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Laboratory Director, Analytical Research Laboratories, Oklahoma City, OK
Research Analyst, Analytical Research Laboratories
Research Analyst, Analytical Research Laboratories
Research Consultant, TriPharma Research, Cashiers, NC
Research Analyst, Analytical Research Laboratories
Research Analyst, Analytical Research Laboratories
Reprints: Mr. Trissel, Research Consultant, c/o TriPharma Research, PO Box 265, Cashiers, NC 28717, fax 828/743-1752, tripharma{at}mail.com
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
Published Online, July 9, 2008. www.theannals.com, DOI 10.1345/aph.1L079
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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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