Study protocol: stability of morphine injected without preservative, delivered with a disposable infusion device.
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.


METHODS
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.


CONCLUSIONS
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.
Oustric-Mendes
A C
AC
Ecole d'Application du Service de Santé des Armées, Chaire de Sciences Pharmaceutiques, Toxicologie et Expertises dans les Armées, Paris, France.
Huart
B
B
Le Hoang
M D
MD
Perrin-Rosset
M
M
Pailler
F M
FM
Darbord
J C
JC
Prognon
P
P
Gard
C
C
Pradeau
D
D
D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000737:chemistry; D004209:Disposable Equipment; D004355:Drug Stability; D004356:Drug Storage; D007260:Infusion Pumps; D008027:Light; D009020:Morphine / Q000008:administration & dosage* / Q000737:chemistry; D011310:Preservatives, Pharmaceutical / Q000737:chemistry; D013447:Sulfites / Q000737:chemistry
D000701:Analgesics, Opioid; D011310:Preservatives, Pharmaceutical; D013447:Sulfites; D009020:Morphine; C030981:metabisulfite