Literature DB >> 23814283

Compatibility and stability of morphine sulphate and naloxone hydrochloride in 0.9% sodium chloride for injection.

Charlotte Kistner1, Mary H H Ensom, Diane Decarie, Gillian Lauder, Roxane R Carr.   

Abstract

BACKGROUND: Naloxone may be administered in conjunction with morphine to reduce the risk of opioid-induced pruritis. Combining these drugs for coadministration may be beneficial, but little is known about their physical compatibility and stability in combined solutions.
OBJECTIVE: To describe the physical compatibility and stability of morphine sulphate and naloxone hydrochloride (at various concentrations) in IV admixtures.
METHODS: The physical compatibility and stability of admixtures of morphine 1000 μg/mL and naloxone 4 μg/mL, 12.5 μg/mL, and 25 μg/mL in 0.9% sodium chloride were studied. For each concentration of naloxone, one bag was stored at room temperature (22°C) for 72 h and one bag was stored under refrigeration (4°C) for 30 days. For all preparations, physical characteristics, including pH, colour, and formation of precipitate, were evaluated. The samples were also analyzed by a stability-indicating high-performance liquid chromatographic method. Stability was defined as the retention of at least 90% of the initial concentration.
RESULTS: No notable changes in pH or colour and no macroprecipitation were observed in any of the preparations after storage at 22°C for up to 72 h or at 4°C for up to 30 days. All preparations maintained more than 90% of the initial concentrations of morphine and naloxone at the end of the respective study periods. The calculated lower limit of the 95% confidence interval also indicated that 90% or more of the initial concentration remained at the end of each study period.
CONCLUSION: Admixtures of morphine sulphate and naloxone hydrochloride were stable for 72 h at room temperature and for 30 days with refrigeration.

Entities:  

Keywords:  compatibility; morphine; naloxone

Year:  2013        PMID: 23814283      PMCID: PMC3694937          DOI: 10.4212/cjhp.v66i3.1253

Source DB:  PubMed          Journal:  Can J Hosp Pharm        ISSN: 0008-4123


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