Composition comprising immunoglobulin
AssigneeCommon Services Agency
InventorsRonald Vance McIntosh, Anne Gillian Welch
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Abstract
Liquid compositions for intravenous administration that comprise an aqueous solution of immunoglobulin and methods of preparing such compositions are disclosed. The solution has a pH in the range of 5.0 to 5.8 and an ionic strength is the range 0.02 to 0.25. The liquid compositions are formulated so as to be stable upon storage such that the immunoglobulin does not substantially aggregate nor degrade and maintains acceptable levels of anti-complementary activity, PKA activity and kallikrein activity during storage for an extended period at a temperature in the range of 4° C. to 25° C.
Claims29
A liquid composition for intravenous administration comprising a solution of an immunoglobulin, which comprises IgG monomers and IgG dimers, in a pharmaceutically acceptable aqueous carrier, the solution having a pH in the range of 5.0 to 5.8 and an ionic strength in the range 0.02 to 0.25, wherein the immunoglobulin has been subjected to treatment with pepsin, wherein the liquid composition is devoid of non-tenside amphiphilic stabilizers, and wherein the liquid composition is stable upon storage for 6 months at 4° C.
A liquid composition for intravenous administration comprising a solution of an immunoglobulin in a pharmaceutically acceptable aqueous carrier, the solution having a pH in the range of 5.25 to 5.75 and an ionic strength in the range 0.03 to 0.18, wherein the immunoglobulin has been subjected to treatment with pepsin, wherein the liquid composition is devoid of non-tenside amphiphilic stabilizers, and wherein the liquid composition is stable upon storage for 6 months at 4° C.
A liquid composition for intravenous administration comprising a solution of an immunoglobulin in a pharmaceutically acceptable aqueous carrier, the solution having a pH in the range of 5.25 to 5.75 and an ionic strength in the range 0.03 to 0.18, wherein the immunoglobulin has been subjected to treatment with pepsin, wherein the liquid composition is devoid of non-tenside amphiphilic stabilizers, and wherein the liquid composition is stable upon storage for 12 months at 4° C.
A liquid composition for intravenous administration comprising a solution of an immunoglobulin in a pharmaceutically acceptable aqueous carrier, the solution having a pH in the range of 5.25 to 5.75 and an ionic strength in the range 0.03 to 0.18, wherein the immunoglobulin has been subjected to treatment with pepsin, wherein the liquid composition is devoid of non-tenside amphiphilic stabilizers, and wherein the liquid composition is stable upon storage for 24 months at 4° C.
Dependencies are inferred from the claim text.