Equivalent Assessment of Ciprofloxacin Tablets Available in KSA : A Post Market Surveillance Study for Cost Effective Treatment. J. Pharm. Sci. & Res. 2016; 8(1),13-18.MM Ahmed*1, Farhat F1, MJ Ansari1, Fahad I Al-Saikhan2, M Khalid. Anwer1, S. Jamil1, Ramadan Al-Shdefat1, Baha E Ali1, MH Fayed1. Mohammed Dakhalallah J Al Shelewi3, Prakash Katakam4Department of Pharmaceutics, College of Pharmacy,Prince Sattam Bin Abdulaziz University, P.O.Box 173, Al-Kharj-11942, KSA.
The aim of this study was to evaluate the physicochemical and pharmaceutical parameters in order to confirm the bioequivalence of the generic formulation available in Saudi Arabia with that of innovator 500 mg ciprofloxacin tablets. Assessment was done based on the compendia Physicochemical, pharmaceutical and microbiological parameters. Three selected brands under studies comply the official specifications for weight variation all the brands are within the 5 % specified limit, The disintegration time laid between 2.2 to 4.2, the dissolution profile shows more than 80 % release in first 30 minutes, and the kinetics study reflects all formulations followed First order release kinetics with f1 difference factor as per the pharmacopeia limit of less than ≤15. The in vitro antibacterial study revealed that the Brand B2 and innovator B3 have the same mean zone of inhibition against S. aureus & E. coli species i.e 14.77 mm. These results indicate that generic version of ciprofloxacin hydrochloride is bioequivalent which can be interchangeable for the cost effective treatment. This study may serve as a tool to monitor post market quality of broad spectrum antibiotic and give confidence to substitute the costly brands with bioequivalent generic ciprofloxacin for cost-effective treatment.
Equivalent Assessment of Ciprofloxacin Tablets Available in KSA : A Post Market Surveillance Study f
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