Pharmacokinetics and bioequivalence testing of five commercial formulations of omeprazole in the horse

Sykes, B. W., Underwood, C., Greer, R., McGowan, C. M. and Mills, P. C. (2015) Pharmacokinetics and bioequivalence testing of five commercial formulations of omeprazole in the horse. Journal of Veterinary Pharmacology and Therapeutics, 39 1: 78-83. doi:10.1111/jvp.12240


Author Sykes, B. W.
Underwood, C.
Greer, R.
McGowan, C. M.
Mills, P. C.
Title Pharmacokinetics and bioequivalence testing of five commercial formulations of omeprazole in the horse
Journal name Journal of Veterinary Pharmacology and Therapeutics   Check publisher's open access policy
ISSN 1365-2885
0140-7783
Publication date 2015-01-01
Year available 2016
Sub-type Article (original research)
DOI 10.1111/jvp.12240
Open Access Status Not yet assessed
Volume 39
Issue 1
Start page 78
End page 83
Total pages 6
Place of publication Oxford, United Kingdom
Publisher Wiley-Blackwell Publishing
Language eng
Subject 3004 Pharmacology
3400 Veterinary
Abstract Omeprazole is widely used in the treatment of equine gastric ulcer syndrome. To date, little is known about the relative pharmacokinetics of the different formulations making comparisons between products difficult. The objectives of the study were to investigate the relative pharmacokinetics of five commercially available formulations of omeprazole in the horse and to test for bioequivalence of four of the formulations using one of the formulations as a reference standard. Twelve mature Thoroughbred horses were fasted for 16 h then administered 2 g of each formulation in a cross-over design. Serial blood samples were collected and plasma omeprazole concentration was determined by ultra high-performance liquid chromatography-mass spectrometry (UHPLC-MS). No significant differences were present between three of the formulations and the reference formulation, while the fourth formulation had a lower C-max and longer T-max than the reference formulation. Bioequivalence against the reference formulation could not be demonstrated for any of the formulations tested. The findings of the study suggested that the method of protection utilised by different formulations of omeprazole (enteric-coated granules vs. buffering) does not significantly alter the pharmacokinetics of the drug. Further work to establish bioequivalence is needed before direct comparisons can be drawn between different formulations.
Formatted abstract
Omeprazole is widely used in the treatment of equine gastric ulcer syndrome. To date, little is known about the relative pharmacokinetics of the different formulations making comparisons between products difficult. The objectives of the study were to investigate the relative pharmacokinetics of five commercially available formulations of omeprazole in the horse and to test for bioequivalence of four of the formulations using one of the formulations as a reference standard. Twelve mature Thoroughbred horses were fasted for 16 h then administered 2 g of each formulation in a cross-over design. Serial blood samples were collected and plasma omeprazole concentration was determined by ultra high-performance liquid chromatography–mass spectrometry (UHPLC-MS). No significant differences were present between three of the formulations and the reference formulation, while the fourth formulation had a lower Cmax and longer Tmax than the reference formulation. Bioequivalence against the reference formulation could not be demonstrated for any of the formulations tested. The findings of the study suggested that the method of protection utilised by different formulations of omeprazole (enteric-coated granules vs. buffering) does not significantly alter the pharmacokinetics of the drug. Further work to establish bioequivalence is needed before direct comparisons can be drawn between different formulations.
Keyword Pharmacology & Pharmacy
Veterinary Sciences
Pharmacology & Pharmacy
Veterinary Sciences
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2016 Collection
School of Veterinary Science Publications
 
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