Method for manufacturing medicinal compounds containing dabigatran

摘要

The invention relates to an improved process for preparing a new medicament formulation of the active substance dabigatran etexilate of formula I;
in the form of the methanesulphonic acid salt thereof, and this new medicament formulation as such.

主权项

1. A process for preparing a suspension 4 of a polymorph I of a methanesulphonic acid salt of dabigatran etexilate of formula I,comprising the step of
mixing polymorph I of dabigatran etexilate methanesulphonate having a melting point of Tmp.=180±3° C. (determined by DSC; heating rate: 10° C./min) with talc in a solution of hydroxypropylcellulose in isopropyl alcohol to form a suspension, wherein the suspension is formed at a temperature between 12° C. and 22° C. by a circulatory dispersal process.