Relates to controlled release compositions for the manufacture of a sustained-release preparation containing a udenafil, in particular, pharmaceutically acceptable salts (A) and udenafil, (B) a solubility control agent, the present invention, (C ) adsorbent, and a controlled release composition for comprising (D) a hydrophilic polymer, to produce a sustained-release preparation containing udenafil. Controlled release compositions for the production of udenafil containing sustained-release preparation according to the present invention is adjusted freely 3 to 24 hours in the release time of the drug by releasing the drug at a constant regardless of the pH in the stomach-intestinal tract after which it can be can be, reduce the variation in efficacy among individuals, the efficacy expression for the treatment of diseases requiring long-term drug taking hepatic portal hypertension and pulmonary arterial hypertension, such as benign prostatic hyperplasia is treated by udenafil it is possible to produce a sustained-release preparation with the optimum conditions for, can be usefully employed for the treatment and prevention of erectile dysfunction by controlling the release in accordance with the appropriate absorption time upon application to a living body.本発明は、ウデナフィルを含有する徐放性製剤を製造するための制御放出組成物に関し、具体的には、(A)ウデナフィルおよび薬学的に許容される塩、(B)溶解度調節剤、(C)吸着剤、および(D)親水性ポリマーを含んでなる、ウデナフィル含有徐放性製剤を製造するための制御放出組成物に関する。本発明に係るウデナフィル含有徐放性製剤を製造するための制御放出組成物は、胃・腸管でpHに関係なく一定に薬物を放出して薬物の放出時間を3~24時間内で自由に調節することができ、個体間の薬効のバラツキを減らすことができるうえ、ウデナフィルによって治療される肺動脈高血圧や肝門脈高血圧、前立腺肥大症などの長期薬物服用を必要とする疾患の治療に薬効発現のための最適条件を持つ徐放性製剤を製造することができ、生体への適用の際に適切な吸収時間に応じて放出を調節して勃起不全の予防および治療にも有用に利用できる。
