In Vitro Biopharmaceutical and Physicochemical Evaluation of Different Brands of Ciprofloxacin Marketed in Aden-Yemen

Wafa F Badulla, Dua’a H Al-Maqdi, Ebtesam S Bamahmood
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Abstract

The current study conducted to evaluate the biopharmaceutical and physicochemical equivalence of the three available pharmaceutical dosage forms of ciprofloxacin (CIP) in the local markets (tablets, infusion and eye drops). Three brands for each dosage form were selected and coded as Tablets I, II, III; CIP infusion (Infusion I, II, III) and CIP eye drops (Eye drops I, II, III). Different in vitro quality control tests, physiochemical and determination of active ingredients contents were performed. All brands of tablets have a satisfactory result that complies with the pharmacopeia specification except the hardness of the tablets was more than the recommended value, and the salinity of Infusion II and III was lower than 0.9, the viscosity of the eye drops was lower than the specified value. Post-marketing surveillance is an essential issue to distinguish poor-quality medicines and must be routinely performed to weed out substandard and counterfeit medicine.
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也门亚丁市售不同品牌环丙沙星的体外生物制药和理化评价
目前进行的研究旨在评估当地市场上三种可用的环丙沙星(CIP)药物剂型(片剂、输液剂和滴眼液)的生物制药和物理化学等效性。每种剂型选择三个牌号,编号为片号I、II、III;CIP输液剂(输液I、II、III)和CIP滴眼液(滴眼液I、II、III)进行不同的体外质控试验、理化及有效成分含量测定。所有品牌的片剂除片剂硬度大于推荐值、输液ⅱ、输液ⅲ矿化度低于0.9、滴眼液粘度低于规定值外,均符合药典规范。上市后监测是区分劣质药品的一个重要问题,必须定期进行监测以淘汰不合格药品和假药。
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发文量
11
审稿时长
20 weeks
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