Abstract

The study investigated the possibility of developing an in vitro – in vivo correlation for four commercial brands of aspirin tablets using USPXXI rotating basket apparatus and urinary excretion profiles from eight human volunteers. Various dissolution and pharmacokinetic parameters were obtained for all the brands. Significant rank order correlations were observed between all the in vitro dissolution parameters such as percent dissolved at 30 min, dissolution rate constants (k) and time for 50% dissolution (DT_50%) and all the in vivobioavailability parameters such as cumulative amount excreted up to 8 h (E₈), maximum excretion rate (dE/dt)_max and time for maximum excretion rate (T_max). However, no correlation could be established between the cumulative amount excreted up to 24 h (E₂₄) and any of the in vitro dissolution parameters. Moreover, statistical analysis showed no significant inter-subject variation among the subjects that participated in the experiments.

Key words: Aspirin tablets, dissolution rate constant, maximum excretion rate, cumulative amount excreted, in vitro-in vivo correlation (IV-IVC).