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US 2019/0160153 A1Published application
Liquid insulin formulations and methods relating thereto
AssigneeDance Biopharm Inc.
InventorsBlaine Bueche, Mei-Chang Kuo, John Patton, Matthew Sander
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Abstract
Liquid formulations of insulin that contain physically and chemically stable insulin but do not contain preservatives or stabilizers are provided. The formulations also lack surfactants. The formulations are useful for various modes of delivery including pulmonary delivery.
Claims20
A method of treating a subject with diabetes mellitus, comprising administering to a subject having diabetes mellitus a therapeutically effective amount of an insulin formulation, comprising:
- insulin at a minimal concentration of 1-13 mM;
- a salt at a concentration of 50-150 mM;
- a pH buffering agent at a concentration of 3-24 mM;
- zinc at a ratio of 1.9-2.7 zinc ions per insulin hexamer;
- and
- a pH in the range of 7.2 to 8.0,
- wherein the formulation does not contain preservatives or stabilizers, and
- wherein the formulation is administered to the subject via injection.
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Dependencies are inferred from the claim text.