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Physical and Chemical Stability of Esomeprazole Sodium Solutions

By Thomas C Kupiec, Vasileios Aloumanis, Michel Ben, Lawrence A Trissel, Pak Chan and Joe Patterson


Esomeprazole sodium is the S-isomerof omeprazole and acts as a proton pump inhibitor gastric antisecretory agent indicated for the short-term treat-ment of gastroesophageal reflux disease in patients with a history of erosive esophagitis. The product information in-dicates that esomeprazole sodium is sta-ble for 6 hours in 5 % dextrose and 12 hours in 0.9 % sodium chloride and in lactated Ringer’s injection.1 There is no information on the longer-term stability of esomeprazole sodium in infusion so-lutions beyond these time frames. The purpose of our study was to eval-uate the physical and chemical stability of esomeprazole at 0.4 and 0.8 mg/mL as the sodium salt in 5 % dextrose, 0.9% sodium chloride, and lactated Ringer’s injection over periods of up to 2 days at room temperature and 5 days under re-frigeration

Year: 2016
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