Zinc-free and low-zinc insulin preparations having improved stability
First Claim
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1. An aqueous liquid formulation comprisingat least one insulin;
- at least one surfactant;
optionally at least one preservative; and
optionally at least one of an isotonicizing agent, a buffer, and an excipient, wherein the formulation is stable and free from or contains less than 0.2% by weight of zinc based on the insulin content of the formulation.
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Abstract
The invention relates to a formulation comprising a polypeptide selected from at least one of insulin, an insulin metabolite, an insulin analog, and an insulin derivative; at least one surfactant; optionally at least one preservative; and optionally at least one of an isotonicizing agent, a buffer or an excipient, wherein the formulation is free from or low in zinc. The invention also relates to the production of such insulin preparations and their use as pharmaceutical formulations.
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Citations
56 Claims
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1. An aqueous liquid formulation comprising
at least one insulin; -
at least one surfactant; optionally at least one preservative; and optionally at least one of an isotonicizing agent, a buffer, and an excipient, wherein the formulation is stable and free from or contains less than 0.2% by weight of zinc based on the insulin content of the formulation. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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29. An aqueous liquid formulation comprising
at least one insulin; -
at least one surfactant; optionally at least one preservative; and optionally at least one of an isotonicizing agent, a buffer, and an excipient, wherein the formulation is stable and free from zinc or contains less than a 2;
6 ratio of zinc to insulin. - View Dependent Claims (30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56)
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Specification