COMPARATIVE IN VITRO BIOEQUIVALENCE EVALUATION OF SIX BRANDS OF AMOXICILLIN CAPSULE MARKETED IN DUTSE, JIGAWA STATE, NIGERIA

COMPARATIVE IN VITRO BIOEQUIVALENCE EVALUATION OF SIX BRANDS OF AMOXICILLIN CAPSULE MARKETED IN DUTSE, JIGAWA STATE, NIGERIA

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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sink volume of 900 ml, temperature 37± 0.5 oC and 100 rpm, samples were withdrawn at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. Four of the six brands (A, B, C and

E) passed the assay test,(90-120) USP 2009 while,brands D and F failed. The uniformity

of weight test all the brands passed with percentage mean deviation <7.5% (BP 2009).All

the brands disintegrated in less than 15 minutes as required by BP 2009.The four methods

developed for the determination of amoxicillin have λmax. 229nm for buffer

solutions(pH 1.2 and 4.5) and 228nm for (pH 6.8 and 7.4).The calibration curves were

linear at the concentration range of 10-60 μg/mltheir correlation co-efficientwere 0.999,

v


0.997, 0.997 and 0.996 for buffer solutions (pH 1.2, 4.5, 6.8 and 7.4) respectively. A

regression equation of y= 0.0133x+0.1847, y=0.0137x+0.1967, y=0.0143x+0.2113, and

y=0.0162x+0.0807for (pH 1.2, 4.5, 6.8 and 7.4) respectively. The percentage recoveries

of the developed methods were within the official range of 98-102%. Likewise, the intra-

day and inter-day precision were within normal range of co-efficient of variation<15%

(2.05% ,3.46%,2.48% ,0.66% and 9.15%,9.00%,5.82%,0.66%) for the simulated

media(pH1.2,4.5, 6.8 and 7.4) respectively. The dissolution profiles obtained for each

medium was subjected to bioequivalence comparison. The result of f1 for brands B and E

were similar and within the acceptable range of ≤15 in each pHs. Similarly, the f2 values

were ≥50 in pH 1.2 and 4.5 for B and pH 4.5 for E while in pH 6.8 and 7.4 for B and pH

1.2, 6.8 and 7.4 for E were below the acceptable range thus, failed f2 test. 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).


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