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Claims for Patent: 8,846,618

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Claims for Patent: 8,846,618

Title:Stable formulation of modified GLP-1
Abstract: Pharmaceutical formulations of GLP-1 compounds and methods for preparation thereof.
Inventor(s): Flink; James M. (Klanpenborg, DK), Larsen; Silke Moller (Charlottenlund, DK), Jensen; Simon Bjerregaard (Frederiksberg, DK), Engelund; Dorthe Kot (Holte, DK)
Assignee: Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:12/785,861
Patent Claims: 1. A pharmaceutical formulation comprising: a GLP-1 compound, wherein said GLP-1 compound is: Arg.sup.34, Lys.sup.26(N-.epsilon.-(.gamma.-Glu(N-.alpha.-hexadecanoyl)))-GLP-1 (7-37), and wherein said GLP-1 compound binds to a GLP-1 receptor with an affinity constant (K.sub.D) below about 1 .mu.M or a potency EC.sub.50 below about 1 .mu.M, and wherein said GLP-1 compound is present in a concentration from 0.1 mg/ml to 100 mg/ml; an isotonic agent; a buffer; and a preservative; wherein said pharmaceutical formulation has a pH from 7.5 to 9.4.

2. The formulation according to claim 1, further comprising water.

3. The formulation according to claim 1, wherein the concentration of said GLP-1 compound is from 0.1 mg/ml to 10 mg/ml.

4. The formulation according to claim 1, wherein the concentration of said GLP-1 compound is 1-5 mg/ml.

5. The formulation according to claim 1, wherein said preservative is present in a concentration from 0.1 mg/ml to 20 mg/ml.

6. The formulation according to claim 1, wherein said isotonic agent is present in a concentration from 1 mg/ml to 50 mg/ml.

7. The formulation according to claim 1, further comprising a chelating agent.

8. The formulation according to claim 7, wherein said chelating agent is present in a concentration from 0.1 mg/ml to 5 mg/ml.

9. The formulation according to claim 1, further comprising a stabiliser.

10. The formulation according to claim 9, wherein said stabiliser is selected from the group consisting of L-histidine, imidazole and arginine.

11. The formulation according to claim 9, wherein said stabiliser is a high molecular weight polymer and/or a low molecular weight compound and is present in a concentration from 0.1 mg/ml to 50 mg/ml.

12. The formulation according to claim 1, further comprising a surfactant.

13. A method of preparing a physically stable pharmaceutical formulation of a GLP-1 compound wherein said GLP-1 compound is Arg.sup.34, Lys.sup.26(N-.epsilon.-(.gamma.-Glu(N-.alpha.-hexadecanoyl)))-GLP-1(7-37)- , and wherein said GLP-1 compound binds to a GLP-1 receptor with an affinity constant (K.sub.D) below about 1 .mu.M or a potency EC.sub.50 below about 1 .mu.M, said method comprising preparing a formulation containing the GLP-1 compound, an isotonic agent, a preservative, and a buffer, wherein said GLP-1 compound is present in a concentration from 0.1 mg/ml to 100 mg/ml, and wherein said formulation has a pH from 7.5 to 9.4.

14. A pharmaceutical formulation comprising: a GLP-1 compound, wherein said GLP-1 compound is Arg.sup.34, Lys.sup.26(N-.epsilon.-(.gamma.-Glu(N-.alpha.-hexadecanoyl)))-GLP-1 (7-37), and wherein said GLP-1 compound binds to a GLP-1 receptor with an affinity constant (K.sub.D) below about 1 .mu.M or a potency EC.sub.50 below about 1 .mu.M; an isotonic agent; a buffer; and a preservative; wherein said pharmaceutical formulation has a pH from 7.5 to 9.4.
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