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格隆溴銨和褔莫特羅組合的穩定的加壓氣霧劑溶液組合物
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:
HK16113732.8
公开号:
HK1225313A
申请日:
2016.12.01
申请国别(地区):
HK
年份:
2017
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.
来源网站:
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