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US 10,987,399 B2Granted
Stable formulations for parenteral injection of peptide drugs
AssigneeXeris Pharmaceuticals, Inc.
InventorsSteven Prestrelski, John Kinzell
Life of this patent
Estimating the term…
Abstract
Stable formulations for parenteral injection of peptide drugs and methods of using such stable formulations are provided. In particular, the present invention provides stable formulations for parenteral injection of glucagon and methods of using such glucagon formulations to treat hypoglycemia, especially severe hypoglycemia in emergency situations.
Claims16
A stable solution for parenteral injection, comprising:
- a pramlintide peptide or a salt thereof, wherein the pramlintide peptide has been dried in a non-volatile buffer selected from glycine buffers, citrate buffers, phosphate buffers, and mixtures thereof, and wherein the dried pramlintide peptide has a pH memory of from about 3.0 to about 6.0 that is about equal to the pH of the pramlintide peptide in the non-volatile buffer, solubilized in an aprotic polar solvent selected from dimethyl sulfoxide (DMSO), N-methyl-2-pyrrolidone (NMP), ethyl acetate, or a mixture thereof;
- wherein the moisture content of the formulation is less than 5% w/w, and wherein the dried pramlintide peptide maintains the pH memory that is about equal to the pH of the peptide in the non-volatile buffer when the dried pramlintide peptide is solubilized in the aprotic polar solvent.
A stable solution for parenteral injection, comprising:
- a pramlintide peptide or a salt thereof, wherein the pramlintide peptide has been dried in a non-volatile buffer, and wherein the dried pramlintide peptide has a pH memory of from about 3.0 to about 6.0 that is about equal to the pH of the pramlintide peptide in the non-volatile buffer, solubilized in an aprotic polar solvent selected from dimethyl sulfoxide (DMSO), N-methyl-2-pyrrolidone (NMP), ethyl acetate, or a mixture thereof;
- wherein the moisture content of the formulation is less than 5% w/w, and wherein the dried pramlintide peptide maintains the pH memory of from about 3.0 to about 6.0 that is about equal to the pH of the pramlintide peptide in the non-volatile buffer when the dried pramlintide peptide is solubilized in the aprotic polar solvent.
Dependencies are inferred from the claim text.