Solid forms of dabigatran etexilate mesylate and processes for their preparation

摘要

It relates to solid forms of dabigatran etexilate mesylate, in particular dabigatran etexilate mesylate in crystalline Form A, and in amorphous form; to processes for their preparation, and to pharmaceutical compositions comprising them. It also relates to a crystalline form of dabigatran etexilate base (Form A), and to a process for its preparation.

主权项

1. A crystalline Form A of dabigatran etexilate mesylate characterized by having an X-ray diffractogram that comprises characteristic peaks at 4.4, 8.9, 9.8, 12.3, 17.8, 18.4, 19.2, 19.7, 21.4, 23.4, 27.3, 28.2±0.1 degrees 2 theta measured in an X-ray diffractometer with Cu Kα radiation (1.5418 Å).