Mast cell stabilizers treatment for systemic disorders

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.