Claims for Patent: 9,370,483

Summary for Patent: 9,370,483

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:	14/662,128
Patent Claims:	1. A stable fixed dose aqueous pharmaceutical composition for nasal administration to a human, the composition being a suspension which comprises (a) mometasone or its salt in particulate form; (b) olopatadine or its salt in dissolved form; wherein the pharmaceutical composition, upon nasal administration of a dose equivalent to 2400 mcg of olopatadine or its salt to a human, results in (a) an area under the curve (AUC).sub.0-.infin. for olopatadine or its salt of about 42.5 nghr/mL to about 116.5 nghr/mL, (b) a C.sub.max for olopatadine or its salt of about 10.3 ng/mL to about 24.1 ng/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 2400 mcg of olopatadine or its salt to a human, results in a T.sub.max for olopatadine or its salt of about 15 mins to about 120 mins. 3. The pharmaceutical composition of claim 1, wherein the AUC.sub.0-.infin. for olopatadine or its salt is from about 56.7 nghr/mL to about 99.8 nghr/mL. 4. The pharmaceutical composition of claim 1, wherein the mometasone salt is mometasone furoate and the olopatadine salt is olopatadine hydrochloride. 5. The pharmaceutical composition of claim 1, wherein the composition comprises about 0.025% w/w to about 0.05% w/w of mometasone or its salt and about 0.6% w/w to about 0.7% w/w olopatadine or its salt. 6. The pharmaceutical composition of claim 1, wherein the C.sub.max of olopatadine is from about 13.8 ng/mL to about 20.7 ng/mL. 7. The pharmaceutical composition of claim 1, further comprising a hydrocolloid. 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 aqueous pharmaceutical composition for nasal administration to a human, the composition being a suspension which comprises (a) mometasone or its salt, (b) olopatadine or its salt, and (c) a fibrillar network comprising a cellulosic material. 10. The pharmaceutical composition of claim 9, wherein the fibrillar network further comprises interfibrillar spaces. 11. The pharmaceutical composition of claim 9, wherein the mometasone or its salt is present in particulate form having an average particle size of less than about 15 .mu.m. 12. The pharmaceutical composition of claim 10, wherein the interfibrillar spaces contain one or more mometasone particles. 13. The pharmaceutical composition of claim 12, wherein the mometasone particles are equidistantly, or substantially equidistantly, spaced within the fibrillar network. 14. The pharmaceutical composition of claim 9, wherein the composition delivers consistent dosing for at least 30 inhalations. 15. The pharmaceutical composition of claim 14, wherein the composition delivers consistent dosing for 60 inhalations. 16. The pharmaceutical composition of claim 14, wherein the composition delivers consistent dosing for 120 inhalations. 17. The pharmaceutical composition of claim 9, further comprising a hydrocolloid. 18. The pharmaceutical composition of claim 17, wherein the hydrocolloid comprises carboxymethylcellulose. 19. The pharmaceutical composition of claim 18, wherein the carboxymethylcellulose is present in the amount of from about 0.1% w/w to about 2% w/w. 20. The pharmaceutical composition of claim 1, wherein the pH of the composition is from about 3.3 to about 4.1. 21. The pharmaceutical composition of claim 20, wherein the pH of the composition is from about 3.5 to about 3.7.