Soluble, stable insulin-containing formulations with a protamine salt
AssigneeNovo Nordisk A/S
InventorsHelle Birk Olsen, Niels Christian Kaarsholm, Per Balschmidt
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Abstract
The present invention relates to pharmaceutical formulations comprising insulin, an insulin analog, an insulin derivative, or a combination of any of the foregoing, and a salt of protamine, to methods of preparing such formulations, and to uses of such formulations in the treatment of diseases and conditions for which use of the insulin peptide(s) contained in such formulations is indicated. The present invention further relates to methods for increasing the stability and/or solubility of insulin in insulin-containing formulations at a pH less than 7.0 by adding a salt of protamine to the insulin-containing formulations.
Claims18
A pharmaceutical formulation which is a solution comprising an insulin, an insulin analog or an insulin derivative or a mixture thereof and a protamine salt, wherein said protamine salt is selected from the group consisting of propionate, lactate, formiate, nitrate and acetate salts of protamine, and is present in said formulation in a concentration of greater than 0.25 mM and wherein said formulation has a pH of about 4.5-6.0.
Dependencies are inferred from the claim text.