Stability of Injectable Ceftobiprole Medocaril (Zevtera®) in PVC Bags and in the Intermate® Infusion System: A Technological Turning Point for Ambulatory Administration of Intravenous Antibiotics

Background: Ceftobiprole medocaril (Zevtera®) is an injectable broad-spectrum antibiotic. Objective: We aim to show that ceftobiprole initiated in hospital may be continued at home through Outpatient Parenteral Antibiotic Therapy (OPAT). Methods: Solutions of ceftobiprole at 2.0 and 2.8 mg/mL were prepared in PVC bags from 500 mg vials and stored at room temperature (RT) or 4 °C. Each sample was analyzed in triplicate samples using high-performance liquid chromatography (HPLC) at multiple time points over a 120 h period. Additionally, 2.5 mg/mL ceftobiprole solutions were prepared in Intermate® infusion devices (n = 3 preparations) and stored at 4 °C. Samples were collected on multiple days from Day 0 to Day 9, both immediately post-refrigeration and after 8 h at RT and analyzed in triplicate. Results: PVC bag solutions retained ≥90% of their initial concentrations. At RT, residual concentration was 90.9% (2.0 mg/mL) and 92.0% (2.8 mg/mL) after 24 h. At 4 °C, the 2.0 mg/mL formulation retained 90.8% after 120 h, and the 2.8 mg/mL formulation retained 90.2% after 96 h. Intermate® devices stored nine days at 4 °C and exposed to RT for 8 h retained ≥90% of the initial concentration of ceftobiprole (2.5 mg/mL; 93.3% before RT exposure; 91.1% after). Conclusions: Ceftobiprole medocaril exhibits sufficient physicochemical stability for OPAT use in PVC bags and Intermate® infusion device under tested conditions.