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

ABSTRACT: 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 accuratel

SUBMITTER: Guimaraes M 

PROVIDER: S-EPMC8816611 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature