Kerč Janez, Opara Jerneja
Lek Pharmaceuticals d.d., Sandoz Development Center Slovenia, Verovškova 57, 1526 Ljubljana, Slovenia.
Lek Pharmaceuticals d.d., Sandoz Development Center Slovenia, Verovškova 57, 1526 Ljubljana, Slovenia.
Int J Pharm. 2007 Apr 20;335(1-2):106-113. doi: 10.1016/j.ijpharm.2006.11.007. Epub 2006 Nov 6.
A new peroral amoxicillin/clavulanate therapeutic system composed of immediate release tablet and controlled release floating capsule was developed and evaluated by in vivo bioavailability study. Pharmacokinetic (PK) parameters for amoxicillin and clavulanic acid of the new therapeutic systems: AUCt, AUCi, (AUCt/AUCi), Cmax, Tmax, kel, T(1/2) and additionally for amoxicillin T(4) and T(2) were calculated from the plasma levels. The study confirmed enhanced pharmacokinetic parameters of a newly developed therapeutic system containing 1500 mg of amoxicillin and 125 mg of clavulanic acid. Prolonged time over MIC of amoxicillin in relation to a regular immediate release amoxicillin/clavulanate formulation was confirmed.
开发了一种由速释片剂和控释漂浮胶囊组成的新型口服阿莫西林/克拉维酸盐治疗系统，并通过体内生物利用度研究进行了评估。根据血浆水平计算了新治疗系统中阿莫西林和克拉维酸的药代动力学（PK）参数：AUCt、AUCi、（AUCt/AUCi）、Cmax、Tmax、kel、T(1/2)，另外还计算了阿莫西林的T(4)和T(2)。该研究证实了新开发的含有1500 mg阿莫西林和125 mg克拉维酸的治疗系统的药代动力学参数有所增强。与常规速释阿莫西林/克拉维酸盐制剂相比，阿莫西林在MIC以上的时间得到了延长。
