Stabilizing alkylglycoside compositions and methods thereof
AssigneeAegis Therapeutics, LLC
InventorEdward T. Maggio
Life of this patent
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Abstract
The present invention relates to alkylglycoside-containing compositions and methods for increasing the stability, reducing the aggregation and immunogenicity, increasing the biological activity, and reducing or preventing fibrillar formation of insulin or an analog thereof.
Claims34
A pharmaceutical composition for increasing the stability, reducing aggregation or reducing immunogenicity of human insulin comprising:
- human insulin;
- and
- an alkylglycoside,
- wherein the alkylglycoside stabilizes, reduces aggregation, or reduces immunogenicity of the human insulin, wherein the alkylglycoside consists essentially of dodecyl-β-D-maltoside, and wherein the composition is stable for at least one month when stored at temperatures from about 25 to 37 degrees Celsius.
A method for increasing the stability of human insulin comprising:
- admixing human insulin and a stabilizing agent to form a composition, wherein the stabilizing agent is an alkylglycoside, wherein the alkylglycoside consists essentially of dodecyl-β-D-maltoside, and wherein the composition is stable for at least one month when stored at temperatures from about 25 to 37 degrees Celsius, thereby increasing the stability of human insulin.
A method for reducing aggregation or immunogenicity of human insulin comprising:
- admixing human insulin, and an agent to form a composition, wherein the agent is an alkylglycoside, wherein the alkylglycoside consists essentially of dodecyl-β-D-maltoside, and wherein the composition is stable for at least one month when stored at temperatures from about 25 to 37 degrees Celsius, thereby reducing aggregation or immunogenicity of human insulin.
A method of manufacturing a non-aggregated aqueous solution of human insulin comprising admixing an alkylglycoside in an aqueous solution of human insulin, wherein the alkylglycoside consists essentially of dodecyl-β-D-maltoside, and wherein the solution is stable for at least one month when stored at temperatures from about 25 to 37 degrees Celsius.
A pharmaceutical composition for increasing the stability, reducing aggregation or reducing immunogenicity of human insulin comprising:
- human insulin;
- and
- an agent comprising at least one alkylglycoside, wherein the alkylglycoside stabilizes, reduces aggregation, or reduces immunogenicity of the human insulin, wherein the alkylglycoside comprises at least 99% dodecyl-β-D-maltoside, and wherein the composition is stable for at least one month when stored at temperatures from about 25 to 37 degrees Celsius.
A method for increasing the stability of human insulin comprising:
- admixing human insulin and a stabilizing agent to form a composition, wherein the stabilizing agent comprises an alkylglycoside, wherein the alkylglycoside comprises at least 99% dodecyl-β-D-maltoside, and wherein the composition is stable for at least one month when stored at temperatures from about 25 to 37 degrees Celsius, thereby increasing the stability of human insulin.
Dependencies are inferred from the claim text.