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.
1. A method of administering a therapeutically effective amount of cromolyn sodium to a patient in need thereof, comprising administering to said patient an aqueous pharmaceutical composition consisting of (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% and about 0.5% by weight of sodium chloride, inclusive of the endpoints, and (B) optionally salts of EDTA, wherein said pharmaceutical composition is administered to said patient by inhalation into the lungs in the form of an aerosol exhibiting a respirable fraction (≤5 μm) as measured by USP <1601> of at least about 60%.
2. The method of claim 1 , wherein the salts of EDTA comprise sodium EDTA.
3. The method of claim 1 , wherein the pharmaceutical composition comprises from about 5 mg to about 80 mg of cromolyn sodium.
4. The method of claim 1 , wherein the pharmaceutical composition comprises from about 36 mg to about 44 mg of cromolyn sodium.
5. The method of claim 1 , wherein the aerosol has a respirable fraction (≤3.3 μm) as measured by USP <1601> of at least about 30%.
6. The method of claim 1 , 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 method of claim 1 , wherein the sodium chloride is at a concentration of between 0.1% to 0.2% by weight, inclusive of the endpoints.
8. The method of claim 1 , wherein the pharmaceutical composition comprises about 4% by weight of cromolyn sodium.
9. The method of claim 1 , wherein the pharmaceutical composition comprises about 6% by weight of cromolyn sodium.
10. A method of administering a therapeutically effective amount of cromolyn sodium to a patient in need thereof, comprising administering to said patient an aqueous pharmaceutical composition comprising (i) from about 2% to about 6% by weight of cromolyn sodium, inclusive of endpoints, and (ii) an osmolarity adjusting agent consisting of (A) between about 0.1% and about 0.5% by weight of sodium chloride, inclusive of the endpoints, and (B) salts of EDTA, wherein said pharmaceutical composition is administered to said patient by inhalation into the lungs in the form of an aerosol exhibiting a respirable fraction (≤5 μm) as measured by USP <1601> of at least about 60%.
11. The method of claim 10 , wherein the pharmaceutical composition comprises about 4% by weight of cromolyn sodium.
12. The method of claim 10 , wherein the pharmaceutical composition comprises about 6% by weight of cromolyn sodium.
13. The method of claim 10 , wherein the pharmaceutical composition comprises from about 5 mg to about 80 mg of cromolyn sodium.
14. The method of claim 10 , wherein the pharmaceutical composition comprises from about 36 mg to about 44 mg of cromolyn sodium.
15. The method of claim 10 , wherein the osmolarity adjusting agent consists of (A) between about 0.1% and about 0.2% by weight of sodium chloride, inclusive of the endpoints, and (B) sodium EDTA.
16. The method of claim 15 , wherein the pharmaceutical composition comprises about 4% by weight of cromolyn sodium.
17. The method of claim 15 , wherein the pharmaceutical composition comprises about 6% by weight of cromolyn sodium.
18. The method of claim 15 , wherein the pharmaceutical composition comprises from about 5 mg to about 80 mg of cromolyn sodium.
19. The method of claim 15 , wherein the pharmaceutical composition comprises from about 36 mg to about 44 mg of cromolyn sodium.
20. The method of claim 10 , wherein the salts of EDTA comprise sodium EDTA.