Granted Patent B2

US 12,514,837 · App. 18/934,749 · Granted Jan 6, 2026

Inventors: Martin Donovan (El Paso, TX); Wendy Hu (San Diego, CA); Richard Fitch (Chicago, IL); Steven Prestrelski (San Diego, CA)

Assignee: Xeris Pharmaceuticals, Inc.

A61K31/198A61K9/0019A61K9/08A61K47/02A61K47/20A61K47/26A61K47/34

Abstract

Claims (12)

1 . A storage stable therapeutic formulation, comprising:

(a) a therapeutic agent, which is levothyroxine or a salt thereof, at a concentration of about 10 mg/mL;

(b) an ionization stabilizing excipient, which is sulfuric acid, at a concentration of about 26 mM to about 32 mM;

(c) an aprotic polar solvent, which is dimethyl sulfoxide (DMSO);

(d) a sugar, which is trehalose or a salt or hydrate thereof, at a concentration of about 5.5% (w/v); and

(e) a sugar alcohol, which is mannitol, at a concentration of less than 3.0% (w/v);

wherein said formulation is storage stable for at least six months at 2° C.-8° C., and wherein said formulation, when administered parenterally to a subject in need thereof, results in the presence of therapeutic levels of levothyroxine in the blood of said subject for at least one week.

2 . The formulation of claim 1 , wherein the therapeutic agent is levothyroxine sodium or levothyroxine free acid.

3 . The formulation of claim 2 , wherein said formulation comprises levothyroxine sodium.

4 . The formulation of claim 1 , further comprising a preservative.

5 . The formulation of claim 1 , wherein the sugar is trehalose dihydrate.

6 . The formulation of claim 4 , wherein the preservative is a benzyl alcohol.

Assignments (1)

Continuity (3)

References Cited (28)