Physical and chemical stability of ceftaroline in an elastomeric infusion device

Abstract

BackgroundSevere infections such as endocarditis and osteomyelitis require long-term treatment with parenteral antibiotics and hence prolonged hospitalisation. Continuous infusion of ceftaroline through elastomeric devices can facilitate early hospital discharge by managing parenteral antibiotics in patient’s home. Therefore, the purpose of this study was to investigate the stability of ceftaroline in a commonly used elastomeric device.MethodA total of 24 elastomeric devices were prepared, and six elastomeric devices containing 6mg/mL of ceftaroline (three in each type of diluents) were stored at one of the following conditions: 4°C for 6 days, 25°C for 24hours, 30°C for 24hours or 35°C for 24hours. An aliquot was withdrawn before storage and at different time points. Chemical stability was measured using a stability indicating high-performance liquid chromatography, and physical stability was assessed as change in pH, colour and particle content.ResultsCeftaroline, when admixed with both diluents, was stable for 144, 24 and 12hours at 4°C, 25°C and 30°C, respectively. At 35°C, ceftaroline admixed with normal saline (NS) and glucose 5% was stable for 12hours and for 6hours, respectively. No evidence of particle formation, colour change or pH change was observed throughout the study period.ConclusionsOur findings support 12 or 24hours continuous elastomeric infusion of ceftaroline-NS admixture, and bulk preparation of elastomeric pumps containing ceftaroline solution in advance. This would facilitate early hospital discharge of patients eligible for the elastomeric-based home therapy and avoid the need for patient’s caregivers travelling to the hospital on a daily basis.

Antimicrobial Dose Reduction in Continuous Renal Replacement Therapy: Myth or Real Need? A Practical Approach for Guiding Dose Optimization of Novel Antibiotics

“…The authors recommended a ceftaroline dosing regimen of 400 mg every 12 in patients undergoing CRRT with an effluent flow rate of 3 L/h. However, it should be highlighted that in those patients with residual renal function, a full dose (600 mg every 12 h) coupled with prolonged infusion up to 12 h [ 43 ] could be needed to achieve more aggressive PK/PD targets.…”

Stability of Antimicrobials in Elastomeric Pumps: A Systematic Review

“…The principal characteristics of each antimicrobial group, such as drug, reference [ 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 ], main conditions (composition of the elastomeric device chosen, concentration, diluent, temperature, and duration of storage), chemical and physical stability obtained, and the most relevant comments for the systematic review, are summarized in Table 1 , Table 2 , Table 3 , Table 4 , Table 5 , Table 6 , Table 7 and Table 8 .…”

Widening the net: a literature review of antimicrobial agents with potential suitability for outpatient parenteral antimicrobial therapy services—the importance of storage and stability

“…Al Madfai et al report stability of ceftaroline 300 mg diluted in 50 mL sodium chloride 0.9% or glucose 5% in Baxter LV10 infusers stored at 35°C. The final test point at which more than 95% ceftaroline remained was 6 hours when diluted with sodium chloride 0.9% and 2 hours with glucose 5% 12…”

“…Cefepime may be suitable for two times per day infusion, but more information is needed on the quantification and clinical relevance of its potentially toxic metabolite, N‐methylpyrrolidine. Data from Al Madfai et al show that ceftaroline is subject to temperature-driven degradation, with greater losses at 35°C than 25°C or 30°C; when stored at 4°C, there was little degradation 12. More investigation would be required to determine how this could translate to usefulness for OPAT services.…”