title: Stability of cidofovir in 0.9% sodium chloride injection and in 5% dextrose injection.
abstract: The stability of cidofovir in i.v. admixtures under refrigerator and room temperature conditions was studied. Admixtures of cidofovir 0.21 and 8.12 mg/mL in 0.9% sodium chloride injection or 5% dextrose injection and of 0.085 and 3.51 mg/mL in 5% dextrose and 0.45% sodium chloride injection were prepared in triplicate in polyvinyl chloride (PVC) or polyethylene-polypropylene containers and i.v. administration sets and stored for 24 hours at 2-8 or 30 degrees C. The lower concentration of cidofovir corresponded to an assumed dose of 0.5 mg/kg for a 40-kg patient, and the higher concentration to an assumed dose of 10 mg/kg for a 100-kg patient. Samples were removed at 0 and 24 hours and analyzed for cidofovir concentration by high-performance liquid chromatography. Physical compatibility was also studied. The stability of cidofovir in 0.9% sodium chloride injection and in 5% dextrose injection at low- and high-dose concentrations was unaffected by storage at either temperature. All admixtures were clear, colorless, and free of visible particles or precipitation. There were no substantial changes in pH or number of particles of > or = 10 microns in diameter. Cidofovir 0.21 and 0.12 mg/mL was stable in 0.9% sodium chloride injection and 5% dextrose injection in PVC and polyethylene-polypropylene containers and i.v. administration sets for up to 24 hours at 2-8 and 30 degrees C. Cidofovir was compatible with the injectable solutions studied.
authors.affiliation: Department of Formulation and Process Development, Gilead Sciences, Inc., Foster City, CA 94404, USA.
authors.forename: L C
authors.initials: LC
authors.lastname: Yuan
authors.forename: G J
authors.initials: GJ
authors.lastname: Samuels
authors.forename: G C
authors.initials: GC
authors.lastname: Visor
mesh_terms: D000998:Antiviral Agents / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D000077404:Cidofovir; D003596:Cytosine / Q000031:analogs & derivatives* / Q000737:chemistry; D004355:Drug Stability; D005947:Glucose; D006863:Hydrogen-Ion Concentration; D007267:Injections; D063065:Organophosphonates; D009943:Organophosphorus Compounds / Q000737:chemistry*; D009994:Osmolar Concentration; D010316:Particle Size; D011143:Polyvinyl Chloride; D012965:Sodium Chloride; D013997:Time Factors
chemical_list: D000998:Antiviral Agents; D063065:Organophosphonates; D009943:Organophosphorus Compounds; D012965:Sodium Chloride; D003596:Cytosine; D011143:Polyvinyl Chloride; D005947:Glucose; D000077404:Cidofovir