Comparative bioequivalence assessment of aspirin tablets marketed in Nigeria

Abstract

Purpose: In the last few years, aspirin has become a life saver against cardiovascular accidents. This investigation was carried out to determine possible bioequivalence between regular aspirin and soluble aspirin tablets marketed in Nigeria. Methods: The in vivo bioavailability profiles of three commercial brands of aspirin tablets and soluble aspirin tablets were assessed in eight healthy
subjects. Pharmacokinetic parameters including
amounts of aspirin excreted up to 24h (E24h), maximum excretion rate (dE/dt)max and time for maximum excretion rate (Tmax) were compared for all the brands. Results: There was no significant difference (p > 0.05) in the maximum excretion rates among all the brands but the amount of soluble aspirin excreted up to 24 hours was a significantly different (p< 0.05) from one of the regular brands of aspirin. The soluble brand had significantly lower Tmax (p < 0.05) than all the three plain brands. There was no significant inter-subject variation among the
subjects that participated in the study. Conclusion: Bioinequivalence exists between some regular aspirin and soluble aspirin marketed in Nigeria.

Keywords: Soluble aspirin, aspirin, pharmacokinetic parameters, in vivo bioequivalence