Comparative bioavailability of two brands of ciprofloxacin.

ABSTRACT

Twelve adult healthy volunteers participated on two occasions in a cross-over study with an interval of 30 days. The bioavailability of ciprofloxacin 500 mg administered as single oral dose was compared in preparation A (Indian, Torrent) and preparation B (Imported, Bayer). The drug was administered early morning on an empty stomach. Blood samples were collected at 1/2,1,2,4,6,8,12 and 24 hours. Plasma levels of ciprofloxacin were determined by HPLC. Time taken to achieve peak plasma concentration (Tmax) was 2 hours (A) and 1.67 +/- 0.49 hours (B). Maximum plasma concentration (Cmax) ranged from 1.8 to 5.1 ug/ml (mean 3.08 +/- 0.99 ug/ml) for 'A' and 2.08 to 5.5 mu g/ml (mean 3.58 +/- 1.37 mu g/me for 'B'. Area under plasma concentration time curve ranged from 30.91 to 118.27 ug/ml/hr (mean 59.97 +/- 26.68 ug/ml/hr) in 'A' and 36.52 to 108.05 (mean 62.80 +/- 22.33 ug/ml/hr) in 'B' which is more than reported in Western literature. Large bioavailability of ciprofloxacin in the present study suggests the need to be cautious while treating patients with renal problems and to use lower doses in Indian patients to achieve desirable results. However, there was no significant difference in the pharmacokinetic parameters between the two brands (Paired 't' test and Wilcoxon Sign Rank test). It is therefore, concluded that both the preparations are comparable in terms of bioavailability.