Pharmaceutical Formulations Comprising an Insulin Derivative
AssigneeNovo Nordisk A/S
InventorsChristian Poulsen, Kasper Huus, Frantisek Hubalek, Dorte Bjerre Steensgaard, Sven Havelund
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Abstract
The invention concerns a soluble pharmaceutical formulation comprising an insulin derivative wherein the formulation further comprises more than 4 zinc atoms per 6 molecules of the insulin derivative, and a citric acid monohydrate and/or a histidine compound used in an amount sufficient to increase the tendency of the insulin derivative to self-associate into dodecamers. The invention further comprises a process for preparing the soluble pharmaceutical formulation.
Claims15
A soluble pharmaceutical formulation comprising an insulin derivative wherein the formulation further comprises
- a) more than 4 zinc atoms per 6 molecules of the insulin derivative,
- b) citric acid monohydrate and/or a histidine compound used in an amount sufficient to increase the tendency of the insulin derivative to self-associate into dodecamers.
A shelf-stable soluble pharmaceutical formulation comprising an insulin derivative wherein the formulation further comprises
- a) more than 4 zinc atoms per 6 molecules of insulin derivative
- b) citric acid monohydrate and/or a histidine compound used in an amount sufficient to increase the tendency of the insulin derivative to self-associate into dodecamers.
A soluble pharmaceutical formulation comprising an insulin derivative for the treatment of type 1 diabetes, type 2 diabetes and other states that cause hyperglycaemia in patients in need of such a treatment, wherein the formulation further comprises
- a) more than 4 zinc atoms per 6 molecules of the insulin derivative,
- b) citric acid monohydrate and/or a histidine compound used in an amount sufficient to increase the tendency of the insulin derivative to self-associate into dodecamers.
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A process for preparing a soluble pharmaceutical formulation comprising
- a) Providing an aqueous phase comprising an insulin derivative,
- b) Providing more than about 4 zinc ions per 6 molecules of the insulin derivative,
- c) Providing citric acid monohydrate and/or a histidine compound to increase the tendency of the insulin derivative to self-associate to dodecamer form,
- mixing the aqueous phase, the zinc ions and the citric acid monohydrate and/or the histidine compound to form a soluble pharmaceutical formulation.
A process for preparing a shelf-stable soluble pharmaceutical formulation comprising
- a) Providing an aqueous phase comprising an insulin derivative
- b) Providing more than about 4 zinc ions per 6 molecules of the insulin derivative,
- c) Providing citric acid monohydrate and/or a histidine compound to increase the tendency of the insulin derivative to self-associate to dodecamer form,
- mixing the aqueous phase, the zinc ions and the citric acid monohydrate and/or a histidine compound to form a soluble pharmaceutical formulation.
Dependencies are inferred from the claim text.