Claims for Patent: 9,901,585

Summary for Patent: 9,901,585

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:	15/070,839
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,901,585
Patent Claims:	1. 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 formulation of claim 1, wherein the formulation has a pH of 4.5 to about 6.5. 3. The formulation of claim 1, wherein the formulation is an aqueous suspension. 4. The formulation of claim 1, wherein the one or more preservatives comprise benzalkonium chloride. 5. The formulation of claim 1, wherein the one or more preservatives comprise edetate disodium and benzalkonium chloride. 6. The formulation of claim 5, comprising 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. 7. The formulation of claim 1, wherein the one or more thickening agents comprise microcrystalline cellulose and carboxymethyl cellulose sodium. 8. The formulation of claim 7, comprising from 0.65% (weight/weight) to 3% (weight/weight) of the one or more thickening agents. 9. The formulation of claim 1, wherein the one or more surfactants comprise polysorbate 80. 10. The formulation of claim 1, wherein the one or more isotonization agents comprise glycerine. 11. The formulation of claim 10, comprising from 2.3% (weight/weight) to 2.6% (weight/weight) of glycerine. 12. The formulation of claim 4, wherein the one or more preservatives further comprise phenyl ethyl alcohol. 13. The formulation of claim 12, comprising 0.25% (weight/weight) of phenyl ethyl alcohol. 14. The formulation of claim 1, comprising edetate disodium, benzalkonium chloride, microcrystalline cellulose, carboxymethyl cellulose sodium polysorbate 80, glycerine, and phenyl ethyl alcohol. 15. The formulation of claim 14, comprising: 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. 16. A nasal spray formulation, comprising: 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 cellulose and carboxymethyl cellulose sodium; polysorbate 80; 2.3% (weight/weight) of glycerine; and 0.25% (weight/weight) of phenyl ethyl alcohol. 17. The formulation of claim 16, wherein the formulation has a pH of 4.5 to about 6.5. 18. The formulation of claim 16, wherein the formulation is an aqueous suspension. 19. A nasal spray product comprising the formulation of claim 1. 20. A nasal spray product comprising the formulation of claim 16. 21. The nasal spray product of claim 19, 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. 22. The nasal spray product of claim 20, 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. 23. The formulation of claim 8, wherein the one or more thickening agents comprise microcrystalline cellulose and carboxymethyl cellulose sodium. 24. The formulation 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. 25. The formulation of claim 24, wherein the one or more isotonization agents comprise glycerine. 26. The formulation of claim 25, comprising from 2.3% (weight/weight) to 2.6% (weight/weight) of glycerine. 27. A nasal spray formulation, comprising: from 0.001% (weight/weight) to 1% (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. 28. The formulation of claim 27, wherein the thickening agent comprises from 0.65% (weight/weight) to 3% (weight/weight) of microcrystalline cellulose and carboxymethyl cellulose sodium. 29. The formulation of claim 27, wherein the formulation is an aqueous suspension. 30. A nasal spray product comprising the formulation of claim 29, 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.