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US 2026/0144850 A1Published application
Long-Acting Formulations of Insulin
AssigneeSanofi
InventorsReinhard Becker, Annke Hahn, Peter Boderke, Christiane Fuerst, Werner Mueller, Ulrich Werner
Life of this patent
Estimating the term…
Abstract
The application relates to an aqueous pharmaceutical formulation comprising 200-1000 U/mL [equimolar to 200-1000 IU human insulin] of insulin glargine.
Claims16
1:
- An aqueous pharmaceutical formulation comprising 200-1000 U/mL [equimolar to 200-1000 IU human insulin] of insulin glargine.
2:
- The aqueous pharmaceutical formulation of claim 2, wherein the aqueous pharmaceutical formulation comprises 270-330 U/mL of insulin glargine [equimolar to 270-330 IU human insulin].
3:
- The aqueous pharmaceutical formulation of claim 1, wherein the aqueous pharmaceutical formulation comprises at least one excipient selected from the group consisting of zinc, m-cresol, glycerol, polysorbate 20, and sodium.
4:
- The aqueous pharmaceutical formulation of claim 3, wherein the aqueous pharmaceutical formulation comprises 90 μg/mL zinc, 2.7 mg/mL m-cresol, and 20 mg/ml glycerol 85%.
5:
- The aqueous pharmaceutical formulation of claim 3, wherein the aqueous pharmaceutical formulation comprises 90 μg/mL zinc, 2.7 mg/mL m-cresol, 20 μg/mL polysorbate 20, and 20 mg/mL glycerol 85%.
6:
- The aqueous pharmaceutical formulation of claim 1, wherein the pH of the aqueous pharmaceutical formulation is between 3.4 and 4.6.
7:
- The aqueous pharmaceutical formulation of claim 6, wherein the pH of the aqueous pharmaceutical formulation is 4.
8:
- The aqueous pharmaceutical formulation of claim 6, wherein the pH of the aqueous pharmaceutical formulation is 4.5.
9:
- A method of treating Type I and Type II Diabetes Mellitus in a patient in need thereof, comprising administering to the patient an aqueous pharmaceutical composition comprising 200-1000 U/mL [equimolar to 200-1000 IU human insulin] of insulin glargine.
10:
- The method of claim 9, wherein the aqueous pharmaceutical composition comprises 270-330 U/mL of insulin glargine [equimolar to 270-330 IU human insulin].
11:
- The method of claim 9, wherein the aqueous pharmaceutical composition comprises at least one excipient selected from the group consisting of zinc, m-cresol, glycerol, polysorbate 20, and sodium.
12:
- The method of claim 11, wherein the aqueous pharmaceutical composition comprises 90 μg/mL zinc, 2.7 mg/mL m-cresol, and 20 mg/ml glycerol 85%.
13:
- The method of claim 11, wherein the aqueous pharmaceutical composition comprises 90 μg/mL zinc, 2.7 mg/mL m-cresol, 20 μg/mL polysorbate 20, and 20 mg/mL glycerol 85%.
14:
- The method of claim 9, wherein the pH of the aqueous pharmaceutical composition is between 3.4 and 4.6.
15:
- The method of claim 14, wherein the pH of the aqueous pharmaceutical composition is 4.
16:
- The method of claim 14, wherein the pH of the aqueous pharmaceutical composition is 4.5.