Stability of omeprazole in an extemporaneously prepared oral liquid

Am J Health Syst Pharm. 1997 Aug 15;54(16):1833-6. doi: 10.1093/ajhp/54.16.1833.

Abstract

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.

Publication types

  • Comparative Study

MeSH terms

  • Anti-Ulcer Agents / chemistry*
  • Dosage Forms
  • Drug Stability
  • Enzyme Inhibitors / chemistry*
  • Omeprazole / chemistry*
  • Proton Pump Inhibitors
  • Temperature

Substances

  • Anti-Ulcer Agents
  • Dosage Forms
  • Enzyme Inhibitors
  • Proton Pump Inhibitors
  • Omeprazole