title: Stability and compatibility of anakinra with ceftriaxone sodium injection in 0.9% sodium chloride or 5% dextrose injection.
abstract: The stability and compatibility of anakinra (recombinant human interleukin-1 receptor antagonist) with ceftriaxone sodium in 0.9% sodium chloride or 5% dextrose injection was determined during a 4-h period at ambient room temperature and light. Anakinra was diluted in 0.9% sodium chloride or 5% dextrose to the concentrations of 4 and 36 mg/ml. Anakinra, at each concentration was mixed with ceftriaxone sodium (20 mg/ml) in a 50:50 proportion and stored in plastic culture vials with polypropylene caps. The samples were collected at 0, 2 and 4 h after mixing. Anakinra and ceftriaxone concentrations were measured using stability-indicating HPLC methods. In 0.9% sodium chloride injection, the mean concentrations of anakinra and ceftriaxone exceeded 98% of initial concentrations at the end of the study period. In 5% dextrose, however, anakinra concentrations were below 90% of the expected initial concentration at the time of first analysis (within 0.5 h). Thus, anakinra appears to be stable and compatible with ceftriaxone sodium when diluted in 0.9% sodium chloride injection, but not in 5% dextrose injection over 4 h at ambient room temperature and light.
authors.affiliation: College of Pharmacy, Ohio State University, Columbus, USA.
authors.forename: M C
authors.initials: MC
authors.lastname: Nahata
authors.forename: R S
authors.initials: RS
authors.lastname: Morosco
authors.forename: B K
authors.initials: BK
authors.lastname: Sabados
authors.forename: T R
authors.initials: TR
authors.lastname: Weber
mesh_terms: D002443:Ceftriaxone / Q000032:analysis / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D004338:Drug Combinations; D004355:Drug Stability; D005947:Glucose / Q000737:chemistry; D006801:Humans; D006863:Hydrogen-Ion Concentration; D053590:Interleukin 1 Receptor Antagonist Protein; D011994:Recombinant Proteins / Q000737:chemistry; D012795:Sialoglycoproteins / Q000032:analysis / Q000737:chemistry*; D012965:Sodium Chloride / Q000737:chemistry; D012996:Solutions; D013696:Temperature
chemical_list: D004338:Drug Combinations; C507763:IL1RN protein, human; D053590:Interleukin 1 Receptor Antagonist Protein; D011994:Recombinant Proteins; D012795:Sialoglycoproteins; D012996:Solutions; D012965:Sodium Chloride; D002443:Ceftriaxone; D005947:Glucose