Medicine container comprising liquid pharmaceutical composition of 1-(5-(2,4-difluorophenyl)-1-((3-fluorophenyl)sulfonyl)-4-methoxy-1H-pyrrol-3-yl)-N-methylmethanamine
The present disclosure relates to a medicine container containing a liquid pharmaceutical composition of 1-(5-(2,4-difluorophenyl)-1-((3-fluorophenyl)sulfonyl)-4-methoxy-1H-pyrrol-3-yl)-N-methylmethanamine, or a pharmaceutically acceptable salt thereof.
1 . A medicine container comprising a liquid pharmaceutical composition containing a compound represented by the following Chemical Formula 1 or a pharmaceutically acceptable salt thereof:
wherein the liquid pharmaceutical composition further comprises an isotonizing agent, wherein the isotonizing agent is D-mannitol or NaCl,
wherein the liquid pharmaceutical composition comprises a beta-cyclodextrin in an amount of 3.0 parts by weight to 25 parts by weight with respect to one part by weight of said compound of Chemical Formula 1,
wherein the medicine container comprises a cyclic olefin polymer (COP) or cyclic olefin copolymer (COC) plastic container; a glass container whose inside face is coated with silicone oil, SiO 2 , or SiOCH; or a dealkalized glass container, and
wherein an amount of related substances in the liquid pharmaceutical composition measured after storing the medicine container under harsh conditions of 60° C. and 80% RH for 4 weeks is 0.5% or less.
2 . The medicine container of claim 1 , wherein the beta-cyclodextrin is (2-hydroxypropyl)-beta-cyclodextrin.
3 . The medicine container of claim 1 , wherein the liquid pharmaceutical composition has a pH of 4.0 to 6.0.
4 . The medicine container of claim 1 , wherein a difference between the amount of related substances in the liquid pharmaceutical composition measured after storing the medicine container under said harsh conditions of 60° C. and 80% RH for 4 weeks and an amount of related substances before being stored under said harsh conditions is 0.45% or less.
5 . The medicine container of claim 1 , wherein an amount of related substances in the liquid pharmaceutical composition measured after heat-sterilizing the medicine container at 100° C. to 150° C. for 3 minutes to 30 minutes and storing it under said harsh conditions of 60° C. and 80% RH for 4 weeks is 0.5% or less.
6 . The medicine container of claim 1 , wherein a difference between an amount of related substances in the liquid pharmaceutical composition measured after heat-sterilizing the medicine container at 100° C. to 150° C. for 3 minutes to 30 minutes, and storing it under said harsh conditions of 60° C. and 80% RH for 4 weeks and the amount of related substances before being treated under said harsh conditions is 0.45% or less.