Intravenously injectable immune serum globulin
AssigneeCutter Laboratories, Inc.
InventorRobert A. Tenold
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Abstract
A composition is disclosed which comprises a solution in a pharmaceutically acceptable carrier of an immune serum globulin, said solution having an ionic strength and a pH to maintain the monomer content and the actual and latent anticomplement activity of the immune serum globulin such that the composition is intravenously injectable. Novel methods are disclosed for preparing the above composition.
Claims14
A stable, sterile, intravenously injectable pharmaceutical composition comprising an aqueous solution of a therapeutic amount of an immune serum globulin, said solution having an ionic strength such that the solution at 5% protein concentration has a nephelometric reading less than 15 NTU, a pH of about 3.5-5.0, and a physiologically-acceptable tonicity.
A method for treating immune serum globulin which comprises
- (a) forming an aqueous solution of an immune serum globulin,
- (b) adjusting the pH of said solution to about 3.5-5.0 by addition of a physiologically acceptable acid,
- (c) treating the solution to reduce its ionic strength (.GAMMA./2) while maintaining the pH of said solution at 5% protein concentration has a nephelometric reading less than 15 NTU, and
- (d) 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.
A dry composition comprising immune serum globulin which upon solution in water has a pH of about 3.5-5.0 and an ionic strength (.GAMMA./2) such that the solution at 5% protein concentration has a nephelometric reading less than about 15 NTU.
Dependencies are inferred from the claim text.