It is desirable to provide a pharmaceutical compsotion comprising a compound represented by formula (I), pharmaceutically acceptable salt or solvate thereof, with activating clotting factor X inhibition, useful for serving as a prophylactic and/or therapeutic agent for thrombotic and/or embolic diseases, and showing good solving-out. According to the present invention, it provides a method for preparing the pharmaceutical composition comprising the compound represented by formula (I), comprising a step of mixing the compound represented by formula (I), pharmaceutically acceptable salt or solvate thereof, one or more of excipient selected from a group consisting of sugar alcohols and water swelling additives, disintegrant and binder, in the condition of maintaining maximal moisture of granulated substance in granulating as 10% and less.本發明希冀提供含有顯示活性化血液凝固第X因子之抑制作用且有用於作為血栓性疾病之預防劑及/或治療劑之式(I)所代表的化合物、其藥學上可容許的鹽或彼等之溶媒合物的醫藥組成物,並顯示良好的溶出性的醫藥組成物。藉由本發明,提供含有式(I)所代表的化合物的醫藥組成物之製造方法,其包含將式(I)所代表的化合物、其藥學上可容許的鹽或彼等之溶媒合物、選自由糖醇類及水膨潤性添加劑組成之群之1種以上之賦形劑、崩解劑及結合劑,於造粒中之造粒物之最大水分值維持於10%以下的條件下,加以混合的步驟。
