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Claims for Patent: 5,474,978

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Claims for Patent: 5,474,978

Title: Insulin analog formulations
Abstract:The present invention discloses a human insulin analog hexamer complex and formulations. More specifically, the present invention relates to various parenteral formulations, which comprise: human insulin analogs in a hexamer conformation, zinc ions, and at least three molecules of a phenolic derivative selected from the group consisting of m-cresol, phenol, or a mixture of m-cresol and phenol. The formulation provides a rapid onset of action.
Inventor(s): Bakaysa; Diane L. (Indianapolis, IN), Brems; David N. (Indianapolis, IN), Frank; Bruce H. (Indianapolis, IN), Havel; Henry A. (Indianapolis, IN), Pekar; Allen H. (Indianapolis, IN)
Assignee: Eli Lilly and Company (Indianapolis, IN)
Application Number:08/260,634
Patent Claims: 1. A human insulin analog complex, which comprises: six molecules of a human insulin analog, two zinc ions, and at least three molecules of a phenolic derivative selected from the group consisting of m-cresol, phenol, or a mixture of m-cresol and phenol; such that the insulin analog complex is a hexamer; wherein the human insulin analog is human insulin wherein Pro at position B28 is substituted with Asp, Lys, Leu, Val, or Ala, and Lys at position B29 is Lys or Pro; des(B28-B30)-human insulin; or des (B27 )-human insulin.

2. A parenteral pharmaceutical formulation comprising the human insulin analog complex of claim 1.

3. The parenteral pharmaceutical formulation of claim 2, which further comprises an isotonicity agent.

4. The parenteral pharmaceutical formulation of claim 3, which further comprises a physiologically tolerated buffer.

5. The parenteral pharmaceutical formulation of claim 4, wherein the buffer is sodium phosphate.

6. The parenteral pharmaceutical formulation of claim 5, wherein the isotonicity agent is glycerol.

7. The parenteral pharmaceutical formulation of claim 6, wherein the phenolic derivative is m-cresol.

8. The parenteral pharmaceutical formulation of claim 7, wherein the human insulin analog is Lys.sup.B28 Pro.sup.B29 -human insulin.

9. A human insulin analog composition of claim 1, wherein the human insulin analog is Lys.sup.B28 Pro.sup.B29 -human insulin.

10. A method of treating a patient suffering from diabetes mellitus, which comprises administering to said patient a pharmaceutical formulation containing the composition of claim 1.

11. The method of claim 10, wherein the human insulin analog is Lys.sup.B28 Pro.sup.B29 -human insulin.

12. A human insulin analog complex, consisting of: six molecules of a human insulin analog, two zinc ions, and at least three molecules of a phenolic derivative selected from the group consisting of m-cresol, phenol, or a mixture of m-cresol and phenol; such that the insulin analog complex is a hexamer;

wherein the human insulin analog is human insulin wherein Pro at position B28 is substituted with Asp, Lye, Leu, Val, or Ala, and Lys at position B29 is Lys or Pro; des(B28-B30)-human insulin; or des(B27)-human insulin.

13. A parenteral pharmaceutical formulation consisting of: about 3.5 mg/mL Lys.sup.B28 Pro.sup.B29 -human insulin, about 19.7 .mu.g/mL zinc, about 7 mM sodium phosphate, about 16 mg/mL glycerin, and about 29 mM m-cresol; wherein Lys.sup.B28 Pro.sup.B29 -human insulin is a hexamer.
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