Stabilized insulin formulations
First Claim
1. An composition comprising a first insulin species and a second insulin species, wherein the first insulin species and the second insulin species form a heterodimeric complex;
- and wherein the first insulin species and the second insulin species are selected such that the heterodimeric complex is more stable than a homodimeric complex formed by the first insulin species or a homodimeric complex formed by the second insulin species.
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Accused Products
Abstract
The present invention is directed to stabilized insulin composition comprising a mixture of insulin species such as insulin and an insulin analog. As disclosed herein, insulin compositions comprising a mixture of insulin and insulin analog species form heterodimeric complexes having a greater stability than the homodimeric complexes formed in compositions comprising single insulin species. Consequently, the present invention provides methods for stabilizing insulin molecules, methods for identifying stable heterodimeric insulin complexes and stabilized insulin compositions.
24 Citations
32 Claims
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1. An composition comprising a first insulin species and a second insulin species, wherein the first insulin species and the second insulin species form a heterodimeric complex;
- and wherein the first insulin species and the second insulin species are selected such that the heterodimeric complex is more stable than a homodimeric complex formed by the first insulin species or a homodimeric complex formed by the second insulin species.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 10, 11, 12, 13, 16, 17, 18, 19, 20)
- 9. A composition comprising a combination of a first insulin species and a second insulin species, wherein the first and second insulin species are selected to generate a composition that is more stable than a composition having only the first insulin species or a composition having only the second insulin species.
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15. A method of making an insulin composition, comprising combining a first insulin species and a second insulin species, wherein the first insulin species and the second insulin species form a heterodimeric complex;
- and wherein the first insulin species and the second insulin species are selected such that the heterodimeric complex is more stable than a homodimeric complex formed by the first insulin species or a homodimeric complex formed by the second insulin species.
- 21. A method of stabilizing an insulin composition, comprising combining a first insulin species and a second insulin species, wherein the first and second insulin species are selected to generate a composition that is more stable than a composition having only the first insulin species or a composition having only the second insulin species.
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27. A method for identifying a stabilized insulin composition comprising the steps of combining a first insulin species with a second insulin species so that a heterodimeric complex formed from the first and second insulin species is generated, comparing the stability of the heterodimeric complex formed from the first and second insulin species with the stability of a homodimeric complex formed from the first insulin species or a homodimeric complex formed from the second insulin species and identifying a formulation wherein the heterodimeric complex formed from the first and second insulin species is more stable than homodimeric complex formed from the first insulin species or a homodimeric complex formed from the second insulin species.
- 30. A method for identifying a stabilized insulin composition comprising the steps of combining a first insulin species with a second insulin species and comparing the stability of the formulation having a combination of the first and second insulin species with the stability of a formulation having only the first insulin species or a formulation having only the second insulin species and identifying an insulin composition wherein the formulation generated by combining the first and second insulin species is more stable than a formulation having only the first insulin species or a formulation having only the second insulin species.
Specification