[Pharmacy compounding of an omeprazole suspension]

ArticleinJournal de pharmacie de Belgique 64(2):54-63 · July 2009with18 Reads
Source: PubMed
Abstract
The problems of preparation of different pharmaceutically compounded formulations of prescribed omeprazole suspensions are discussed. Problems that can be cited are: inadequate preparation, chemical and physical stability problems, taste problems and low bioavailability. The formulation of the omeprazole suspension is optimized, taking into account the cited problems. At the same time, some formulations are presented, ensuring chemical stability of omeprazole and its bioavailability.
  • [Show abstract] [Hide abstract] ABSTRACT: To determine the stability of lansoprazole and omeprazole suspensions at ambient and refrigerated temperatures using HPLC. The contents of lansoprazole and omeprazole capsules were suspended in separate flasks containing sodium bicarbonate 8.4% to concentrations of 3 and 2 mg/mL, respectively. The contents of each flask were drawn into six amber-colored oral syringes, with one-half of the syringes stored at 22 degrees C (ambient) and the other half at 4 degrees C. Lansoprazole and omeprazole concentrations were determined by a stability-indicating HPLC assay at baseline and at 4, 8, 12, and 24 hours, and on days 4, 7, 14, 21, 30, 45, and 60 after mixing. Both omeprazole and lansoprazole were considered stable if they retained > or =90% of the baseline drug concentration. Omeprazole was stable for up to 14 days at 22 degrees C and 45 days at 4 degrees C. Lansoprazole was stable for eight hours at 22 degrees C and for 14 days at 4 degrees C. When compared with ambient or refrigerated storage conditions, omeprazole was stable for a longer duration than lansoprazole. Pharmacists may use these results to guide compounding and storage of proton-pump inhibitor suspensions.
    Full-text · Article · May 2000
  • [Show abstract] [Hide abstract] ABSTRACT: The pharmacokinetics of omeprazole delayed-release capsules and a simplified omeprazole suspension (SOS) were studied. Seven healthy volunteers randomly received either one 20-mg omeprazole delayed-release capsule or SOS (omeprazole 20 mg in 10 mL) for seven days before being crossed over to the opposite treatment for seven more days after a two-week washout period. On days 1 and 7, blood samples were drawn at intervals up to 360 minutes after drug administration. Plasma omeprazole concentrations were determined by a validated high-performance liquid chromatographic method, and pharmacokinetic values were determined. Area under the concentration-versus-time curve (AUC) from zero to six hours, AUC from time zero to infinity (AUC0-infinity), and maximum plasma concentration (Cmax) increased by 102%, 113%, and 85%, respectively, after seven days of treatment with the capsule. AUC0-infinity for SOS on day 1 was 58% of that for the capsule (p = 0.0141), and on day 7 it was 49% of that for the capsule (p = 0.0044). AUC0-infinity for SOS increased by 85% from day 1 to 7, but the difference was not significant. Cmax for SOS on day 1 was twice that for the capsule (p = 0.0014), but by day 7 the difference between the two formulations was negligible. Time to Cmax (tmax) for SOS on days 1 and 7 was shorter than for the capsule by 82% (p < 0.0001) and 70% (p < 0.0006), respectively. After one week of therapy, omeprazole absorption was faster and tmax was 70% shorter for SOS than for the capsule formulation, but AUC0-infinity was 49% lower for SOS.
    Article · May 2001
  • [Show abstract] [Hide abstract] ABSTRACT: 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. 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 degrees C in darkness (refrigerated) or 22-25 degrees 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. 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. Omeprazole-sodium bicarbonate suspensions of 0.6-4 mg/mL omeprazole were stored at 4 degrees 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.
    Article · Dec 2006