Pharmaceutical Product With Increased Stability Comprising Immunoglobulins
AssigneeCSL Behring GmbH
InventorsRenzo PEDRUSSIO, Regula STYGER
Life of this patent
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Abstract
The present invention pertains to a pharmaceutical product comprising a polyclonal immunoglobulin solution in a pre-filled polymer syringe in secondary packaging comprising an oxygen scavenger.
Claims29
1-23. (canceled)
A method of increasing the storage stability of a polyclonal immunoglobulin solution, comprising packaging a polymer syringe barrel prefilled with the immunoglobulin solution in air-tight packaging with an oxygen scavenger, wherein the immunoglobulin solution comprises about 15% (w/v) to about 30% (w/v) IgG, wherein the polyclonal immunoglobulin solution does not comprise the oxygen scavenger, wherein the polyclonal immunoglobulin solution is stable over a period of at least 24 months at 25° C. in the polymer syringe barrel, and wherein the polyclonal immunoglobulin solution has a lower absorbance at 350 nm and a lower anticomplementary activity (ACA) after 24 months at 25° C. in the polymer syringe barrel than that of an identical polyclonal immunoglobulin solution stored under identical conditions in a glass vial under inert gas.
A method of treating an immunodeficiency disorder, an autoimmune disorder, or a neurological disorder, comprising administering to a patient in need thereof a pharmaceutical product comprising a polymer syringe barrel prefilled with the immunoglobulin solution in air-tight packaging with an oxygen scavenger, wherein the immunoglobulin solution comprises about 15% (w/v) to about 30% (w/v) IgG, wherein the polyclonal immunoglobulin solution does not comprise the oxygen scavenger, wherein the polyclonal immunoglobulin solution is stable over a period of at least 24 months at 25° C. in the polymer syringe barrel, and wherein the polyclonal immunoglobulin solution has a lower absorbance at 350 nm and a lower anticomplementary activity (ACA) after 24 months at 25° C. in the polymer syringe barrel than that of an identical polyclonal immunoglobulin solution stored under identical conditions in a glass vial under inert gas.
A method of treating an immunodeficiency disorder, an autoimmune disorder, or a neurological disorder comprising administering to a patient in need thereof a pharmaceutical product comprising an air-tight packaging comprising:
- (a) a pre-filled polymer syringe barrel comprising a polyclonal immunoglobulin solution comprising about 15% (w/v) to about 30% (w/v) IgG and one or more stabilizers, and (b) an oxygen scavenger, wherein the polyclonal immunoglobulin solution does not comprise the oxygen scavenger, wherein the polyclonal immunoglobulin solution is stable over a period of at least 24 months at 25° C. in the polymer syringe barrel, wherein the one or more stabilizers are amino acid arginine, glycine, proline, or a combination thereof, and wherein the headspace within the pre-filled polymer syringe barrel is less than 20% of the volume of the polyclonal immunoglobulin solution, and wherein the polyclonal immunoglobulin solution has a lower absorbance at 350 nm and a lower anticomplementary activity (ACA) after 24 months at 25° C. in the polymer syringe barrel than that of an identical polyclonal immunoglobulin solution stored under identical conditions in a glass vial under inert gas.
Dependencies are inferred from the claim text.