Hydrolytic Degradation Study of Dabigatran Etexilate Mesylate: Isolation and Structural Elucidation of New Degradants

Physiologically‐based pharmacokinetics modeling to investigate formulation factors influencing the generic substitution of dabigatran etexilate

“…Apart from the P‐gp efflux, potential pH mediated degradation of DABE in the GI tract can add an additional layer of complexity in its absorption. However, in vitro stability studies have demonstrated that minimal degradation of DABE in both acidic and basic environment 36 . Therefore, pH mediated degradation of DABE is not expected to play any role in its absorption.…”

“…However, in vitro stability studies have demonstrated that minimal degradation of DABE in both acidic and basic environment. 36 Therefore, pH mediated degradation of DABE is not expected to play any role in its absorption.…”