Assessment of ceftolozane/tazobactam stability in elastomeric devices and suitability for continuous infusion via outpatient parenteral antimicrobial therapy
Jamieson, Conor Drummond, Felicity Hills, Tim Ozolina, Laima Gilchrist, Mark Seaton, Andrew R. Santillo, Mark Wilkinson, Alan-Shaun Allwood, Michael C.
Jamieson, Conor
Drummond, Felicity
Hills, Tim
Ozolina, Laima
Gilchrist, Mark
Seaton, Andrew R.
Santillo, Mark
Wilkinson, Alan-Shaun
Allwood, Michael C.
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Affiliation
British Society for Antimicrobial Chemotherapy (BSAC); Nottingham University Hospitals NHS Trust; Imperial College Healthcare NHS Trust; Sandwell and West Birmingham NHS Trust
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Publication date
2021-09-03
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Abstract
Objectives
To investigate the stability of ceftolozane/tazobactam 5 mg/mL and 20 mg/mL solutions for infusion in two elastomeric devices: FOLFusor LV10 (Baxter Healthcare) and Easypump® II (B. Braun Medical Ltd) and determine if an extended shelf life of up to 8 days storage at 2–8°C plus 24 h ‘in use’ at 32°C was achievable.
Methods
Testing was as per the latest NHS Pharmaceutical Quality Assurance Committee Yellow Cover Document (YCD) requirements. A stability-indicating LC method was used for assessing the stability of solutions of ceftolozane/tazobactam at 5 mg/mL and 20 mg/mL (combined concentration of both actives) respectively, tested in two batches in triplicate (n = 3) at five timepoints according to the requirements of the YCD.
Results
Ceftolozane/tazobactam, diluted in 0.9% w/v sodium chloride at 5 mg/mL and 20 mg/mL, degraded during in-use storage at 32°C with <95% remaining after 18 h for some device/concentration combinations and all device/concentration combinations at 24 h, respectively. The data does support extended storage of up to 8 days at 2–8°C plus 12 h at 32°C ‘in-use’ when using either FOLFusor LV10 or Easypump® II devices and is compliant with YCD.
Conclusions
Solutions of ceftolozane/tazobactam can be administered in outpatient parenteral antimicrobial therapy (OPAT) services following refrigerated storage for up to 8 days, when limited to a 12 h infusion at in-use temperature of 32°C. For UK OPAT services where twice daily dosing is feasible, our data provides another treatment option for challenging infections. In countries where a 10% loss of ceftolozane/tazobactam is acceptable, a 24 h infusion is supported by the data.
Citation
Conor Jamieson, Felicity Drummond, Tim Hills, Laima Ozolina, Mark Gilchrist, R Andrew Seaton, Mark Santillo, Alan-Shaun Wilkinson, Michael C Allwood, Assessment of ceftolozane/tazobactam stability in elastomeric devices and suitability for continuous infusion via outpatient parenteral antimicrobial therapy, JAC-Antimicrobial Resistance, Volume 3, Issue 3, September 2021, dlab141.
Type
Article