COMPARATIVE RELATIVE BIOAVAILABILITY STUDIES OF SIX BRANDS OF OFLOXACIN MARKETED
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ABSTRACT
This study was aimed at assessing the comparative bioavailability of six brands of ofloxacin marketed in Zaria. Comparative bioavailability studies of six brands of ofloxacin marketed in Zaria was successfully conducted. Quality assessment was conducted on the randomly selected six brands of ofloxacin marketed in Zaria. Identification test, assay, weight variation, friability, disintegration time and dissolution rate were determined according to BP 2009. Cheap, simple and accurate U. V. Spectrophotometry method for analysis of ofloxacin in GAA from saliva sample at 295nm was developed and validated based on ICH guideline. Calibration curve was constructed within the range of 3-18µg/ml and validated. The developed method was then employed in the comparative bioavailability studies of six brands of ofloxacin with a washout period of one week. All the brands were found to have the labeled active ingredient. The six brands passed the assay as they were within the accepted range of 99.8-102%. Weight variation was conducted and all the brands passed as their percentage deviations were less than 5%. Similarly all the brands passed the friability except Brand E with more than 1% friability. Disintegration test reveals that all the brands disintegrate in less than 15minutes and all the brands passed the dissolution rate as more than 85% of the active ingredient was released in 30 minutes. The percentage recovery of the developed method was within the accepted range of 98 - 102%. Calibration curve was linear within the range of 3-18µg/ml as the correlation co-efficient was 0.998. The regression equation was y= 0.092x + 0.008. All the brands were well tolerated by the subjects as no adverse effects were reported. The mean Cmax (µg/ml) of brands B, C, E and F were found to be significantly vi (p≥0.05) different from that of the brand A (innovator) while brand D was not significantly (p≥0.05) different (16.66 ± 1.41, 11.7 ± 1.83, 9.82 ± 0.67, 16.25 ± 2.54, 15.35 ± 1.43 and 11.99 ± 0.37 for brand A, B, C, D, E, and F respectively). The mean tmax (hr) of brand C and D were found to be statistically similar (p≥0.05) with that of the innovator while that of brand B, E and F were significantly (p≥0.05) different from that of the innovator (3.5 ± 0.2, 4.0 ± 1.83, 3.5 ± 0.61, 4.5 ± 0.61, 2 ± 0.45 and 2.5 ± 0.22 for brand A, B, C, D, E, and F respectively). For AUC0-8 (µg/ml.h), the values of brands B and D were found to be statistically similar (p≥0.05) with that of the innovator while the values of brands C, E and F were significantly (p≥0.05) different from that of the innovator (72.68 ± 3.58, 56.53 ± 13.26, 43.24 ± 4.25, 100.40 ± 16.01, 92.74 ± 6.75 and 28.17 ± 0.62 for brand A, B, C, D, E, and F respectively). The elimination half life (t1/2 (h)) of brands B and C were statistically similar (p≥0.05) with that of the innovator while brands D, E and F half life values were significantly (p≥0.05) different from that of the innovator (3.08 ± 0.11, 2.89 ± 0.27, 3.01 ± 0.09, 4.27 ± 0.02, 4.23 ± 0.09 and 1.63 ± 0.02 for brand A, B, C, D, E, and F respectively). Brand D was found to be comparatively bioavailable with the innovator. Therefore, it could be used in preference to the innovator due to its cheap price compared to the innovator. Brand B, C, E and F were not comparatively bioavailable as both the rate and extent of absorption were significantly different at p≥0.05 level of significance
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