04-07-2013 дата публикации
Номер: US20130167838A1
This invention relates to a solution formulation for nasal administration comprising azelastine, beclomethasone dipropionate, a co-solvent, an acid and an HFA propellant. 1. A solution formulation for nasal administration comprising azelastine , beclomethasone dipropionate , a co-solvent , an acid and an HFA propellant.2. A formulation as claimed in claim 1 , wherein the acid is hydrochloric acid.3. A formulation as claimed in claim 2 , wherein the molar ratio of azelastine free base to hydrochloric acid is 6:1 to 15:1.4. A formulation as claimed in claim 3 , wherein the molar ratio of azelastine free base to hydrochloric acid is 9:1 to 12:1.5. A formulation as claimed in claim 1 , wherein the azelastine is present in the form of both azelastine free base and an azelastine salt.6. A formulation as claimed in claim 1 , wherein the co-solvent is ethanol.7. A formulation as claimed in claim 1 , wherein the HFA propellant is selected from the group consisting of 1 claim 1 ,1 claim 1 ,1 claim 1 ,2-tetrafluoroethane (P134a) claim 1 , 1 claim 1 ,1 claim 1 ,1 claim 1 ,2 claim 1 ,3 claim 1 ,3 claim 1 ,3-heptafluoropropane (P227) and a mixture thereof.8. A formulation for nasal administration comprising azelastine claim 1 , beclomethasone dipropionate claim 1 , ethanol claim 1 , hydrochloric acid and a propellant selected from the group consisting of 1 claim 1 ,1 claim 1 ,1 claim 1 ,2-tetrafluoroethane (P134a) claim 1 , 1 claim 1 ,1 claim 1 ,1 claim 1 ,2 claim 1 ,3 claim 1 ,3 claim 1 ,3-heptafluoropropane (P227) and a mixture thereof claim 1 , wherein the molar ratio of azelastine free base to hydrochloric acid is 9:1 to 10:9.9. A formulation as claimed in claim 1 , wherein the formulation is used for the prophylaxis and/or treatment of seasonal allergic rhinitis (including hay fever) and perennial rhinitis.10. A nasal spray device for the delivery of a pharmaceutical solution to the nasal cavity in metered doses claim 1 , wherein the pharmaceutical solution is the ...
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