Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections
The present disclosure provides a composition comprising Compound 1, or a pharmaceutically acceptable salt thereof, cyclodextrin, and, optionally, pH adjusting agents.
1. A composition comprising
(i) a Compound 1 in an amount of from 1% to 10% w/w
or a pharmaceutically acceptable salt thereof, and
(ii) cyclodextrin in an amount of from 90% to 99% w/w;
wherein the composition is a lyophilized composition.
2. The composition of claim 1 , wherein the cyclodextrin is a beta-cyclodextrin.
3. The composition of claim 2 , wherein the beta-cyclodextrin is sulfobutylalkylether-beta-cyclodextrin, betadex-sulfobutylether sodium, or hydroxypropyl-beta-cyclodextrin.
4. The composition of claim 2 , wherein the beta-cyclodextrin is betadex-sulfobutylether sodium.
5. The composition of claim 1 , comprising
(i) the Compound 1 in an amount of from 1% to 5% w/w; and
(ii) the cyclodextrin in an amount of from 95% to 99% w/w.
6. The composition of claim 5 , wherein the cyclodextrin is betadex-sulfobutylether sodium.
7. The composition of claim 1 , comprising
(i) the Compound 1 in an amount of from 2% to 4% w/w; and
(ii) the cyclodextrin in an amount of from 96% to 98% w/w.
8. The composition of claim 7 , wherein the cyclodextrin is betadex-sulfobutylether sodium.
9. The composition of claim 1 , comprising
(i) the Compound 1 in an amount of from 3% to 3.5% w/w; and
(ii) the cyclodextrin in an amount of from 96.5% to 97% w/w.
10. The composition of claim 9 , wherein the cyclodextrin is betadex-sulfobutylether sodium.
11. The composition of claim 10 , that is contained in a sealed vial.
12. The composition of claim 1 , consisting essentially of
the Compound 1 in an amount of 3.2% w/w, and the cyclodextrin betadex-sulfobutylether sodium in an amount of 96.8% w/w.