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 cromolyn sodium to a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising cromolyn sodium using an inhalation device that produces an aerosol of the pharmaceutical composition, wherein administration of the pharmaceutical composition to the patient using the inhalation device produces in the patient an AUC (0-∞) of cromolyn between from about 5.3 ng*h/mL to about 8.5 ng*h/mL per milligram of cromolyn sodium administered to the patient.
2. The method of claim 1 , wherein the device is a nebulizer or a dry powder inhaler.
3. The method of claim 2 , wherein the device is a nebulizer.
4. The method of claim 3 , wherein the nebulizer is a high-efficiency nebulizer.
5. The method of claim 3 , wherein the nebulizer is a jet nebulizer.
6. The method of claim 2 , wherein the device is a dry-powder inhaler.
7. The method of claim 1 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤5 μm) as measured by USP <1601> or USP <601> of at least about 60%.
8. The method of claim 1 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤5 μm) as measured by USP <1601> or USP <601> of at least about 75%.
9. The method of claim 1 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤3.3 μm) as measured by USP <1601> or USP <601> of at least about 30%.
10. The method of claim 4 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤3.3 μm) as measured by USP <1601> of at least about 30%.
11. The method of claim 1 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤5 μm) as measured by USP <1601> or USP <601> of at least about 60% and a respirable fraction (≤3.3 μm) as measured by USP <1601> or USP <601> of at least about 30%.
12. The method of claim 1 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤5 μm) as measured by USP <1601> or USP <601> of at least about 75% and a respirable fraction (≤3.3 μm) as measured by USP <1601> or USP <601> of at least about 30%.
13. The method of claim 11 , wherein the device is a nebulizer or a dry powder inhaler.
14. The method of claim 13 , wherein the device is a nebulizer.
15. The method of claim 14 , wherein the nebulizer is a high-efficiency nebulizer.
16. The method of claim 14 , wherein the nebulizer is a jet nebulizer.
17. The method of claim 13 , wherein the device is a dry-powder inhaler.
18. A method of administering cromolyn sodium to a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising cromolyn sodium using an inhalation device that produces an aerosol of the pharmaceutical composition, wherein administration of the pharmaceutical composition to the patient using the inhalation device produces in the patient a Cmax of cromolyn between from about 2.2 ng/mL to about 3.9 ng/mL per milligram of cromolyn sodium administered to the patient.
19. The method of claim 18 , wherein the device is a nebulizer or a dry powder inhaler.
20. The method of claim 19 , wherein the device is a nebulizer.
21. The method of claim 20 , wherein the nebulizer is a high-efficiency nebulizer.
22. The method of claim 20 , wherein the nebulizer is a jet nebulizer.
23. The method of claim 19 , wherein the device is a dry-powder inhaler.
24. The method of claim 18 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤5 μm) as measured by USP <1601> or USP <601> of at least about 60%.
25. The method of claim 18 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (<5 μm) as measured by USP <1601> or USP <601> of at least about 75%.
26. The method of claim 18 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤3.3 μm) as measured by USP <1601> or USP <601> of at least about 30%.
27. The method of claim 21 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤3.3 μm) as measured by USP <1601> of at least about 30%.
28. The method of claim 18 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤5 μm) as measured by USP <1601> or USP <601> of at least about 60% and a respirable fraction (≤3.3 μm) as measured by USP <1601> or USP <601> of at least about 30%.
29. The method of claim 21 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤5 μm) as measured by USP <1601> of at least about 60% and a respirable fraction (≤3.3 μm) as measured by USP <1601> of at least about 30%.
30. The method of claim 21 , wherein the aerosol of the pharmaceutical composition exhibits a respirable fraction (≤5 μm) as measured by USP <1601> of at least about 75% and a respirable fraction (≤3.3 μm) as measured by USP <1601> of at least about 30%.