Stability Study of Admixtures Combining Ziconotide With Morphine or Sufentanil in Polypropylene Syringes.
ICH
UPLC DAD
morphine
polypropylene syringe
stability indicating method
sufentanil
ziconotide
Journal
Neuromodulation : journal of the International Neuromodulation Society
ISSN: 1525-1403
Titre abrégé: Neuromodulation
Pays: United States
ID NLM: 9804159
Informations de publication
Date de publication:
Oct 2021
Oct 2021
Historique:
revised:
15
09
2020
received:
17
07
2020
accepted:
16
09
2020
pubmed:
24
10
2020
medline:
27
10
2021
entrez:
23
10
2020
Statut:
ppublish
Résumé
The association of morphine ziconotide or sufentanil ziconotide was used to manage cancer pain. Moving these patients is sometimes difficult. In order to transport these syringes for pump refilling, it could be interesting to demonstrate the stability of the mixture and so to be able to ensure the best transport conditions of syringes. A stability indicating UPLC-DAD method was developed and validated according to the ICH guidelines. Fur mixtures of each association have been stored in 5 ± 3°C and 25 ± 2°C and were evaluated for seven days and compared to the initial observed concentrations. The stability of these associations was demonstrated at 5°C for seven days thanks to relative concentrations (95% confidence intervals of the mean of three samples) systematically positioned between 95% and 105%. No degradation product was observed during the stability study. This study shows the stability of these association morphine ziconotide or sufentanil ziconotide at 5°C for seven days in polypropylen syringes. This result will allow the transport of the preparation under optimal conditions. Advance preparations for intrathecal pump refills could also be feasible.
Sections du résumé
BACKGROUND
BACKGROUND
The association of morphine ziconotide or sufentanil ziconotide was used to manage cancer pain. Moving these patients is sometimes difficult. In order to transport these syringes for pump refilling, it could be interesting to demonstrate the stability of the mixture and so to be able to ensure the best transport conditions of syringes.
MATERIALS AND METHODS
METHODS
A stability indicating UPLC-DAD method was developed and validated according to the ICH guidelines. Fur mixtures of each association have been stored in 5 ± 3°C and 25 ± 2°C and were evaluated for seven days and compared to the initial observed concentrations.
RESULTS
RESULTS
The stability of these associations was demonstrated at 5°C for seven days thanks to relative concentrations (95% confidence intervals of the mean of three samples) systematically positioned between 95% and 105%. No degradation product was observed during the stability study.
CONCLUSION
CONCLUSIONS
This study shows the stability of these association morphine ziconotide or sufentanil ziconotide at 5°C for seven days in polypropylen syringes. This result will allow the transport of the preparation under optimal conditions. Advance preparations for intrathecal pump refills could also be feasible.
Identifiants
pubmed: 33095956
doi: 10.1111/ner.13289
pii: S1094-7159(21)06445-X
doi:
Substances chimiques
Polypropylenes
0
omega-Conotoxins
0
Morphine
76I7G6D29C
ziconotide
7I64C51O16
Sufentanil
AFE2YW0IIZ
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1145-1156Informations de copyright
© 2020 International Neuromodulation Society.
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