Post Marketing Bioequivalence Study of Six Brands of Ciprofloxacin HCL in Egyptian Market and Evaluation as a Treatment of Human Periodontal Pockets

Citation:
Kassem, M. A., M. M.I, and M. E. I. Assal, "Post Marketing Bioequivalence Study of Six Brands of Ciprofloxacin HCL in Egyptian Market and Evaluation as a Treatment of Human Periodontal Pockets", Journal of Medical and Pharmaceutical Innovation, vol. 1 (6) , issue 2347-8136 , pp. 35-43, 2014.

Abstract:

ABSTRACT
The availability of numerous brands of ciprofloxacin HCl in our drug market today places clinicians and pharmacists in a difficult situation of choice of a suitable brand or the possibility of alternative use. The aim of the present study was to evaluate physical standards of six brands of ciprofloxacin HCl tablets marketed in Egypt using in-vitro tests and then in vivo bioequivalence of best two brands of ciprofloxacin HCL, finally their evaluation in treatment of human periodontal pockets. The in-vitro dissolution study was carried out on six brands of ciprofloxacin HCl tablets using basket method according to US pharmacopoeia guidelines. Other general quality assessment tests like Weight variation, hardness, friability, drug content uniformity y and disintegration were also determined. Then brands of ciprofloxacin HCl were subjected to in-vivo efficacy studies in treatment of human periodontal pockets. Significant results were obtained with respect to both microbiological and clinical parameters. For evaluation of bioequivalence of best two brands of ciprofloxacin HCl, blood samples were taken, plasma concentration of ciprofloxacin HCl brands were determined by simple HPLC method. The pharmacokinetic parameters, Including peak plasma concentrations and time needed to reach the peak were obtained directly from plasma concentration–time profiles. The area under the curve was calculated using noncompartmental methods. Statistical analysis of in-vitro and in-vivo studies shows that ciprofloxacin brands are effective in treating periodontal pockets in order of ciprobay, cipromax, mifoxin, ciprocin, rancif and ciprofar. Statistical analysis of main parameters confirm the bioequivalence of the ciprofloxacin formulations in terms of pharmacokinetic characteristic, the results from this study demonstrate that Ciprobay and Cipromax are interchangeable in the clinical setting.

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