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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.
Insights
Morphine hydrochloride stability in portable infusion devices is excellent when preserved with sodium metabisulphite. Even without preservatives, morphine solutions show slow degradation over 30 days, ensuring patient safety.
Area of Science:
- Pharmaceutical Science
- Drug Stability Studies
- Analytical Chemistry
Background:
- Morphine hydrochloride is a key analgesic increasingly administered via portable disposable infusion devices.
- Assessing the stability of morphine in these devices is crucial for safe and effective pain management.
Purpose of the Study:
- To evaluate the stability of morphine hydrochloride at 2.50 and 5.00 mg/ml concentrations in disposable infusion devices over 30 days.
- To determine the impact of sodium metabisulphite as a preservative on morphine stability.
Main Methods:
- High-performance liquid chromatography (HPLC) was employed to analyze morphine solutions stored in infusion devices.
- Stability was assessed over a 30-day period under various conditions (room temperature, light/dark).
Main Results:
- Morphine solutions with sodium metabisulphite showed no degradation products after 30 days, regardless of light exposure.
- Solutions without sodium metabisulphite exhibited slow degradation, forming pseudomorphine (0.205%-0.235% at 6 days, 0.94%-1.50% at 30 days).
Conclusions:
- Morphine hydrochloride solutions demonstrate slow degradation in disposable infusion devices, especially when preserved with sodium metabisulphite.
- The drug is stable for at least 5 days, meeting the typical storage requirements for these devices.