Abstract
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 120 mL 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 120 mL 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 211 nm for tazobactam and 230 nm 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. Conclusion Under these conditions, 4 g/120 mL of Piperacillin/Tazobactam® Sandoz or Tazocin® in D5 infusion in polyolefin bags remains stable at least for 58 days at 5 ± 3 °C after FMT
Highlights
Piperacillin, an antibiotic of the penicillin family, is active against a wide range of Gram-negative organisms, including Klebsiella pneumonia, Pseudomonas aeruginosa and the enterobacteriacae
The stability of piperacillin in combination with tazobactam has been investigated under a variety of conditions, including different concentrations, different diluents (5 % dextrose in water, 0.9 sodium chloride, peritoneal dialysis solution,), containers, temperatures (37 °C, 25 °C, 4 °C, −15 °C, −20 °C), and storage periods [3,4,5,6,7,8,9,10]
Ten polyolefin bags (Viaflo, co-extruded layers of polyethylene, polyamide, polypropylene, Baxter, Lessines, Belgium, lot 12D27G61) of 100 mL of dextrose 5 % among which five have been supplemented with 4 g of Piperacillin/Tazobactam® (Sandoz, Vilvoorde, Belgium, lot CG2904) reconstituted in 20 mL of injectable water and 5 other supplemented with 4 g of Tazocin® (Pfizer, AGVG/11) reconstituted in 20 mL of injectable water were prepared under aseptic conditions to obtain a final concentration of 4 g/120 mL of piperacillin and 0.5 g/120 mL of tazobactam
Summary
Piperacillin, an antibiotic of the penicillin family, is active against a wide range of Gram-negative organisms, including Klebsiella pneumonia, Pseudomonas aeruginosa and the enterobacteriacae. The combination of piperacillin with tazobactam, a beta-lactamase inhibitor, broadens the bactericidal activity [1] This antibiotic may be infused in 30 min after dilution with NaCl 0.9 % or dextrose 5 % or by extended infusion [2]. The stability of piperacillin in combination with tazobactam has been investigated under a variety of conditions, including different concentrations (from 0.2 + 0.025 mg/ mL to 200 + 25.0 mg/mL), different diluents (5 % dextrose in water, 0.9 sodium chloride, peritoneal dialysis solution,), containers (glass, plastic bags, syringes, portable pumps), temperatures (37 °C, 25 °C, 4 °C, −15 °C, −20 °C), and storage periods (from 18 hours to 98 days) [3,4,5,6,7,8,9,10]. 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
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
