Stability of omeprazole in an extemporaneously prepared oral liquid.
The stability of omeprazole 2 mg/mL. in an extemporaneously prepared oral liquid was studied. The contents of five 20-mg omeprazole capsules were mixed with 50 mL of 8.4% sodium bicarbonate solution in a Luer-Lok syringe. Three vials of this liquid were prepared for storage at 24, 5, and -20 degrees C. A 3-mL. sample of each was taken initially and on days 1, 2, 3, 4, 6, 8, 10, 12, 14, 18, 22, 26, and 30 and assayed by high-performance liquid chromatography. The liquids stored at 5 degrees C and at -20 degrees C did not change color during the study period, but the color of the liquid stored at 24 degrees C changed from white to brown. There were no significant changes in the omeprazole concentrations of the liquids stored at 5 and -20 degrees C during the study period, but the omeprazole concentration of the liquid stored at 24 degrees C was < 90% of the initial concentration on day 18. Omeprazole 2 mg/mL in an oral liquid compounded extemporaneously from capsules and sodium bicarbonate injection was stable for up to 14 days at 24 degrees C and for up to 30 days at 5 and -20 degrees C.
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Department of Pharmacy Services, Hartford Hospital, CT 06102, USA. hhdicchow@aol.com
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Liu
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Chow
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D000897:Anti-Ulcer Agents / Q000737:chemistry*; D004304:Dosage Forms; D004355:Drug Stability; D004791:Enzyme Inhibitors / Q000737:chemistry*; D009853:Omeprazole / Q000737:chemistry*; D054328:Proton Pump Inhibitors; D013696:Temperature
D000897:Anti-Ulcer Agents; D004304:Dosage Forms; D004791:Enzyme Inhibitors; D054328:Proton Pump Inhibitors; D009853:Omeprazole