[Stability in serum of intravenous busulfan in a polyolefin pack].
BACKGROUND
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 bulsulfan. 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 serum and different conservation conditions, in a new plastic pack made from polyolefin/polyamide laminates.


METHODS
High-efficiency liquid chromatography with ultraviolet detection was used to determine the concentration of busulfan derivate with sodium diethyldithiocarbamatetrihydrate. Stability was assessed for both concentrations; refrigerated and at room temperature, using the t(90) of each sample.


RESULTS
The percentage of the remaining busulfan concentration at 24 h was always less than 90%. At 25 degrees C and 0.24 mg/mL concentration, the t90 was 8.4 h; at 4 degrees C and a concentration of 0.24 mg/mL it was 16.7 h; at 25 degrees C and a concentration of 0.12 mg/mL it was 12 h and at 4 degrees C and a concentration of 0.12 mg/mL it was 11.5 h.


CONCLUSIONS
This study show that busulfan in a concentration of 0.24 mg/mL in serum is stable in the bags tested during a refrigerated storage period of 12 h plus two additional hours of administration of the drug.
Nebot Martínez
J
J
Servicio de Farmacia, Hospital General de Castellón, Castellón, España. janebot@hotmail.com
Alós Almiñana
M
M
Díez Sales
O
O
D002066:Busulfan; D004355:Drug Stability; D010969:Plastics; D011090:Polyenes; D012965:Sodium Chloride
D010969:Plastics; D011090:Polyenes; D012965:Sodium Chloride; C035051:PL 732; D002066:Busulfan