Abstract

The current study conducted to evaluate the biopharmaceutical and physicochemical equivalence of the three available pharmaceutical dosage forms of ciprofloxacin (CIP) in the local markets (tablets, infusion and eye drops). Three brands for each dosage form were selected and coded as Tablets I, II, III; CIP infusion (Infusion I, II, III) and CIP eye drops (Eye drops I, II, III). Different in vitro quality control tests, physiochemical and determination of active ingredients contents were performed. All brands of tablets have a satisfactory result that complies with the pharmacopeia specification except the hardness of the tablets was more than the recommended value, and the salinity of Infusion II and III was lower than 0.9, the viscosity of the eye drops was lower than the specified value. Post-marketing surveillance is an essential issue to distinguish poor-quality medicines and must be routinely performed to weed out substandard and counterfeit medicine.

Highlights

  • Ciprofloxacin (CIP) is a synthetic antibacterial of the fluoroquinolones’ group

  • Low-quality medicines pose many hazards to public health and many of them are sold without control in developing countries (Pecoul et al.1999; World Health Organization (WHO) 2005)

  • The amount of CIP released is not less than 80% of the stated amount (British Pharmacopeia 2016)

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Summary

Introduction

Ciprofloxacin (CIP) is a synthetic antibacterial of the fluoroquinolones’ group It has a concentration-dependent bactericidal effect (Hamam 2014). It is effective for urinary, respiratory and gastrointestinal tracts, soft tissue, and sexual infections (Rao and Nagaraju 2004; Lode and Allewelt 2002; Bedor et al 2007). It is one of the most prescribed antibiotics by physicians in Yemen. Like many developing countries some of the marketed drugs in this city are substandard, falsified or counterfeits. Low-quality medicines pose many hazards to public health and many of them are sold without control in developing countries (Pecoul et al.1999; WHO 2005)

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