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RESEARCH PRODUCT

Stability in physiological saline of intravenous busulfan in a polyolefin pack

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Abstract Introduction Although it has been used orally, the variability in its absorption and the risk of causing vomiting has lead to a push towards the intravenous use of busulfan. This study looks at the stability of 60 mg of busulfan, in fixed volumes of 250 mL (0.24 mg/mL) and 500 mL (0.12 mg/mL) of physiological saline and different conservation conditions, in a new plastic pack made from polyolefin/polyamide laminates. Material and methods High-performance liquid chromatography with ultraviolet detection was used to determine the concentration of busulfan derivate with sodium diethyldithiocarbamate trihydrate. Stability was assessed for both concentrations; refrigerated and at room temperature, using the t90 of each sample. Results The percentage of the remaining busulfan concentration at 24 h was always less than 90%. At 25°C and 0.24 mg/mL concentration, the t90 was 8.4 h; at 4°C and a concentration of 0.24 mg/mL it was 16.7 h; at 25°C and a concentration of 0.12 mg/mL it was 12 h and at 4°C and a concentration of 0.12 mg/mL it was 11.5 h. Conclusions This study shows that busulfan in a concentration of 0.24 mg/mL in physiological saline is stable in the bags tested during a refrigerated storage period of 12 h plus 2 additional hours of administration of the drug.