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.
Claims27
An aqueous pharmaceutical composition for nasal administration to a human in the form of a single phase suspension comprising mometasone furoate and olopatadine hydrochloride, wherein the suspension remains in a single phase after 3 months of storage at 25±2° C. and 60%±5% relative humidity.
An aqueous pharmaceutical composition for nasal administration to a human in the form of a single phase suspension comprising 25 μg mometasone furoate and 665 μg olopatadine hydrochloride, wherein the suspension remains in a single phase after 3 months of storage at 25±2° C. and 60%±5% relative humidity.
An aqueous pharmaceutical composition for nasal administration to a human in the form of a single phase suspension comprising mometasone furoate and olopatadine hydrochloride, wherein the composition is substantially free of crystals of olopatadine hydrochloride after 3 months of storage at 25±2° C. and 60%±5% relative humidity.
Dependencies are inferred from the claim text.