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Evaluation of the stability of ceftazidime/avibactam in elastomeric infusion devices used for outpatient parenteral antimicrobial therapy utilizing a national stability protocol framework.
Naicker, Saiyuri; Roberts, Jason A; Won, Hayoung; Wallis, Steven C; Unwin, Sean; Jamieson, Conor; Hills, Tim; Gilchrist, Mark; Santillo, Mark; Seaton, R Andrew; Drummond, Felicity; Sime, Fekade B.
Afiliación
  • Naicker S; The University of Queensland Centre for Clinical Research, University of Queensland, Brisbane, Australia.
  • Roberts JA; The University of Queensland Centre for Clinical Research, University of Queensland, Brisbane, Australia.
  • Won H; Herston Infectious Diseases Institute (HeIDI), Metro North Health, Brisbane, Australia.
  • Wallis SC; Departments of Pharmacy and Intensive Care Medicine, Royal Brisbane and Women's Hospital, Brisbane, Australia.
  • Unwin S; Division of Anaesthesiology Critical Care Emergency and Pain Medicine, Nîmes University Hospital, University of Montpellier, Nîmes, France.
  • Jamieson C; The University of Queensland Centre for Clinical Research, University of Queensland, Brisbane, Australia.
  • Hills T; The University of Queensland Centre for Clinical Research, University of Queensland, Brisbane, Australia.
  • Gilchrist M; Infection Management Services, Princess Alexandra Hospital, Metro South Health, Brisbane, Australia.
  • Santillo M; Medical Directorate, NHS England (Midlands), Birmingham, UK.
  • Seaton RA; Pharmacy Department, Nottingham University Hospitals NHS Trust, Nottingham, UK.
  • Drummond F; Department of Pharmacy/Infection, Imperial College Healthcare NHS Trust, London, UK.
  • Sime FB; Department of Infectious Diseases, Imperial College London, London, UK.
JAC Antimicrob Resist ; 6(2): dlae056, 2024 Apr.
Article en En | MEDLINE | ID: mdl-38585225
ABSTRACT

Objectives:

To evaluate the stability of ceftazidime/avibactam in elastomeric infusers, utilizing the UK's Yellow Cover Document (YCD) stability testing framework, in conditions representative of OPAT practice.

Methods:

Ceftazidime/avibactam was reconstituted with sodium chloride 0.9% (w/v) in two elastomeric infusers at concentrations (dose) levels of 1500/375, 3000/750 and 6000 mg/1500 mg in 240 mL. The infusers were exposed to a fridge storage (2°C-8°C) for 14 days followed by 24 h in-use temperature (32°C).

Results:

After 14 days of fridge storage and subsequent 24 h exposure to 32°C, mean ±â€ŠSD of ceftazidime percent remaining was 75.5% ±â€Š1.8%, 79.9% ±â€Š1.1%, 82.4% ±â€Š0.6%, for Easypump, and 81.7% ±â€Š1.2%, 82.5% ±â€Š0.5%, 85.4% ±â€Š1.1% for Dosi-Fuser devices at the high, intermediate and low doses tested, respectively. For avibactam, mean ±â€ŠSD percent remaining was 83.2% ±â€Š1.8%, 87.4% ±â€Š2.0%, 93.1% ±â€Š0.9% for Easypump, and 85.1% ±â€Š2.0%, 86.7% ±â€Š0.1%, 92.5% ±â€Š0.1% for Dosi-Fuser devices. The cumulative amount of pyridine generated in the devices ranged from 10.4 mg at low dose to 76.9 mg at high dose. Regression-based simulation showed that the degradation of both ceftazidime and avibactam was <10% for at least 12 h of the running phase, if stored in a fridge for not more than 72 h prior to in-use temperature exposure.

Conclusions:

Whilst not meeting the strict UK YCD criteria for ≤5% degradation, ceftazidime/avibactam may be acceptable to administer as a continuous 12 hourly infusion in those territories where degradation of ≤10% is deemed acceptable.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: JAC Antimicrob Resist Año: 2024 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: JAC Antimicrob Resist Año: 2024 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Reino Unido