Last Updated: May 10, 2026

Claims for Patent: 11,590,205

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Summary for Patent: 11,590,205

Title:	Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents
Abstract:	Certain embodiments are directed to a formulation of a therapeutic agent, as well as a method of making such a formulation, comprising at least one therapeutic agent dissolved in an aprotic polar solvent system comprising at least one ionization stabilizing excipient in a concentration sufficient to impart physical and chemical stability to the therapeutic agent.
Inventor(s):	Steven Prestrelski, Martin Donovan, Michael Sandoval
Assignee:	Xeris Pharmaceuticals Inc
Application Number:	US15/763,050
Patent Claims:	1. A stable formulation comprising: (a) a glucagon peptide or salt thereof at a concentration of 5 mg/mL; (b) sulfuric acid as an ionization stabilizing excipient at a concentration of between greater than 2.0 and up to 12.6 mM; (c) dimethyl sulfoxide (DMSO) as an aprotic polar solvent; and (d) trehalose at less than 10, 5, or 3% w/v; wherein the glucagon peptide or salt thereof and sulfuric acid are dissolved directly in DMSO without drying the glucagon peptide or salt thereof from a buffered aqueous solution prior to reconstitution in DMSO. 2. The formulation of claim 1, wherein the moisture content is less than 10, 5, or 3% w/w. 3. The formulation of claim 1, further comprising a preservative at less than 10, 5, or 3% w/v. 4. The formulation of claim 3, wherein the preservative is benzyl alcohol. 5. A method of treating hypoglycemia in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of the stable formulation of claim 1. 6. The method of claim 5, wherein the administering is by parenteral injection. 7. The method of claim 6, wherein the injection is intracutaneous injection. 8. A method of preparing the stable formulation of claim 1, wherein the method comprises the steps of: (a) mixing sulfuric acid with DMSO; and (b) dissolving the glucagon peptide or salt thereof directly in DMSO containing sulfuric acid without drying the glucagon peptide or salt thereof from a buffered aqueous solution prior to reconstitution in DMSO, wherein sulfuric acid is present in DMSO at a concentration of between greater than 2.0 and up to 12.6 mM.

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