Aqueous solution comprising a glutathione salt
This disclosure provides pharmaceutical preparations, products, and methods relating to ARINA-1 for use in treating patients with chronic inflammatory lung diseases, such as lung transplant, cystic fibrosis (CF), non-CF bronchiectasis, chronic obstructive pulmonary disease (COPD, and other inflammatory lung diseases.
1. A preparation comprising an aqueous solution in a closed container with a headspace, wherein:
(i) the aqueous solution comprises a salt having Formula I:
(ii) the atmosphere of the headspace comprises 90% or more carbon dioxide by volume; and
(iii) M + is Na + , Li + , K + or Cs + .
2. The preparation of claim 1 , wherein the aqueous solution has a pH of 6.0±0.4 for 24 hours or more at about 5° C.
3. The preparation of claim 2 , wherein the aqueous solution has a pH of 6.0±0.1 for 24 hours or more at about 5° C.
4. The preparation of claim 1 , wherein the aqueous solution further comprises a salt having Formula II:
wherein M + is Na + , Li + , K + or Cs + .
5. The preparation of claim 1 , wherein the aqueous solution further comprises a salt having Formula III:
wherein M + is Na + , Li + , K + or Cs + .
6. The preparation of claim 1 , wherein the atmosphere of the headspace comprises 95% or more of carbon dioxide by volume.
7. The preparation of claim 1 , wherein the aqueous solution comprises about 10 wt % to about 20 wt % of the salt having Formula I.
8. The preparation of claim 7 , wherein the aqueous solution comprises about 13 wt % to about 17 wt % of the salt having Formula I.
9. The preparation of claim 8 , wherein the aqueous solution comprises about 14.7 wt % of the salt having Formula I.
10. The preparation of claim 4 , wherein the aqueous solution comprises about 5 wt % to about 15 wt % of the salt having Formula II.
11. The preparation of claim 10 , wherein the aqueous solution comprises about 7 wt % to about 11 wt % of the salt having Formula II.
12. The preparation of claim 11 , wherein the aqueous solution comprises about 9.1 wt % of the salt having Formula II.
13. The preparation of claim 1 , wherein the aqueous solution has a density of about 1.13 g/L.
14. The preparation of claim 1 , wherein the aqueous solution is frozen.
15. The preparation of claim 1 , wherein M + is Na + .
16. The preparation of claim 1 , packaged as a single unit dose.
17. The preparation of claim 1 , wherein the preparation is a pharmaceutical product.