Abstract

Comparative in vitro dissolution study of Aceclofenac Marketed Tablets in Two Different Dissolution Media by Validated Analytical MethodS.M. Ashraful Islam, Sharmi Islam, Mohammad Shahriar, Irin Dewan

Highlights

  • Ciprofloxacin is a synthetic fluoroquinolone derivative with broad spectrum antibacterial activity

  • All tested generic products passed USP monograph dissolution testing except one product which failed to pass both similarity factor (f2) and difference factor (f1) tests required by FDA bioequivalence testing

  • The percentage price differences showed that the price of ciprofloxacin innovator is higher than all generic products in Saudi market with differences varying from 38.6% to 67.3%. (Cipro-4) had the lowest percentage price difference from innovator of

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Summary

Introduction

Ciprofloxacin is a synthetic fluoroquinolone derivative with broad spectrum antibacterial activity. It is widely used in the treatment of lower respiratory tract infections, urinary tract infections, skin and soft tissue infections, bacterial diarrhea, bone and joint infections, and in surgical prophylaxis (Mandell et al, 2002). Ciprofloxacin is considered to be the drug of choice by most physicians in most of the cases. This caused continuous increase in demand and the need to increase supply of generic products of ciprofloxacin in the market. The generic substitution can be considered when a generic product of an innovator drug contains identical amounts of the same active ingredient in the same dose, same dosage form and route of administration together with meeting standards for strength, purity, quality, and identity (Meredith et al, 2003)

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