3PC-008 Physicochemical stability of five beta-lactam antibiotics under simulated real-life conditions in outpatient parenteral antimicrobial therapy (OPAT)
Year: 2025
Type: conference-paper
Abstract: Background and Importance The use of OPAT is growing exponentially due to its advantages for both patients and healthcare systems. However, one of its major challenges is ensuring drug stability under the variable conditions encountered in outpatient settings. Aim and Objectives To evaluate the physicochemical stability of five beta-lactam antibiotics in two different containers at three different external temperature conditions. Material and Methods The antibiotics studied were: meropenem 12mg/mL, ceftazidime 24mg/mL, ceftazidime/avibactam 24/6mg/mL, cefiderocol 10mg/mL, and ceftaroline fosamil 6mg/mL, all in 0.9% saline polyolefin bags. Pyridine concentration, a degradation product of ceftazidime, was also analysed. Physical characteristics and pH were evaluated. Antibiotic concentrations were measured by UHPLC. All samples were analysed in triplicate at four storage temperatures: below 10°C, 15°C, 23°C and 30°C. Temperature evolution inside portable thermal bags and porexpan boxes was monitored for 24h at three different external temperatures: 23°C, 30°C and 40°C. Finally, antibiotic stability was correlated with the temperature inside the portable coolbox to define the maximum stability time for each antibiotic under specific external temperature conditions. Results Chromatographic methods for the six molecules were developed and validated. No changes in physical characteristics or pH were observed. Time above 90% of the initial concentration for each antibiotic is shown in table 1. Pyridine concentration did not exceed European Pharmacopoeia limits (<500ppm) at any point during the study. Temperature inside the porexpan box remained below 23°C for 24h and below 10°C for 16h, regardless of the external temperature tested. In the portable coolbox, the internal temperature stayed below 23°C for 24h when external temperature was 23°C; for 12h at 30°C, and for only 8h at 40°C. Conclusion and Relevance All antibiotics studied remained stable for at least 24h, even at the highest temperature tested, when stored in a porexpan box. When stored in a portable coolbox, all antibiotics were stable for at least 24h at 23°C. However, at 30°C, only ceftazidime, ceftazidime/avibactam, and cefiderocol remained stable for 24h. At higher temperatures, a more hermetic container would be recommended to ensure 24-hour stability. References and/or Acknowledgements Conflict of Interest No conflict of interest
Authors: C Lopez-Cabezas, P Clares, G Gotor, J Baguena, G Ballesteros, S Ruiz, S Ceamanos, M Barrantes, D Soy Muner
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: gold
OpenAlex ID: W4408376410