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Pharmacokinetics of two once‐daily parenteral cephalexin formulations in dogs
Author(s) -
REBUELTO M.,
MONTOYA L.,
KREIL V.,
AMBROS L.,
WAXMAN S.,
ALBARELLOS G.,
HALLU R.
Publication year - 2005
Publication title -
journal of veterinary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.527
H-Index - 60
eISSN - 1365-2885
pISSN - 0140-7783
DOI - 10.1111/j.1365-2885.2005.00676.x
Subject(s) - pharmacokinetics , bioequivalence , beagle , medicine , confidence interval , dosing , geometric mean , pharmacology , mathematics , statistics
The aims of this study were to describe and compare the pharmacokinetic profiles and T > MIC 90 of two commercially available once‐daily recommended cephalexin formulations in healthy adult dogs administered by the intramuscular (i.m.) route. Six beagle dogs received a 10 mg/kg dose of an 18% parenteral suspension of cephalexin of laboratory A (formulation A) and laboratory B (formulation B) 3 weeks apart. Blood samples were collected in predetermined times after drug administration. The main pharmacokinetic parameters were (mean ± SD): AUC (0−∞) , 72.44 ± 15.9 and 60.83 ± 13.2 μ g·h/mL; C max , 10.11 ± 1.5 and 8.50 ± 1.9 μ g/mL; terminal half‐life, 3.56 ± 1.5 and 2.57 ± 0.72 h and MRT (0−∞) , 5.86 ± 1.5 and 5.36 ± 1.2 h for formulations A and B, respectively. T > MIC 90 was 63.1 ± 14.7 and 62.1 ± 14.7% of the dosing interval for formulations A and B, respectively. Median (range) for t max was 2.0 (2.0–3.0) h and 3.0 (2.0–4.0) for formulations A and B, respectively. Geometric mean ratios of natural log‐transformed AUC (0−∞) and C max and their 90% confidence intervals (CI) were 0.84 (0.72–0.98) and 0.83 (0.64–1.07), respectively. The plasma profiles of cephalexin following the administration of both formulations were similar. No statistical differences between pharmacokinetic parameters or T > MIC 90 were observed, however, bioequivalence between both formulations could not be demonstrated, as lower 90% CI failed to fell within the selected range of 80–125% for bioequivalence.