PMC:7554011 / 25746-26957 JSONTXT

{"project":"2_test","denotations":[{"id":"33051713-16707408-26822","span":{"begin":1102,"end":1104},"obj":"16707408"},{"id":"33051713-18296556-26823","span":{"begin":1105,"end":1107},"obj":"18296556"},{"id":"33051713-15102869-26824","span":{"begin":1108,"end":1110},"obj":"15102869"}],"text":"The ratios between the AUC0–4 h in vitro (from the in vitro dissolution profiles of Singulair® granules directly administered or mixed with milk, formula or applesauce, under fasted-state gastric conditions followed by fasted- or fed-state intestinal conditions) and the AUC0–4 h in vivo (from the absorption profiles in infants 1 to 3 months, 3 to 6 months and 6 to 24 months) are presented in Fig. 4. In the cases of direct introduction of Singulair® granules and mixing with applesauce, the in vitro drug dissolution was much slower than the in vivo absorption of montelukast, in all subgroups (% AUC0–4 h in vitro/AUC0–4 h in vivo ratio lower than 80%).\nFig. 4 Ratio (%) between each AUC0–4 h in vitro and AUC0–4 h in vivo (AUC0–4 h in vitro/AUC0–4 h in vivo × 100). AUC0–4 h in vitro: a in vitro fasted-state gastric followed by fasted-state intestinal conditions; and b in vitro fasted-state gastric followed by fed-state intestinal conditions. AUC0–4 h in vivo: calculated from the absorption profiles after deconvolution of the in vivo plasma profiles of Singulair® granules (4 mg) in infants (16,17,19); (grey area represents the range criteria (80–125%) set for prediction of in vivo drug performance)"}