PHARMACEUTICAL COMPOSITIONS IN AEROSOL CONTAINING FLUTICASONE PROPIONATE IN AN AQUEOUS SOLUTION.

摘要

The present invention refers to aerosol formulations for administering drugs in an aqueous solution, more particularly, fluticasone propionate by inhalation. The invention provides novel aerosol formulations comprising (a) Fluticasone propionate, (b) a polar co-solvent, (c) a moisturizing agent, a lubricating agent or surfactant and (d) a hydrofluorocarbon (HFC) or hydrofluoroalkane (HFA) propellant. The formulation is characterized in that it is chlorofluorocarbon (CFC) propellant-free, containing non-solvated or modified fluticasone propionate in the surface thereof and the drug completely solubilized therein, which facilitates the absorption of the active principle by the airways. The invention ensures the uniformity of the doses administered in each shot and promotes the physical stability of the final formulation. The invention is further characterized in that the fluticasone propionate is drug-free and the formula is contained in a suitable aluminium container, which does not ha ve an inner coating. The present invention includes a non-conventional manufacturing method useful for dispensing the components of the formula without requiring freezing or especial environmental conditions, the same being practically, quickly and easily operated as especial cooling fittings are not required, the dispensing action can be adjusted during the process. Said method is more cost effective since an additional energy consumption is not required, and has the same advantages of the conventional filling method under cooling.