Insulin analog formulations
AssigneeEli Lilly and Company
InventorsDiane L. Bakaysa, David N. Brems, Bruce H. Frank, Henry A. Havel, Allen H. Pekar
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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.
Claims13
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.
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.
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.
Dependencies are inferred from the claim text.