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

WIPO Patent Application WO/2022/146061

A1

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.

LEE YE RI (KR)
JUN SUNG HOON (KR)
KIM JONG SIL (KR)
LEE KYE WAN (KR)

PCT/KR2021/020236

July 07, 2022

December 30, 2021

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DONG KOOK PHARM CO LTD (KR)

A61K9/20; A61K31/4985; A61K31/58; A61P13/08; A61P15/10

KR101835506B1	2018-03-07
KR20160023962A	2016-03-04
KR101716878B1	2017-03-15
KR20090021380A	2009-03-03
KR20180036638A	2018-04-09
KR101745425B1	2017-06-09
KR101712524B1	2017-03-08
KR101780739B1	2017-09-26

TURK J UROL, vol. 44, no. 4, July 2018 (2018-07-01), pages 294 - 297
"Remington's The Science and Practice of Pharmacy", 2005, LIPPINCOTT WILLIAMS & WILKINS
"Handbook of Pharmaceutical Excipients", 2017, APHA PUBLICATIONS

PARK, Jong Hyeok (KR)

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