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RESEARCH REPORTS |
1 Laboratory Director, Analytical Research
Laboratories, Oklahoma City, OK
2 Research Analyst, Analytical Research
Laboratories
3 Research Analyst, Analytical Research Laboratories
4 Research Consultant, TriPharma
Research, Cashiers, NC
* To whom correspondence should be addressed. E-mail: tripharma{at}mail.com.
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Abstract |
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BACKGROUND: Esomeprazole sodium (Nexium IV, AstraZeneca) is the S-isomer of omeprazole and acts as a proton pump inhibitor gastric antisecretory agent indicated for the short-term treatment of gastroesophageal reflux disease in patients with a history of erosive esophagitis. Currently, there is no information on the long-term stability of esomeprazole sodium in infusion solutions beyond 12 hours.
OBJECTIVE: To evaluate the stability of esomeprazole sodium in 5% dextrose, 0.9% sodium chloride, and lactated Ringer's injection, at 2 concentrations, at room temperature and when refrigerated.
METHODS: Triplicate samples of esomeprazole 0.4 and 0.8 mg/mL as the sodium salt were prepared in the solutions required. Stability evaluations were performed initially, over 2 days stored at 23 °C, and over 5 days stored at 4 °C. Physical stability was assessed using turbidimetric and particulate measurement, as well as visual observation. Chemical stability was evaluated by stability-indicating high-performance liquid chromatography.
RESULTS: The samples in all 3 infusion solutions were physically stable throughout the study. None of the samples had evidence of visible haze or particulates. Most samples developed a slight yellow discoloration within 24 hours, but this discoloration was not accompanied by an excessive loss of drug content. The esomeprazole sodium samples in all 3 infusion solutions exhibited less than 7% loss over 2 days at 23 °C and over 5 days at 4 °C.
CONCLUSIONS: Esomeprazole 0.4 and 0.8 mg/mL as the sodium salt in the infusion solutions tested is chemically and physically stable for at least 2 days at room temperature and 5 days under refrigeration.
Key Words: admixture, esomeprazole, stability
Reprints: Mr. Trissel, Research Consultant, c/o TriPharma Research, PO Box 265, Cashiers, NC 28717, fax 828/743-1752, tripharma@mail.com
This study (IRUSESOM0548) was supported by a grant from Astra- Zeneca, Wilmington, DE.
This article has been cited by other articles:
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  M. A.C. Broeren, E. A.M. Geerdink, H. L. Vader, and A. W. L. van den Wall Bake Hypomagnesemia Induced by Several Proton-Pump Inhibitors Ann Intern Med, November 17, 2009; 151(10): 755 - 756. [Full Text] [PDF]
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