/mL in 20% fat emulsion was stable for one week under all the storage conditions. Amphotericin B in the 1- and 2-mg/mL 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 evidence of incompatibility. There were no substantial changes in particle-size distribution for the 1-mg/mL admixtures; appreciable changes were detected for the 2-mg/mL admixtures. Amphotericin B 1 and 2 mg/mL was stable in 20% fat emulsion for four days at 20-25 degrees C exposed to fluorescent 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 emulsion for seven days under the three storage conditions.
authors.affiliation: Biochemistry Service, Hospital General Universitario Vall d'Hebron, Barcelona, Spain.
authors.forename: R M
authors.initials: RM
authors.lastname: Lopez
authors.forename: A
authors.initials: A
authors.lastname: Ayestaran
authors.forename: L
authors.initials: L
authors.lastname: Pou
authors.forename: J B
authors.initials: JB
authors.lastname: Montoro
authors.forename: M
authors.initials: M
authors.lastname: Hernandez
authors.forename: I
authors.initials: I
authors.lastname: Caragol
mesh_terms: D000666:Amphotericin B / Q000008:administration & dosage / Q000737:chemistry*; D000935:Antifungal Agents / Q000008:administration & dosage / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage; D005217:Fat Emulsions, Intravenous / Q000008:administration & dosage / Q000737:chemistry*; D006801:Humans; D010316:Particle Size
chemical_list: D000935:Antifungal Agents; D005217:Fat Emulsions, Intravenous; D000666:Amphotericin B