Acidic Insulin Preparations Having Improved Stability
First Claim
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1. A pharmaceutical formulation comprising:
- (a) Gly(A21), Arg(B31), Arg(B32)-human insulin;
(b) polysorbate 20;
(c) sodium chloride;
(d) glycerol;
(e) m-cresol; and
(f) water,wherein the pharmaceutical formulation has a pH in the acidic range from 3.5 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
13 Claims
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1. A pharmaceutical formulation comprising:
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(a) Gly(A21), Arg(B31), Arg(B32)-human insulin; (b) polysorbate 20; (c) sodium chloride; (d) glycerol; (e) m-cresol; and (f) water, wherein the pharmaceutical formulation has a pH in the acidic range from 3.5 to 6.8. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. The pharmaceutical formulation as claimed in claimed 1, wherein the pharmaceutical formulation has a pH in the acidic range from 3.5 to 4.5.
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13. The pharmaceutical formulation as claimed in claimed 1, wherein the pharmaceutical formulation has a pH of 4 (+/−
- 0.2).
Specification