Claims for Patent: 8,168,620

Summary for Patent: 8,168,620

Title:	Combination of azelastine and steroids
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 pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, preferably the product or formulation being in a form suitable for nasal or ocular administration.
Inventor(s):	Lulla; Amar (Mumbai, IN), Malhotra; Geena (Mumbai, IN)
Assignee:	CIPLA Limited (Mumbai, IN)
Application Number:	10/518,016
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,168,620
Patent Claims:	1. A pharmaceutical formulation comprising: azelastine, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable ester of fluticasone, wherein said pharmaceutical formulation is in a dosage form suitable for nasal administration. 2. The pharmaceutical formulation of claim 1, wherein said pharmaceutically acceptable salt of azelastine is azelastine hydrochloride. 3. The pharmaceutical formulation of claim 1, wherein said pharmaceutically acceptable ester of fluticasone is fluticasone propionate or fluticasone valerate. 4. The pharmaceutical formulation of claim 1, wherein said formulation has a particle size of less than 10 .mu.m. 5. The pharmaceutical formulation of claim 1, wherein said formulation is an aqueous suspension comprising from 0.0005% (weight/weight) to 2% (weight/weight) of said azelastine, or said pharmaceutically acceptable salt thereof, and from 0.0357% (weight/weight) to 1.5% (weight/weight) of said pharmaceutically acceptable ester of fluticasone. 6. The pharmaceutical formulation according to claim 5, comprising from 0.001% (weight/weight) to 1% (weight/weight) of said azelastine, or said pharmaceutically acceptable salt thereof, and from 0.0357% (weight/weight) to 1.5% (weight/weight) of said pharmaceutically acceptable ester of fluticasone. 7. The pharmaceutical formulation of claim 1, further comprising at least one additive selected from the group consisting of a buffer, a preservative, a suspending agent a thickening agent, a surfactant, an isotonic agent and combinations thereof. 8. The pharmaceutical formulation of claim 7, wherein said surfactant comprises a polysorbate, poloxamer or combinations thereof. 9. The pharmaceutical formulation of claim 7, wherein said isotonic agent comprises sodium chloride, saccharose, glucose, glycerine, sorbitol, 1,2-propylene glycol or combinations thereof. 10. The pharmaceutical formulation of claim 7, wherein said preservative comprises edetic acid or its alkali salts, lower alkyl p-hydroxybenzoates, chlorhexidine, phenyl mercury borate, or benzoic acid or a salt thereof, a quaternary ammonium compound, sorbic acid or a salt thereof, or combinations thereof. 11. The pharmaceutical formulation of claim 7, wherein said suspending agent or said thickening agent comprises cellulose derivatives, gelatin, polyvinylpyrrolidone, tragacanth, alginic acid, polyvinyl alcohol, polyacrylic acid, pectin, or combinations thereof. 12. The pharmaceutical formulation of claim 1, which is an aqueous suspension. 13. The pharmaceutical formulation of claim 1, wherein said dosage form suitable for nasal administration comprises nasal drops or a nasal spray. 14. The pharmaceutical formulation of claim 1, wherein said dosage form suitable for nasal administration comprises nasal drops. 15. The pharmaceutical formulation of claim 1, wherein said dosage form suitable for nasal administration comprises a nasal spray. 16. The pharmaceutical formulation of claim 1, wherein said formulation is used in the treatment of conditions for which administration of one or more anti-histamine and/or one or more steroid is indicated. 17. The pharmaceutical formulation of claim 1, wherein said pharmaceutically acceptable salt of azelastine is azelastine hydrochloride and said pharmaceutically acceptable ester of fluticasone is fluticasone propionate, and wherein said formulation is used in the treatment of conditions for which administration of one or more anti-histamine and/or one or more steroid is indicated. 18. The pharmaceutical formulation of claim 1, wherein said pharmaceutically acceptable salt of azelastine is azelastine hydrochloride and said pharmaceutically acceptable ester of fluticasone is fluticasone propionate, and wherein said formulation further comprises a pharmaceutically acceptable carrier or excipient therefor. 19. The pharmaceutical formulation of claim 1, wherein said pharmaceutically acceptable salt of azelastine is azelastine hydrochloride and said pharmaceutically acceptable ester of fluticasone is fluticasone valerate, and wherein said formulation is used in the treatment of conditions for which administration of one or more anti-histamine and/or one or more steroid is indicated. 20. The pharmaceutical formulation of claim 1, wherein said pharmaceutically acceptable salt of azelastine is azelastine hydrochloride and said pharmaceutically acceptable ester of fluticasone is fluticasone valerate, and wherein said formulation further comprises a pharmaceutically acceptable carrier or excipient therefor. 21. A process of preparing a pharmaceutical formulation of claim 1, which process comprises admixing a pharmaceutically acceptable carrier or excipient with azelastine, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable ester of fluticasone. 22. The pharmaceutical formulation of claim 1, wherein said pharmaceutically acceptable ester of fluticasone is fluticasone propionate. 23. The pharmaceutical formulation of claim 1, wherein said pharmaceutically acceptable ester of fluticasone is fluticasone valerate. 24. A pharmaceutical formulation comprising azelastine hydrochloride; and, fluticasone propionate, wherein said formulation is in the dosage form of as a nasal spray, and wherein said formulation is used in the treatment of conditions for which administration of one or more anti-histamine and/or one or more steroid is indicated. 25. A nasal spray formulation comprising (i) azelastine, or a pharmaceutically acceptable salt thereof, (ii) a pharmaceutically acceptable ester of fluticasone, and (iii) a pharmaceutically acceptable carrier or excipient therefor. 26. The pharmaceutical formulation of claim 6, comprising 0.1% (weight/weight) of azelastine hydrochloride, and from 0.0357% to 1.5% (weight/weight) of fluticasone propionate. 27. The pharmaceutical formulation of claim 6, comprising 0.1% (weight/weight) of azelastine hydrochloride, and from 0.0357% to 1.5% (weight/weight) of fluticasone valerate. 28. The pharmaceutical formulation of claim 6, wherein said dosage form suitable for nasal administration comprises a nasal spray. 29. The pharmaceutical formulation of claim 26, wherein said dosage form suitable for nasal administration comprises a nasal spray. 30. The pharmaceutical formulation of claim 27, wherein said dosage form suitable for nasal administration comprises a nasal spray. 31. The pharmaceutical formulation of claim 28, wherein said pharmaceutically acceptable salt of azelastine is azelastine hydrochloride and wherein said pharmaceutically acceptable ester of fluticasone is fluticasone propionate. 32. The pharmaceutical formulation of claim 28, wherein said pharmaceutically acceptable salt of azelastine is azelastine hydrochloride and wherein said pharmaceutically acceptable ester of fluticasone is fluticasone valerate. 33. The pharmaceutical formulation of claim 25, wherein said pharmaceutically acceptable salt of azelastine is azelastine hydrochloride and wherein said pharmaceutically acceptable ester of fluticasone is fluticasone propionate. 34. The pharmaceutical formulation of claim 25, wherein said pharmaceutically acceptable salt of azelastine is azelastine hydrochloride and wherein said pharmaceutically acceptable ester of fluticasone is fluticasone valerate. 35. The pharmaceutical formulation of claim 5, wherein said pharmaceutically acceptable salt of azelastine is azelastine hydrochloride. 36. The pharmaceutical formulation of claim 6, wherein said pharmaceutically acceptable salt of azelastine is azelastine hydrochloride. 37. The pharmaceutical formulation of claim 28, wherein said pharmaceutically acceptable salt of azelastine is azelastine hydrochloride. 38. The pharmaceutical formulation of claim 8, wherein said surfactant comprises a polysorbate. 39. The pharmaceutical formulation of claim 9, wherein said isotonic agent comprises glycerine. 40. The pharmaceutical formulation of claim 10, wherein said preservative comprises edetate disodium and benzalkonium chloride. 41. The pharmaceutical formulation of claim 11, wherein said suspending agent or said thickening agent comprises cellulose derivatives. 42. The pharmaceutical formulation of claim 1, further comprising edetate disodium, glycerine, a thickening agent comprising microcrystalline cellulose and sodium carboxy methyl cellulose, polysorbate 80, benzalkonium chloride, phenyl ethyl alcohol, and purified water. 43. The pharmaceutical formulation of claim 24, further comprising edetate disodium, glycerine, a thickening agent comprising microcrystalline cellulose and sodium carboxy methyl cellulose, polysorbate 80, benzalkonium chloride, phenyl ethyl alcohol, and purified water. 44. The pharmaceutical formulation of claim 25, further comprising edetate disodium, glycerine, a thickening agent comprising microcrystalline cellulose and sodium carboxy methyl cellulose, polysorbate 80, benzalkonium chloride, phenyl ethyl alcohol, and purified water. 45. The pharmaceutical formulation of claim 1, wherein said formulation comprises a pH from 3 to 7. 46. The pharmaceutical formulation of claim 1, wherein said formulation comprises a pH from 4.5 to 6.5. 47. A pharmaceutical formulation comprising from 0.001% (weight/weight) to 1% (weight/weight) of azelastine hydrochloride, and from 0.0357% (weight/weight) to 1.5% (weight/weight) of fluticasone propionate, wherein said pharmaceutical formulation is an aqueous suspension suitable for nasal administration. 48. A pharmaceutical formulation comprising 1% (weight/weight) of azelastine hydrochloride, and from 0.0357% (weight/weight) to 1.5% (weight/weight) of fluticasone propionate, wherein said pharmaceutical formulation is an aqueous suspension suitable for nasal administration.