Novel formulations
AssigneeArecor Limited
InventorsDavid GERRING, Sarah HOWELL, Jan JEZEK, Leon ZAKRZEWSKI
Life of this patent
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Abstract
There is provided inter alia an aqueous liquid pharmaceutical formulation comprising (i) an insulin compound, (ii) ionic zinc, (iii) a zinc binding species at a concentration of 1 mM or more selected from species having a log K with respect to zinc ion binding in the range 4.5-12.3 at 25° C., and (iv) a non-ionic surfactant which is an alkyl glycoside; and wherein the formulation is substantially free of EDTA and any other zinc binding species having a log K with respect to zinc ion binding of more than 12.3 at 25° C.
Claims73
An aqueous liquid pharmaceutical formulation comprising (i) an insulin compound, (ii) ionic zinc, (iii) a zinc binding species at a concentration of 1 mM or more selected from species having a log K with respect to zinc ion binding in the range 4.5-12.3 at 25° C., and (iv) a non-ionic surfactant which is an alkyl glycoside;
- and wherein the formulation is substantially free of EDTA and any other zinc binding species having a log K with respect to zinc ion binding of more than 12.3 at 25° C.
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A dry solid pharmaceutical composition suitable for reconstitution with an aqueous medium which comprises, following reconstitution, (i) an insulin compound, (ii) ionic zinc, (iii) a zinc binding species at a concentration of 1 mM or more selected from species having a log K with respect to zinc ion binding in the range 4.5-12.3 at 25° C., and (iv) a non-ionic surfactant which is an alkyl glycoside;
- and wherein the composition is substantially free of EDTA and any other zinc binding species having a log K with respect to zinc ion binding of more than 12.3 at 25° C.
A method of improving the storage stability of an aqueous liquid pharmaceutical formulation comprising (i) an insulin compound, (ii) ionic zinc and (iii) a zinc binding species at a concentration of 1 mM or more selected from species having a log K with respect to zinc ion binding in the range 4.5-12.3 at 25° C.;
- wherein the formulation is substantially free of EDTA and any other zinc binding species having a log K with respect to zinc ion binding of more than 12.3 at 25° C.;
- which comprises adding a non-ionic surfactant which is an alkyl glycoside to the formulation.
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An aqueous liquid pharmaceutical formulation comprising (i) an insulin compound at a concentration of 400-1000 U/ml and (ii) ionic zinc;
- wherein the formulation is bioequivalent to a corresponding formulation comprising the insulin compound at a concentration of 100 U/ml.
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Dependencies are inferred from the claim text.