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US 11,590,205 B2Granted
Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents
AssigneeXeris Pharmaceuticals, Inc.
InventorsSteven Prestrelski, Martin Donovan, Michael Sandoval
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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.
Claims8
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.
3 more elements
Dependencies are inferred from the claim text.