Methods for rapidly treating severe hypoglycemia

摘要

Disclosed is a method for treating or preventing hypoglycemia in a patient comprising administering an effective amount of a composition comprising a glucagon peptide which has been dried in a non-volatile buffer, and wherein the glucagon peptide has a pH memory that is about equal to the pH of the glucagon peptide in the non-volatile buffer, and an aprotic polar solvent, wherein the moisture content of the formulation is less than 5%, and wherein the dried glucagon peptide maintains the pH memory that is about equal to the pH of the glucagon peptide in the non-volatile buffer when the dried glucagon peptide is reconstituted in the aprotic polar solvent, wherein the patient has been diagnosed as having a blood glucose level between 0 mg/dL and less than 50 mg/dL or has an indication of impending hypoglycemia based on a blood glucose monitoring device before administration of the composition, and wherein the patient has a blood glucose level greater than 50 mg/dL to 180 mg/dL within 1 to 20 minutes after administration of the composition.

主权项

1. A method for treating hypoglycemia in a patient comprising administering an effective amount of a composition consisting essentially of:
(a) about 0.45 wt. % of a glucagon peptide which has been dried in a non-volatile glycine buffer, and wherein the glucagon peptide has a pH memory that is about equal to the pH of the glucagon peptide in the non-volatile buffer, wherein the pH memory is between 2.5 to 3.5; (b) about 92 wt. % to 96 wt. % of an aprotic polar solvent, wherein the peptide is solubilized in the aprotic polar solvent, and wherein the aprotic polar solvent is dimethyl sulfoxide (DMSO); (c) about 3 wt. % to 7 wt. % of trehalose; (d) about 0.01 wt. % of glycine; and (e) optionally hydrochloric acid, wherein the moisture content of the composition is less than 5 wt. %.