C1-INH compositions and methods for the prevention and treatment of disorders associated with C1 esterase inhibitor deficiency
Compositions and methods for the treatment and/or prevention of disorders associated with C1 esterase inhibitor deficiency are disclosed.
1. A pharmaceutical composition comprising C1 esterase inhibitor, sodium citrate, and having a pH ranging from 6.5-8.0, wherein the C1 esterase inhibitor has a concentration of about 400-600 U/mL, and wherein the C1 esterase inhibitor comprises the amino acid sequence of residues 23 to 500 of SEQ ID NO: 1.
2. The pharmaceutical composition of claim 1 , wherein the pH is between about 6.5 to about 7.5.
3. The pharmaceutical composition of claim 1 , wherein the pH is between about 6.5 to about 7.0.
4. The pharmaceutical composition of claim 1 , wherein the sodium citrate is present at about 10 mM to about 30 mM.
5. The pharmaceutical composition of claim 1 , wherein the sodium citrate is present at 10 mM to 30 mM.
6. The pharmaceutical composition of claim 1 , wherein the sodium citrate is present at about 10 mM.
7. The pharmaceutical composition of claim 1 , wherein the composition further comprises at least one amino acid or salt thereof.
8. The pharmaceutical composition of claim 1 , wherein the C1 esterase inhibitor is present in the composition in the range of about 1500 U to about 2500 U.
9. The pharmaceutical composition of claim 1 , wherein the C1 esterase inhibitor is present in the composition in at least about 2000 U.
10. The pharmaceutical composition of claim 1 , wherein the C1 esterase inhibitor is present in the composition at about 2000 U.
11. The pharmaceutical composition of claim 9 , wherein the C1 esterase inhibitor is present in the composition less than about 5000 U.
12. The pharmaceutical composition of claim 1 , wherein the C1 esterase inhibitor is present in the composition in about 5000 U.
13. The pharmaceutical composition of claim 1 , wherein the C1 esterase inhibitor is isolated or purified from human plasma.
14. The pharmaceutical composition of claim 13 , wherein the C1 esterase inhibitor isolated or purified from human plasma is nanofiltered.
15. The pharmaceutical composition of claim 13 , wherein the C1 esterase inhibitor isolated or purified from human plasma is pasteurized.
16. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is prepared in liquid form.
17. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is reconstituted with water from at least one lyophilized powder.
18. The pharmaceutical composition of claim 1 , wherein the composition has a viscosity of less than about 20 mPa-s.
19. The pharmaceutical composition of claim 1 , wherein the composition has a viscosity of less than about 10 mPa-s.
20. The pharmaceutical composition of claim 1 , wherein the C1 esterase inhibitor present in the composition comprises at least 50-60% of the total protein in the composition.
21. The pharmaceutical composition of claim 1 , wherein the C1 esterase inhibitor present in the composition comprises at least 75% of the total protein in the composition.
22. The pharmaceutical composition of claim 1 , wherein the C1 esterase inhibitor has less than a 10% loss in monomer content when stored for two years at 4° C.
23. The pharmaceutical composition of claim 1 , wherein the C1 esterase inhibitor has less than about 20% loss in monomer content loss when stored for one week at 40° C.
24. The pharmaceutical composition of claim 1 , wherein the C1 esterase inhibitor has less than about 10% loss in monomer content loss when stored for two weeks at 25° C.
25. The pharmaceutical composition of claim 1 , wherein the C1 esterase inhibitor has less than about 2% loss in purity when stored for one week at 40° C.
26. The pharmaceutical composition of claim 1 , wherein the C1 esterase inhibitor has less than about 1% loss in purity when stored for one week at 40° C.
27. The pharmaceutical composition of claim 1 , wherein the C1 esterase inhibitor has less than about 2% loss in purity when stored for two weeks at 25° C.
28. The pharmaceutical composition of claim 1 , wherein the C1 esterase inhibitor has less than about 1% loss in purity when stored for two weeks at 25° C.
29. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is a monoformulation of active pharmaceutical ingredient, wherein said active pharmaceutical ingredient consists essentially of C1 esterase inhibitor.