Pharmacokinetic comparison of omeprazole capsules and a simplified omeprazole suspension.
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.
Song
J C
JC
Department of Pharmacy Services, Hartford Hospital (HH), 80 Seymour Street, Hartford, CT 06102-5037, USA.
Quercia
R A
RA
Fan
C
C
Tsikouris
J
J
White
C M
CM
D000328:Adult; D000897:Anti-Ulcer Agents / Q000737:chemistry / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008297:Male; D009853:Omeprazole / Q000737:chemistry / Q000493:pharmacokinetics*; D012016:Reference Values; D013535:Suspensions
D000897:Anti-Ulcer Agents; D002214:Capsules; D003692:Delayed-Action Preparations; D013535:Suspensions; D009853:Omeprazole