Bioequivalence studies on some selected brands of ciprofloxacin hydrochloride tablets in the Nigerian market with ciproflox® as innovator brand.
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Date
2011-08
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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.
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Keywords
Ciprofloxacin hydrochloride, tablets, brands, bioequivalence, tablet characteristics, microbiological
Citation
Osonwa Uduma E, Agboke Ayodeji A, Amadi Rosemary C, Okorie, Ogbonna, Opurum Christian C. Bioequivalence studies on some selected brands of ciprofloxacin hydrochloride tablets in the Nigerian market with ciproflox® as innovator brand. Journal of Applied Pharmaceutical Science. 2011 Aug; 1(6): 80-84.