STABLE PHARMACEUTICAL SOLUTION FORMULATIONS FOR PRESSURIZED METERED DOSE INHALERS.

摘要

A MEDICINAL AEROSOL SOLUTION FORMULATION PRODUCT COMPRISING A PRESSURIZED METERED DOSE INHALER AND A MEDICINAL AEROSOL FORMULATION FOR USE IN THE METERED DOSE INHALER WHICH COMPRISE 8-HYDROXY-5-[( 1 R)- I -HDROXY-2-[[( 1 R)-2-(4-METHOXYPHENYL)-1 -METHYLETHYL]AMINO] ETHYL]-2( 1 H)-QUINOLINONE OR A SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT (TA 2005), AS AN ACTIVE INGREDIENT, A PROPELLANT CONTAINING A HYDROFLUOROALKANE, AND A COSOLVENT, WHEREIN THE ACTIVE INGREDIENT IS STABILIZED BY ADDITION OF A SPECIFIC SMALL AMOUNT OF A HIGH CONCENTRATED PHOSPHORIC ACID AND OPTIONALLY BY THE USE OF A SUITABLE CANISTER HAVING PART OR ALL OF ITS INTERNAL METALLIC SURFACES LINED WITH AN INERT ORGANIC COATING AND EQUIPPED WITH A METERING VALVE PROVIDED WITH SEALING RINGS MADE OF A VULCANISATE OF AN ELASTOMERIC COMPOSITION OF A BUTYL RUBBER.