PMC:7554011 / 26958-28205 JSONTXT

{"target":"http://pubannotation.org/docs/sourcedb/PMC/sourceid/7554011","sourcedb":"PMC","sourceid":"7554011","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7554011","text":"For the mixing of Singulair® granules with formula scenario, when testing under fasted-state gastric conditions followed by fed-state intestinal conditions, the AUC0–4 h in vitro/AUC0–4 h in vivo ratio fell inside the 80–125% limits for infants of 1 to 3 months old. The in vitro-in vivo ratio was lower than the 80% limit for all subgroups when testing under fasted-state gastric conditions followed by fasted-state intestinal conditions. These results indicate that the biorelevant in vitro dissolution test under fasted-state gastric conditions followed by fed-state intestinal conditions gives a good prediction of the in vivo product performance for the 1 to 3 months subgroup, when the granules are mixed with formula. For the Singulair® granules mixed with milk, when testing under fasted-state gastric conditions followed by fed-state intestinal conditions and comparing with in vivo results in infants from all subgroups, the AUC0–4 h in vitro/AUC0–4 h in vivo ratio fell inside the 80–125% limits. For infants of 1 to 3 months, a good relationship was also found between the in vivo performance and the in vitro performance when using milk and testing under fasted-state gastric conditions followed by fasted-state intestinal conditions.","tracks":[]}