Bioequivalence studies on some selected brands of ciprofloxacin hydrochloride tablets in the Nigerian market with ciproflox® as innovator brand.

ABSTRACT

This work assesses the bioequivalence of four selected brands of ciprofloxacin hydrochloride in the Nigerian market to Ciproflox® as a selected innovator brand. The brands selected were reperesented by samples A, B, C and D all are of Asian origin. The following parameters were employed in the assay- Weight uniformity, tablet hardness, friability, disintegration time and dissolution profile in 0.1N HCl , and minimum inhibitory concentration (MIC) determined by zones of inhibition on clinical isolates of Staphylococcus aureus. The mean hardness results were in the order Ciproflox(R) (14.55 ± 3.97) > C (12.51 ± 3.01) > D (9.87 ± 2.38) > B (9.67 ± 1.37) > A (8.98 ± 3.46) and they all fell within the acceptable values of 3 kgs ≤.hardness. The mean friability results were in the order A (0.07) < D (0.12) < Ciproflox (0.17) < B (0.30) < D (0.31). The drug content values were in the order -Ciproflox (500.02) > D (483.54) > Cipromax B > C (458.86) > A (420.29). By the USP standard, only A failed the test; while, by the BP standard only Ciproflox and D passed the test. The disintegration times were in the order- A (1.73±0.27) > C (3.22±0.20)> B (4.15±1.07)> Ciproflox (4.88±0.54)> D (7.60±0.44). The tablet dissolution rates (P12min values) were in the order – A (59.528 ± 8.427) > C (42.468 ± 1.863) > B (35.124 ± 4.408)> Ciproflox (15.403 ± 0.799) > D (8.808 ± 0.856). Ciproflox(R) with the highest drug content had the lowest MIC on Staphylococcus aureus (0.064 μg/ml ). This shows that Ciproflox is the most effective of the five brands, followed by D, C, B and A. The highest MIC value on Staphylococcus aureus was obtained with A 0.255 μg/ml which also had the lowest drug content. Ciproflox (R) with this reseach stands to be the oustanding product among the five brands.