LAUSR

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.