Stability of Ceftobiprole Medocaril in Portable Elastomeric Infusion Devices.

Abstract

Introduction: Ceftobiprole medocaril is a new fifth-generation cephalosporin commercially available as a prodrug. Since it is newly introduced in therapy, there is limited data on its physicochemical stability for outpatient parenteral antimicrobial therapy (OPAT). This work aimed to demonstrate the suitability of ceftobiprole medocaril in OPAT, determining the physicochemical stability within portable elastomeric infusion devices (Accufuser C0100L 10 mL/h 300 mL).

Methods: Physicochemical stability was evaluated in 6.25 mg/mL solutions in sodium chloride 0.9% and dextrose 5% at three temperatures (2-8 °C, 25 °C, and 32 °C) using a previously validated liquid chromatography triple quadrupole mass spectrometry (LC-QQQ-MS) method. Drug adsorption onto device walls was also determined at the end of the study.

Results: Ceftobiprole medocaril remained above 95% of the initial concentration in sodium chloride 0.9% for up to 24 h at both refrigerated (2-8 °C) and ambient conditions (25 °C). Stability was reduced in dextrose 5% solutions. While pH increased slightly over time, it remained within acceptable limits for intravenous administration, and no particle formation was detected. Drug adsorption to the elastomeric device was negligible (< 0.1%).

Conclusion: Ceftobiprole medocaril is suitable for administration in OPAT at 6.25 mg/mL in sodium chloride 0.9% over 24 h at 25 °C using Accufuser^® portable elastomeric infusion devices. These findings support the development of practical administration protocols for ceftobiprole medocaril in home-based antimicrobial therapy. Ceftobiprole medocaril is a new antibiotic used to treat serious infections. Because it was recently introduced, there is limited information about its stability when used for outpatient parenteral antimicrobial therapy (OPAT), a treatment that allows patients to receive intravenous antibiotics at home using portable elastomeric infusion devices. This study examined how stable ceftobiprole medocaril remains when stored and administered in portable elastomeric infusion devices. The antibiotic was diluted in two commonly used fluids (saline and dextrose) and kept at different temperatures: refrigerated (2-8 °C), room temperature (25 °C), and body temperature (32 °C). Researchers measured how much of the drug remained active over 24 hours and whether it adhered to the inside of the device. The results showed that ceftobiprole medocaril in saline solution (sodium chloride 0.9%) remained stable for 24 hours at room temperature and when refrigerated, keeping over 95% of its original amount. In dextrose, the drug was less stable. The pH changed slightly, but no harmful particles formed, and less than 0.1% of the drug stuck to the infusion device, confirming that the device is suitable for this use. On the basis of these findings, ceftobiprole medocaril can be safely administered in saline solution over 24 hours at room temperature using portable infusion devices. This helps support safe and effective use of the antibiotic in OPAT settings.