RESUMO
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.
Assuntos
Ceftriaxona/química , Sialoglicoproteínas/química , Ceftriaxona/análise , Cromatografia Líquida de Alta Pressão , Combinação de Medicamentos , Estabilidade de Medicamentos , Glucose/química , Humanos , Concentração de Íons de Hidrogênio , Proteína Antagonista do Receptor de Interleucina 1 , Proteínas Recombinantes/química , Sialoglicoproteínas/análise , Cloreto de Sódio/química , Soluções , TemperaturaRESUMO
We designed a study to evaluate the stability and compatibility of anakinra (recombinant human interleukin-1 receptor antagonist) with cimetidine hydrochloride or famotidine in 0.9% sodium chloride injection during a 4-h period at room temperature (22 degrees C) and light. Anakinra was diluted in 0.9% sodium chloride to concentrations of 4 and 36 mg/ml. At each concentration, anakinra was mixed with 3 mg/ml cimetidine or with 1 mg/ml famotidine, in a 50:50 proportion and stored in plastic culture vials with polypropylene caps. The mean concentrations of anakinra, cimetidine hydrochloride, and famotidine exceeded 95% of initial concentrations throughout the study. No changes were noted in the physical appearance, pH, or the chromatograms during the study period. Thus, anakinra appears to be stable and compatible with cimetidine hydrochloride or famotidine when diluted into 0.9% sodium chloride injection for 4 h at ambient room temperature and light.