Claims for Patent: 10,561,672

Summary for Patent: 10,561,672

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 R. (Maharashtra, IN), Katkurwar; Ashok (Maharashtra, IN), Gupta; Yashwant (Maharashtra, IN), Ankam; Rajesh (Maharashtra, IN), Dhatrak; Chandrakant (Maharashtra, IN)
Assignee:	GLENMARK SPECIALTY S.A. (La Chaux-de-Fonds, CH)
Application Number:	15/703,780
Patent Claims:	1. An aqueous pharmaceutical composition for nasal administration to a human in the form of a suspension comprising (a) mometasone furoate in the form of particles having a mean particle size of from 1 .mu.m to 20 .mu.m, (b) olopatadine hydrochloride, and (c) a hydrocolloid 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, wherein the mometasone furoate and olopatadine hydrochloride are the sole active ingredients in the composition. 2. The aqueous pharmaceutical composition of claim 1, wherein the mean particle size of the mometasone furoate is from 1 .mu.m to 15 .mu.m. 3. The aqueous pharmaceutical composition of claim 1, wherein the composition has a pH of between 3.3 and 4.1. 4. The aqueous pharmaceutical composition of claim 1, wherein the composition has an osmolality of 250 mOsm/kg to 350 mOsm/kg. 5. The aqueous pharmaceutical composition of claim 1, wherein the composition has a viscosity of 20 to 150 cps. 6. An aqueous pharmaceutical composition for nasal administration to a human in the form of a suspension comprising (a) 0.025% to 0.05% by weight of mometasone furoate in the form of particles having a mean particle size of from 1 .mu.m to 20 .mu.m, (b) 0.6% to 0.7% by weight of olopatadine hydrochloride, and (c) a hydrocolloid 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, wherein the mometasone furoate and olopatadine hydrochloride are the sole active ingredients in the composition. 7. The aqueous pharmaceutical composition of claim 6, wherein the mean particle size of the mometasone furoate is from 1 .mu.m to 15 .mu.m. 8. The aqueous pharmaceutical composition of claim 6, wherein the mometasone furoate is mometasone furoate monohydrate. 9. The aqueous pharmaceutical composition of claim 6, wherein the hydrocolloid comprises carboxymethylcellulose sodium. 10. The aqueous pharmaceutical composition of claim 6, wherein the pharmaceutical composition has a viscosity of 20 cps to 150 cps. 11. The aqueous pharmaceutical composition of claim 6, wherein the composition has a pH of 3.3 to 4.1. 12. The aqueous pharmaceutical composition of claim 6, wherein the composition has a pH of 3.5 to 3.9. 13. The aqueous pharmaceutical composition of claim 6, wherein the composition has an osmolality in the range of 250 mOsm/kg to 350 mOsm/kg. 14. An aqueous pharmaceutical composition for nasal administration to a human in the form of a suspension, wherein the composition comprises: 0.025% w/w mometasone furoate monohydrate in the form of particles having a mean particle size of from 1 .mu.m to 20 .mu.m; 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 3.3 to 4.1, and wherein the mometasone furoate and olopatadine hydrochloride are the sole active ingredients in the composition. 15. The aqueous pharmaceutical composition of claim 6, wherein the composition is substantially free of crystals of olopatadine hydrochloride after 3 months of storage at 25.+-.2.degree. C. and 60%.+-.5% relative humidity. 16. The aqueous pharmaceutical composition of claim 6, wherein the composition is substantially free of crystals of olopatadine hydrochloride after 6 months of storage at 25.+-.2.degree. C. and 60%.+-.5% relative humidity. 17. The aqueous pharmaceutical composition of claim 1, wherein the composition has a pH of 3.5 to 3.9. 18. The aqueous pharmaceutical composition of claim 1, wherein the pharmaceutical composition has a viscosity of 20 cps to 60 cps. 19. The aqueous pharmaceutical composition of claim 14, wherein the composition has a pH of 3.5 to 3.9. 20. The aqueous pharmaceutical composition of claim 14, wherein the pharmaceutical composition has a viscosity of 20 cps to 60 cps. 21. The aqueous pharmaceutical composition of claim 6, wherein the composition comprises 0.025% by weight of mometasone furoate. 22. An aqueous fixed dose pharmaceutical composition for nasal administration to a human in the form of a suspension comprising (a) 0.025% w/w mometasone furoate in the form of particles having a mean particle size of from 1 .mu.m to 20 .mu.m, (b) 0.665% w/w olopatadine hydrochloride, and (c) a hydrocolloid 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, wherein the mometasone furoate and olopatadine hydrochloride are the sole active ingredients in the composition.