Stabilized acylated insulin formulations
OwnerMark L. Brader, Michael J. Beckageinventors
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Abstract
A storage stable formulation comprising an aqueous solution suitable for parenteral delivery, particularly as an injectable formulation to a patient, preferably having a pH of 7.1 to 7.6, containing a fatty acid-acylated insulin or a fatty acid-acylated insulin analog and stabilized using zinc and preferably a phenolic compound.
Claims26
A storage stable insulin formulation comprising an aqueous solution of a fatty acid-acylated insulin containing at least about 0.2 to 0.7 mole of zinc per mole of said fatty acid-acylated insulin and having a pH of 6.8 to 7.8.
A storage stable insulin formulation comprising an aqueous solution of a fatty acid-acylated insulin analog containing at least about 0.2 to 0.7 mole of zinc per mole of said fatty acid-acylated insulin and having a pH of 6.8 to 7.8.
A storage stable acylated insulin formulation comprising a lyophilized powder of said acylated insulin fortified with zinc in an amount of 0.2 to 0.7 mole zinc per mole of said acylated insulin.
Dependencies are inferred from the claim text.