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Background <p>Amoxicillin-clavulanic acid combination (AMX-CA) is a widely used oral antibiotic for companion animals. In Thailand, various AMX-CA formulations are available. This study aimed to evaluate and compare the pharmacokinetic profiles and relative bioavailability of two AMX-CA formulations using a randomized, two-period, two-treatment crossover design in six healthy Beagle dogs. Each dog received a 250&#xa0;mg AMX-CA tablet (formulation A or B) at a dosage of 20.5 ± 2.5&#xa0;mg/kg, with a 7-day washout period between treatments. Blood samples were collected over a 24-h period post-administration, then AMX and CA concentrations were measured using LC–MS/MS. Bioequivalence was assessed based on the 90% confidence intervals (CI) for peak plasma concentration (C<sub>max</sub>) and the area under the plasma concentration–time curve extrapolated to infinity (AUC<sub>0-∞</sub>), which required to fall within 80%-125%.</p> Results <p>The relative bioavailability of formulation B was 76.5% for AMX and 72.7% for CA, compared to formulation A. Only CA's C<sub>max</sub> met the bioequivalence criteria, while the CIs for AUC<sub>0-∞</sub> and C<sub>max</sub> of AMX and AUC<sub>0-∞</sub> of CA were outside the acceptable range.</p> Conclusions <p>Bioequivalence between the two formulations was not established, indicating that these formulations are not interchangeable.</p>

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Comparative bioavailability study of two oral formulations of amoxicillin-clavulanic acid in healthy dogs

  • 期刊论文

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  • 发表日期：

    2025年3月17日

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  • Kananuch Vasuntrarak,
  • Koranis Patthanachai,
  • Piyawan Charoenlertkul,
  • Suphachai Nuanualsuwan,
  • Henrique Cheng,
  • Nipattra Suanpairintr

摘要

Background

Amoxicillin-clavulanic acid combination (AMX-CA) is a widely used oral antibiotic for companion animals. In Thailand, various AMX-CA formulations are available. This study aimed to evaluate and compare the pharmacokinetic profiles and relative bioavailability of two AMX-CA formulations using a randomized, two-period, two-treatment crossover design in six healthy Beagle dogs. Each dog received a 250 mg AMX-CA tablet (formulation A or B) at a dosage of 20.5 ± 2.5 mg/kg, with a 7-day washout period between treatments. Blood samples were collected over a 24-h period post-administration, then AMX and CA concentrations were measured using LC–MS/MS. Bioequivalence was assessed based on the 90% confidence intervals (CI) for peak plasma concentration (Cmax) and the area under the plasma concentration–time curve extrapolated to infinity (AUC0-∞), which required to fall within 80%-125%.

Results

The relative bioavailability of formulation B was 76.5% for AMX and 72.7% for CA, compared to formulation A. Only CA's Cmax met the bioequivalence criteria, while the CIs for AUC0-∞ and Cmax of AMX and AUC0-∞ of CA were outside the acceptable range.

Conclusions

Bioequivalence between the two formulations was not established, indicating that these formulations are not interchangeable.