Long-Term Stability Comparison between an Original and a Generic Version of Piperacillin/Tazobactam in Dextrose 5% Infusion Polyolefin Bags at 5 ± 3 °C after Microwave Freeze-Thaw Treatment

Huvelle, Sophie;Godet, Marie;Galanti, Laurence;Closset, Mélanie;Hecq, Jean-Daniel;et.al.
(2018) Pharmaceutical Technology in Hospital Pharmacy — Vol. 3, n° 3, p. 143-141 (2018)

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Authors
  • Huvelle, SophieUCLouvain
    Author
  • Godet, MarieUCLouvain
    Author
  • Galanti, LaurenceUCLouvain
    Author
  • Closset, MélanieUCLouvain
    Author
  • BIHIN, BenoîtUCLouvain
    Author
  • Jamart, JacquesUCLouvain
    Author
  • Hecq, Jean-DanielUCLouvain
    Author
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Abstract
Background: Piperacillin-Tazobactam is frequently infused in hospitals. The use of a generic version was considered after the out of stock of the brand name Tazocin®. The stability of 4 g of Tazocin® in 120mL of dextrose 5% (D5)was demonstrated during 35 days at 5 °C ± 3 °C after freezing (−20 °C) and microwave thawing (FMT). The aim of the study was to investigate and compare the long-term stability of Tazocin® and a generic product in the same conditions. Methods: Five polyolefin bags of 4 g of Piperacillin/Tazobactam® Sandoz and 5 bags of 4 g of Tazocin® were prepared under aseptic conditions in 120mL of D5 and stored 3 months at 20 °C then thawed and stored 58 days at 5 ± 3 °C. Spectrophotometric absorbance at different wavelengths, pH measurement, visual and microscopic observations were also performed. The concentrations were measured by HPLC, at 211nm for tazobactam and 230nm for piperacilline. Results: No significant change in pH values or optic densities, no crystals were detected. The lower confidence limit at 95% of the concentration for the solutions remains superior to 90% of the initial concentration until 58 days of storage at 5 ± 3 °C.
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Huvelle, S., Godet, M., Galanti, L., Closset, M., BIHIN, B., Jamart, J., & Hecq, J.-D. (2018). Long-Term Stability Comparison between an Original and a Generic Version of Piperacillin/Tazobactam in Dextrose 5% Infusion Polyolefin Bags at 5 ± 3 °C after Microwave Freeze-Thaw Treatment. Pharmaceutical Technology in Hospital Pharmacy, 3(3), 143-141. https://doi.org/10.1515/pthp-2018-0014 (Original work published 2018)