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STABLE PRESSURE AEROSOL SOLUTION COMPOSITION OF GLYCOPYRRONIUM BROMIDE AND FORMOTEROL COMBINATION
专利权人:
Chiesi Farmaceutici S.p.A.
发明人:
BONELLI, Sauro,COPELLI, Diego,DAGLI ALBERI, Massimiliano,USBERTI, Francesca,ZAMBELLI, Enrico
申请号:
DK14825154
公开号:
DK3089735T3
申请日:
2014.12.23
申请国别(地区):
DK
年份:
2018
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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