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.
Claims51
A method of treating allergic rhinitis comprising intranasal administration of a fixed dose aqueous pharmaceutical composition comprising (a) 0.001% w/w to 0.075% w/w mometasone or its salt in particulate form;
- (b) 0.5% w/w to 0.8% w/w olopatadine or its salt in dissolved form;
- and (c) a hydrocolloid, wherein the composition is stable for at least 24 hours when stored at about 25° C. and about 60% relative humidity.
A method of treating seasonal allergic rhinitis comprising intranasal administration of a fixed dose aqueous pharmaceutical composition comprising (a) 0.001% w/w to 0.075% w/w mometasone or its salt in particulate form;
- (b) 0.5% w/w to 0.8% w/w olopatadine or its salt in dissolved form;
- and (c) a hydrocolloid, wherein the composition is stable for at least 24 hours when stored at about 25° C. and about 60% relative humidity.
A method of treating perennial allergic rhinitis comprising intranasal administration of a fixed dose aqueous pharmaceutical composition comprising (a) 0.001% w/w to 0.075% w/w mometasone or its salt in particulate form;
- (b) 0.5% w/w to 0.8% w/w olopatadine or its salt in dissolved form;
- and (c) a hydrocolloid, wherein the composition is stable for at least 24 hours when stored at about 25° C. and 60% relative humidity.
A method of treating allergic rhinitis comprising intranasal administration of a stable fixed dose aqueous pharmaceutical composition comprising 0.025% or 0.05% 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;
- and 0.01% w/w polysorbate 80, wherein the composition has a pH of 3.3 to 4.1.
A stable fixed dose aqueous pharmaceutical composition for nasal administration to a human, the composition comprises (a) 0.001% w/w to 0.075% w/w mometasone or its salt;
- (b) 0.5% w/w to 0.8% w/w olopatadine or its salt;
- (c) one or more cellulose derivatives, and (d) one or more additional excipients.
An aqueous pharmaceutical composition for nasal administration to a human, the composition comprises (a) 0.001% w/w to 0.075% w/w mometasone or its salt;
- (b) 0.5% w/w to 0.8% w/w olopatadine hydrochloride, wherein the composition is substantially free of crystals of olopatadine hydrochloride.
A stable fixed dose aqueous pharmaceutical composition for nasal administration to a human, the composition comprises (a) 0.001% w/w to 0.075% w/w mometasone or its salt;
- (b) 0.5% w/w to 0.8% w/w olopatadine or its salt;
- (c) 0.1% w/w to 3% w/w of sodium carboxymethyl cellulose, and (d) one or more additional excipients, wherein the composition has a pH of 3.3 to 4.1.
Dependencies are inferred from the claim text.