Estabilidad en suero fisiológico del busulfán intravenoso en un envase de poliolefinas / Stability in serum of intravenous busulfan in a polyolefin pack

Introducción: Aunque se ha utilizado por vía oral, la variabilidad en su absorción y el riesgo de que se produzcan vómitos, ha impulsado la utilización intravenosa de busulfán. En el presente trabajo se estudiará la estabilidad de 60 mg de busulfán, en volúmenes fijos de 250 ml (0,24 mg/ml) y 500 ml (0,12 mg/ml) de suero fisiológico y diferentes condiciones de conservación, en un nuevo envase de plástico, de lámina construida de poliolefina/poliamida. Material y métodos: Se empleó la cromatografía líquida de alta eficacia con detección ultravioleta para determinar las concentraciones de busulfán derivatizado con dietilditiocarbamatotrihidrato sódico. La estabilidad se evaluó, para ambas concentraciones, tanto en nevera como a temperatura ambiente, mediante el t90 de cada ensayo. Resultados: El porcentaje de concentración remanente de busulfán a las 24 h siempre fue inferior al 90%. A 25 ºC y concentración de 0,24 mg/ml el t90 fue de 8,4 h; a 4 ºC y concentración de 0,24 mg/ml fue de 16,7 h; a 25 ºC y concentración de 0,12 mg/ml fue de 12 h, y a 4 ºC y concentración de 0,12 mg/ml fue de 11,5 h. Conclusiones: El presente estudio demuestra que el busulfán a una concentración de 0,24 mg/ml en suero fisiológico será estable en las bolsas ensayadas durante un período de almacenamiento de 12 h en nevera más las 2 h de administración del fármaco (AU)

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 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. Material and 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 t90 of each sample. Results: The percentage of the remaining busulfan concentration at 24 h was always less than 90%. At 25 oC and 0.24 mg/mL concentration, the t90 was 8.4 h; at 4 oC and a concentration of 0.24 mg/mL it was 16.7 h; at 25 oC and a concentration of 0.12 mg/mL it was 12 h and at 4 oC 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 (AU)

[Stability in serum of intravenous busulfan in a polyolefin pack]. / Estabilidad en suero fisiológico del busulfán intravenoso en un envase de poliolefinas.

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 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. MATERIAL AND 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.