Claims for Patent: 11,266,681

Summary for Patent: 11,266,681

Title:	Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections
Abstract:	The present disclosure provides a composition comprising Compound 1, or a pharmaceutically acceptable salt thereof, cyclodextrin, and, optionally, pH adjusting agents.
Inventor(s):	Larson; Nate (Saint George, UT), Strickley; Robert G. (San Mateo, CA)
Assignee:	Gilead Sciences, Inc. (Foster City, CA)
Application Number:	16/865,209
Patent Claims:	1. A method of treating a viral infection in a human in need thereof, the method comprising (a) reconstituting with safe water for injection a lyophilized pharmaceutical composition comprising: (i) Compound 1, ##STR00009## or a pharmaceutically acceptable salt thereof, in an amount of from 1% to 10% w/w, and (ii) cyclodextrin in an amount of from 90% to 99% w/w, thereby forming a reconstituted pharmaceutical composition; and (b) administering to the human a therapeutically effective amount of the reconstituted pharmaceutical composition; wherein the viral infection is caused by an Arenaviridae virus, a Coronaviridae virus, a Filoviridae virus, or a Paramyxoviridae virus. 2. The method of claim 1, wherein the lyophilized pharmaceutical composition comprises: (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. 3. The method of claim 2, wherein the cyclodextrin is sulfobutylalkylether-beta-cyclodextrin, betadex-sulfobutylether sodium, or hydroxypropyl-beta-cyclodextrin. 4. The method of claim 3, wherein the cyclodextrin is betadex-sulfobutylether sodium. 5. The method of claim 1, wherein the lyophilized pharmaceutical composition comprises: (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. 6. The method of claim 5, wherein the cyclodextrin is sulfobutylalkylether-beta-cyclodextrin, betadex-sulfobutylether sodium, or hydroxypropyl-beta-cyclodextrin. 7. The method of claim 6, wherein the cyclodextrin is betadex-sulfobutylether sodium. 8. The method of claim 1, wherein the lyophilized pharmaceutical composition comprises: (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. 9. The method of claim 8, wherein the cyclodextrin is betadex-sulfobutylether sodium. 10. The method of claim 1, wherein the lyophilized pharmaceutical composition comprises the Compound 1 in an amount of from 50 mg to 250 mg. 11. The method of claim 10, wherein the lyophilized pharmaceutical composition comprises the Compound 1 in an amount of 100 mg. 12. The method of claim 10, wherein the lyophilized pharmaceutical composition comprises the Compound 1 in an amount of 200 mg. 13. The method of claim 1, wherein the cyclodextrin is a beta-cyclodextrin. 14. The method of claim 13, wherein the beta-cyclodextrin is sulfobutylalkylether-beta-cyclodextrin, betadex-sulfobutylether sodium, or hydroxypropyl-beta-cyclodextrin. 15. The method of claim 14, wherein the cyclodextrin is betadex-sulfobutylether sodium. 16. The method of claim 1, wherein the lyophilized pharmaceutical composition consists essentially of: (i) the Compound 1 in an amount of 3.2% w/w, and (ii) the cyclodextrin betadex-sulfobutylether sodium in an amount of 96.8% w/w. 17. The method of claim 1, wherein the reconstituted pharmaceutical composition further comprises a pH adjusting agent. 18. The method of claim 17, wherein the pH adjusting agent comprises HCl, NaOH, or a combination thereof. 19. The method of claim 17, wherein the reconstituted pharmaceutical composition has a pH of from 3 to 4. 20. The method of claim 1, wherein the reconstituted pharmaceutical composition comprises from 1 mg/mL to 10 mg/mL of the Compound 1. 21. The method of claim 20, wherein the reconstituted pharmaceutical composition comprises from 4 mg/mL to 6 mg/mL of the Compound 1. 22. The method of claim 21, wherein the reconstituted pharmaceutical composition comprises about 5 mg/mL of the Compound 1. 23. The method of claim 1, wherein the reconstituted pharmaceutical composition comprises from 5% (w/v) to 50% (w/v) of the cyclodextrin. 24. The method of claim 23, wherein the reconstituted pharmaceutical composition comprises from 10% (w/v) to 20% (w/v) of the cyclodextrin. 25. The method of claim 24, wherein the reconstituted pharmaceutical composition comprises about 15% (w/v) of the cyclodextrin. 26. The method of claim 1, wherein the viral infection is caused by a Coronaviridae virus. 27. The method of claim 1, wherein the administering further comprises one or more additional therapeutic agents. 28. A method of treating a viral infection in a human in need thereof, the method comprising administering to the human a therapeutically effective amount of a composition comprising a lyophilized pharmaceutical composition, wherein the lyophilized pharmaceutical composition comprises: (i) Compound 1, ##STR00010## or a pharmaceutically acceptable salt thereof, in an amount of from 1% to 10% w/w; and (ii) cyclodextrin in an amount of from 90% to 99% w/w; wherein the viral infection is caused by an Arenaviridae virus, a Coronaviridae virus, a Filoviridae virus, or a Paramyxoviridae virus. 29. The method of claim 28, wherein the lyophilized pharmaceutical composition comprises: (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. 30. The method of claim 29, wherein the cyclodextrin is sulfobutylalkylether-beta-cyclodextrin, betadex-sulfobutylether sodium, or hydroxypropyl-beta-cyclodextrin. 31. The method of claim 30, wherein the cyclodextrin is betadex-sulfobutylether sodium. 32. The method of claim 28, wherein the lyophilized pharmaceutical composition comprises: (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. 33. The method of claim 32, wherein the cyclodextrin is sulfobutylalkylether-beta-cyclodextrin, betadex-sulfobutylether sodium, or hydroxypropyl-beta-cyclodextrin. 34. The method of claim 33, wherein the cyclodextrin is betadex-sulfobutylether sodium. 35. The method of claim 28, wherein the lyophilized pharmaceutical composition comprises: (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. 36. The method of claim 35, wherein the cyclodextrin is betadex-sulfobutylether sodium. 37. The method of claim 28, wherein the lyophilized pharmaceutical composition comprises the Compound 1 in an amount of from 50 mg to 250 mg. 38. The method of claim 37, wherein the lyophilized pharmaceutical composition comprises the Compound 1 in an amount of 100 mg. 39. The method of claim 37, wherein the lyophilized pharmaceutical composition comprises the Compound 1 in an amount of 200 mg. 40. The method of claim 28, wherein the cyclodextrin is a beta-cyclodextrin. 41. The method of claim 40, wherein the beta-cyclodextrin is sulfobutylalkylether-beta-cyclodextrin, betadex-sulfobutylether sodium, or hydroxypropyl-beta-cyclodextrin. 42. The method of claim 41, wherein the cyclodextrin is betadex-sulfobutylether sodium. 43. The method of claim 28, wherein the lyophilized pharmaceutical composition consists essentially of: (i) the Compound 1 in an amount of 3.2% w/w, and (ii) the cyclodextrin betadex-sulfobutylether sodium in an amount of 96.8% w/w. 44. The method of claim 28, wherein the viral infection is caused by a Coronaviridae virus. 45. The method of claim 28, wherein the administering further comprises one or more additional therapeutic agents.