3-[(2-{[4-(Hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridine-2-yl-amino]-propionic acid ethyl ester methane sulphonate and use thereof as a medicament

摘要

Disclosed is ethyl 3-[(2-{[4-(hexyloxycarbonylamino-imino-methyl)-phenylamino]-methyl}-1-methyl-1H-benzimidazole-5-carbonyl) pyridine-2-yl-amino]propionate methanesulfonate (BIBR 1048 MS) in crystalline form, characterised by a melting poing of Tm.p = 190 +/- 3 degrees Celsius (polymorph II) (determined by DSC; evaluation by peak maximum; heating rate 10 degrees Celsius per minute. Also disclosed is the preparation of the above polymorph and its use for the preparation of a pharmaceutical composition which is suitable for the post-operative prophylaxis of deep vein thrombosis and the prevention of stroke.