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 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 μm) as measured by USP <1601>of at least about 60%.
2. The method of claim 1 , wherein said salts of EDTA comprise sodium EDTA.
3. The method of claim 1 , wherein said pharmaceutical composition comprises from about 5 mg to about 80 mg of cromolyn sodium.
4. The method of claim 1 , wherein said pharmaceutical composition comprises from about 36 mg to about 44 mg of cromolyn sodium.
5. The method of claim 1 , wherein said 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 said 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 said 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 said osmolarity adjusting agent consists of between 0.1% to 0.2% by weight of sodium chloride, inclusive of the endpoints, and sodium EDTA.
9. The method of claim 1 , wherein said pharmaceutical composition comprises from about 4% to about 6% by weight of cromolyn sodium.
10. The method of claim 9 , wherein said osmolarity adjusting agent consists of between 0.1% to 0.2% by weight of sodium chloride, inclusive of the endpoints, and sodium EDTA.
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:
(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%.
12. The method of claim 11 , wherein said salts of EDTA comprise sodium EDTA.
13. The method of claim 11 , wherein said pharmaceutical composition comprises from about 5 mg to about 80 mg of cromolyn sodium.
14. The method of claim 11 , wherein said pharmaceutical composition comprises from about 36 mg to about 44 mg of cromolyn sodium.
15. The method of claim 11 , wherein said aerosol has a respirable fraction (≤3.3 μm) as measured by USP <1601>of at least about 30%.
16. The method of claim 11 , wherein said aerosol has a respirable fraction (≤3.3 μtm) as measured by USP <1601>of at least about 30% and a respirable fraction (≤5 μtm) as measured by USP <1601>of at least about 75%.
17. The method of claim 11 , wherein said sodium chloride is at a concentration of between 0.1% to 0.2% by weight, inclusive of the endpoints.
18. The method of claim 11 , wherein said osmolarity adjusting agent consists of between 0.1% to 0.2% by weight of sodium chloride, inclusive of the endpoints, and sodium EDTA.
19. The method of claim 11 , wherein said pharmaceutical composition comprises from about 4% to about 6% by weight of cromolyn sodium.
20. The method of claim 19 , wherein said osmolarity adjusting agent consists of between 0.1% to 0.2% by weight of sodium chloride, inclusive of the endpoints, and sodium EDTA.
21. The method of claim 11 , wherein the fibrosis is Kidney fibrosis.
22. The method of claim 11 , wherein the fibrosis is Hepatic fibrosis.