Excipient stabilization of polypeptides treated with organic solvents
First Claim
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1. A method of stabilizing a polypeptide against denaturation in an organic solvent when treated with the organic solvent, wherein the method comprises admixing the polypeptide with a polyol, wherein the molecular weight of the polyol is less than about 70,000 kD and is trehalose, to form an admixture;
- and treating the admixture with the organic solvent.
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Abstract
Methods for excipient stabilization of dry or aqueous polypeptides treated with organic solvents are disclosed, wherein the polypeptide is admixed with trehalose, a polyol having a molecular weight less than about 70,000 kD.
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Citations
16 Claims
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1. A method of stabilizing a polypeptide against denaturation in an organic solvent when treated with the organic solvent, wherein the method comprises admixing the polypeptide with a polyol, wherein the molecular weight of the polyol is less than about 70,000 kD and is trehalose, to form an admixture;
- and treating the admixture with the organic solvent.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method of formulating a polypeptide using a denaturing organic solvent comprising
a) admixing the polypeptide in an aqueous solution with a polyol having a molecular weight less than about 70,000 kD, wherein the polyol is trehalose; - and
b) treating the polypeptide in the aqueous solution with the organic solvent. - View Dependent Claims (13, 14)
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15. A method of formulating a dry polypeptide for controlled release using a denaturing organic solvent comprising
a) admixing the polypeptide with an excipient, wherein said excipient is a polyol having a molecular weight less than about 70,000 kD, and the polyol is trehalose; - and
b) treating the product of step a) with the organic solvent. - View Dependent Claims (16)
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Specification