Comparative In Vitro Bioequivalence Evaluation of Six Brands of Amoxicillin Capsule Marketed in Dutse, Jigawa State, Nigeria.
ABSTRACT
Comparative in vitro bioequivalence study of biopharmaceutics class I and III drugs hadgained prominence in recent times. In vitro bioequivalence offered many benefits compared to conventional in-vivobioequivalence studies, due to its reduced cost and time of product release as well as avoiding unnecessary use of human volunteers.
This study is aimedat evaluating and comparing the in vitro bioequivalence of branded and generic amoxicillin capsules available in Dutse, Jigawa State,Nigeria.Thesamples were randomly selected and evaluated for quality control studies via BP 2009 and USP 2009 specifications.
Four UVSpectrophotometry methods for thedetermination of amoxicillin in simulated physiological media (pH 1.2, 4.5, 6.8, and 7.4), were developed and validated according to ICH guideline.
Dissolution testing was conducted using USP apparatus I, sink volume of 900 ml, temperature 37± 0.5 oC and 100 rpm, samples were withdrawn at an interval of 5, 15, 25, 35 and 45 minutes respectively.
Bioequivalence of the samples were compared using different statistical methods; the difference factor (f1), similarity factor (f2) and the dissolution efficiency (% D.E.).
From the result of quality control studies, all the brands were found to passed identification test as their IR spectra were superimposable with reference amoxicillin spectrum.
Also the % D.E. values of each of the simulated pHs for brands B and E were within the acceptable limit of ±10 %. So, from the result they are consideredbioequivalent with A. While, brands C, D and F failed both f1, f2 and % D. E. comparison as their values were outside the accepted range.
Also, the analysis of variance (ANOVA) and dunnett multiple comparisonresultsfurther, confirmed the observed difference among the brands obtained using f1, f2 and % D.E methods at (p<0.05).
Therefore, brands C, D and F, are not bioequivalent with A. About 60 % of the samples may not be considered bioequivalent with innovator (A).
INTRODUCTION
Bioequivalence evaluation usingin vivo pharmacokinetic parametersare often assumed to be the gold standard to established product bioequivalence (BE) of immediaterelease solid oral dosage forms(Polli et al., 2008).
However, in vitro studies are sometimes better than invivo studies in assessing BE of immediate release solid oral dosage formsdue to the fact thatin vitro studies serve as the better method that lead to reduce costs, directly assess product performance, offers benefits in terms of ethical considerations (Polli et al., 2008).
In vitro studies directly assess product performance than do conventionalhuman pharmacokinetic BE studies, since in vitro studies focus on comparative drug absorption from thetwo products (Arleneet al., 2014). Alsoin vivo BE testing suffers from complications due to its indirect approach (Polli et al., 2008).
Regarding ethical considerations, in vitro studies better embrace the principle ―No unnecessary humantesting should be performed’ and can result in faster product development (Polli et al., 2008).
Dissolution of solid oral dosage is preceded by disintegration prior to being absorbed into blood circulation to be made bioavailable at the site (s) of a drugaction(Kassaye and Genete, 2013).
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