Adult and pediatric physiologically-based biopharmaceutics modeling to explain lamotrigine immediate release absorption process.

ABSTRACT: Physiologically-based biopharmaceutics modeling (PBBM) has potential to accelerate the development of new drug and formulations. An important application of PBBM is for special populations such as pediatrics that have pharmacokinetics dependent on the maturation process. Lamotrigine (LTG) is a Biopharmaceutics Classification System (BCS) II drug and is widely prescribed. Therefore, the goal of this study was to assess the biopharmaceutics risk of the low-soluble drug LTG when the ontogeny on gastrointestinal tract (GIT) physiological parameters are considered. An oral physiologically-based pharmacokinetic model and a PBBM were developed and verified using GastroPlus™ software for both adults and children (2-12 years old, 12-52 kg). The biopharmaceutics properties and GIT physiological para

SUBMITTER: Caleffi-Marchesini ER 

PROVIDER: S-EPMC10864931 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature