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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

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Huvelle, Sophie [UCL] Godet, Marie [UCL] Galanti, Laurence [UCL] Closset, Mélanie [UCL] BIHIN, Benoît [UCL] Jamart, Jacques [UCL] Hecq, Jean-Daniel [UCL]

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.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès interdit
Publication date 2018
Language Anglais
Journal information "Pharmaceutical Technology in Hospital Pharmacy" - Vol. 3, no. 3, p. 143-141
Peer reviewed yes
Publisher De Gruyter
Publication status Publié
Affiliations UCL - (MGD) Laboratoire de biologie clinique
UCL - (MGD) Département de pharmacie
UCL - (MGD) Unité de support scientifique
UCL - SSS/IREC/MONT - Pôle Mont Godinne
Keywords piperacillin ; tazobactam infusion ; physicochemical stability ; high performance liquid chromatography ; microwave freeze-thaw treatment ; centralized intravenous admixture services ; hospital pharmacy
Links
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Bibliographic reference Huvelle, Sophie ; Godet, Marie ; Galanti, Laurence ; Closset, Mélanie ; BIHIN, Benoît ; et. al. 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. In: Pharmaceutical Technology in Hospital Pharmacy, Vol. 3, no. 3, p. 143-141
Permanent URL http://hdl.handle.net/2078.1/201627