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 the patient a pharmaceutical composition comprising cromolyn sodium using a device that produces an aerosol of the pharmaceutical composition exhibiting a respirable fraction (≤5 μm) of at least about 60%, and wherein administration of the pharmaceutical composition to the patient produces in the patient an AUC (0-∞) of cromolyn greater than about 5.3 ng*h/mL per milligram of cromolyn sodium administered to the patient.
2. The method of claim 1 , wherein administration of the pharmaceutical composition to the patient produces in the patient an AUC (0-∞) of cromolyn greater than about 6.6 ng*h/mL per milligram of cromolyn sodium administered to the patient.
3. The method of claim 1 , wherein administration of the pharmaceutical composition to the patient produces in the patient an AUC (0-∞) of cromolyn greater than about 8.5 ng*h/mL per milligram of cromolyn sodium administered to the patient.
4. The method of claim 1 , wherein the device is a nebulizer, a high-efficiency nebulizer, or a dry powder inhaler.
5. The method of claim 1 , wherein the administration of the pharmaceutical composition to the patient produces in the patient a C max of cromolyn greater than about 2.2 ng/mL per milligram of cromolyn sodium administered to the patient.
6. The method of claim 5 , wherein the device is a nebulizer, a high-efficiency nebulizer, or a dry powder inhaler.
7. A method of treating an inflammatory disorder in a patient, comprising administering to the patient a pharmaceutical composition comprising cromolyn sodium using a device that produces an aerosol of the pharmaceutical composition exhibiting a respirable fraction (≤5 μm) of at least about 60%, and wherein administration of the pharmaceutical composition to the patient produces in the patient a C max of cromolyn greater than about 2.2 ng/mL per milligram of cromolyn sodium administered to the patient.
8. The method of claim 7 , wherein administration of the pharmaceutical composition to the patient produces in the patient a C max of cromolyn greater than about 3 ng/mL per milligram of cromolyn sodium administered to the patient.
9. The method of claim 7 , wherein administration of the pharmaceutical composition to the patient produces in the patient a C max of cromolyn greater than about 3.9 ng/mL per milligram of cromolyn sodium administered to the patient.
10. The method of claim 7 , wherein administration of the pharmaceutical composition to the patient produces in the patient an AUC (0-∞) of cromolyn greater than about 6.6 ng*h/mL per milligram of cromolyn sodium administered to the patient.
11. The method of claim 7 , wherein the device is a nebulizer, a high-efficiency nebulizer, or a dry powder inhaler.
12. A method of treating fibrosis in a patient, comprising administering to the patient a pharmaceutical composition comprising cromolyn sodium using a device that produces an aerosol of the pharmaceutical composition exhibiting a respirable fraction (≤5 μm) of at least about 60%, and wherein administration of the pharmaceutical composition to the patient produces in the patient an AUC (0-∞) of cromolyn greater than about 5.3 ng*h/mL per milligram of cromolyn sodium administered to the patient.
13. The method of claim 12 , wherein administration of the pharmaceutical composition to the patient produces in the patient an AUC (0-∞) of cromolyn greater than about 6.6 ng*h/mL per milligram of cromolyn sodium administered to the patient.
14. The method of claim 12 , wherein administration of the pharmaceutical composition to the patient produces in the patient an AUC (0-∞) of cromolyn greater than about 8.5 ng*h/mL per milligram of cromolyn sodium administered to the patient.
15. The method of claim 12 , wherein administration of the pharmaceutical composition to the patient produces in the patient a C max of cromolyn greater than about 2.2 ng/mL per milligram of cromolyn sodium administered to the patient.
16. The method of claim 12 , wherein said fibrosis is kidney fibrosis.
17. The method of claim 12 , wherein said fibrosis is hepatic fibrosis.
18. The method of claim 12 , wherein the device is a nebulizer, a high-efficiency nebulizer, or a dry powder inhaler.
19. The method of claim 12 , wherein the administration of the pharmaceutical composition to the patient produces in the patient a C max of cromolyn greater than about 3 ng/mL per milligram of cromolyn sodium administered to the patient.
20. A method of treating fibrosis in a patient, comprising administering to the patient a pharmaceutical composition comprising cromolyn sodium using a device that produces an aerosol of the pharmaceutical composition exhibiting a respirable fraction (≤5 μm) of at least about 60%, and wherein administration of the pharmaceutical composition to the patient produces in the patient a C max of cromolyn greater than about 2.2 ng/mL per milligram of cromolyn sodium administered to the patient.
21. The method of claim 20 , wherein administration of the pharmaceutical composition to the patient produces in the patient a C max of cromolyn greater than about 3 ng/mL per milligram of cromolyn sodium administered to the patient.
22. The method of claim 20 , wherein administration of the pharmaceutical composition to the patient produces in the patient a C max of cromolyn greater than about 3.9 ng/mL per milligram of cromolyn sodium administered to the patient.
23. The method of claim 20 , wherein administration of the pharmaceutical composition to the patient produces in the patient an AUC (0-∞) of cromolyn greater than about 6.6 ng*h/mL per milligram of cromolyn sodium administered to the patient.
24. The method of claim 20 , wherein said fibrosis is kidney fibrosis.
25. The method of claim 20 , wherein said fibrosis is hepatic fibrosis.
26. The method of claim 20 , wherein the device is a nebulizer, a high-efficiency nebulizer, or a dry powder inhaler.
27. The method of claim 4 , wherein the device is a nebulizer or a high-efficiency nebulizer.
28. The method of claim 27 , wherein the device is a high-efficiency nebulizer.
29. The method of claim 18 , wherein the device is a nebulizer or a high-efficiency nebulizer.
30. The method of claim 29 , wherein the device is a high-efficiency nebulizer.
31. The method of claim 1 , wherein the aerosol of the pharmaceutical composition further exhibits a respirable fraction (≤3.3 μm) of at least about 30%.
32. The method of claim 31 , wherein the device is a nebulizer, a high-efficiency nebulizer, or a dry powder inhaler.
33. The method of claim 32 , wherein the device is a high-efficiency nebulizer.
34. The method of claim 7 , wherein the aerosol of the pharmaceutical composition further exhibits a respirable fraction (≤3.3 μm) of at least about 30%.
35. The method of claim 34 , wherein the device is a nebulizer, a high-efficiency nebulizer, or a dry powder inhaler.
36. The method of claim 35 , wherein the device is a high-efficiency nebulizer.
37. The method of claim 12 , wherein the aerosol of the pharmaceutical composition further exhibits a respirable fraction (≤3.3 μm) of at least about 30%.
38. The method of claim 37 , wherein the device is a nebulizer, a high-efficiency nebulizer, or a dry powder inhaler.
39. The method of claim 38 , wherein the device is a high-efficiency nebulizer.
40. The method of claim 20 , wherein the aerosol of the pharmaceutical composition further exhibits a respirable fraction (≤3.3 μm) of at least about 30%.
41. The method of claim 40 , wherein the device is a nebulizer, a high-efficiency nebulizer, or a dry powder inhaler.
42. The method of claim 41 , wherein the device is a high-efficiency nebulizer.