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In VitroDissolution andIn VivoBioavailability of Six Brands of Ciprofloxacin Tablets Administered in Rabbits and Their Pharmacokinetic Modeling

机译:六种环丙沙星片在兔中的体外溶出度和体内生物利用度及其药代动力学模型

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This study was undertaken to assess thein vitrodissolution andin vivobioavailability of six brands of ciprofloxacin oral tablets available in the UAE market using rabbits. Thein vitrodissolution profiles of the six ciprofloxacin products were determined using the USP dissolution paddle method. Pharmacokinetic modeling using compartmental and noncompartmental analysis was done to determine the pharmacokinetic parameters of ciprofloxacin after single-dose oral administration.In vitrorelease study revealed that the amount of ciprofloxacin released in 20 minutes was not less than 80% of the labeled amount which is in accordance with the pharmacopoeial requirements. All tested products are considered to be very rapid dissolving except for formulae A and D. Ciprofloxacin plasma concentration in rabbits was best fitted to a two-compartment open model. The lowest bioavailability was determined to be for product A (93.24%) while the highest bioavailability was determined to be for product E (108.01%). Postmarketing surveillance is very crucial to ensure product quality and eliminating substandard products to be distributed and, consequently, ensure better patient clinical outcome. The tested ciprofloxacin generic products distributed in the UAE market were proven to be of good quality and could be used interchangeably with the branded ciprofloxacin product.
机译:进行这项研究以评估使用兔子在阿联酋市场上可获得的六种环丙沙星口服片剂的体外溶解度和体内生物利用度。使用USP溶出桨法确定了六种环丙沙星产品的体外溶出曲线。用隔室和非隔室分析进行药代动力学模型测定单剂量口服后环丙沙星的药代动力学参数。体外释放研究表明,环丙沙星在20分钟内释放的量不少于标记量的80%,这与符合药典要求。除式A和D以外,所有被测产品均被认为溶解速度非常快。兔中环丙沙星的血浆浓度最适合两室开放模型。最低的生物利用度被确定为产品A(93.24%),而最高的生物利用度被确定为产品E(108.01%)。上市后监督对于确保产品质量并消除要分销的不合格产品,从而确保更好的患者临床结果至关重要。经验证,在阿联酋市场上销售的经测试的环丙沙星仿制药具有良好的质量,可以与品牌的环丙沙星产品互换使用。

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