Compositions comprising azelastine and methods of use thereof
DCFirst Claim
1. A liquid pharmaceutical composition for treating allergic rhinitis or non-allergic vasomotor rhinitis, said liquid pharmaceutical composition comprising:
- about 0.100% (w/v) azelastine hydrochloride;
about 0.100% (w/v) of hypromellose;
about 0.05% (w/v) disodium edetate;
about 0.025% (w/v) benzalkonium chloride 50% solution, NF;
about 0.150% (w/v) sucralose;
about 6.4% (w/v) sorbitol 70%;
about 0.068% (w/v) sodium citrate dihydrate; and
QS water,wherein said liquid pharmaceutical composition is formulated in the form of a nasal spray or nasal drops.
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Litigations
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Accused Products
Abstract
The present invention provides pharmaceutical compositions comprising azelastine, or a pharmaceutically acceptable salt or ester thereof including azelastine hydrochloride, and optionally one or more additional active agents. Preferred such compositions further comprise one or more pharmaceutically acceptable carriers or excipients that reduce the amount of post-nasal drip, and/or that minimize or mask the unpleasant bitter taste associated with post-nasal drip, of the compositions into the oral cavity, upon intranasal or ocular administration of the compositions. Especially effective excipients used in the compositions of the present invention are hypromellose as a viscosity modifier and sucralose as a taste-masking agent. The invention also provides methods of treating or preventing certain disorders, or symptomatic relief therefrom, by administering the compositions of the invention to a patient, e.g., for the symptomatic relief of allergic rhinitis, non-allergic vasomotor rhinitis, allergic conjunctivitis, as well as other disorders. The compositions and methods of the present invention provide significant value in terms of patient acceptability, convenience, and compliance.
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Citations
28 Claims
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1. A liquid pharmaceutical composition for treating allergic rhinitis or non-allergic vasomotor rhinitis, said liquid pharmaceutical composition comprising:
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about 0.100% (w/v) azelastine hydrochloride; about 0.100% (w/v) of hypromellose; about 0.05% (w/v) disodium edetate; about 0.025% (w/v) benzalkonium chloride 50% solution, NF; about 0.150% (w/v) sucralose; about 6.4% (w/v) sorbitol 70%; about 0.068% (w/v) sodium citrate dihydrate; and QS water, wherein said liquid pharmaceutical composition is formulated in the form of a nasal spray or nasal drops. - View Dependent Claims (4, 5, 6, 13, 16, 17)
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2. A liquid pharmaceutical composition for treating allergic rhinitis or non-allergic vasomotor rhinitis, said liquid pharmaceutical composition comprising:
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about 0.1% to about 0.15% (w/v) azelastine hydrochloride; about 0.1% to about 0.15% (w/v) sucratose; and about 0.1% to about 10% (w/v) sorbitol 70%, wherein said liquid pharmaceutical composition is formulated in the form of a nasal spray or nasal, drops. - View Dependent Claims (7, 8, 9, 14, 18, 19, 22, 23, 24, 26, 28)
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3. A liquid pharmaceutical composition for treating allergic rhinitis or non-allergic vasomotor rhinitis, said liquid pharmaceutical composition comprising:
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about 0.150% (w/v) azelastine hydrochloride; about 0.100% (w/v) of hypromellose; about 0.05% (w/v) disodium edetate; about 0.001% to about 0.5% (w/v) benzalkonium chloride 50% solution, NF; about 0.150% (w/v) sucralose; about 0.1% to about 10% (w/v) sorbitol 70%; about 0.068% (w/v) sodium citrate dihydrate; and QS water, wherein said liquid pharmaceutical composition is formulated in the form of a nasal spray or nasal drops. - View Dependent Claims (10, 11, 12, 15, 20, 21, 25, 27)
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Specification