Assessment of the stability of citrate-buffered piperacillin/tazobactam for continuous infusion when stored in two commercially available elastomeric devices for outpatient parenteral antimicrobial chemotherapy : a study compliant with the NHS Yellow Cover Document requirements
Ozolina, Laima Seaton, R Andrew Gilchrist, Mark Hills, Tim Drummond, F Wilkinson, Alan Shaun
Ozolina, Laima
Seaton, R Andrew
Gilchrist, Mark
Hills, Tim
Drummond, F
Wilkinson, Alan Shaun
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Affiliation
Sandwell and West Birmingham NHS Trust; Biopharma Stability Testing Laboratory Ltd; Queen Elizabeth University Hospital, Glasgow; Imperial College Healthcare NHS Trust; et al.
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2020-09-25
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Abstract
Objectives: To investigate the effect of pH control through the use of a citrate-buffered saline diluent pH 7 on the degradation rate of piperacillin/tazobactam solutions for infusion and to determine if an extended shelf-life of up to 13 days fridge 2°C-8°C plus 24 hours 'in-use' at 32°C in two elastomeric devices: FOLFusor LV10 (Baxter Healthcare, Thetford, UK) and Easypump II (B. Braun Medical Ltd, Sheffield, UK) can be achieved. Methods: Testing was as per the latest National Health Service (NHS) Pharmaceutical Quality Assurance Committee Yellow Cover Document (YCD) requirements.A validated stability indicating high-performance liquid chromatography method was used for assessing the stability of the solutions of piperacillin/tazobactam at a combined concentration of 25 mg/mL and 90 mg/mL respectively. Solutions were tested in two batches in replicate (n=3) at five time points according to the requirements of the YCD. Results: Piperacillin/tazobactam stability was significantly improved when 0.3% w/v citrate-buffered saline pH 7 was used as the diluent, compared with using 0.9% w/v saline as diluent. Greater than 95% of the zero-time concentration of both actives remained following storage at 2°C-8°C for up to 13 days plus 24 hours at 32°C in both devices. The data support extended storage of up to 13 days 2°C-8°C plus 24 hours at 32°C 'in-use' when using FOLFusor LV10 (Baxter) or Easypump II (B. Braun) pump devices. Conclusions: The enhanced stability complies with UK national standards as stated in the YCD for stability testing of aseptically produced small molecules and supports the storage of piperacillin/tazobactam for up to 13 days 2°C-8°C plus 24 hours at 32°C 'in-use' within two elastomeric pump devices. The extended shelf-life provides a significant advantage over the stability of piperacillin/tazobactam solutions for infusion when reconstituted and diluted in 0.9% w/v saline as diluent. The data open up the possibility of a continuous infusion of piperacillin/tazobactam delivered by elastomeric pump devices over 24 hours in an outpatient parenteral antimicrobial therapy setting.
Citation
Jamieson C, Ozolina L, Seaton RA, Gilchrist M, Hills T, Drummond F, Wilkinson AS; BSAC Drug Stability Testing Working Group. Assessment of the stability of citrate-buffered piperacillin/tazobactam for continuous infusion when stored in two commercially available elastomeric devices for outpatient parenteral antimicrobial chemotherapy: a study compliant with the NHS Yellow Cover Document requirements. Eur J Hosp Pharm. 2022 Jul;29(4):212-216. doi: 10.1136/ejhpharm-2020-002340. Epub 2020 Sep 25
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