Claims for Patent: 10,765,686

Summary for Patent: 10,765,686

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:	15/703,828
Patent Claims:	1. A method of delivering a nasal spray comprising: nasally delivering an aqueous pharmaceutical composition in the form of a single phase suspension, said composition comprising (a) mometasone furoate in particulate form; (b) olopatadine hydrochloride in dissolved form, 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, and the spray provides a droplet size distribution having a D10 of 5-25 .mu.m, a D50 of 20-50 .mu.m, a D90 of 40-120 .mu.m, and a SPAN of not more than 4. 2. A method of claim 1, wherein the spray provides a droplet size distribution having a D10 of 10-22 .mu.m, D50 of 35-45 .mu.m, and D90 of 75-115 .mu.m, and SPAN is not more than 3. 3. A method of claim 1, wherein the composition comprises 25 .mu.g mometasone furoate. 4. A method of claim 1, wherein the composition comprises 665 .mu.g olopatadine hydrochloride. 5. A method of claim 1, wherein the composition has a pH between 3.3 to 4.1. 6. A method of delivering a nasal spray comprising: nasally delivering an aqueous pharmaceutical composition in the form of a single phase suspension, said composition comprising (a) mometasone furoate in particulate form; (b) olopatadine hydrochloride in dissolved form; 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, and the spray provides a droplet size distribution having a D10 of 5-25 .mu.m, a D50 of 20-50 .mu.m, a D90 of 40-120 .mu.m, and a SPAN of not more than 4, the composition has a viscosity of 10 to 200 cps, and the pH of the composition is 3.5 to 3.9. 7. A method of claim 1, wherein the pH of the composition is 3.5 to 3.7. 8. A method of claim 1, wherein the mean particle size of the mometasone furoate is from 1 .mu.m to 20 .mu.m. 9. A method of claim 1, wherein the composition has an osmolality of 250 mOsm/kg to 350 mOsm/kg. 10. A method of claim 1, wherein the composition has a viscosity of 10 to 200 cps. 11. A method of claim 1, wherein the composition remains in a single phase after at least 3 months of storage at 25.+-.2.degree. C. and 60%.+-.5% relative humidity. 12. A method of claim 6, wherein the composition results in a spray pattern having a longest axis of 15-75 mm, a shortest axis of 10-65 mm, and an ellipticity of 1-2. 13. A method of claim 1, wherein the hydrocolloid comprises carboxymethylcellulose sodium. 14. A method of claim 1, wherein the composition comprises: 0.025% 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 dibasic sodium phosphate heptahydrate; and 0.01% w/w polysorbate 80, wherein the pH is from 3.5 to 3.9.