Cromolyn compositions for treatment of pulmonary fibrosis
The disclosure provides a method of treating pulmonary fibrosis, including idiopathic pulmonary fibrosis, in a comprising administering to the subject a pharmaceutical composition comprising from about 1% by weight to about 99% by weight of cromolyn sodium with an inhalation device.
1. A method of preventing a decline of forced vital capacity (% PVC) in a subject having idiopathic pulmonary fibrosis, comprising administering to a subject in need thereof a pharmaceutical composition with a high-efficiency nebulizer,
wherein the pharmaceutical composition comprises from about 1% by weight to about 99% by weight of cromolyn sodium;
wherein the pharmaceutical composition has an osmolality of between about 120 mOsm/kg and about 140 mOsm/kg,
wherein the administration of the pharmaceutical composition to the subject produces in the subject an AUC (0-∝) of cromolyn greater than about 5.3 ng*hr/mL per mg of cromolyn sodium administered to the subject; and
wherein the pharmaceutical composition does not comprise a sugar alcohol or propylene glycol.
2. The method according to claim 1 , wherein the nebulizer, a high-efficiency nebulizer is a vibrating mesh nebulizer.
3. The method according to claim 2 , wherein the vibrating mesh nebulizer provides an aerosol of the pharmaceutical composition having a respirable fraction ≤3.3 μm of at least about 30% and a respirable fraction ≤5 μm of at least about 65%.
4. The method according to claim 2 , wherein the vibrating mesh nebulizer provides an aerosol of the pharmaceutical composition having a respirable fraction ≤3.3 μm of at least about 45% and a respirable fraction ≤5 μm of at least about 75%.
5. The method according to claim 1 , wherein the subject experiences a decline of forced vital capacity (% PVC) of less than about 10% following administration of the pharmaceutical composition to the subject for at least 2 weeks.
6. The method according to claim 1 , wherein the subject experiences a decline of forced vital capacity (% PVC) of less than about 9% following administration of the pharmaceutical composition to the subject for at least 2 weeks.
7. The method according to claim 1 , wherein the subject experiences a decline of forced vital capacity (% PVC) of less than about 8% following administration of the pharmaceutical composition to the subject for at least 2 weeks.
8. The method according to claim 1 , wherein the subject experiences a decline of forced vital capacity (% PVC) of less than about 7% following administration of the pharmaceutical composition to the subject for at least 2 weeks.
9. The method according to claim 1 , wherein the subject experiences a decline of forced vital capacity (% PVC) of less than about 6% following administration of the pharmaceutical composition to the subject for at least 2 weeks.
10. The method according to claim 1 , wherein the subject experiences a decline of forced vital capacity (% PVC) of less than about 5% following administration of the pharmaceutical composition to the subject for at least 2 weeks.
11. The method according to claim 1 , wherein the subject experiences a decline of forced vital capacity (% PVC) of less than about 4% following administration of the pharmaceutical composition to the subject for at least 2 weeks.
12. The method according to claim 1 , wherein the subject experiences a decline of forced vital capacity (% PVC) of less than about 3% following administration of the pharmaceutical composition to the subject for at least 2 weeks.
13. The method according to claim 1 , wherein the subject experiences a decline of forced vital capacity (% PVC) of less than about 2% following administration of the pharmaceutical composition to the subject for at least 2 weeks.
14. The method according to claim 1 , wherein the subject experiences a decline of forced vital capacity (% PVC) of less than about 1% following administration of the pharmaceutical composition to the subject for at least 2 weeks.
15. The method according to claim 1 , wherein the subject experiences no decline of forced vital capacity (% PVC) following administration of the pharmaceutical composition to the subject for at least 2 weeks.
16. The method according to claim 1 , wherein the pharmaceutical composition comprises about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or about 99% by weight of cromolyn sodium.
17. The method according to claim 16 , wherein the pharmaceutical composition comprises about 2%, about 4%, or about 6% by weight of cromolyn sodium.
18. The method according to claim 2 , wherein said pharmaceutical composition further comprises sodium chloride.
19. The method according to claim 2 , wherein the pharmaceutical composition does not comprise a non-ionic osmotic agent.
20. The method according to claim 1 , wherein the administration of the pharmaceutical composition to the subject produces in the subject a C max of greater than about 1.9 ng/mL per mg of cromolyn sodium administered to the subject.