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Claims for Patent: 9,259,428

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Claims for Patent: 9,259,428

Title:Combination of azelastine and fluticasone 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.
Inventor(s): Lulla; Amar (Mumbai, IN), Malhotra; Geena (Mumbai, IN)
Assignee: Cipla Limited (Mumbai, IN)
Application Number:14/661,720
Patent Claims: 1. A method for the treatment of seasonal allergic rhinitis, comprising administration of a therapeutically effective amount of a nasal spray formulation comprising: from 0.001% (weight/weight) to 1% (weight/weight) of azelastine hydrochloride; from 0.0357% (weight/weight) to 1.5% (weight/weight) of fluticasone propionate; one or more preservatives; one or more thickening agents; one or more surfactants; and one or more isotonization agents.

2. The method of claim 1, wherein the formulation has a pH of 4.5 to about 6.5.

3. The method of claim 1, wherein the formulation is an aqueous suspension.

4. The method of claim 1, wherein the one or more preservatives comprise from 0.002% (weight/weight) to 0.05% (weight/weight) of edetate disodium and from 0.002% (weight/weight) to 0.05% (weight/weight) of benzalkonium chloride.

5. The method of claim 1, wherein the one or more thickening agents comprise microcrystalline cellulose and carboxymethyl cellulose sodium.

6. The method of claim 1, wherein the one or more surfactants comprise polysorbate 80.

7. The method of claim 1, wherein the one or more isotonization agents comprise from 2.3% (weight/weight) to 2.6% (weight/weight) of glycerine.

8. The method of claim 4, wherein the one or more preservatives further comprise 0.25% (weight/weight) of phenyl ethyl alcohol.

9. The method of claim 1, wherein the formulation comprises edetate disodium, benzalkonium chloride, microcrystalline cellulose, carboxymethyl cellulose sodium, polysorbate 80, glycerine, and phenyl ethyl alcohol.

10. The method of claim 9, wherein the formulation comprises: from 0.002% (weight/weight) to 0.05% (weight/weight) of edetate disodium; from 0.002% (weight/weight) to 0.05% (weight/weight) of benzalkonium chloride; from 0.65% (weight/weight) to 3% (weight/weight) of a combination of microcrystalline cellulose and carboxymethyl cellulose sodium; and from 2.3% (weight/weight) to 2.6% (weight/weight) of glycerine.

11. The method of claim 1, wherein the formulation comprises: 0.1% (weight/weight) azelastine hydrochloride; from 0.0357% (weight/weight) to 1.5% (weight/weight) of fluticasone propionate; from 0.002% (weight/weight) to 0.05% (weight/weight) of edetate disodium; from 0.002% (weight/weight) to 0.02% (weight/weight) of benzalkonium chloride; from 0.65% (weight/weight) to 3% (weight/weight) of a combination of microcrystalline and carboxymethyl cellulose sodium; polysorbate 80; 2.3% (weight/weight) of glycerine; and 0.25% (weight/weight) of phenyl ethyl alcohol.

12. The method of claim 1, wherein the one or more isotonization agents is present in an amount that a reduction in the freezing point of from 0.50.degree. C., to 0.56.degree. C. is attained in comparison to pure water.

13. The method of claim 1, wherein the formulation is contained in a nasal spray product; and wherein from 0.03 mg to 3 mg of azelastine hydrochloride and from 0.05 mg to 0.15 mg of fluticasone propionate is released per individual actuation of the nasal spray product.

14. A method for minimizing symptoms of seasonal allergic rhinitis, comprising administration of a therapeutically effective amount of a nasal spray formulation comprising: from 0.001% (weight/weight) to 1% (weight/weight) of azelastine hydrochloride; from 0.0357% (weight/weight) to 1.5% (weight/weight) of fluticasone propionate; one or more preservatives; one or more thickening agents; one or more surfactants; and one or more isotonization agents.

15. The method of claim 14, wherein the formulation has a pH of 4.5 to about 6.5.

16. The method of claim 14, wherein the formulation is an aqueous suspension.

17. The method of claim 14, wherein the one or more preservatives comprise from 0.002% (weight/weight) to 0.05% (weight/weight) of edetate disodium and from 0.002% (weight/weight) to 0.05% (weight/weight) of benzalkonium chloride.

18. The method of claim 14, wherein the one or more thickening agents comprise microcrystalline cellulose and carboxymethyl cellulose sodium.

19. The method of claim 14, wherein the one or more surfactants comprise polysorbate 80.

20. The method of claim 14, wherein the one or more isotonization agents comprise from 2.3% (weight/weight) to 2.6% (weight/weight) of glycerine.

21. The method of claim 17, wherein the one or more preservatives further comprise 0.25% (weight/weight) of phenyl ethyl alcohol.

22. The method of claim 14, wherein the formulation comprises edetate disodium, benzalkonium chloride, microcrystalline cellulose, carboxymethyl cellulose sodium, polysorbate 80, glycerine, and phenyl ethyl alcohol.

23. The method of claim 22, wherein the formulation comprises: from 0.002% (weight/weight) to 0.05% (weight/weight) of edetate disodium; from 0.002% (weight/weight) to 0.05% (weight/weight) of benzalkonium chloride; from 0.65% (weight/weight) to 3% (weight/weight) of a combination of microcrystalline cellulose and carboxymethyl cellulose sodium; and from 2.3% (weight/weight) to 2.6% (weight/weight) of glycerine.

24. The method of claim 14, wherein the formulation comprises: 0.1% (weight/weight) azelastine hydrochloride; from 0.0357% (weight/weight) to 1.5% (weight/weight) of fluticasone propionate; from 0.002% (weight/weight) to 0.05% (weight/weight) of edetate disodium; from 0.002% (weight/weight) to 0.02% (weight/weight) of benzalkonium chloride; from 0.65% (weight/weight) to 3% (weight/weight) of a combination of microcrystalline and carboxymethyl cellulose sodium; polysorbate 80; 2.3% (weight/weight) of glycerine; and 0.25% (weight/weight) of phenyl ethyl alcohol.

25. The method of claim 14, wherein the one or more isotonization agents is present in an amount that a reduction in the freezing point of from 0.50.degree. C. to 0.56.degree. C. is attained in comparison to pure water.

26. The method of claim 14, wherein the formulation is contained in a nasal spray product; and wherein from 0.03 mg to 3 mg of azelastine hydrochloride and from 0.05 mg to 0.15 mg of fluticasone propionate is released per individual actuation of the nasal spray product.

27. The method of claim 18, wherein the formulation comprises from 0.65% (weight/weight) to 3% (weight/weight) of microcrystalline cellulose and carboxymethyl cellulose sodium.

28. A method for the treatment of seasonal allergic rhinitis, comprising administration of a therapeutically effective amount of a nasal spray formulation comprising: from 0.001% (weight/weight) % (weight/weight) of azelastine hydrochloride; from about 50 .mu.g/mL to about 5 mg/mL of fluticasone propionate; from 0.002% (weight/weight) to 0.05% (weight/weight) of benzalkonium chloride; from 0.002% (weight/weight) to 0.05% (weight/weight) of edetate disodium; glycerine; polysorbate; and a thickening agent; wherein the formulation has a pH of 4.5 to about 6.5; and wherein the formulation is an aqueous suspension.

29. The method of claim 28, wherein the formulation is contained in a nasal spray product; and wherein from 0.03 mg to 3 mg of azelastine hydrochloride and from 0.05 mg to 0.15 mg of fluticasone propionate is released per individual actuation of the nasal spray product.

30. The method of claim 28, wherein the thickening agent comprises microcrystalline cellulose and carboxymethyl cellulose sodium.
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