Relative bioavailability of ertugliflozin tablets containing the amorphous form versus tablets containing the cocrystal form.

ABSTRACT:

Objectives

Ertugliflozin is a selective sodium-glucose cotransporter 2 inhibitor approved for the treatment of type 2 diabetes in adults. In its natural form, ertugliflozin exists as an amorphous solid with physicochemical properties that prevent commercial manufacture. The commercial product was developed as an immediate-release tablet, consisting of an ertugliflozin-L-pyroglutamic acid cocrystal of 1 : 1 molar stoichiometry as the active pharmaceutical ingredient. The ertugliflozin cocrystal may partially dissociate when exposed to high humidity for extended periods, leading to the formation of free amorphous ertugliflozin. Therefore, a study was conducted to estimate the relative bioavailability of ertugliflozin when administered in non-commercial formulated tablets containing t

SUBMITTER: Sahasrabudhe V 

PROVIDER: S-EPMC9238437 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature