Acidic insulin preparations having improved stability
DC CAFCFirst Claim
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1. A pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin;
- at least one chemical entity chosen from esters and ethers of polyhydric alcohols;
at least one preservative; and
water,wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8.
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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.
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Citations
20 Claims
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1. A pharmaceutical formulation comprising Gly(A21), Arg(B31), Arg(B32)-human insulin;
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at least one chemical entity chosen from esters and ethers of polyhydric alcohols; at least one preservative; and water, wherein the pharmaceutical formulation has a pH in the acidic range from 1 to 6.8. - View Dependent Claims (2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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7. The pharmaceutical formulation as claimed in claimed 6, wherein the pharmaceutical formulation has a pH in the acidic range from 3.5 to 4.5.
Specification