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Claims for Patent: 7,476,652

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Claims for Patent: 7,476,652

Title:Acidic insulin preparations having improved stability
Abstract:The invention relates to a pharmaceutical formulation comprising a polypeptide selected from the group consisting of insulin, an insulin metabolite, an insulin analog, an insulin derivative and combinations thereof; a surfactant or combinations of two or more surfactants; optionally a preservative or combinations of two or more preservatives; and optionally an isotonicizing agent, buffers or further excipients or combinations thereof, the pharmaceutical formulation having a pH in the acidic range.
Inventor(s): Brunner-Schwarz; Anette (Frankfurt, DE), Lill; Norbert (Kronberg, DE)
Assignee: Sanofi-Aventis Deutschland GmbH (Frankfurt, DE)
Application Number:11/089,777
Patent Claims: 1. A pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin; at least one chemical entity chosen from polysorbate 20 and polysorbate 80; at least one preservative; and water, wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.

2. The pharmaceutical formulation as claimed in claim 1, wherein the at least one chemical entity comprises polysorbate 20.

3. The pharmaceutical formulation as claimed in claim 2, wherein the at least one preservative is chosen from phenols.

4. The pharmaceutical formulation as claimed in claim 3, wherein at least one preservative is cresol.

5. The pharmaceutical formulation as claimed in claim 4, further including zinc.

6. The pharmaceutical formulation as claimed in claim 1 further including at least one isotonicizing agent.

7. A pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin, at least one chemical entity chosen from polysorbate and poloxamers; at least one preservative; and water, wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.

8. The pharmaceutical formulation as claimed in claim 2, wherein the polysorbate 20 is present in an effective amount to avoid turbidity.

9. The pharmaceutical formulation as claimed in claim 5, wherein the pharmaceutical formulation has a pH in the acidic range from 3.5 to 6.8.

10. The pharmaceutical formulation as claimed in claim 9, wherein the pharmaceutical formulation has a pH in the acidic range from 3.5 to 4.5.

11. The pharmaceutical formulation as claimed in claim 1, wherein the at least one preservative is chosen from phenol, cresol, chlorocresol, benzyl alcohol, and parabens.

12. The pharmaceutical formulation as claimed in claim 6, wherein the at least one isotonicizing agent is chosen from mannitol, sorbitol, lactose, dextrose, trehalose, sodium chloride, and glycerol.

13. The pharmaceutical formulation as claimed in claim 1, further comprising a buffer.

14. The pharmaceutical formulation as claimed in claim 13, wherein the buffer is chosen from TRIS, phosphate, citrate, acetate, and glycylglycine.

15. The pharmaceutical formulation as claimed in claim 1, wherein the Gly(A21), Arg(B31), Arg(B32)-human insulin is present in a concentration of 60-6000 nmol/ml.

16. The pharmaceutical formulation as claimed in claim 15, wherein the Gly(A21), Arg(B31), Arg(B32)-human insulin is present in a concentration of 240-3000 nmol/ml.

17. The pharmaceutical formulation as claimed in claim 1, wherein the at least one chemical entity is present in a concentration of 5-200 .mu.g/ml.

18. The pharmaceutical formulation as claimed in claim 17, wherein the at least one chemical entity is present in a concentration of 5-120 .mu.g/ml.

19. The pharmaceutical formulation as claimed in claim 18, wherein the at least one chemical entity is present in a concentration of 20-75 .mu.g/ml.

20. The pharmaceutical formulation as claimed in claim 12, wherein at least one isotonicizing agent is chosen from glycerol and mannitol and wherein said at least one isotonicizing agent is present in a concentration of 100-250 mM.

21. The pharmaceutical formulation as claimed in claim 1, wherein NaCl is present in a concentration of up to 150 mM.

22. The pharmaceutical formulation as claimed in claim 13, wherein said buffer is present in a concentration of 5-250 mM.

23. The pharmaceutical formulation as claimed in claim 6, wherein the at least one chemical entity comprises polysorbate 20, at least one preservative is cresol, and the pharmaceutical formulation has a pH in the acidic range from 3.5 to 4.5.

24. A pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin: at least one chemical entity chosen from polysorbate and poloxamers; at least one preservative chosen from cresol; and water, wherein the pharmaceutical formulation has a pH in the acidic range from 3.5 to 4.5.

25. The pharmaceutical formulation as claimed in claim 1, further comprising one or more excipients chosen from acids, alkalis and salts.
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