Laboratory of Pharmacological and Toxicological Studies (LEFyT), Faculty of Veterinary Science, Universidad Nacional de La Plata , La Plata , Argentina.
Clinical Pharmacy and Pharmacotherapy Unit, Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Barcelona , Barcelona , Spain.
Front Vet Sci. 2016 Jun 23;3:50. doi: 10.3389/fvets.2016.00050. eCollection 2016.
The aim of this study was to evaluate the bioequivalence of two commercial long-acting formulations based on oxytetracycline (OTC) hydrochloride between the reference formulation (Terramycin LA, Pfizer) and a test formulation (Cyamicin LA, Fort Dodge Saude Animal). Both formulations were administered in a single intramuscular route at a dose of 20 mg OTC/kg of body weight in clinically healthy bovines. The study was carried out according to a one-period parallel design. Plasma samples were analyzed by high-pressure liquid chromatography. The limit of quantitation was 0.050 μg/mL with an accuracy of 101.67% with a coefficient of variation of 13.15%. Analysis of variance and 90% confidence interval tests were used to compare the bioavailability parameters (maximum plasma concentration, C max, and the area under the concentration-versus-time curve extrapolated to infinity, AUC0-∞) of both products. In the case of the time to maximum concentration (T max), non-parametric tests based on Wilcoxon's signed rank test were preferred. The comparison of the mean AUC0-∞ values did not reveal any significant differences (311.40 ± 93.05 μg h/mL and 287.71 ± 45.31 μg h/mL, respectively). The results were similar for the T max (3.58 ± 0.90 h versus 3.42 ± 0.51 h). However, when comparing the mean C max some significant differences were found (8.73 ± 3.66 μg/mL and 10.43 ± 3.84 μg/mL, respectively). The 90% confidence intervals for the ratio of AUC0-∞ and T max values for the reference and test product are within the interval 80-125%, but the 90% confidence intervals for the ratio of C max falls outside the proposed interval. It was concluded that C max of test product are not within the 20% of those of the reference, thus suggesting that test OTC is not bioequivalent to the reference formulation.
本研究旨在评估两种市售长效盐酸土霉素制剂（辉瑞制药的 Terramycin LA 和 Fort Dodge Saude Animal 的 Cyamicin LA）之间的生物等效性。在临床健康的牛中，两种制剂均以 20mg OTC/kg 体重的单剂量肌内途径给药。该研究按照单周期平行设计进行。采用高压液相色谱法分析血浆样品。定量下限为 0.050μg/mL，准确度为 101.67%，变异系数为 13.15%。方差分析和 90%置信区间检验用于比较两种产品的生物利用度参数（最大血浆浓度 C max 和浓度-时间曲线下面积外推至无穷大 AUC0-∞）。对于最大浓度时间（T max），首选基于 Wilcoxon 符号秩检验的非参数检验。平均 AUC0-∞值的比较未显示出任何显著差异（分别为 311.40±93.05μg h/mL 和 287.71±45.31μg h/mL）。T max 的结果也相似（3.58±0.90 h 与 3.42±0.51 h）。然而，当比较平均 C max 时，发现一些显著差异（分别为 8.73±3.66μg/mL 和 10.43±3.84μg/mL）。参考和测试产品 AUC0-∞和 T max 值比值的 90%置信区间在 80-125% 之间，但 C max 值比值的 90%置信区间超出了建议的范围。结论是，测试产品的 C max 不在参考制剂的 20%范围内，因此表明测试 OTC 与参考制剂不是生物等效的。
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