Combination of Azelastine and Mometasone for Nasal Administration

Abstract

A pharmaceutical product or formulation, which comprises azelastine or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, and a steroid, or a pharmaceutical acceptable salt, solvate or physiologically functional derivative thereof, preferably the product or formulation being in a form suitable for nasal or ocular administration.

What is claimed is: 
     
         1 . A method for the prophylaxis or treatment of nasal polyps in a mammal comprising intranasal administration to said mammal of a therapeutically effective amount of a pharmaceutical composition comprising (a) azelastine, or a pharmaceutically acceptable salt thereof; and (b) a pharmaceutically acceptable ester of mometasone, wherein the pharmaceutical composition is in a dosage form suitable for nasal administration. 
     
     
         2 . The method of  claim 1 , wherein the dosage form suitable for nasal administration is an aerosol, an ointment, nasal drops, a nasal spray, or an inhalation solution. 
     
     
         3 . The method of  claim 1 , wherein the dosage form suitable for nasal administration is a nasal spray. 
     
     
         4 . The method of  claim 1 , wherein the dosage form suitable for nasal administration is nasal drops. 
     
     
         5 . The method of  claim 1 , wherein the pharmaceutical composition is the form of an aqueous suspension or solution. 
     
     
         6 . The method of  claim 1 , wherein the pharmaceutical composition has a particle size of less than 10 μm. 
     
     
         7 . The method of  claim 1 , wherein the pharmaceutically acceptable salt of azelastine is azelastine hydrochloride. 
     
     
         8 . The method of  claim 1 , wherein the pharmaceutically acceptable ester of mometasone is mometasone furoate or mometasone furoate monohydrate. 
     
     
         9 . The method of  claim 1 , wherein the pharmaceutically acceptable salt of azelastine is azelastine hydrochloride and the pharmaceutically acceptable ester of mometasone is mometasone furoate. 
     
     
         10 . The method of  claim 1 , wherein the pharmaceutically acceptable salt of azelastine is azelastine hydrochloride and the pharmaceutically acceptable ester of mometasone is mometasone furoate monohydrate. 
     
     
         11 . The method of  claim 1 , wherein the pharmaceutical composition further comprises at least one additive selected from the group consisting of a surfactant, an isotonic agent, a buffer, a preservative, and a suspending agent or a thickening agent, and combinations thereof. 
     
     
         12 . The method of  claim 11 , wherein the surfactant is selected from the group consisting of a polysorbate surfactant, poloxamer surfactant, and combinations thereof 
     
     
         13 . The method of  claim 11 , wherein the isotonic agent is selected from the group consisting of sodium chloride, saccharose, glucose, glycerine, sorbitol, 1,2-propylene glycol, and combinations thereof 
     
     
         14 . The method of  claim 11 , wherein the buffer comprises a citric acid-citrate buffer. 
     
     
         15 . The method of  claim 11 , wherein the preservative is selected from the group consisting of edetic acid and its alkali salts, lower alkyl p-hydroxybenzoates, chlorhexidine, phenyl mercury borate, benzoic acid or a salt thereof, a quaternary ammonium compound, sorbic acid or a salt thereof, and combinations thereof. 
     
     
         16 . The method of  claim 11 , wherein the suspending agent or thickening agent is selected from the group consisting of cellulose derivatives, gelatin, polyvinylpyrrolidone, tragacanth, ethoxose, alginic acid, polyvinyl alcohol, polyacrylic acid, pectin, and combinations thereof. 
     
     
         17 . The method of  claim 11 , wherein the pharmaceutical composition has a pH of from 3 to 7. 
     
     
         18 . The method of  claim 1 , wherein the mammal is a human. 
     
     
         19 . The method of  claim 3 , wherein the pharmaceutically acceptable salt of azelastine is azelastine hydrochloride. 
     
     
         20 . The method of  claim 11 , wherein the pharmaceutically acceptable salt of azelastine is azelastine hydrochloride.