title: Study of comparative bioavailability of omeprazole pellets.
abstract: The objective of this study was to assess the bioequivalence between the omeprazole laboratory based formulation and the commercial formulation, Zimor Rubio, Spain, considered as reference formulation. The experiment was carried out according to a 2-period, 2-sequence crossover design with a two week washout period. A validated high performance liquid chromatographic method was applied for in vivo experiments. It was observed that omeprazole contents were comparable in all formulations. To establish bioequivalence, 90% confidence intervals (CI) for the differences of total AUCs of the test and reference formulations were calculated. The 95% CI ratio of the AUC within 0.80 to 1.25 was considered as bioequivalent. The carryout effect was investigated prior to assessing the bioequivalence of the two formulations. The test formulation of omeprazole was found to be comparable with the reference formulation (Zimor) with regard to bioavailability.
authors.forename: Sabiha
authors.initials: S
authors.lastname: Karim
authors.forename: Yuen Kah
authors.initials: YK
authors.lastname: Hay
authors.forename: Saringat H
authors.initials: SH
authors.lastname: Baie
authors.forename: Nadeem Irfan
authors.initials: NI
authors.lastname: Bukhari
authors.forename: Ghulam
authors.initials: G
authors.lastname: Murtaza
mesh_terms: D000284:Administration, Oral; D000818:Animals; D019540:Area Under Curve; D001682:Biological Availability; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D003692:Delayed-Action Preparations; D008297:Male; D009853:Omeprazole / Q000008:administration & dosage / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics*; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics*; D011817:Rabbits; D012995:Solubility; D013678:Technology, Pharmaceutical / Q000379:methods; D013810:Therapeutic Equivalency
chemical_list: D002214:Capsules; D003692:Delayed-Action Preparations; D054328:Proton Pump Inhibitors; D009853:Omeprazole