LONG-ACTING FORMULATIONS OF INSULINS
The application relates to an aqueous pharmaceutical formulation comprising 200-1000 U/mL [equimolar to 200-1000 IU human insulin] of insulin glargine.
1 . An aqueous pharmaceutical formulation comprising 300 U/mL of insulin glargine [equimolar to 300 IU human insulin].
2 . The aqueous pharmaceutical formulation of claim 1 comprising an analogue of exendin-4.
3 . The aqueous pharmaceutical formulation of claim 2 , wherein the analogue of exedin-4 is selected from a group comprising lixisentatide, exenatide and liraglutide.
4 . The aqueous pharmaceutical formulation of claim 3 comprising 0.1 μg to 10 μg lixisenatide per U insulin glargine.
5 . The aqueous pharmaceutical formulation of claim 4 comprising 0.2 to 1 μg lixisenatide per U insulin glargine.
6 . The aqueous pharmaceutical formulation of claim 5 comprising 0.25 μg to 0.7 μg lixisenatide per U insulin glargine.
7 . The aqueous pharmaceutical formulation of claim 1 comprising at least one excipient selected from the group comprising zinc, m-cresol, glycerol, polysorbate 20 and sodium.
8 . The aqueous pharmaceutical formulation of claim 7 comprising 90 μg/mL zinc, 2.7 mg/mL m-cresol and 20 mg/ml glycerol 85%.
9 . The aqueous pharmaceutical formulation of claim 7 comprising 90 μg/mL zinc, 2.7 mg/mL m-cresol, 20 μg/mL polysorbate 20 and 20 mg/mL glycerol 85%.
10 . The aqueous pharmaceutical formulation of claim 1 , wherein the pH is between 3.4 and 4.6.
11 . The aqueous pharmaceutical formulation of claim 10 , wherein the pH is 4.
12 . The aqueous pharmaceutical formulation of claim 10 , wherein the pH is 4.5.
13 . A method of treating Type I and Type II Diabetes Mellitus in a patient comprising administering to said patient an aqueous pharmaceutical formulation comprising 300 U/mL of insulin glargine [equimolar to 300 IU human insulin].
14 . The method of claim 13 wherein said aqueous pharmaceutical formulation further comprises an analogue of exendin-4.
15 . The method of claim 14 wherein the analogue of exendin-4 is selected from a group comprising lixisentatide, exenatide and liraglutide.
16 . The method of claim 15 comprising 0.1 μg to 10 μg lixisenatide per U insulin glargine.
17 . The method of claim 16 comprising 0.2 to 1 μg lixisenatide per U insulin glargine.
18 . The method of claim 17 comprising 0.25 μg to 0.7 μg lixisenatide per U insulin glargine.
19 . The method of claim 13 further comprising at least one excipient selected from the group comprising zinc, m-cresol, glycerol, polysorbate 20 and sodium.
20 . The method of claim 19 comprising 90 μg/mL zinc, 2.7 mg/mL m-cresol and 20 mg/mL glycerol 85%.
21 . The method of claim 19 comprising 90 μg/mL zinc, 2.7 mg/mL m-cresol, 20 μg/mL polysorbate 20 and 20 mg/mL glycerol 85%.
22 . The method of claim 13 wherein the pH is between 3.4 and 4.6.
23 . The method of claim 22 wherein the pH is 4.
24 . The method of claim 22 wherein the pH is 4.5.
25 . An aqueous pharmaceutical formulation comprising 300 U/mL of insulin glargine [equimolar to 300 IU human insulin], 90 μg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, HCL and NaOH ad and having a pH of 4.0.