Intravenously injectable immune serum globulin

Claim 1

A pharmaceutical composition comprising a solution, in a pharmaceutically acceptable aqueous carrier, of an immune serum globulin that is substantially free from chemical modification, said solution having a physiologically acceptable tonicity and an ionic strength such that the solution at 5 percent protein concentration has a nephelometric reading less than 15 NTU and a pH which ranges from about 3.5 to 5.0 to maintain, without significant change during storage at room temperature for extended periods, the monomer content at greater than about 90% and the actual anticomplement activity of the immune serum globulin at a level greater than about 2 mg protein/C'H50 unit wherein one C'H50 unit is defined as the amount of protein capable of inactivating 50% of complement in an optionally titered complement and hemolysin system such that the composition is intravenously administrable and has a buffer capacity which causes very little disruption, if any, of the physiological pH when compared with the administration of an immune serum globulin at equivalent pH but essentially buffered.

Claim 7

A method for rendering immune serum globulin intravenously injectable, which comprises (a) forming an aqueous solution of immune serum globulin that is substantially free from chemical modification, (b) adjusting the pH to about 3.5 to 5.0 and ionic strength of the solution such that the solution at 5% protein concentration has a nephelometric reading less than 15 NTU to maintain, without significant change during storage at room temperature for extended periods, the monomer content at greater than about 90% and the actual anticomplement activity of the immune serum globulin at a level greater than about 2 mg protein/C'H50 unit wherein one C'H50 unit is defined as the amount of protein capable of inactivating 50% of complement in an optionally titered complement and hemolysin system such that the composition is intravenously injectable and has a buffer capacity which causes very little disruption, if any, of the physiological pH when compared with the administration of an immune serum globulin at equivalent pH but essentially buffered, (c) adjusting the tonicity of the solution to a physiologically acceptable level by addition of an agent selected from the group consisting of amino acids, carbohydrates, and sugar alcohols, and mixtures thereof, and (d) sterilizing the solution.

Claim 8

A method for rendering immune serum globulin intravenously injectable, which comprises (a) forming an aqueous solution of immune serum globulin that is substantially free from chemical modification, (b) adjusting the pH to about 3.5 to 5.0 and ionic strength of the solution such that the solution at 5% protein concentration has a nephelometric reading less than 15 NTU to maintain, without significant change during storage at room temperature for extended periods, the monomer content at greater than about 90% and the actual anticomplement activity of the immune serum globulin at a level greater than about 2 mg protein/C'H50 unit wherein one C'H50 unit is defined as the amount of protein capable of inactivating 50% of complement in an optionally titered complement and hemolysin system such that the composition is intravenously injectable and has a buffer capacity which causes very little disruption, if any, of the physiological pH when compared with the administration of an immune serum globulin at equivalent pH but essentially buffered, (c) adjusting the tonicity of the solution to a physiologically acceptable level by addition of an agent selected from the group consisting of amino acids, carbohydrates, and sugar alcohols, and mixtures thereof, and (d) sterilizing the solution.