Mechanistic Modelling of Lidocaine and Prilocaine Absorption from EMLA Cream upon Topical Application using Physiologically Based Pharmacokinetic Modelling.

ABSTRACT: Physiologically based pharmacokinetic (PBPK) modelling can be utilized in dermal drug development and to support regulatory assessments by integrating information related to the active pharmaceutical ingredient (API), drug product, and skin physiology into a mechanistic simulation framework. The purpose of this study was to develop a mechanistic skin absorption model to predict the absorption of lidocaine and prilocaine following topical application of EMLA cream (lidocaine/prilocaine topical cream, 2.5%/2.5%) in virtual subjects. The multi-phase multi-layer mechanistic dermal absorption (MPML MechDermA™) model was used to simulate in vitro permeation of both APIs. Changes in formulation pH post application were studied experimentally, and these dynamic changes were captured in the model w

SUBMITTER: Telaprolu KC 

PROVIDER: S-EPMC12817310 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature