Izadi Ensieh, Afshan Gull, Patel Rahul P, Rao Venkatesan M, Liew Kai Bin, Meor Mohd Affandi Meor Mohd Redzuan, Kifli Nurolaini, Suleiman Amal, Lee Kah Seng, Sarker Md Moklesur R, Zaidi Syed Tabish, Ming Long Chiau
Division of Pharmacy, School of Medicine, University of Tasmania, Hobart, TAS, Australia.
Department of Pulmonary Medicine, Liaquat National Hospital and Medical College, Karachi, Pakistan.
Front Pharmacol. 2019 Aug 14;10:881. doi: 10.3389/fphar.2019.00881. eCollection 2019.
Counterfeit and substandard medicines are recognized as one of serious threats to public health. The product quality of antibacterial medicine will compromise patients' recovery and increase the chance of antibacterial resistance. The review aims to provide a summary of low quality levofloxacin issues and the risk factors as well as suggesting the aspects of product quality that need to be regulated strictly. Quality of the active ingredient, levofloxacin, has an important role to contribute to successful therapy. The poor quality of raw material, directly and indirectly, causes treatment failure as the presence of insufficient dose, mislabeled content, and poor dissolution characteristics can lead to lower bioavailability. Identifying and reporting these factors can potentially help in improving the quality of drug marketed in various developing countries and may also reduce the incidences of treatment failure. Dissolution test is used for testing the dissolution profiles and the rate of drug release from solid formulation such as oral formulations, thus providing information regarding the in vivo performance of a formulation and its bioequivalence. On the other hand, quality-testing procedures are used for comparing the quality of products.
假冒伪劣药品被公认为是对公众健康的严重威胁之一。抗菌药物的产品质量会影响患者的康复，并增加抗菌耐药性的几率。本综述旨在总结低质量左氧氟沙星问题及其风险因素，并提出需要严格监管的产品质量方面。活性成分左氧氟沙星的质量对于成功治疗起着重要作用。原材料质量差直接或间接导致治疗失败，因为剂量不足、含量标注错误和溶出特性差会导致生物利用度降低。识别和报告这些因素可能有助于提高在各个发展中国家销售的药品质量，也可能减少治疗失败的发生率。溶出度试验用于测试口服制剂等固体制剂的溶出曲线和药物释放速率，从而提供有关制剂体内性能及其生物等效性的信息。另一方面，质量检测程序用于比较产品质量。
