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Article Dans Une Revue Pharmaceuticals Année : 2023

Stability Study of Parenteral N-Acetylcysteine, and Chemical Inhibition of Its Dimerization

Nicolas Primas
Guillaume Lano
Damien Brun
  • Fonction : Auteur
Christophe Curti
  • Fonction : Auteur
Marion Sallée
  • Fonction : Auteur
Emmanuelle Sampol-Manos
  • Fonction : Auteur
Charleric Bornet
  • Fonction : Auteur
Stéphane Burtey
Patrice Vanelle

Résumé

Parenteral N-acetylcysteine has a wide variety of clinical applications, but its use can be limited by a poor chemical stability. We managed to control parenteral N-acetylcysteine stability, and to study the influence of additives on the decrease of N-acetylcysteine degradation. First, an HPLC-UV dosing method of N-acetylcysteine and its main degradation product, a dimer, was validated and the stability without additive was studied. Then, the influence of several additives (ascorbic acid, sodium edetate, tocopherol and zinc) and of temperature on N-acetylcysteine dimerization was evaluated. Finally, the influence of zinc gluconate at different concentrations (administrable to patients) was investigated. Zinc gluconate at 62.5 µg·mL−1 allows the stabilization of 25 mg·mL−1 N-acetylcysteine solution for at least 8 days when stored at 5 ± 3 °C.
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Dates et versions

hal-04490664 , version 1 (05-03-2024)

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Nicolas Primas, Guillaume Lano, Damien Brun, Christophe Curti, Marion Sallée, et al.. Stability Study of Parenteral N-Acetylcysteine, and Chemical Inhibition of Its Dimerization. Pharmaceuticals, 2023, 16 (1), pp.72. ⟨10.3390/ph16010072⟩. ⟨hal-04490664⟩
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