Pulmonary insulin crystals
AssigneeNovo Nordisk A/S
InventorSvend Havelund
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Abstract
The present invention relates to zinc free insulin crystals having a diameter below 10 μm and to therapeutic powder formulations suitable for pulmonary administration containing such insulin crystals. The crystals of the present invention exhibit a better stability profile than powders of essentially the same composition prepared by spray drying, freeze-drying, vacuum drying and open drying. The therapeutic powder formulations elucidate better flowing properties than corresponding amorphous powder formulations.
Claims18
Zinc free insulin crystals having a diameter below 10 μm, wherein said insulin is selected from the group consisting of human insulin and LysB29(N-ε-acylated) des(B30) human insulin.
A method for the preparation of zinc free insulin crystals having a diameter below 10 μm, comprising the steps of:
- a) providing a first solution of insulin having a pH between 7.0 and 9.5;
- b) mixing said first solution with a second solution of a salt of an alkali metal or an ammonium salt, wherein either or both of said first and second solutions comprises a water miscible organic solvent selected from the group consisting of ethanol, methanol, acetone and 2-propanol in an amount which provides a concentration of said organic solvent of 5 to 25% (v/v) in the solution obtained after mixing, and wherein the first and second solution are mixed within a period of less than 15 minutes;
- and
- c) recovering the formed crystals.
Dependencies are inferred from the claim text.