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 or a solvate of said salt, optionally in combination with one or more additional active ingredient, stabilised by a sel...

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Bibliographische Detailangaben
Hauptverfasser:	Zambelli, Enrico, Usberti, Francesca, Bonelli, Sauro, Dagli Alberi, Massimiliano, Copelli, Diego
Format:	Patent
Sprache:	eng
Schlagworte:	ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS,e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES,DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS CONVEYING DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROMTHE BODY HANDLING THIN OR FILAMENTARY MATERIAL HUMAN NECESSITIES HYGIENE MEDICAL OR VETERINARY SCIENCE PACKAGES PACKAGING ELEMENTS PACKING PERFORMING OPERATIONS PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES STORING TRANSPORTING
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Beschreibung
Zusammenfassung:	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-[l-hydroxy-2-[l-(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.