Claims for Patent: 9,937,189

Summary for Patent: 9,937,189

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):	Ulhas R. DHUPPAD, Ashok Katkurwar, Yashwant Gupta, Rajesh Ankam, Chandrakant Dhatrak
Assignee:	Glenmark Specialty SA
Application Number:	US15/210,692
Patent Claims:	1. A fixed dose aqueous pharmaceutical composition for nasal administration to a human, the composition being a suspension which comprises (a) mometasone furoate in particulate form; and (b) olopatadine hydrochloride in dissolved form, wherein the pharmaceutical composition, upon nasal administration of a dose equivalent to 200 mcg of mometasone furoate to a human, results in (a) an area under the curve (AUC)0-∞ for mometasone furoate of 50 pg•hr/mL to 140 pg•hr/mL, (b) a Cmax for mometasone furoate of 6.5 pg/mL to 16 pg/ml, or (c) any combination of any of the foregoing. 2. The pharmaceutical composition of claim 1, wherein the composition, upon nasal administration of a dose equivalent to 200 mcg of mometasone furoate to a human, results in a Tmax for mometasone furoate of 15 minutes to 120 minutes. 3. The pharmaceutical composition of claim 1, wherein the AUC0-∞ for mometasone furoate is from 68 pg•hr/mL to 124 pg•hr/mL. 4. The pharmaceutical composition of claim 1, wherein the composition comprises 0.025% w/w to 0.05% w/w of mometasone furoate and 0.6% w/w to 0.7% w/w olopatadine hydrochloride. 5. The pharmaceutical composition of claim 1, wherein the Cmax for mometasone furoate is from 8.6 pg/mL to 12.9 pg/ml. 6. The pharmaceutical composition of claim 1, wherein the composition has a viscosity in the range of 20 cps to 150 cps. 7. The pharmaceutical composition of claim 1, further comprising a hydrocolloid. 8. The pharmaceutical composition of claim 1, wherein the composition comprises 0.025% w/w of mometasone furoate and 0.665% w/w olopatadine hydrochloride. 9. The pharmaceutical composition of claim 8, further comprising a hydrocolloid. 10. The pharmaceutical composition of claim 7, wherein the hydrocolloid comprises carboxymethyl cellulose sodium. 11. The pharmaceutical composition of claim 9, wherein the hydrocolloid comprises carboxymethyl cellulose sodium. 12. The pharmaceutical composition of claim 1, wherein the composition when shaken and then stored for at least 24 hours at ambient conditions does not show phase separation on visual inspection. 13. The pharmaceutical composition of claim 1, wherein the pH of the composition is from 3.5 to 3.9. 14. The pharmaceutical composition of claim 1, further comprising dibasic sodium phosphate. 15. A fixed dose aqueous pharmaceutical composition for nasal administration to a human, the composition being a suspension which comprises (a) mometasone furoate in particulate form; and (b) olopatadine hydrochloride in dissolved form, wherein the pharmaceutical composition, upon nasal administration to a human, results in an area under the curve (AUC)0-∞ for mometasone furoate of 50 pg•hr/mL to 140 pg•hr/mL. 16. The pharmaceutical composition of claim 15, wherein the composition, upon nasal administration to a human, results in a Tmax for mometasone furoate of 15 minutes to 120 minutes. 17. The pharmaceutical composition of claim 15, wherein the AUC0-∞ for mometasone furoate is from 68 pg•hr/mL to 124 pg•hr/mL. 18. The pharmaceutical composition of claim 15, wherein the composition comprises 0.025% w/w mometasone furoate and 0.6% w/w to 0.7% w/w olopatadine hydrochloride. 19. The pharmaceutical composition of claim 15, wherein the composition comprises 0.025% w/w of mometasone furoate and 0.665% w/w olopatadine hydrochloride. 20. The pharmaceutical composition of claim 15, wherein the composition has a viscosity in the range of 20 cps to 150 cps. 21. The pharmaceutical composition of claim 15, further comprising a hydrocolloid. 22. The pharmaceutical composition of claim 21, wherein the hydrocolloid comprises carboxymethyl cellulose sodium. 23. The pharmaceutical composition of claim 15, wherein the composition when shaken and then stored for at least 24 hours at ambient conditions does not show phase separation on visual inspection. 24. The pharmaceutical composition of claim 15, wherein the pH of the composition is from 3.5 to 3.9. 25. The pharmaceutical composition of claim 15, further comprising dibasic sodium phosphate. 26. A fixed dose aqueous pharmaceutical composition for nasal administration to a human, the composition being a suspension which comprises (a) mometasone furoate in particulate form; and (b) olopatadine hydrochloride in dissolved form, wherein the pharmaceutical composition, upon nasal administration to a human, results in a Cmax for mometasone furoate of 6.5 pg/mL to 16 pg/ml. 27. The pharmaceutical composition of claim 26, wherein the composition, upon nasal administration to a human, results in a Tmax for mometasone furoate of 15 minutes to 120 minutes. 28. The pharmaceutical composition of claim 26, wherein the composition comprises 0.025% w/w of mometasone furoate and 0.6% w/w to 0.7% w/w olopatadine hydrochloride. 29. The pharmaceutical composition of claim 26, wherein the composition comprises 0.025% w/w of mometasone furoate and 0.665% w/w olopatadine hydrochloride. 30. The pharmaceutical composition of claim 26, wherein the Cmax for mometasone furoate is from 8.6 pg/mL to 12.9 pg/ml. 31. The pharmaceutical composition of claim 26, wherein the composition has a viscosity in the range of 20 cps to 150 cps. 32. The pharmaceutical composition of claim 26, further comprising a hydrocolloid. 33. The pharmaceutical composition of claim 32, wherein the hydrocolloid comprises carboxymethyl cellulose sodium. 34. The pharmaceutical composition of claim 26, wherein the composition when shaken and then stored for at least 24 hours at ambient conditions does not show phase separation on visual inspection. 35. The pharmaceutical composition of claim 26, wherein the pH of the composition is from 3.5 to 3.9. 36. The pharmaceutical composition of claim 26, further comprising dibasic sodium phosphate.