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US 10,765,686 B2Granted
Stable fixed dose pharmaceutical composition comprising mometasone and olopatadine
AssigneeGlenmark Specialty S.A.
InventorsUlhas R. Dhuppad, Ashok Katkurwar, Yashwant Gupta, Rajesh Ankam, Chandrakant Dhatrak
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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.
Claims14
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° 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 μm, a D50 of 20-50 μm, a D90 of 40-120 μm, and a SPAN of not more than 4.
1 more element
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° 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 μm, a D50 of 20-50 μm, a D90 of 40-120 μm, 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.
4 more elements
Dependencies are inferred from the claim text.