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JANE E. BURNETT, B.S., is Senior Research Specialist, Department of Surgery, University of Missouri Hospital and Clinics (UMHC), Columbia. ETHAN R. BALKIN, B.A., is Graduate Research Assistant, Area of Pathobiology, Harry S. Truman Memorial Veterans’ Hospital, Columbia; at the time of the study he was Senior Research Laboratory Technician, Department of Surgery, UMHC.

Address correspondence to Ms. Burnett at the Department of Surgery, University of Missouri Hospital and Clinics, NW301 Medical Sciences Building DC096.00, Columbia, MO 65212 (burnettj{at}health.missouri.edu).

Purpose. The stability and viscosity of preparations of a commercially available, flavored, immediate-release powder for oral suspension (omeprazole–sodium bicarbonate) during refrigerator and room temperature storage were investigated. Methods. Omeprazole–sodium bicarbonate 20-mg packets were suspended to initial omeprazole concentrations of 0.6 and 2 mg/mL, and omeprazole–sodium bicarbonate 40-mg packets were suspended to initial omeprazole concentrations of 1.2, 2, 3, and 4 mg/mL. Suspensions were stored at 4 °C in darkness (refrigerated) or 22–25 °C (room temperature) in light for one week. A third set of suspensions was stored refrigerated for one month. Omeprazole’s stability was quantified after 0, 6, 12, 24, 48, and 168 hours in one-week samples and after 0, 7, 14, 21, and 28 days in one-month samples using high-pressure liquid chromatography. Viscosities of refrigerated suspensions were measured after 0, 1, and 7 days. Results. Refrigerated suspensions retained >98% and >96% of their initial omeprazole concentrations after one week and one month, respectively. Stability of room temperature suspensions was concentration dependent. After one week, the 0.6- and 1.2-mg/mL suspensions retained 87.2% and 93.1% of their respective initial omeprazole concentrations, whereas the 2-, 3-, and 4-mg/mL suspensions retained >97% of their initial omeprazole concentrations. Suspension viscosities varied 10-fold over the concentrations studied, but all were within the viscosity ranges of other commercially available oral suspensions. Prolonged refrigeration did not increase the suspensions’ viscosities. Conclusion. Omeprazole–sodium bicarbonate suspensions of 0.6–4 mg/mL omeprazole were stored at 4 °C in darkness for up to 28 days. The viscosities of refrigerated suspensions did not increase over 7 days. Except for the 0.6 mg/mL preparations, suspensions stored at room temperature in the light retained >90% of their initial omeprazole content after 7 days, despite turning yellow. Index terms: Antacids; Color; Concentration; Gastrointestinal drugs; Omeprazole; Pediatrics; Photodecomposition; Sodium bicarbonate; Stability; Storage; Suspensions; Temperature; Viscosity