Bioequivalence in dogs of a meloxicam formulation administered as a transmucosal oral mist with an orally administered pioneer suspension product. Issue 1 (26th April 2012)

• Record Type: Journal Article
• Authors: LEES, P.; CHENG, Z.; KEEFE, T. J.; WEICH, E.; BRYD, J.; CEDERGREN, R.; COZZI, E.
• Is Part Of: Journal of veterinary pharmacology and therapeutics. Volume 36:Issue 1(2013)
• Page Start: 78
• Page End: 84
• Publication Date: 2012-04-26
• Subjects: Veterinary pharmacology -- Periodicals; Therapeutics -- Periodicals; 636.0895105
• DOI: 10.1111/j.1365-2885.2012.01402.x
• Languages: English
• ISSNs: 0140-7783

Abstract

<abstract abstract-type="main" xml:lang="en"> <title> <x xml:space="preserve">Abstract</x> </title> <p>Lees, P., Cheng, Z., Keefe, T. J., Weich, E., Bryd, J., Cedergren, R., Cozzi, E. Bioequivalence in dogs of a meloxicam formulation administered as a transmucosal oral mist with an orally administered pioneer suspension product. <italic>J. vet. Pharmacol. Therap.</italic> <bold>36</bold>, 78–84.</p> <p>A mucosal mist formulation of meloxicam, administered as a spray into the mouth (test article), was compared for bioequivalence to a pioneer meloxicam suspension for oral administration (reference article). Pharmacokinetic profiles and average bioequivalence were investigated in 20 dogs. The study design comprised a two‐period, two‐sequence, two‐treatment cross‐over design, with maximum concentration (<italic>C</italic><sub>max</sub>) and area under plasma concentration–time curve to last sampling time (AUC<sub>last</sub>) used as pivotal bioequivalence variables. Bioequivalence of the products was confirmed, based on relative ratios of geometric mean concentrations (and 90% confidence intervals within the range 0.80–1.25) for <italic>C</italic><sub>max</sub> of 101.9 (97.99–106.0) and for AUC<sub>last</sub> of 97.24 (94.44–100.1). The initial absorption of meloxicam was more rapid for the test article, despite virtually identical <italic>C</italic><sub>max</sub> values for the two products. Mean elimination half‐lives were 29.6 h (test article) and 30.0 h (reference article). The meloxicam plasma concentration–time profiles were considered in relation to published data on the inhibition of the cyclooxygenase‐1 (COX‐1) and COX‐2 isoenzymes by meloxicam.</p> </abstract>