Stable pharmaceutical solution formulations for pressurized...

A - Human Necessities – 61 – K

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A61K 9/12 (2006.01) A61K 31/4704 (2006.01) A61M 15/00 (2006.01) B65D 83/14 (2006.01)

Patent

CA 2557435

Aerosol solution formulations for use in an aerosol inhaler which comprise 8- hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino] ethyl]-2(1H)-quinolinone or a salt thereof, in particular the hydrochloride salt (TA 2005), as an active ingredient, a propellant containing a hydrofluoroalkane, and a cosolvent, stabilized by addition of a specific small amount of a high concentrated phosphoric acid and optionally by the use of a suitable can having part or all of its internal metallic surfaces lined with an inert organic coating.

L'invention concerne des formulations de solutions pour aérosol destinées à être utilisées dans un inhalateur pour aérosol, comprenant : une 8-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-méthoxyphényl)-1-méthyléthyl]amino] éthyl]-2(1H)-quinolinone, ou un sel de celle-ci, en particulier le sel chlorhydrate (TA2005), en tant qu'ingrédient actif, un propulseur contenant un hydrofluoroalcane, et un co-solvant, stabilisé par addition d'une petite quantité spécifique d'un acide phosphorique hautement concentré et, éventuellement, par utilisation d'une bombe appropriée dont une partie, ou la totalité, de sa surface métallique interne est enduite d'un revêtement organique inerte.

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