Stabilization of immunoglobulins through aqueous formulation with histidine at weak acidic to neutral ph
AssigneesBaxter International Inc., Baxter Healthcare S.A.
InventorsHarald Arno Butterweck, Bernhard Kölbl, Lucia Hofbauer, Wolfgang Teschner, Hans-Peter Schwarz
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Abstract
The present invention provides, among other aspects, storage stabile aqueous formulations of immunoglobulins with histidine at a mildly acidic to neutral pH. The present invention also provides methods for stabilizing immunoglobulin compositions by formulating with histidine at a mildly acidic to neutral pH. Advantageously, the methods and formulations provided herein allow stabile aqueous compositions of immunoglobulins at mildly acidic to neutral pH useful for parenteral administration.
Claims40
A storage stable, aqueous immunoglobulin composition comprising:
- (a) an immunoglobulin
- (b) from 100 mM to 500 mM histidine;
- (c) from 0 mM to 10 mM of an alkali metal cation;
- and
- (d) a pH from 5.5 to 7.0,
- wherein the composition does not contain a surfactant or sugar.
(canceled)
A method for stabilizing an immunoglobulin composition, the method comprising formulating the composition at a pH between 5.5 and 7.0,
- wherein the formulated composition comprises:
- (a) an immunoglobulin
- (b) from 100 mM to 500 mM histidine;
- and
- (c) from 0 mM to 10 mM of an alkali metal cation,
- wherein the formulated composition does not contain a surfactant or sugar.
Dependencies are inferred from the claim text.