Compositions comprising azelastine and methods of use thereof
First Claim
1. A composition of matter comprising:
- (a) a single unit dosage of a pharmaceutical composition; and
(b) a unit dosage container comprising;
(i) a squeezable chamber holding said single unit dosage and having an opening; and
(ii) a closure mechanism removably attached to said opening of said squeezable chamber,wherein said unit dosage container is made of high density polyethylene (HDPE),wherein said single unit dosage of said pharmaceutical composition has a volume of less than about 0.6 ml,wherein said squeezable chamber has a volume of less than or equal to about 1.0 ml,wherein when said closure mechanism is removed, said unit dosage is retained in said squeezable chamber when said unit dosage container is inverted, andwherein when said squeezable chamber is squeezed, said squeezable chamber is deformed, the pressure within said container is increased, and said single unit dosage exits said opening in droplet form.
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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 generally relates to pharmaceutical compositions comprising one or more active pharmaceutical ingredients, such as azelastine or pharmaceutically acceptable salts or esters thereof including azelastine hydrochloride, particularly wherein the compositions are provided in unit dosage form. In certain embodiments, the invention provides such unit dosage pharmaceutical compositions comprising azelastine hydrochloride formulated for use as nasal sprays and/or ocular solutions or drops. 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 a variety of allergic and non-allergic conditions, particularly conjunctivitis, sinusitis, rhinitis and rhinosinusitis. The compositions and methods of the present invention provide significant value in terms of patient acceptability, convenience, and compliance.
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Citations
141 Claims
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1. A composition of matter comprising:
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(a) a single unit dosage of a pharmaceutical composition; and (b) a unit dosage container comprising; (i) a squeezable chamber holding said single unit dosage and having an opening; and (ii) a closure mechanism removably attached to said opening of said squeezable chamber, wherein said unit dosage container is made of high density polyethylene (HDPE), wherein said single unit dosage of said pharmaceutical composition has a volume of less than about 0.6 ml, wherein said squeezable chamber has a volume of less than or equal to about 1.0 ml, wherein when said closure mechanism is removed, said unit dosage is retained in said squeezable chamber when said unit dosage container is inverted, and wherein when said squeezable chamber is squeezed, said squeezable chamber is deformed, the pressure within said container is increased, and said single unit dosage exits said opening in droplet form. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 130, 136)
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37. A composition of matter comprising:
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(a) a plurality of unit dosage containers, each of said unit dosage containers comprising a single unit dosage of a pharmaceutical composition, wherein each unit dosage container comprises; (b) a squeezable chamber holding said single unit dosage and having an opening wherein the pressure within said container is increased and said single unit dosage exits said opening in droplet form when said squeezable chamber is squeezed, wherein said squeezeable chamber is deformed when squeezed, and wherein said, unit dosage is retained in said squeezable chamber when said unit dosage container is inverted; and (c) a closure mechanism removably attached to said opening of said squeezable chamber, wherein said unit dose container is made of high density polyethylene (HDPE), and wherein said single unit dosage of said pharmaceutical composition has a volume of less than about 0.6 ml and wherein said squeezable chamber has a volume of less than or equal to about 1.0 ml. - View Dependent Claims (38, 39, 40, 41, 42, 131, 137)
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43. A unit dosage form comprising a unit dosage container made of high density polyethylene, said unit dosage container comprising a squeezable chamber holding a single unit dosage and having an opening,
wherein the pressure within said container is increased and said unit dosage exits said opening in droplet form when said squeezable chamber is squeezed, wherein said unit dosage is retained in said squeezable chamber when said unit dosage container is inverted, said unit dosage container having a volume of less than about 0.6 ml, said squeezable chamber having a volume of less than about 1.0 ml, and said unit dosage form containing one or more antihistamines or pharmaceutically acceptable salts thereof.
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70. A unit dosage form comprising a unit dosage container made of high density polyethylene, said unit dosage container comprising a squeezable chamber holding a single unit dosage and having an opening,
wherein the pressure within said container is increased and said unit dosage exits said opening in droplet form when said squeezable chamber is squeezed, wherein said unit dosage is retained in said squeezable chamber when said unit dosage container is inverted, said unit dosage container having a volume of less than about 0.6 ml, said squeezable chamber having a volume of less than about 1.0 ml containing about 0.1% to about 0.15% azelastine HCl, about 0.05% to about 0.15% sucralose and about 1% to about 10% sorbitol.
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71. A unit dosage form comprising a unit dosage container made of high density polyethylene, said unit dosage container comprising a squeezable chamber holding a single unit dosage and having an opening,
wherein the pressure within said container is increased and said unit dosage exits said opening in droplet form when said squeezable chamber is squeezed, wherein said unit dosage is retained in said squeezable chamber when said unit dosage container is inverted, said unit dosage container having a volume of less than about 0.6 ml, and said squeezable chamber having a volume of less than about 1.0 ml containing about 0.15% azelastine HCl, about 0.15% sucralose and about 5% to about 10% sorbitol.
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72. A method for treating a physical disorder or a symptom thereof, said method comprising:
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(a) providing a unit dosage form of a pharmaceutical formulation comprising a unit dosage container made of high density polyethylene containing a pharmaceutical composition in a volume of less than about 0.6 ml, wherein said unit dosage container comprises a squeezable chamber holding said pharmaceutical composition and having an opening, wherein the pressure within said container is increased and said pharmaceutical composition exits said opening in droplet form when said squeezable chamber is squeezed, wherein said unit dosage is retained in said squeezable chamber when said unit dosage container is inverted, said squeezable chamber having a volume of less than about 1.0 ml, and said pharmaceutical composition comprising one or more antihistamines or pharmaceutically acceptable salts thereof; and (b) administering the pharmaceutical composition in said unit dosage form to a subject in need thereof. - View Dependent Claims (73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102)
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103. A method of treating or preventing a physical disorder or condition in a patient comprising administering a unit dosage form comprising azelastine or a pharmaceutically acceptable salt thereof to a subject in need thereof, wherein said physical disorder or condition is selected from the group consisting of postoperative ocular inflammation, acute anterior uveitis, dermatitis/keratitis, allergic blepharitis and keratitis, said method comprising:
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(a) providing a unit dosage form of a pharmaceutical formulation comprising a unit dosage container made of high density polyethylene containing a pharmaceutical composition in a volume of less than about 0.6 ml, wherein said unit dosage container comprises a squeezable chamber holding said pharmaceutical composition and having an opening, wherein the pressure within said container is increased and said pharmaceutical composition exits said opening in droplet form when said squeezable chamber is squeezed, wherein said unit dosage is retained in said squeezable chamber when said unit dosage container is inverted, said squeezable chamber having a volume of less than about 1.0 ml, and said pharmaceutical composition comprising one or more antihistamines or pharmaceutically acceptable salts thereof; and (b) administering the pharmaceutical composition in said unit dosage form to a subject in need thereof.
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104. A high density polyethylene (HDPE) unit dosage container containing a formulation for nasal or ocular administration,
wherein said unit dosage container comprises a squeezable chamber holding said formulation and having an opening, wherein the pressure within said container is increased and said formulation exits said opening in droplet form when said squeezable chamber is squeezed, and wherein said unit dosage is retained in said squeezable chamber when said unit dosage container is inverted, wherein said formulation consists essentially of a therapeutically effective amount of one or more antihistamines, one or more pharmaceutically acceptable carriers or diluents, sucralose and/or sorbitol, wherein said unit dosage container has a volume of less than about 1.0 ml.
Specification