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Long-term Stability of Vancomycin Hydrochloride in Glucose 5% Polyolefin Bags: The Brand Name Versus a Generic Product

Author(s):  Huvelle Sophie, Godet Marie, Hecq Jean-Daniel, Gillet Patricia, Jamart Jacques, Galanti Laurence M

Issue:  Sep/Oct 2016 - Volume 20, Number 5
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Abstract:  The objectives of this study were to determine if the preparation of vancomycin hydrochloride in advance of infusion could improve the quality of the drug, time management of drug delivery, cost savings of drug delivery, and to investigate the long-term stability of vancomycin hydrochloride (brand name Vancocin®) infusion in glucose 5% polyolefin bags versus the generic (Vancomycine®) at 5°C ± 3°C. Five bags of each infusion 1 g/100 mL vancomycin hydrochloride in 5% glucose (Vancocin ® and Vancomycine®) were stored up to 57 days at 5°C ± 3°C. A visual inspection and pH measurement were performed periodically during the storage, and the concentrations were measured by high-performance liquid chromatography-diode array detection. No color change or precipitation in the solution was observed throughout the study period. As recommended by the U.S. Food and Drug Administration, the lower confidence limit at 95% of the concentration for the solutions remained superior to 90% of the initial concentration up to 43 days for the brand vancomycin (Vancocin®) infusion (96% ± 2%) and up to 57 days for the generic (Vancomycine®) (95% ± 4%). The solutions prepared either from brand or generic vancomycin hydrochloride were chemically stable more than one month (43 days for the brand and 57 days for the generic solution) and could be prepared in advance in a centralized intravenous additive service facility.

Related Keywords: Sophie Huvelle, PharmD, Marie Godet, BSc, PhD, Jean-Daniel Hecq, PharmD, PhD, Patricia Gillet, PharmD, Jacques Jamart, MD, MSc, Laurence M. Galanti, MD, PhD, vancomycin, glycopeptide antibiotic, antimicrobial agent, continuous infusion, 5% polyolefin storage bags, long-term stability, drug costs, proprietary formulations, quality control, aseptic compounding, compounded sterile preparations


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