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 a peptide, polypeptide, or variant thereof, for example insulin and Peptide T or analog thereof.
Claims15
A method for increasing the stability of parathyroid hormone (PTH), fragment PTH 1-34, or fragment PTH 3-34 comprising:
- admixing the parathyroid hormone, fragment PTH 1-34, or fragment PTH 3-34 and a stabilizing agent to form a composition, wherein the stabilizing agent is at least one alkylglycoside surfactant selected from the group consisting of dodecyl maltoside, tridecyl maltoside, tetradecyl maltoside, sucrose mono-dodecanoate, sucrose mono-tridecanoate and sucrose mono-tetradecanoate, thereby increasing the stability of the parathyroid hormone, fragment PTH 1-34, or fragment PTH 3-34.
A method for reducing aggregation of a parathyroid hormone (PTH), fragment PTH 1-34, or fragment PTH 3-34 comprising:
- admixing the parathyroid hormone (PTH), fragment PTH 1-34, or fragment PTH 3-34 and an aggregation reducing agent, wherein the aggregation reducing agent is at least one alkylglycoside surfactant selected from the group consisting of dodecyl maltoside, tridecyl maltoside, tetradecyl maltoside, sucrose mono-dodecanoate, sucrose mono-tridecanoate and sucrose mono-tetradecanoate, thereby reducing aggregation of the parathyroid hormone (PTH), fragment PTH 1-34, or fragment PTH 3-34.
A method for reducing immunogenicity of a parathyroid hormone (PTH), or fragment PTH 1-34, or fragment PTH 3-34 upon administration to a vertebrate, comprising:
- a) admixing a parathyroid hormone (PTH), or fragment PTH 1-34, or fragment PTH 3-34 and an immunogenicity reducing agent to form a composition, wherein the immunogenicity reducing agent is at least one alkylglycoside surfactant selected from the group consisting of dodecyl maltoside, tridecyl maltoside, tetradecyl maltoside, sucrose mono-dodecanoate, sucrose mono-tridecanoate and sucrose mono-tetradecanoate;
- and
- b) administering the composition to a vertebrate thereby reducing immunogenicity upon administration of the parathyroid hormone (PTH), or fragment PTH 1-34, or fragment PTH 3-34.
A method of manufacturing a non-aggregated aqueous solution of a parathyroid hormone (PTH), or fragment PTH 1-34, or fragment PTH 3-34 comprising:
- admixing the parathyroid hormone (PTH), or fragment PTH 1-34, or fragment PTH 3-34 and at least one alkylglycoside surfactant to form an aqueous solution, wherein the surfactant is selected from the group consisting of dodecyl maltoside, tridecyl maltoside, tetradecyl maltoside, sucrose mono-dodecanoate, sucrose mono-tridecanoate and sucrose mono-tetradecanoate, thereby manufacturing the non-aggregated aqueous solution.
Dependencies are inferred from the claim text.