Mast cell stabilizers treatment for systemic disorders
Methods for the treatment of systemic disorders treatable with mast cell stabilizers, including mast cell related disorders, are provided. Some embodiments relate to dosage forms. Dosage forms can include an aqueous pharmaceutical composition containing (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 an inhalation device that forms an aerosol of said pharmaceutical composition, said aerosol exhibiting a respirable fraction of said pharmaceutical composition (<5 μm) as measured by USP <1601> of at least about 60%, are provided.
1. 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 μm) as measured by USP <1601> of at least about 60%.
2. The dosage form of claim 1 , wherein the salts of EDTA comprise sodium EDTA.
3. The dosage form of claim 1 or 2 , wherein the pharmaceutical composition comprises from about 5 mg to about 80 mg of cromolyn sodium.
4. The dosage form of claim 1 or 2 , wherein the pharmaceutical composition comprises from about 36 mg to about 44 mg of cromolyn sodium.
5. The dosage form of claim 1 or 2 , wherein the aerosol has a respirable fraction (≦3.3 μm) as measured by USP <1601> of at least about 30%.
6. The dosage form of claim 1 or 2 , wherein the aerosol has a respirable fraction (≦3.3 μm) as measured by USP <1601> of at least about 30% and a respirable fraction (≦5 μm) as measured by USP <1601> of at least about 75%.
7. The dosage form of claim 1 or 2 , wherein the sodium chloride is at a concentration of between 0.1% to 0.2% by weight, inclusive of the endpoints.