Stability of Vancomycin 25 mg/mL in Ora-Sweet and Water in Unit-Dose Cups and Plastic Bottles at 4°C and 25°C

Abstract

Background: Solutions of vancomycin for oral administration are not available commercially in Canada or the United States but are needed for patients who cannot swallow capsules.Objective: To evaluate the stability of vancomycin solutions stored in unit-dose cups and plastic bottles under refrigeration (4°C) and at room temperature (25°C) for up to 75 days. Methods:Vancomycin 25 mg/mL in Ora-Sweet vehicle and water (1:1 ratio by volume) was dispensed into opaque blue polyethylene unit-dose cups with aluminum seal (14 replicates) or amber plastic prescription bottles (6 replicates). Seven cups and 3 bottles were refrigerated (4°C), and the remainder of the containers were stored at room temperature (25°C). At the time of preparation and at 15, 30, 40, 50, 63, and 75 days, 3 aliquots were collected from one of the cups and from every bottle and were stored frozen (-85°C) until the time of analysis. Physical characteristics were evaluated at each time point, including measurement of pH and visual assessment of colour and precipitation. After thawing, the samples were analyzed in triplicate by a validated stability-indicating high-performance liquid chromatography method. A solution was considered stable if 90% of the initial concentration of vancomycin was maintained. Results:No notable changes in colour, taste, or pH were observed in vancomycin solutions stored in the unit-dose cups at 4°C or 25°C or in the plastic bottles stored at 4°C over the 75-day study period. Starting on day 63, a white precipitate was observed in the solutions stored in plastic bottles at 25°C, but there were no notable changes in taste or pH during the 75-day period. The 95% confidence interval of the slope of the curve relating concentration to time, determined by linear regression, indicated that vancomycin solutions stored in cups or bottles at 4°C would maintain at least 93.6% of the initial vancomycin concentration for 75 days and that solutions stored at 25°C would maintain at least 90.0% of the initial concentration for 30 days (cups) or 26 days (bottles), with 95% confidence. Conclusions:Vancomycin 25 mg/mL stored in unit-dose cups or plastic bottles at 4°C was stable for at least 75 days, whereas solutions stored in cups or bottles at 25°C are expected to be stable for 30 or 26 days, respectively.

Specific inhibitors for identifying pathways for methane production from carbon monoxide by a nonadapted anaerobic mixed culture

“…However this study indicates that 0.07 mmol/L vancomycin in the bottles is enough to maintain an inhibitory effect for at least 32 days at 35°C with the wastewater-treatment sludge used. This outcome is consistent with a few clinical studies regarding vancomycin stability in storage (Das et al 1986;Ensom et al 2010), which showed that vancomycin solutions stored at 25°C could maintain at least 90% of their initial concentration for up to 30 days. Another study (Murray et al 1995) established that there were no differences in vancomycin antimicrobial potency and stability for over 1 month when kept at room temperature.…”

Vancomycin 50 mg/mL Suspension in Oral Syrup: Stability in Plastic Bottles and Syringes at 2 Temperatures

“…§Calculated from lower limit of 95% CI of the slope of the curve relating concentration to time, determined by linear regression, according to the following formula: [(90% -lower limit of 95% CI of concentration at time 0) ÷ slope of 95% CI of linear regression curve). In contrast to a previous study using a lower concentration of vancomycin (25 mg/mL) in a different vehicle, 1 there was a high degree of variability in taste, subjective palatability, viscosity, and miscibility of samples prepared from both liquid and powdered vancomycin. The mean pH (± standard deviation) for both types of preparation increased over time (for liquid, pH 3.29 ± 0.017 on day 0 to 3.85 ± 0.078 on day 91; for powder, pH 3.52 ± 0.021 on day 0 to 3.96 ± 0.032 on day 91), as has been observed previously.…”

“…Forced degradation decreased the amount of vancomycin (with base, a 91.8% decrease; with heat, a 87.8% decrease) but no changes in peak shape or retention time. Small degradation peaks were observed 1,2 ; however, there were no interfering peaks compared to controls.…”

MoS2/TiO2 Hybrid Nanostructure‐Based Field‐Effect Transistor for Highly Sensitive, Selective, and Rapid Detection of Gram‐Positive Bacteria

“…No significant changes were observed in the transfer characteristic of the biosensor. Vancomycin has also been shown to be stable at room temperature for at least 26 days in solution . This suggests that the FET device need not be stored at special temperature controlled conditions.…”