Fahmy Sahar, Abu-Gharbieh Eman
Department of Pharmaceutical Sciences, Faculty of Pharmacy, Helwan University, Cairo 11790, Egypt.
Department of Pharmacology and Toxicology, Dubai Pharmacy College, P.O. Box 19099, Dubai, UAE.
Biomed Res Int. 2014;2014:590848. doi: 10.1155/2014/590848. Epub 2014 Jun 3.
This study was undertaken to assess the in vitro dissolution and in vivo bioavailability of six brands of ciprofloxacin oral tablets available in the UAE market using rabbits. The in vitro dissolution 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 vitro release 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.
本研究旨在使用兔子评估阿联酋市场上六种品牌环丙沙星口服片剂的体外溶出度和体内生物利用度。采用美国药典溶出桨法测定六种环丙沙星产品的体外溶出曲线。使用房室分析和非房室分析进行药代动力学建模,以确定单剂量口服给药后环丙沙星的药代动力学参数。体外释放研究表明,20分钟内环丙沙星的释放量不少于标示量的80%,符合药典要求。除配方A和D外,所有受试产品均被认为溶出速度很快。兔子体内的环丙沙星血浆浓度最适合二室开放模型。确定产品A的生物利用度最低(93.24%),而产品E的生物利用度最高(108.01%)。上市后监测对于确保产品质量和消除待分销的不合格产品非常关键,从而确保更好的患者临床结局。在阿联酋市场销售的受试环丙沙星仿制药被证明质量良好,可与品牌环丙沙星产品互换使用。