IngentaConnect Pharmacodynamics and kinetics of omeprazole MUPS 20 mg and pantop...

Authors: Geus, W. P.¹; Mathôt, R. A. A.²; Mulder, P. G. H.³; Lamers, C. B. H. W.⁴

Source: Alimentary Pharmacology & Therapeutics, Volume 14, Number 8, August 2000 , pp. 1057-1064(8)

Abstract:

Background:

Omeprazole has become available in a tablet formulation, a Multiple Unit Pellet System (MUPS) containing a large number of small individually enteric-coated micropellets. Aim:

To compare the acid-inhibitory effect of omeprazole MUPS 20 mg with pantoprazole 40 mg and to describe the pharmacokinetics of both drugs following administration on day 1 and day 6. Methods:

Randomized, two-way crossover study. Sixteen Helicobacter pylori-negative healthy subjects, whose gastric acidity fell below pH 4 for 70% of a 24-h baseline period were included. Intragastric pH was measured continuously. Results:

On day 1 both drugs significantly raised median 24-h gastric pH compared to baseline. Median pH and percentages of time above pH 3 and 4 on day 1 and day 6 of administration were not significantly different, with the exception of median daytime pH on day 6, which was significantly higher with omeprazole (4.65 vs. 4.05). AUC and C_max of omeprazole were significantly increased on day 6. AUC and C_max of pantoprazole were not significantly increased. Conclusions:

No significant difference in acid-inhibitory effect on day 1. On day 6 median daytime pH was significantly higher with omeprazole MUPS, but the percentages of time spent above pH 3 and 4 were not significantly different. The significant increase in bioavailability of omeprazole may contribute to the increased effect on day 6.

Document Type: Research article

DOI: 10.1046/j.1365-2036.2000.00806.x

Affiliations: 1: Departments of Intensive Care and Gastroenterology, Leyenburg Hospital, the Hague, the Netherlands, 2: Department of Pharmacy and Pharmacology, Slotervaart Hospital, Amsterdam, the Netherlands, 3: Departments of Epidemiology and Biostatistics, Erasmus University Rotterdam, the Netherlands, 4: Department of Gastroenterology, Leiden University Medical Center, the Netherlands

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Pharmacodynamics and kinetics of omeprazole MUPS 20 mg and pantoprazole 40 mg during repeated oral administration in Helicobacter pylori-negative subjects