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US 2018/0000844 A1Published application
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.
Claims15
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 or its salt in particulate form;
- (b) olopatadine or its salt in dissolved form,
- wherein the spray provides a droplet size distribution having a D10 of about 5-25 μm, a D50 of about 20-50 μm, a D90 of about 40-120 μm, a SPAN of not more than 4, and a % Volume of <10 μm of not more than 10%.
Dependencies are inferred from the claim text.