图拉霉素制剂在牛体内的生物等效性

Suman Lh
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引用次数: 0

摘要

检测可视为仿制药的抗菌药物制剂的质量对于确保可持续的医疗实践至关重要。因此,比较药代动力学研究成为必要。在本试验中,以该大环内酯衍生物的参比制剂(即含有100 mg Pisadrax®的TTM商业制剂,由PiSA Agropacuaria S.A. de C.V.生产,参考品牌为TTM Draxxin®(Zoetis,墨西哥))为对照,提交了一种新的图拉霉素(TTM)药物制剂进行生物等效性试验。24头夏罗莱/婆罗门阉牛随机分为两组,每组12头,皮下注射任意一种制剂2.5 mg/kg。采用经验证的图拉霉素血药浓度hplc -质谱分析技术,每隔固定时间测定TTM血药浓度,测定时间为240 h。通过区室分析和非区室分析获得关键药动学参数。结果表明,图拉霉素实验制剂(Pisadrax®)与对照制剂(Draxxin®)在小鼠体内具有生物等效性,因为两种制剂的AUC0-240、MRT和K / 2 el值在统计学上无法区分,置信区间> 95%。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Bioequivalence of a Preparation of Tulathromycin in Cattle
Testing the quality of antibacterial pharmaceutical preparations that can be regarded as generic is of utmost importance to ensure sustainable medical practices. Hence, comparative pharmacokinetics studies become necessary. In this trial, a new pharmaceutical preparation of tulathromycin (TTM) was submitted to a bioequivalence test, taking the reference preparation of this macrolide derivative as control i.e., the commercial preparation of TTM containing 100 mg of the drug Pisadrax ® , manufactured by PiSA Agropacuaria S.A. de C.V. and the reference brand of TTM Draxxin ® (Zoetis, Mexico). Twenty-four young steers Charolais/Brahman randomly divided into two groups of twelve animals each, received a single injection of 2.5 mg/kg subcutaneously of either preparation. A validated HPLC-masses analytical technique of plasma concentrations of tulathromycin was used to determine TTM plasma concentrations at fixed intervals for 240 h. The key pharmacokinetic parameters were obtained by compartmental and non-compartmental analysis. Results show that the experimental preparation of tulathromycin (Pisadrax ® ) can be regarded as bioequivalent to the reference one (Draxxin ® ) in steers, given that AUC0-240, MRT, and K½el values from both preparations resulted statistically indistinguishable and with confidence interval > 95%.
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