Concentrated human immunoglobulin composition

Abstract

A liquid pharmaceutical composition containing human immunoglobulin G, preferably at 230 g/l or higher. The composition, suitable for subcutaneous or intramuscular administration, can be used to treat various diseases, e.g., an antibody production defect and Kawasaki disease.

1 . A liquid pharmaceutical composition obtained by the following process:
 a. providing a human immunoglobulin G (IgG) preparation;   b. adding to the preparation at least one surfactant and/or at least one amino acid;   c. concentrating the IgG by ultrafiltration; and   d. adding a surfactant identical to or different from the surfactant added in step b;   
       in which the pharmaceutical composition obtained is at a pH between 4.2 and 5.5. 
     
     
         2 . A liquid pharmaceutical composition obtained by the following process:
 a. providing a human immunoglobulin G (IgG) preparation;   b. adding to the preparation at least one surfactant and/or at least one amino acid;   c. concentrating the IgG by ultrafiltration; and   d. adding a surfactant identical to or different from the surfactant added in step b;   
       in which the pharmaceutical composition obtained is at a pH between 6.8 and 7.8. 
     
     
         3 . A liquid pharmaceutical composition comprising human immunoglobulin G (IgG), wherein the IgG concentration is at least 230 g/l. 
     
     
         4 . The liquid pharmaceutical composition according to  claim 3 , wherein the IgG concentration is between 230 and 350 g/l. 
     
     
         5 . The liquid pharmaceutical composition according to  claim 4 , further comprising:
 glycine;   optionally sodium acetate buffer; and   a polysorbate or a poloxamer.   
     
     
         6 . The liquid pharmaceutical composition according to  claim 5 , wherein the IgG concentration is about 250 g/l. 
     
     
         7 . The liquid pharmaceutical composition according to  claim 5 , wherein the polysorbate is polysorbate 80. 
     
     
         8 . The liquid pharmaceutical composition according to  claim 6 , wherein the polysorbate is polysorbate 80. 
     
     
         9 . The liquid pharmaceutical composition according to  claim 5 , comprising:
 concentrated IgG between 230 and 350 g/l;   200 to 300 mM of glycine;   0 to 100 mM of sodium acetate buffer; and   50 to 300 ppm of polysorbate.   
     
     
         10 . The liquid pharmaceutical composition according to  claim 9 , wherein the IgG concentration is about 250 g/l. 
     
     
         11 . The liquid pharmaceutical composition according to  claim 10 , comprising:
 200 mM of glycine;   50 mM of sodium acetate buffer; and   200 ppm of polysorbate.   
     
     
         12 . The liquid pharmaceutical composition according to  claim 10 , comprising:
 250 mM of glycine; and   200 ppm of polysorbate.   
     
     
         13 . The liquid pharmaceutical composition according to  claim 10 , comprising:
 250 mM glycine;   50 mM of sodium acetate buffer; and   200 ppm of polysorbate 80,   
       wherein the pH of the composition is between 4.2 and 5.5. 
     
     
         14 . A liquid pharmaceutical composition comprising human immunoglobulin G (IgG), wherein the IgG concentration is at about 230 g/l and the pH is between 6.8 and 7.8. 
     
     
         15 . The liquid pharmaceutical composition according to  claim 14 , wherein the IgG concentration is between 230 and 350 g/l. 
     
     
         16 . The liquid pharmaceutical composition comprising human immunoglobulin G (IgG), wherein the IgG concentration is at least 230 g/l and the pH is 7.3. 
     
     
         17 . The liquid pharmaceutical composition according to  claim 16 , wherein the IgG concentration is between 230 and 350 g/l. 
     
     
         18 . The liquid pharmaceutical composition according to  claim 1  in a form suitable for subcutaneous or intramuscular administration. 
     
     
         19 . The liquid pharmaceutical composition according to  claim 18 , wherein the surfactant added in step d is a non-ionic detergent. 
     
     
         20 . A method for treating a disease, which method comprises administering the liquid pharmaceutical composition of  claim 1 , comprising human immunoglobulin G (IgG), to a patient in need thereof, wherein said disease is selected from the group consisting of primary immune deficiencies with an antibody production defect, Kawasaki disease, childhood and adult immune thrombocytopaenic purpura, secondary immune deficiencies with an antibody production defect, in particular chronic lymphoid leukaemia or myeloma that are associated with recurrent infections, HIV infection of children associated with bacterial infections, multifocal motor neuropathies, Guillain-Barré syndrome, chronic or severe acute Parvovirus B19 infections, acquired or constitutional immunodeficiency, cortico-resistant dermatomyositis, acute myasthenia, chronic idiopathic polyradiculoneuritis, immune thrombocytopaenic purpura, for example associated with HIV infection, stiff-person syndrome, autoimmune neutropaenia, resistant autoimmune erythroblastopenia, autoantibody-induced acquired anticoagulant syndrome, rheumatoid arthritis, and uveitis. 
     
     
         21 . The method according to  claim 20 , wherein the surfactant added in step d is a non-ionic detergent.