Claims for Patent: 8,518,919

Summary for Patent: 8,518,919

Title:	Compositions comprising azelastine and methods of use thereof
Abstract:	The present invention provides pharmaceutical compositions comprising azelastine, or a pharmaceutically acceptable salt or ester thereof including azelastine hydrochloride, and optionally one or more additional active agents. Preferred such compositions further comprise one or more pharmaceutically acceptable carriers or excipients that reduce the amount of post-nasal drip, and/or that minimize or mask the unpleasant bitter taste associated with post-nasal drip, of the compositions into the oral cavity, upon intranasal or ocular administration of the compositions. Especially effective excipients used in the compositions of the present invention are hypromellose as a viscosity modifier and sucralose as a taste-masking agent. The invention also provides methods of treating or preventing certain disorders, or symptomatic relief therefrom, by administering the compositions of the invention to a patient, e.g., for the symptomatic relief of allergic rhinitis, non-allergic vasomotor rhinitis, allergic conjunctivitis, as well as other disorders.
Inventor(s):	Dang; Phuong Grace (Corona, CA), Lawrence; Brian D. (Somerset, NJ), Balwani; Gul (West Windsor, NJ), D'Addio; Alexander D. (Piscataway, NJ)
Assignee:	MEDA Pharmaceuticals Inc. (Somerset, NJ)
Application Number:	13/294,069
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,518,919
Patent Claims:	1. A method of treating a physical disorder in an animal suffering from or predisposed thereto, comprising administering to said animal an effective amount of a liquid pharmaceutical composition comprising; about 0.1% to about 0.15% (w/v) azelastine hydrochloride; about 0.1% to about 0.15% (w/v) sucralose; and about 0.1% to about 10% (w/v) sorbitol 70% wherein said physical disorder is selected from the group consisting of allergic rhinitis and non-allergic vasomotor rhinitis, and wherein said liquid pharmaceutical composition is formulated in the form of a nasal spray or nasal drops. 2. The method of claim 1, wherein said animal is a mammal. 3. The method of claim 2, wherein said mammal is a human. 4. The method of claim 1, wherein the liquid pharmaceutical composition is formulated in the form of a nasal spray. 5. The method of claim 1, wherein the liquid pharmaceutical composition is formulated in the form of nasal drops. 6. The method of claim 1, wherein said liquid pharmaceutical composition is contained within an intranasal delivery system. 7. The method of claim 6, wherein said intranasal delivery system comprises a bottle and a pump. 8. The method of claim 7, wherein said pump is a metered multi-dose pump. 9. The method of claim 4, wherein said liquid pharmaceutical composition is formulated to intranasally deliver a volume of said composition of about 0.07 ml to about 0.15 ml per spray. 10. The method of claim 9, wherein said liquid pharmaceutical composition is formulated to intranasally deliver a volume of said composition of about 0.14 ml per spray. 11. The method of claim 1, wherein said azelastine hydrochloride is about 0.100% (w/v) azelastine hydrochloride; said sucralose is about 0.150% (w/v) sucralose; said sorbitol is about 6.4% (w/v) sorbitol 70%; and wherein said liquid pharmaceutical composition further comprises about 0.100% (w/v) of hypromellose; about 0.05% (w/v) disodium edetate; about 0.025% (w/v) benzalkonium chloride 50% solution, NF; about 0.068% (w/v) sodium citrate dihydrate; and QS water. 12. The method of claim 1, wherein said liquid pharmaceutical composition further comprises: hypromellose; disodium edetate; benzalkonium chloride 50% solution, NF; sodium citrate dihydrate; and QS water. 13. The method of claim 12, wherein said liquid pharmaceutical composition further comprises: about 0.001% to about 5.00% (w/v) of hypromellose; about 0.01% to about 0.1% (w/v) disodium edetate; about 0.001% to about 0.5% (w/v) benzalkonium chloride 50% solution, NF; about 0.068% (w/v) sodium citrate dihydrate; and QS water. 14. The method of claim 1, wherein said azelastine hydrochloride is about 0.150% (w/v) azelastine hydrochloride; said sucralose is about 0.150% (w/v) sucralose: said sorbitol is about 0.1% to, about 10% (w/v) sorbitol 70%; and said liquid pharmaceutical composition further comprises about 0.100% (w/v) of hypromellose; about 0.05% (w/v) disodium edetate; about 0.001% to about 0.5% (w/v) benzalkonium chloride 50% solution, NF; about 0.068% (w/v) sodium citrate dihydrate; and QS water. 15. The method of claim 1, wherein the concentration of sorbitol in said pharmaceutical composition is sufficient for the osmolality of said liquid pharmaceutical composition to be from about 220 mOsmol/kg to about 350 mOsmol/kg. 16. The method of claim 1, wherein said physical disorder is allergic rhinitis. 17. The method of claim 16, wherein said allergic rhinitis is seasonal allergic rhinitis. 18. The method of claim 1, wherein said physical disorder is non-allergic vasomotor rhinitis. 19. The method of claim 1, wherein said liquid pharmaceutical composition comprises sucralose at a concentration of about 0.15% (w/v). 20. The method of claim 14, wherein the concentration of sorbitol in said pharmaceutical composition is sufficient for the osmolality of said liquid pharmaceutical composition to be from about 220 mOsmol/kg to about 350 mOsmol/kg.