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Long-term Stability of Vancomycin Hydrochloride in Oral Solution: The Brand Name Versus a Generic Product

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

Issue:  Jul/Aug 2016 - Volume 20, Number 4
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Page(s):  347-350

Long-term Stability of Vancomycin Hydrochloride in Oral Solution: The Brand Name Versus a Generic Product Page 1
Long-term Stability of Vancomycin Hydrochloride in Oral Solution: The Brand Name Versus a Generic Product Page 2
Long-term Stability of Vancomycin Hydrochloride in Oral Solution: The Brand Name Versus a Generic Product Page 3
Long-term Stability of Vancomycin Hydrochloride in Oral Solution: The Brand Name Versus a Generic Product Page 4

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Abstract:  Vancomycin hydrochloride is often used for antibiotherapy in oral solution for hospitalized patients. Preparation of this solution in advance could improve time management or cost savings of drug delivery. Brand and generic products of vancomycin hydrochloride are now commercially available. The aim of this study was to investigate the long-term stability of the vancomycin hydrochloride brand name Vancocin versus the generic Vancomycine at 5°C ± 3°C. Five vials of each oral solution of 1.25 g/100 mL Vancocin and Vancomycine were stored up to 57 days at 5°C ± 3°C. Concentrations were measured by high-performance liquid chromatography-diode array detection. Visual inspection by microscopy and spectrophotometry, as well as pH measurement, were performed periodically during the storage period. No color change or precipitation in the solution was observed throughout the study period. The lower confidence limit of the concentration for these solutions remained superior to 90% of the initial concentration as recommended by the U.S. Food and Drug Administration up to a 57-day storage period for Vancocin (106.47%) and vancomycin (102.73%). The solutions prepared either from brand or generic vancomycin hydrochloride were chemically stable for more than one month and could be prepared in advance.

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, antibiotic, antimicrobial, MRSA, drug costs, oral solution, long-term stability

Related Categories: PEER-REVIEWED, STABILITIES, COMPATIBILITIES, DOSAGE FORMS/DRUG CARRIERS, INFECTIOUS DISEASE, STORAGE

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