Bioequivalence Study of Two Long-acting Oxytetracycline Formulations in Sheep


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Abstract

Two commercially available long-acting oxytetracycline hydrochloride formulations (Primamycin LA (Pfizer) and Terralent 20% LA (İ.E. Ulagay)) were administered by the intramuscular route to 20 clinically healthy sheep at a dose of 20 mg/kg. The study was performed in a two-period crossover design. Plasma samples were analysed by high-pressure liquid chromatography. The mean maximum concentrations (Cmax) was 8.00 ± 2.05μg/mland 8.61 ± 1.42μg/ml, respectively. The mean area under the concentration time curve (AUC) values were 154.95 ± 50.37(μgh)/ml and 161.70 ± 47.02(μgh)/ml, respectively. The 90%confidence intervals for the ratio of Cmax and AUC values for the test and reference product are with in the interval 70−143% for Cmax and interval 80−125% for AUC proposed by EMEA. It was concluded that Primamycin LA and Terralent 20% LA formulations are bioequivalent in their rate and extent of drug absorbtion.

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