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The Canadian veterinary journal = La revue veterinaire canadienne2015; 56(7); 730-736;

Pharmacokinetics and bioequivalence of 2 meloxicam oral dosage formulations in healthy adult horses.

Abstract: Meloxicam, a non-steroidal anti-inflammatory drug, is approved for use in horses in several countries, but an equine formulation is not available in North America. However, meloxicam is being used in an extra-label manner in horses in Canada. The purpose of this study, therefore, was to assess the bioequivalence of an approved oral meloxicam suspension (Metacam 15 mg/mL for horses; Boehringer Ingelheim Vetmedica GmBH, Ingelheim, Germany) from the European Union with human meloxicam tablets (Meloxicam 15 mg tablets; TEVA Canada, Toronto, Ontario) compounded with molasses to improve palatability and administration. The geometric mean ratios (GMR test/reference) and the 90% confidence intervals of the pivotal pharmacokinetic parameters (area under the curve and maximum concentration) were within the defined limits of 80% to 125% generally accepted for products to be considered bioequivalent. Therefore, use of human meloxicam tablets compounded with molasses would be expected to produce a similar clinical response in horses as the approved oral product from the European Union. Le méloxicam, un médicament anti-inflammatoire non stéroïdien, est approuvé pour utilisation chez les chevaux dans plusieurs pays, mais une formulation équine n’est pas disponible en Amérique du Nord. Cependant, le méloxicam est utilisé en dérogation des directives de l’étiquette chez les chevaux du Canada. Par conséquent, le but de la présente étude était d’évaluer la bioéquivalence d’une suspension orale approuvée de méloxicam (Metacam 15 mg/ml pour les chevaux; Boehringer Ingelheim Vetmedica GmBH, Ingelheim, Allemagne) de l’Union européenne avec celle des comprimés de méloxicam pour les humains (comprimés de 15 mg de méloxicam; TEVA Canada, Toronto, Ontario) préparés avec de la mélasse pour améliorer la sapidité et l’administration. Les ratios géométriques moyens (test RGM/référence) et les intervalles de confiance de 90 % des paramètres phamacocinétiques clés (secteur sous la courbe et concentration maximale) se situaient dans les limites définies de 80 % à 125 % généralement attendues pour des produits considérés comme bioéquivalents. Par conséquent, l’utilisation des comprimés de méloxicam pour humains préparés avec de la mélasse devrait produire une réponse clinique semblable chez les chevaux à celle du produit oral approuvé provenant de l’Union européenne.(Traduit par Isabelle Vallières).
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Publication Date: 2015-07-02 PubMed ID: 26130835PubMed Central: PMC4466825
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  • Journal Article
  • Randomized Controlled Trial
  • Research Support
  • Non-U.S. Gov't

Summary

This research summary has been generated with artificial intelligence and may contain errors and omissions. Refer to the original study to confirm details provided. Submit correction.

This research study has compared the effects of an approved European equine oral formulation of meloxicam, an anti-inflammatory drug, with a human version of the drug compounded with molasses, in horses. The study discovered that the human formula is just as effective as the equine formula, providing a valuable alternative for use in North America where the equine formulation is not available.

Objective and Need for the Research

  • The main intention of the research was to evaluate if the human version of meloxicam when combined with molasses can provide equivalent bioavailability as the approved equine variant of the drug from the European Union.
  • As the equine version of meloxicam – a non-steroidal anti-inflammatory drug – is not available in North America, there had been instances where veterinarians were using the human formula in an extra-label manner. This study aimed to understand and confirm the effectiveness and safety of such actions.

Process and Methodology

  • The researchers compared two versions of the drug – Metacam 15 mg/mL for horses from Boehringer Ingelheim Vetmedica and Meloxicam 15 mg tablets from TEVA Canada. The latter being a human dosage form and was compounded with molasses to improve palatability and facilitate administration in horses.
  • The bioequivalence was measured based on pivotal pharmacokinetic parameters that include ‘area under the curve’ and ‘maximum concentration’.

Findings

  • The geometric mean ratios (GMR test/reference) and the 90% confidence intervals calculated for these pharmacokinetic parameters fell within the average rule-of-thumb limits of 80% to 125%. This boundary range is typically followed when considering whether two products are bioequivalent.
  • Based on these findings, the researchers concluded that the human variant of meloxicam, when mixed with molasses, can be expected to induce a similar clinical response in horses as the approved equine oral formula from the European Union.

Relevance and conclusion

  • This research offers hope for veterinarians in North America in treating horses with a suitable alternative of an anti-inflammatory drug. The lack of a horse-specific formula of meloxicam in the region now has a potential solution with a compounded version of the human meloxicam tablet.

Cite This Article

APA
Vivancos M, Barker J, Engbers S, Fischer C, Frederick J, Friedt H, Rybicka JM, Stastny T, Banse H, Cribb AE. (2015). Pharmacokinetics and bioequivalence of 2 meloxicam oral dosage formulations in healthy adult horses. Can Vet J, 56(7), 730-736.

Publication

The Canadian veterinary journal = La revue veterinaire canadienne
ISSN: 0008-5286
NlmUniqueID: 0004653
Country: Canada
Language: English
Volume: 56
Issue: 7
Pages: 730-736

Researcher Affiliations

Vivancos, Melanie
  • Faculty of Veterinary Medicine, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada T2N 4Z6.
Barker, Jessica
  • Faculty of Veterinary Medicine, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada T2N 4Z6.
Engbers, Sarah
  • Faculty of Veterinary Medicine, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada T2N 4Z6.
Fischer, Carrie
  • Faculty of Veterinary Medicine, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada T2N 4Z6.
Frederick, Jami
  • Faculty of Veterinary Medicine, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada T2N 4Z6.
Friedt, Heather
  • Faculty of Veterinary Medicine, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada T2N 4Z6.
Rybicka, Joanna M
  • Faculty of Veterinary Medicine, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada T2N 4Z6.
Stastny, Tereza
  • Faculty of Veterinary Medicine, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada T2N 4Z6.
Banse, Heidi
  • Faculty of Veterinary Medicine, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada T2N 4Z6.
Cribb, Alastair E
  • Faculty of Veterinary Medicine, University of Calgary, 3280 Hospital Drive NW, Calgary, Alberta, Canada T2N 4Z6.

MeSH Terms

  • Administration, Oral
  • Animals
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / chemistry
  • Anti-Inflammatory Agents, Non-Steroidal / pharmacokinetics
  • Area Under Curve
  • Cross-Over Studies
  • Dosage Forms
  • Female
  • Half-Life
  • Horses / blood
  • Horses / metabolism
  • Male
  • Meloxicam
  • Therapeutic Equivalency
  • Thiazines / administration & dosage
  • Thiazines / chemistry
  • Thiazines / pharmacokinetics
  • Thiazoles / administration & dosage
  • Thiazoles / chemistry
  • Thiazoles / pharmacokinetics

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Citations

This article has been cited 6 times.
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