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This study aimed to build a physiologically based pharmacokinetic (PBPK) model coupled with age-appropriate  in vitro  dissolution data to describe drug performance in adults and pediatric patients. Montelukast sodium was chosen as a model drug. Two case studies were investigated: case study 1 focused on the description of formulation performance from adults to children; case study 2 focused on the description of the impact of medicine co-administration with vehicles on drug exposure in infants. The PBPK model for adults and pediatric patients was developed in Simcyp ®  v18.2 informed by age-appropriate  in vitro  dissolution results obtained in a previous study. Oral administration of montelukast was simulated with the ADAM™ model. For case study 1, the developed PBPK model accurately described montelukast exposure in adults and children populations after the administration of montelukast chewable tablets. Two-stage dissolution testing in simulated fasted gastric to intestinal conditions resulted in the best description of  in vivo  drug performance in adults and children. For case study 2, a good description of  in vivo  drug performance in infants after medicine co-administration with vehicles was achieved by incorporating  in vitro  drug dissolution (under simulated fasted gastric to fed intestinal conditions) into a fed state PBPK model with consideration of the  in vivo  dosing conditions (mixing of formulation with applesauce or formula). The case studies presented demonstrate how a PBPK absorption modelling strategy can facilitate the description of drug performance in the pediatric population to support decision-making and biopharmaceutics understanding during pediatric drug development. Graphical abstract

Performance Evaluation of Montelukast Pediatric Formulations: Part II — a PBPK Modelling Approach