{
  "abstract": "Background and Importance Cefotaxime is a 3rd-generation cephalosporin, a time-dependant antibiotic whose efficacy is optimised by continuous infusion.If treatment can be continued at home, the portable device, a passive system, is the preferred administration device. To limit the number of nursing visits, stability data are needed to enable the total daily dose to be administered in 1 to 2 infusions per day. The stability of a molecule in a portable device must be achieved between 32-37°C, as this device is positioned close to the patient. Temperature is a factor influencing molecule stability. Loeuille et al . demonstrated a physical instability of cefotaxime 25 mg/mL at 37°C diluted in 0.9% sodium chloride (0.9% NaCl) and dextrose in water (D5W) in portable device after 6 hours‘ storage.Aim and Objectives The aim was to study the stability of 12.5 mg/mL cefotaxime solutions diluted in 0.9% NaCl or D5W in elastomeric devices, at 32°C. Stability is tested after preparation and after 8, 12, 24 hours.Material and Methods Three devices per condition were prepared. At each analysis time, 3 samples from each device were analysed using a validated high-performance liquid chromatography analytical method. pH was measured a each analysis time. Physical stability was assessed by visual and subvisual examination. The solution is considered stable when it retains more than 90% of its initial concentration (Ci), with a maximum pH variation of 1 unit, no significant visual change, and compliant subvisual examination.Results Diluted in D5W, cefotaxime solutions at a concentration of 12.5 mg/mL retained 97%±2% of Ci after 12 hours and 81%±1% after 24 hours (percentages calculted by averaging the results of the 3 devices prepared for one condition). In 0.9% NaCl, solutions of cefotaxime at a concentration of 12.5 mg/mL retained 94%±1% of Ci after 12 hours and 79%±3% after 24 hours. pH variation was below 1 unit.Visual inspection of cefotaxime solutions diluted in each solvent is satisfactory after 24 hours. Subvisual examination was in accordance with European Pharmacopoeia monograph 2.9.19.Conclusion and Relevance At 12.5 mg/mL, diluted in 0.9% NaCl or D5W, cefotaxime can be administered continuously via a portable device up to 12 hours, enabling patients to be managed on an outpatient basis.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "CHRU Nancy, Meurthe-Et-Moselle, Vandoeuvre-Lès-Nancy, France"
      ],
      "name": "I Boutouha"
    },
    {
      "affiliations": [
        "CHRU Nancy, Meurthe-Et-Moselle, Vandoeuvre-Lès-Nancy, France"
      ],
      "name": "E D’huart"
    },
    {
      "affiliations": [
        "CHRU Nancy, Meurthe-Et-Moselle, Vandoeuvre-Lès-Nancy, France"
      ],
      "name": "F Blaise"
    },
    {
      "affiliations": [
        "CHRU Nancy, Meurthe-Et-Moselle, Vandoeuvre-Lès-Nancy, France"
      ],
      "name": "C Marquet"
    },
    {
      "affiliations": [
        "CHRU Nancy, Meurthe-Et-Moselle, Vandoeuvre-Lès-Nancy, France"
      ],
      "name": "N Sobalak"
    },
    {
      "affiliations": [
        "CHRU Nancy, Meurthe-Et-Moselle, Vandoeuvre-Lès-Nancy, France"
      ],
      "name": "A Charmillon"
    },
    {
      "affiliations": [
        "CHRU Nancy, Meurthe-Et-Moselle, Vandoeuvre-Lès-Nancy, France"
      ],
      "name": "B Demoré"
    }
  ],
  "title": "5PSQ-061 Study of the physico-chemical stability of cefotaxime in elastomeric devices at 32°C",
  "uid": "12203143-c5de-5177-b1cc-477e1d16741e"
}