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Study protocol: stability of morphine injected without preservative, delivered with a disposable infusion device
A C Oustric-Mendes1, B Huart, M D Le Hoang
1Ecole d'Application du Service de Santé des Armées, Chaire de Sciences Pharmaceutiques, Toxicologie et Expertises dans les Armées, Paris, France.
Background And Objective:
Morphine hydrochloride, a major analgesic drug, is being increasingly administered using portable disposable infusion devices. The objective of this study was to investigate the stability of morphine in such a system at two concentrations (2.50 and 5.00 mg/ ml) over a 30-day period.
Method:
High-performance liquid chromatography of stored morphine solutions.
Results:
The best stability was observed with disposable infusion devices filled with a morphine solution containing sodium metabisulphite as a preservative. No breakdown products were detected after 1 month of storage at room temperature, in light or darkness. On the other hand, 2.50 and 5.00 mg/ml morphine solutions without sodium metabisulphite, stored in the infusion device led to the formation of 0.205% and 0.235% of pseudomorphine, respectively, after 6 days of storage in the light, and 1.50% and 0.94% after 30 days storage.
Conclusion:
Morphine hydrochloride solutions stored in disposable infusion devices degraded very slowly, particularly when preserved with sodium metabisulphite. The solutions are stable over 5 days, the maximum period of storage normally required when using disposable infusers.