Comparison of the AUC0–4 h in vitro of the dissolution profiles (4 h) is presented in Fig. 2. Results of the AUC0–4 h in vitro confirmed that dissolution of montelukast from the two formulations tested was significantly affected by co-administration with vehicles, compared with the direct administration scenario. The AUC0–4 h in vitro was also shown to be significantly higher when testing under fed-state simulated intestinal conditions in comparison with the fasted state.
Fig. 2 AUC0–4 h in vitro (% dissolved * h) of montelukast dissolution profiles after direct administration of formulation (left panel: Singulair® granules, right panel: Actavis® chewable tablets) and after mixing with the vehicles. (a denotes statistical difference between direct administration (blue bars) and co-administration with vehicles (other colours); * denotes a statistical difference on drug dissolution between testing under fasted-state gastric conditions followed by fasted-state (full bar) or fed-state (dashed bar) intestinal conditions (p < 0.05))