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A Bioequivalence Evaluation of Two Different Olanzapine Orodispersible Tablet ormulations.
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| Author:
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UPLOADED BY-ADMIN, ARVIND R. DESAI, RAJESH KUMAR GOEL
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| Abstract:
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The objective was to demonstrate bioequivalence between olanzapine orodispersible
10mg tablet formulation (Torrent Pharmaceutical Ltd., India) as test and Zyprexa® Zydis®
(Olanzapine) 10mg tablet (Eli Lilly & Company, Brazil) as reference. A total of 24 healthy
human volunteers were participate. Each volunteer has received a single dose of olanzapine
in each period of the study. The study design used was single-dose, randomized, open-label,
two-period, two-treatment, two-sequence and crossover. Blood samples were taken before,
and up to 144 hrs after drug administration. Plasma concentrations of olanzapine were determined
by a validated LC-MS/MS method. The pharmacokinetic parameters, Cmax and
Tmax, were obtained directly from plasma concentration data, Ke was estimated by log-linear
regression, and the area under curve (AUC) was calculated by the linear trapezoidal rule. The
parameter Cmax, AUC0-t and AUC0-inf, were tested for bioequivalence after logtransformation
of data, while the differences of Tmax were evaluated non-parametrically.
When Cmax, AUC0-t and AUC0-inf were analysed using analysis of variance, no statistically
significant difference was observed between the two different olanzapine orodispersible
10mg tablet formulations. The 90% confidence intervals of the mean values for Cmax,
AUC0-t and AUC0-inf were 95.44-111.47%, 95.27-111.03% and 89.43-109.16% respectively.
All of these values were within the bioequivalence acceptance range of 80-125%. We
found that both formulations were bioequivalent and therefore interchangeable in clinical
practice.
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| Keyword:
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US-FDA, ANOVA, AUC, Vd, t1/2
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| EOI:
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| DOI:
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