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Volume 17
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Article

The Infusion of Piperacillin/Tazobactam with an Elastomeric Device: A Combined 24-H Stability Study and Drug Solution Flow Rate Analysis

by
Laura Négrier
1,*,
Anthony Martin Mena
1,
Christian Dupont
2,
Philémon Gamache
1,
Jeanne-Olive Zimbril
1,
Yasmine Abdoune
1,
Youness Karrout
3,
Pascal Odou
1,
Stéphanie Genay
1 and
Bertrand Décaudin
1
1
Univ. Lille, CHU Lille, ULR 7365—GRITA—Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France
2
Hôpital Universitaire Cochin, Assistance Publique—Hôpitaux de Paris, 75014, France—GIFAV—Groupe Interdisciplinaire Francophone sur les Accès Vasculaires, 75014 Paris, France
3
Univ. Lille, INSERM, CHU Lille, U1008, F-59000 Lille, France
*
Author to whom correspondence should be addressed.
Pharmaceuticals 2024, 17(8), 1085; https://doi.org/10.3390/ph17081085
Submission received: 8 July 2024 / Revised: 2 August 2024 / Accepted: 12 August 2024 / Published: 19 August 2024
(This article belongs to the Special Issue Pharmaceutical Preparations, Challenges in Formulations and Compatibility Studies)
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Abstract

Bacterial respiratory tract infections (e.g., in patients with cystic fibrosis) may be treated with the intravenous infusion of a piperacillin/tazobactam (P/T) solution through an elastomeric device. In the present work, we combined a 24-h drug stability study with an assessment of the drug solution flow rate during an in vitro simulated infusion. Experiments were performed in triplicate with two excipient-free generic P/T solutions and an excipient-containing proprietary P/T solution in saline (all 50/6.25 mg/mL) released from an elastomeric infusion device at 32 °C. The P/T solutions’ stability was assessed by an HPLC-UV assay, pH and osmolality measurements, a visual assessment, and particle counting. Before these analyses, a forced degradation study was performed. To assess the flow rate, a precision scale was used to weigh the solution collected at the infusion line outlet. The stability criteria were <10% degradation and a flow rate within ± 15% of the nominal value over the 24-h infusion period: all three P/T solutions were found to be stable. The actual flow rate was lower than the expected flow rate; this difference was probably due to the drug solution’s high viscosity and must be taken into account in clinical use.
Keywords: piperacillin/tazobactam; flow rate; stability study; outpatient parenteral antimicrobial therapy (OPAT); continuous infusion; HPLC-UV piperacillin/tazobactam; flow rate; stability study; outpatient parenteral antimicrobial therapy (OPAT); continuous infusion; HPLC-UV

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MDPI and ACS Style

Négrier, L.; Mena, A.M.; Dupont, C.; Gamache, P.; Zimbril, J.-O.; Abdoune, Y.; Karrout, Y.; Odou, P.; Genay, S.; Décaudin, B. The Infusion of Piperacillin/Tazobactam with an Elastomeric Device: A Combined 24-H Stability Study and Drug Solution Flow Rate Analysis. Pharmaceuticals 2024, 17, 1085. https://doi.org/10.3390/ph17081085

AMA Style

Négrier L, Mena AM, Dupont C, Gamache P, Zimbril J-O, Abdoune Y, Karrout Y, Odou P, Genay S, Décaudin B. The Infusion of Piperacillin/Tazobactam with an Elastomeric Device: A Combined 24-H Stability Study and Drug Solution Flow Rate Analysis. Pharmaceuticals. 2024; 17(8):1085. https://doi.org/10.3390/ph17081085

Chicago/Turabian Style

Négrier, Laura, Anthony Martin Mena, Christian Dupont, Philémon Gamache, Jeanne-Olive Zimbril, Yasmine Abdoune, Youness Karrout, Pascal Odou, Stéphanie Genay, and Bertrand Décaudin. 2024. "The Infusion of Piperacillin/Tazobactam with an Elastomeric Device: A Combined 24-H Stability Study and Drug Solution Flow Rate Analysis" Pharmaceuticals 17, no. 8: 1085. https://doi.org/10.3390/ph17081085

APA Style

Négrier, L., Mena, A. M., Dupont, C., Gamache, P., Zimbril, J.-O., Abdoune, Y., Karrout, Y., Odou, P., Genay, S., & Décaudin, B. (2024). The Infusion of Piperacillin/Tazobactam with an Elastomeric Device: A Combined 24-H Stability Study and Drug Solution Flow Rate Analysis. Pharmaceuticals, 17(8), 1085. https://doi.org/10.3390/ph17081085

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