Manufacture, compositions and uses of coagulation factor VIIa modulator
View Patent ↗Treatment of cancer and thromboembolic disorders using inhibitors of Factor VIIa are disclosed herein using a compound of Formula I.
1. A composition comprising:
(a) a compound of Formula I, or a salt, thereof dissolved in water
(b) sodium hydroxide; and
(c) tromethamine;
and
having a pH between about 8.0 and about 9.5.
2. The composition of claim 1 , wherein the concentration of the compound of Formula I is greater than about 30 mg/mL.
3. The composition of any of claim 1 , wherein the concentration of the compound of Formula I is about 120 mg/mL.
4. The composition of claim 1 , wherein the composition is formulated for subcutaneous administration to a human.
5. A method of treating a cancer, a thromboembolic disorder, or a cancer and a thromboembolic disorder in a mammal in need thereof, comprising subcutaneously administering to the mammal a composition comprising:
(a) a compound of Formula I dissolved in water
(b) sodium hydroxide; and
(c) tromethamine;
and
having a pH between about 8.0 and about 9.5.
6. The method of claim 5 , wherein the concentration of the compound of Formula I is greater than about 30 mg/mL.
7. The method of claim 5 , wherein the concentration of the compound of Formula I is about 120 mg/mL.
8. The method of claim 5 , wherein the cancer is selected from prostate cancer, pancreatic cancer, breast cancer, colorectal cancer, lung cancer and melanoma.
9. The method of claim 5 , further comprising administering radiation therapy, a chemotherapeutic agent, or radiation therapy and a chemotherapeutic agent to the mammal.
10. The composition of claim 1 , wherein the composition is a non-viscous aqueous solution within about 15° C. of room temperature and a thickened solution between about 2° C. and about 8° C.
11. The composition of claim 10 , wherein the thickened solution is a gel, semi-solid, paste or jelly.
12. The composition of claim 10 , wherein the thickened solution has increased stability as compared to the non-viscous aqueous solution.
13. The composition of claim 10 , wherein viscosity of the thickened solution is at least 1000 cps.
14. The method of claim 5 , wherein the composition is a non-viscous aqueous solution within 15° C. of room temperature and a thickened solution between about 2° C. and about 8° C.
15. The method of claim 14 , wherein the thickened solution is a gel, semi-solid, paste or jelly.
16. The method of claim 14 , wherein the thickened solution has increased stability as compared to the non-viscous aqueous solution.
17. The method of claim 14 , wherein viscosity of the thickened solution is at least 1000 cps.