C1-inh compositions and methods for the prevention and treatment of disorders associated with c1 esterase inhibitor deficiency

Abstract

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.