Estabilidad de pantoprazol en unidades para nutricion parenteral / Stability of pantoprazole in parenteral nutrition units

Introduccion: El pantoprazol es una base debil (pka * 4) y su estabilidad en solucion acuosa es dependiente del pH. Teniendo en cuenta que el pH de las unidades de nutricion parenteral (UNP) puede oscilar entre 6,0 y 6,5, y puesto que pantoprazol parece ser el inhibidor de la bomba de protones mas estable a pH acido, se evaluo la posibilidad de adicionarlo a las UNP con objeto de facilitar su administracion a los pacientes. Metodos: Se determina por cromatografia liquida de alta resolucion (HPLC, del ingles high performance liquid chromatographic) la riqueza de pantoprazol en una UNP a diferentes intervalos de tiempo. Resultados: La determinacion cromatografica de las concentraciones de pantoprazol reflejo un rapido y progresivo envejecimiento de la muestra. Pasadas 24 h la cantidad de farmaco detectado en la UNP es inferior al 50% del total adicionado. Conclusiones: A la vista de estos resultados se desaconseja este vehiculo para la administracion de pantoprazol, ya que puede poner en riesgo la seguridad de los pacientes al infradosificar la medicacion que requieren y exponerlos a los posibles efectos desconocidos de los diferentes productos de degradacion del farmaco (AU)

Introduction: Pantoprazole is a weak base (pka ¡Ö 4) with its stability in aqueous solution dependent on pH. Keeping in mind that the pH of the parenteral nutrition units (PNU) can range between 6.0 and6.5 and since pantoprazole seems to be the most stable protonpump inhibitor (PPI) for pH acid, we want to assess the possibility of adding it to PNU with the aim of simplifying its administration to patients. Methods: Using high performance liquid chromatographic (HPLC) to measure pantoprazole content in PNU at different time intervals. Results: The chromatographic determination of pantoprazole concentration reflected a rapid and progressive aging of the sample. After 24 h the quantity of drug detected in the PNU was below 50% of the total added. Conclusions: In view of these results, we therefore do not suggest this as a suitable vehicle for pantoprazole administration as it could put patients at risk of being under-dosed and therefore exposing them to potential unknown side effects of the different drug degradation products (AU)

[Stability of pantoprazole in parenteral nutrition units]. / Estabilidad de pantoprazol en unidades para nutrición parenteral.

INTRODUCTION: Pantoprazole is a weak base (pka approximately equal to 4) with its stability in aqueous solution dependent on pH. Keeping in mind that the pH of the parenteral nutrition units (PNU) can range between 6.0 and 6.5 and since pantoprazole seems to be the most stable proton pump inhibitor (PPI) for pH acid, we want to assess the possibility of adding it to PNU with the aim of simplifying its administration to patients. METHODS: Using high performance liquid chromatographic (HPLC) to measure pantoprazole content in PNU at different time intervals. RESULTS: The chromatographic determination of pantoprazole concentration reflected a rapid and progressive aging of the sample. After 24 h the quantity of drug detected in the PNU was below 50% of the total added. CONCLUSIONS: In view of these results, we therefore do not suggest this as a suitable vehicle for pantoprazole administration as it could put patients at risk of being under-dosed and therefore exposing them to potential unknown side effects of the different drug degradation products.