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 deficienty are disclosed.
1 - 15 . (canceled)
16 . A lyophilized pharmaceutical composition comprising C1 esterase inhibitor, sodium citrate, at least about 2000 U C1 esterase inhibitor and less than about 5000 U C1 esterase inhibitor wherein when said lyophilized composition is reconstituted in sterile water to prepare a solution with a concentration of 400-600 U/mL of C1-esterase inhibitor the solution is suitable for subcutaneous administration to treat HAE, the sodium citrate has concentration of at least 10 mM, and the solution has a pH ranging from 6.5-8.0, and wherein the C1 esterase inhibitor comprises the amino acid sequence of residues 23 to 500 of SEQ ID NO: 1.
17 . The lyophilized pharmaceutical composition of claim 16 , wherein the lyophilized composition is reconstituted in sterile water to prepare a solution with a concentration of 500 U/mL of C1-esterase inhibitor.
18 . A lyophilized pharmaceutical composition of claim 16 , wherein the pH of the solution ranges from about 6.5 to about 7.5.
19 . The lyophilized pharmaceutical composition of claim 16 , wherein the pH of the solution ranges from about 6.5 to about 7.
20 . The lyophilized pharmaceutical composition of claim 16 , wherein the concentration of citrate in the solution is about 7 mM to about 13 mM.
21 . The lyophilized pharmaceutical composition of claim 20 , wherein the concentration of citrate in the solution is about 10 mM.
22 . A kit comprising the lyophilized pharmaceutical composition as defined in claim 16 .
23 . A lyophilized pharmaceutical composition comprising C1 esterase inhibitor, sodium citrate, at least about 2000 U C1 esterase inhibitor and less than about 5000 U C1 esterase inhibitor wherein when said lyophilized composition is reconstituted in sterile water to prepare a solution with a concentration of 500 U/mL of C1-esterase inhibitor the solution is suitable for subcutaneous administration to treat HAE, the sodium citrate has concentration of at least 10 mM, and the solution has a pH ranging from 6.5-8.0, and wherein the C1 esterase inhibitor comprises the amino acid sequence of residues 23 to 500 of SEQ ID NO: 1.