Stable insulin formulations
First Claim
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1. A solution formulation comprising:
- a physiologically tolerated buffer selected from the group consisting of TRIS and arginine;
a monomeric insulin analog wherein the insulin analog is LysB28 ProB29 -human insulin;
zinc; and
a phenolic preservative.
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Abstract
The present invention provides a monomeric insulin analog formulation stabilized against aggregation in which the buffering agent is either TRIS or arginine. The stable formulations of the present invention are useful for treating diabetes, and are particularly advantageous in treatment regimes requiring lengthy chemical and physical stability, such as, in continuous infusion systems.
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Citations
19 Claims
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1. A solution formulation comprising:
- a physiologically tolerated buffer selected from the group consisting of TRIS and arginine;
a monomeric insulin analog wherein the insulin analog is LysB28 ProB29 -human insulin;
zinc; and
a phenolic preservative. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15, 16, 17, 18, 19)
- a physiologically tolerated buffer selected from the group consisting of TRIS and arginine;
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12. A stable, soluble formulation of a monomeric insulin analog, for use in a continuous infusion system, consisting essentially of:
- an isotonicity agent;
a buffer selected from the group consisting of TRIS and arginine;
LysB28 ProB29 -human insulin;
zinc; and
a phenolic preservative.
- an isotonicity agent;
Specification