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Estabilidad y compatibilidad física del clorhidrato de nalbufina parenteral durante la perfusión continua en
Romain Paoli-Lombardo1,2, Vincent Arcani1, Delphine Dazan1
1Service Central de la Qualité et de l'Information Pharmaceutiques (SCQIP), Pharmacy Department, AP-HM, Hôpital de la Conception, Marseille, France.
PloS one
|September 4, 2025
Resumen
El clorhidrato de nalbufina es estable en solución salina normal durante 24 horas en infusiones pediátricas, pero se deben comprobar las incompatibilidades de fármacos como la furosemida y la anfotericina B cuando se administran simultáneamente.
Área de la Ciencia:
- Farmacología pediátrica
- Análisis farmacéutico
- Estabilidad y compatibilidad del fármaco
Sus antecedentes:
- El clorhidrato de nalbufina se utiliza en la práctica pediátrica mediante perfusión continua.
- Existen datos previos de estabilidad para concentraciones más altas, pero no para diluciones pediátricas.
- La administración pediátrica requiere la comprensión de la estabilidad y la compatibilidad en solución salina normal durante 24 horas.
Objetivo del estudio:
- Evaluar la estabilidad del clorhidrato de nalbufina en solución salina normal en concentraciones pediátricas.
- Evaluar la compatibilidad del clorhidrato de nalbufina con los medicamentos pediátricos de uso común.
- Validar un método cromatográfico indicador de estabilidad para la cuantificación del clorhidrato de nalbufina.
Principales métodos:
- Se ha validado un nuevo método de cromatografía líquida de alto rendimiento (HPLC).
- Se monitoreó la estabilidad del clorhidrato de nalbufina y los productos de degradación en condiciones forzadas (luz, calor, oxidación, pH) durante 24 horas.
- Se evaluó la compatibilidad física con medicamentos administrados al mismo tiempo mediante inspección visual y conteo de partículas.
Principales resultados:
- El método HPLC fue validado y demostró ser indicador de estabilidad.
- El clorhidrato de nalbufina en solución salina normal demostró su estabilidad durante al menos 24 horas a temperatura ambiente, sin protección contra la luz.
- Compatible con varios medicamentos, pero incompatible con la furosemida y la anfotericina B.
Conclusiones:
- El clorhidrato de nalbufina es estable en solución salina normal para su administración pediátrica con bomba de jeringuilla durante 24 horas.
- La consideración cuidadosa de las incompatibilidades entre fármacos es crucial para la administración simultánea a través de colectores multipuerto o conexiones en el sitio Y.
- Este estudio proporciona datos esenciales para el uso pediátrico seguro de las perfusiones de clorhidrato de nalbufina.
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