Stability of Pantoprazole in Parenteral Nutrition Units

Valverde Molina, E.; González Muñiz, V.; Gómez-Maldonado, J.; Muñoz Castillo, I.

doi:10.1016/S2173-5085(08)70050-9

Farmacia Hospitalaria

ISSN: 1130-6343

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Pantoprazole is a weak base (pka∼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 chromatography (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 24h 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.

Key words:

Drug stability

HPLC

Pantoprazole

Parenteral nutrition

Introducción

El pantoprazol es una base débil (pka∼4) y su estabilidad en solución acuosa es dependiente del pH. Teniendo en cuenta que el pH de las unidades de nutrición parenteral (UNP) puede oscilar entre 6,0 y 6,5, y puesto que pantoprazol parece ser el inhibidor de la bomba de protones más estable a pH ácido, se evaluó la posibilidad de adicionarlo a las UNP con objeto de facilitar su administración a los pacientes.

Métodos

Se determinó por cromatografía líquida de alta resolución (HPLC, del inglés high performance liquid chromatography) la riqueza de pantoprazol en una UNP a diferentes intervalos de tiempo.

Resultados

La determinación cromatográfica de las concentraciones de pantoprazol reflejó un rápido y progresivo envejecimiento de la muestra. Pasadas 24h la cantidad de fármaco detectado en la UNP es inferior al 50% del total adicionado.

Conclusiones

A la vista de estos resultados se desaconseja este vehículo para la administración de pantoprazol, ya que puede poner en riesgo la seguridad de los pacientes al infradosificar la medicación que requieren y exponerlos a los posibles efectos desconocidos de los diferentes productos de degradación del fármaco.

Palabras clave:

Estabilidad fisicoquímica

HPLC

Pantoprazol

Nutrición parenteral

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References

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Oral bioavailability of pantoprazole suspended in sodium bicarbonate solution.

Am J Health-Syst Pharm, 60 (2003), pp. 1324-1329

Medline