Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination

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, optionally in combination with one or more additional active ingredient, stabilised by a selected amount of a mineral...

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Bibliographic Details
Main Authors DIEGO COPELLI, FRANCESCA USBERTI, MASSIMILIANO DAGLI ALBERI, SAURO BONELLI, ENRICO ZAMBELLI
Format Patent
LanguageChinese
English
Published 23.07.2021
Subjects
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS
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Summary: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, 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 DEG C and 60% relative humidity (RH) for 6 months in an aerosol can provided with a metering valve having at least a butyl rubber gasket. 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. 本发明涉及预期用于加压定量雾化吸入器的气雾剂溶液组合物，其包含格隆溴铵和福莫特罗或其盐或所述盐的溶剂合物、任选地与一种或多种另外的活性成分的组合，该气雾剂溶液用选择用量的无机酸稳定，且其
Bibliography:Application Number: CN202110424305