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Pharmacokinetic and pharmacodynamic effects of 2 registered omeprazole preparations and varying dose rates in horses

Citation

Wise, JC and Hughes, KJ and Edwards, S and Jacobson, GA and Narkowicz, CK and Raidal, SL, Pharmacokinetic and pharmacodynamic effects of 2 registered omeprazole preparations and varying dose rates in horses, Journal of Veterinary Internal Medicine, 35, (1) pp. 620-631. ISSN 0891-6640 (2021) [Refereed Article]


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Copyright Statement

2020 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals LLC on behalf of American College of Veterinary Internal Medicine. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) License, (https://creativecommons.org/licenses/by-nc-nd/4.0/) which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

DOI: doi:10.1111/jvim.15971

Abstract

Background: Omeprazole preparations vary in bioavailability in horses.

Hypothesis/Objectives: To characterize the pharmacokinetics and pharmacodynamics of an existing enteric-coated oral omeprazole paste (REF) and a novel, in-feed, enteric-coated dry granule preparation (NOV).

Animals: Twelve Standardbred/Thoroughbred mares free from clinical disease.

Methods: A prospective, blinded randomized interventional study was trial, conducted in 3 parts: (a) bioavailability study, (b) dose titration study, and (c) comparative clinical pharmacodynamic study, each using a blocked crossover design.

Results: Consistent with the larger dose administered, Cmax (median, 1032 ng/mL; range, 576-1766) and AUC0-24 (median, 63.9 μg/mL*min; range, 42.4-152.4) were greater after single oral administration of NOV than REF (282.7 ng/mL; range, 94.8-390.2, and 319 23.8 μg/mL*min; range, 8.2-42.3, respectively; both P = .004). No differences were observed between products for absolute oral bioavailability (NOV 55% range, 15-88; REF 17% range, 10-77; P = .25). Treatment with both preparations was associated with reduced gastric squamous ulcer scores and increased pH of gastric fluid. Bioequivalence was demonstrated for pharmacodynamic measures with the exception of % time pH <4, despite differences in dose rate and subsequent plasma omeprazole concentrations.

Conclusions and Clinical Importance: The findings of this study indicate that the NOV product would be a suitable alternative to the reference product, and confirm that plasma concentrations of omeprazole and omeprazole dose do not predict drug pharmacodynamics in horses.

Item Details

Item Type:Refereed Article
Keywords:pharmacokinetics, pharmacodynamics, drug analysis
Research Division:Agricultural, Veterinary and Food Sciences
Research Group:Veterinary sciences
Research Field:Veterinary pharmacology
Objective Division:Animal Production and Animal Primary Products
Objective Group:Other animal production and animal primary products
Objective Field:Animal welfare
UTAS Author:Jacobson, GA (Associate Professor Glenn Jacobson)
UTAS Author:Narkowicz, CK (Dr Christian Narkowicz)
ID Code:143067
Year Published:2021 (online first 2020)
Deposited By:Pharmacy
Deposited On:2021-02-24
Last Modified:2021-04-21
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