Mast cell stabilizers treatment for systemic disorders
First Claim
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1. A method of treating an inflammatory disorder in a patient, comprising administering to said patient a therapeutically effective amount of cromolyn sodium utilizing a dosage form comprising:
- (a) an aqueous pharmaceutical composition comprising (i) from about 2% to about 6% by weight of cromolyn sodium, and (ii) an osmolarity adjusting agent consisting of (A) between about 0.1% to about 0.5% by weight of sodium chloride, inclusive of the endpoints, and (B) optionally salts of EDTA; and
(b) an inhalation device that forms an aerosol of said pharmaceutical composition, said aerosol exhibiting a respirable fraction of said pharmaceutical composition (≤
5 μ
m) as measured by USP <
1601>
of at least about 60%.
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Abstract
Methods for the treatment of systemic disorders treatable with mast cell stabilizers, including mast cell related disorders, are provided.
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Citations
22 Claims
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1. A method of treating an inflammatory disorder in a patient, comprising administering to said patient a therapeutically effective amount of cromolyn sodium utilizing a dosage form comprising:
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(a) an aqueous pharmaceutical composition comprising (i) from about 2% to about 6% by weight of cromolyn sodium, and (ii) an osmolarity adjusting agent consisting of (A) between about 0.1% to about 0.5% by weight of sodium chloride, inclusive of the endpoints, and (B) optionally salts of EDTA; and (b) an inhalation device that forms an aerosol of said pharmaceutical composition, said aerosol exhibiting a respirable fraction of said pharmaceutical composition (≤
5 μ
m) as measured by USP <
1601>
of at least about 60%. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method of treating fibrosis in a patient, comprising administering to said patient a therapeutically effective amount of cromolyn sodium utilizing a dosage form comprising:
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(a) an aqueous pharmaceutical composition comprising (i) from about 2% to about 6% by weight of cromolyn sodium, and (ii) an osmolarity adjusting agent consisting of (A) between about 0.1% to about 0.5% by weight of sodium chloride, inclusive of the endpoints, and (B) optionally salts of EDTA; and (b) an inhalation device that forms an aerosol of said pharmaceutical composition, said aerosol exhibiting a respirable fraction of said pharmaceutical composition (≤
5 μ
m) as measured by USP <
1601>
of at least about 60%. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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Specification