Claims for Patent: 9,078,923

Summary for Patent: 9,078,923

Title:	Stable fixed dose pharmaceutical composition comprising mometasone and olopatadine
Abstract:	The present invention relates to a stable fixed dose aqueous pharmaceutical composition (e.g., contained in a container) for nasal administration to a human, comprising mometasone or its salt, olopatadine or its salt. The composition may further include a hydrocolloid. The invention also relates to a process for preparing the pharmaceutical composition, and the use of the pharmaceutical composition in the treatment of rhinitis in a subject.
Inventor(s):	Dhuppad; Ulhas (Maharashtra, IN), Katkurwar; Ashok (Maharashtra, IN), Gupta; Yashwant (Maharashtra, IN), Ankam; Rajesh (Maharashtra, IN), Dhatrak; Chandrakant (Maharashtra, IN)
Assignee:	GLENMARK PHARMACEUTICALS LIMITED (Mumbai, IN)
Application Number:	14/483,837
Patent Claims:	1. A stable fixed dose aqueous pharmaceutical composition for nasal administration to a human, the composition being a single phase suspension which comprises (a) about 0.001% w/w to about 0.075% w/w mometasone or its salt in particulate form; (b) about 0.5% w/w to about 0.8% w/w olopatadine or its salt in dissolved form; and (c) a hydrocolloid system in an amount sufficient to inhibit phase separation for at least 24 hours when stored at 25.+-.2.degree. C. and 60% .+-.5% relative humidity. 2. The pharmaceutical composition of claim 1, wherein the mometasone or its salt and the olopatadine or its salt are present in a weight ratio of about 1:3 to about 1:106. 3. The pharmaceutical composition of claim 1, wherein the mometasone salt is mometasone furoate and the olopatadine salt is olopatadine hydrochloride. 4. The pharmaceutical composition of claim 1, wherein the mometasone or its salt has a mean particle size in the range of about 1 .mu.m to about 20 .mu.m. 5. The pharmaceutical composition of claim 1, wherein the composition has a pH of about 3.3 to about 4.1. 6. The pharmaceutical composition of claim 4, wherein the suspension comprises a sufficient amount of a hydrocolloid system to inhibit phase separation for at least 7 days of storage at 25.+-.2.degree. C. and 60%.+-.5% relative humidity. 7. The pharmaceutical composition of claim 1, wherein the composition has a pH of about 3.3-4.1, and an osmolality in the range of about 200 mOsm/kg to about 400mOsm/kg. 8. The pharmaceutical composition of claim 1, wherein the composition has a viscosity in the range of about 20 cps to about 150 cps. 9. A stable fixed dose pharmaceutical composition for nasal administration to a human, said composition is a single phase aqueous suspension comprising (1) about 0.025% w/w to about 0.05% w/w mometasone or its salt in particulate form, (2) about 0.6% w/w to about 0.7% w/w olopatadine or its salt in dissolved form, and (3) a hydrocolloid system in an amount sufficient to inhibit phase separation for at least 24 hours when stored at 25.+-.2.degree. C. and 60%.+-.5% relative humidity. 10. The pharmaceutical composition of claim 9, wherein the composition comprises about 0.025% w/w mometasone furoate. 11. The pharmaceutical composition of claim 9, wherein the composition comprises about 0.05% w/w mometasone furoate. 12. The pharmaceutical composition of claim 9, wherein the composition comprises about 0.665% w/w olopatadine hydrochloride. 13. The pharmaceutical composition of claim 9, wherein the composition further comprises a pharmaceutically acceptable excipient selected from the group consisting of chelating agents, preservatives, buffers, surfactants, isotonicity agent, and any combination of any of the foregoing. 14. The pharmaceutical composition of claim 9, wherein the composition has a pH of about 3.5-3.9, and an osmolality in the range of about 250 mOsm/kg to about 350mOsm/kg. 15. The pharmaceutical composition of claim 9, wherein the composition has a viscosity in the range of about 20 cps to about 150 cps. 16. The pharmaceutical composition of claim 9, wherein the composition has a viscosity in the range of about 20 cps to about 150 cps and is contained in a container, and when delivered as a nasal spray has a spray pattern having a longest axis of 15-75 mm, a shortest axis of 10-65 mm, and an ellipticity of 1-2. 17. A method of treating rhinitis in a human in need thereof comprising administering by the nasal route to the human the pharmaceutical composition of claim 1. 18. The pharmaceutical composition of claim 9, wherein the composition has a pH of 3.3 to 4.1. 19. A stable fixed dose pharmaceutical composition for nasal administration to a human, the composition being a single phase aqueous suspension comprising: 0.025% or 0.05% w/w mometasone furoate monohydrate; 0.665% w/w olopatadine hydrochloride; 0.5% w/w carboxymethyl cellulose sodium; 1.2% w/w of a mixture of microcrystalline cellulose and carboxymethyl cellulose sodium; 0.02% w/w benzalkonium chloride; 0.41% w/w sodium chloride; 0.01% w/w di-sodium edetate; 0.94% w/w sodium phosphate heptahydrate; and 0.01% w/w polysorbate 80; wherein the composition has a pH of about 3.3 to about 4.1. 20. The pharmaceutical composition of claim 19, wherein the composition has an osmolality of 250 mOsm/kg to 350 mOsm/kg, a viscosity of 20 cps to 150 cps, and the mometasone furoate monohydrate has a mean particle size of 1 .mu.m to 20 .mu.m. 21. A method of treating rhinitis in a human in need thereof comprising administering by the nasal route to the human the pharmaceutical composition of claim 19.