Comparative Study of Brand and Generics Ciprofloxacin Tablets Available in the Saudi Market

IF 1 4区医学 Q4 PHARMACOLOGY & PHARMACY

Dissolution Technologies Pub Date : 2023-01-01 DOI:10.14227/dt300223pgc12

Hassan M. Alsulais, Ali K. Alqaisum, Ahmed A. Aldoulah, Ashfaq A Mohsin, Hassan M. Ghonaim

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引用次数: 1

Abstract

Introduction : Ciprofloxacin is a fluoroquinolone class of antibiotics with broad-spectrum antibacterial activity. Biowaiver studies of generic ciprofloxacin products can be used to establish bioequivalence with the reference product. Methods : The experiments are carried out using the reference product, Ciprobay (Bayer, Germany), and three generic products, Cipromax (Spimaco Addwaeih, Saudi Arabia), Ciproxen (Jamjoom Pharma, Saudi Arabia), and Quinox (Tabuk Pharmaceuticals, Saudi Arabia). In vitro tests were done according to the United States Pharmacopeia (USP) standards to evaluate the physicochemical characteristics including weight variation, hardness, thickness, disintegration, and dissolution. Results : All four products tested met the standard limits for physical and physicochemical parameters. In addition, the dissolution test indicated that the three generics are equivalent to the reference product in terms of quality, and all products released more than 80% of drug within 30 minutes. Conclusion: The four tested brands of ciprofloxacin can be used interchangeably.

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沙特市场上品牌与仿制药环丙沙星片的比较研究

简介:环丙沙星是一类具有广谱抗菌活性的氟喹诺酮类抗生素。环丙沙星非专利产品的生物释放性研究可用于建立与参比产品的生物等效性。方法:采用参比品西probay(德国拜耳公司)和仿制药环丙美(沙特阿拉伯斯匹马科制药公司)、环丙生(沙特阿拉伯Jamjoom制药公司)和喹诺克斯(沙特阿拉伯Tabuk制药公司)进行实验。根据美国药典(USP)标准进行体外试验，评估其理化特性，包括重量变化、硬度、厚度、崩解和溶出度。结果:4种产品的理化参数均符合标准限量要求。另外，溶出度试验表明，3个仿制药在质量上与参比品相当，30分钟内释药量均在80%以上。结论:环丙沙星四个检测品牌可互换使用。

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来源期刊

Dissolution Technologies 医学-药学

CiteScore

1.20

自引率

33.30%

发文量

审稿时长

3 months

期刊介绍： Dissolution Technologies is a peer reviewed quarterly publication reporting ongoing, useful information on dissolution testing of pharmaceuticals. It provides an international forum for dissolution analysts to receive and exchange information on various dissolution topics. Dissolution Technologies welcomes submissions related to dissolution, in vitro release, and disintegration testing. These topics should be the major focus of the article. Do not submit articles where the focus is formulation development with dissolution testing as one of many tests.