PHARMACEUTICAL COMPOSITION COMPRISING TADALAFIL OR PHARMACEUTICALLLY ACCEPTABLE SALT THEREOF AND DUTASTERIDE OR PHARMACEUTICALLLY ACCEPTABLE SALT THEREOF EXHIBITING NOVEL DISSOLUTION RATE

Provided is a pharmaceutical composition comprising as active ingredients: 5mg of tadalafil or a pharmaceutically acceptable salt thereof; and 0.5 mg of dutasteride or a pharmaceutically acceptable salt thereof, wherein the dissolution rate of tadalafil under the dissolution conditions of a paddle r...

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Bibliographische Detailangaben
Hauptverfasser: KIM, Jong Sil, LEE, Kye Wan, JUN, Sung Hoon, LEE, Ye Ri
Format: Patent
Sprache:eng ; fre ; ger
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Zusammenfassung:Provided is a pharmaceutical composition comprising as active ingredients: 5mg of tadalafil or a pharmaceutically acceptable salt thereof; and 0.5 mg of dutasteride or a pharmaceutically acceptable salt thereof, wherein the dissolution rate of tadalafil under the dissolution conditions of a paddle rate of 50 rpm in 500 mL of a dissolution solution having a pH of 1.2 and containing 0.25% of SLS is 60-75% after 5 minutes and 80% or more after 30 minutes, and the dissolution rate of dutasteride under the dissolution conditions of a paddle rate of 50 rpm in 500 mL of a dissolution solution containing water and 0.1% of SLS is 50% or more after 15 minutes and 85% or more after 30 minutes.