COMPARATIVE BIOEQUIVALENCE STUDIES OF SOME BRANDS OF METRONIDAZOLE TABLETS MARKETED IN ZARIA, NIGERIA
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ABSTRACT
Multisource pharmaceutical products are intended to be pharmaceutically equivalent or pharmaceutical alternatives that are bioequivalent and hence are therapeutically equivalent and interchangeable. Thus, this study was aimed at carrying out a comparative in-vitro and in-vivo bioequivalence studies of some brands of Metronidazole (200 mg) tablets marketed in Zaria, Nigeria. BP 2002 method was use for the assessment of the pharmaceutical and chemical equivalences of the samples of metronidazole tablets. Tablet hardness and friability testing were also carried out to reinforce the official methods for the in vitro studies. The analytical method for the in vivo studies was adopted from the work of Kolawole and Ameh (2004). The method was validated according to ICH/WHO guideline. Six healthy human volunteers were enrolled for the studies according to the normal protocols for bioequivalence studies. The study yielded the following results: The presence of metronidazole was observed in all the samples with a content uniformity of 92.45 - 106.16 %. All the samples had acceptable level of weight variation, except MT05, MT08 and MT12 with 5, 4 and 14 tablets respectively deviated from the mean weight. All the samples disintegrated within 15 minutes (BP specification) with the exception of MT07 which disintegrated in 18.97 minutes. Each of the samples had at least a dissolution of 70 % within 45 minutes. All the samples had acceptable level of friability, except MT05, MT07, MT08 and MT11 with value of 1.70 %, 1.81 %, 1.62 % and 10.25 % respectively above the 1 % acceptable limit. All the samples of the tablets had acceptable hardness within the limit of 4-10 kgF, except MT10 and MT11 with a value of 10.70 kgF and 10.6 kgF respectively. The validated method was found to have an intra- and inter-day precision of 0.491 and 0.417 % respectively expressed as percentage relative standard deviation. The accuracy of the method was 1.98 % with a mean percentage recovery of 98.3 %. All the samples had acceptable level of bioequivalence xiv within the range of 0.93-1.05 with reference to MT01® as the reference standard using point estimate ratio of the mean Cmax and AUC0→8h /µg. In conclusion, the samples of the metronidazole 200 mg tablets analysed can be used interchangeably even though there was some variation in their pharmaceutical equivalences.
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