Reconstituted HDL formulation
AssigneeCSL Limited
InventorsYvonne Vucica, Gary Lee Warren
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Abstract
The present invention relates to reconstituted high density lipoprotein (rHDL) formulations comprising an apolipoprotein, a lipid and a lyophilization stabilizer. Said formulations have reduced renal toxicity and good long-term stability, especially in lyophilized form.
Claims20
A reconstituted high density lipoprotein (rHDL) formulation comprising an apolipoprotein, a lipid, and a lyophilization stabilizer, wherein the ratio between the apolipoprotein and the lipid is from about 1:45 to about 1:65 (mol:mol), and the total concentration of all lyophilization stabilizers present in the composition is from about 1.0% to less than 6.0% (w/w of the rHDL formulation).
A method of producing a rHDL formulation comprising an apolipoprotein, a lipid, and a lyophilization stabilizer having a ratio between the apolipoprotein and the lipid of from about 1:45 to about 1:65 (mol:mol), comprising adding the lyophilization stabilizer to a solution comprising the lipid and the apolipoprotein to provide a total concentration of all lyophilization stabilizers present in the rHDL formulation of from about 1.0% to less than 6.0% (w/w) is reached.
Dependencies are inferred from the claim text.