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Stable pressurized aerosol solution composition of a combination of glycopyrronium bromide and formoterol
专利权人:
シエシー ファルマセウティチィ ソシエタ ペル アチオニ
发明人:
ボネッリ、 サウロ,コペッリ、 ディエゴ,ダリ アルベリ、 マッシミリアノ,ウスベルティ、 フランチェスカ,ザンベッリ、 エンリコ
申请号:
JP2016561079
公开号:
JP6563950B2
申请日:
2014.12.23
申请国别(地区):
JP
年份:
2019
代理人:
摘要:
The invention concerns an aerosol solution composition intended for use with a pressurised metered dose inhaler, comprising glycopyrronium bromide and formoterol, or a salt thereof or a solvate of said salt, optionally in combination with one or more additional active ingredient, stabilised by a selected amount of a mineral acid and wherein the amount of the degradation product N-(3-bromo)-[2-hydroxy-5-[1-hydroxy-2-[1-(4-methoxyphenyl) propan-2-ylamino]ethyl] phenyl]formamide is lower than the limit of quantification, when stored in accelerated conditions at 25°C and 60% relative humidity (RH) for 6 months in a can internally coated by a resin comprising a fluorinated ethylene propylene (FEP) polymer. The optional one or more active ingredient may be an inhalation corticosteroid selected from beclometasone dipropionate, budesonide or its 22R-epimer, ciclesonide, flunisolide, fluticasone propionate, fluticasone furoate, mometasone furoate, etc.
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