C1-INH compositions and methods for the prevention and treatment of disorders associated with C1 esterase inhibitor deficiency
AssigneeViropharma Biologics LLC
InventorsStephen Ruddy, Mark Cornell Manning, Ryan Erik Holcomb
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Abstract
Compositions and methods for the treatment and/or prevention of disorders associated with C1 esterase inhibitor deficiency are disclosed.
Claims35
A pharmaceutical composition comprising about 400 U/mL to about 600 U/mL of C1 esterase inhibitor, a citrate buffer or a phosphate buffer, and a pH range from about 6.5 to about 8.0, wherein said composition is for subcutaneous administration, and wherein the composition is for hereditary angioedema (HAE) prophylactic treatment in a subject in need thereof.
A lyophilized pharmaceutical composition comprising sodium citrate, and at least 2000 U of C1 esterase inhibitor and less than 5000 U of C1 esterase inhibitor, wherein following reconstitution, said lyophilized composition achieves a solution comprising:
- (i) a concentration of about 400 to about 600 U/mL of C1 esterase inhibitor, (ii) citrate at a concentration of about 5 mM to about 15 mM, and (iii) a pH ranging from about 6.5 to about 8.0, wherein the solution is for subcutaneous administration to treat HAE and wherein the C1 esterase inhibitor comprises the amino acid sequence of residues 23 to 500 of SEQ ID NO:
- 1.
Dependencies are inferred from the claim text.