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Comparative Bioequivalence Studies of Some Selected Brands of Ciprofloxacin Tablets Marketed In Zaria

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Description

– Comparative Bioequivalence Studies of Some Selected Brands of Ciprofloxacin Tablets Marketed In Zaria –

Download Comparative Bioequivalence Studies of Some Selected Brands of Ciprofloxacin Tablets Marketed In Zaria. Students who are writing their projects can get this material to aid their research work.

Abstract

Comparative bioequivalence studies of six selected brands of ciprofloxacin tablets was successfully conducted. In-vitro quality control studies were carried out on six randomly selected brands of ciprofloxacin to establish identity,

weight uniformity, friability, crushing strength, disintegration, dissolution and assay according to BP 2002 and 2009.

Cheap, simple and available method of analysis of ciprofloxacin in saliva sample was developed by U.V Spectrophotometer with variable wavelengths.

The developed method was validated based on ICH guidelines. Bioequivalence parameters (Cmax, Tmax and AUC) were evaluated on the six brands of ciprofloxacin to determine their interchangeability after a wash-out period of one week.

From the result of in-vitro studies all brands passed the test indicating pharmaceutical equivalence. All the brands were found to have the labeled active ingredient as they were within the accepted range of 95-105%.

The percentage recovery was within the accepted range of 95 – 105%. Calibration curve was constructed and was linear within the range of 1-6µg/ml as the correlation coefficient was 0.9889.

Introduction

1.1 Background of the Study

There is growing trade in substandard and counterfeit drugs including antibiotics around the world. The prevalence of such substandard drugs in Nigerian markets has been worrisome to both regulatory agencies and all concerned.

The availability of drugs, especially antibiotics in open markets has led to indiscriminate use and may contribute to high incidence of antibiotic-resistant strains (Mukhtar et al., 2010).

The need to select one product from several generic drug products of the same active ingredients during the course of therapy is also a cause for concern to healthcare practitioners (Adegbolagun et al., 2007). Generic drug is a product sold under the chemical name of a branded drug, after the expiry of the patent for a branded drug.

Both the branded and the generic versions must have the same potency, be available in the same dosage forms (i.e. tablets, liquids, injectables) and be demonstrated to be safe and effective.

The generic drugs are less expensive as compared to branded drugs as generic manufacturers do not have the investment costs of the developer of a new drug.

New drugs are generally developed under patent protection. Generic drugs are usually far cheaper than branded drugs, sometime up to 90%.Efficacy and safety of pharmaceutical product depend on its standards preset to assure the desired purpose

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