Reconstituted high density lipoprotein formulation and production method thereof
AssigneeCSL Limited
InventorsSamuel Wright, Martin Imboden, Reinhard Bolli, Marcel Waelchli
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Abstract
A reconstituted high density lipoprotein formulation having relatively low toxicity comprises an apolipoprotein such as ApoAI or fragment thereof, a lipid and a detergent at a level which is about 5-50% of that which would normally cause liver toxicity upon administration to a human. The lipid is optimally phosphatidylcholine at about 30-50 g/L and the molar ratio of apolipoprotein:lipid is optimally in the range 1:40 to 1:75. The formulation is useful for treating diseases or conditions such as cardiovascular disease, hypercholesterolaemia and hypocholesterolaemia inclusive of acute coronary syndrome (ACS), atherosclerosis and myocardial infarction.
Claims11
A reconstituted high density lipoprotein (rHDL) formulation comprising an apolipoprotein;
- a lipid;
- and a detergent at a level selected from the group consisting of about 0.5-1.5 g/L and about 0.010-0.030 g/g apolipoprotein;
- wherein the apolipoprotein is Apo-A1, the lipid is phosphatidylcholine, and the detergent is sodium cholate.
A method of producing a rHDL formulation comprising an apolipoprotein;
- a lipid;
- and a detergent, said method including the step of providing said detergent at a level selected from the group consisting of about 0.5-1.5 g/L and about 0.010-0.030 g/g apolipoprotein;
- wherein the apolipoprotein is Apo-A1, the lipid is phosphatidylcholine, and the detergent is sodium cholate.
A method of treating a disease, disorder or condition selected from the group consisting of one or more of cardiovascular disease, hypercholesterolaemia or hypocholesterolaemia in a human including the step of administering to the human a rHDL formulation, to thereby treat said disease, disorder or condition in the human;
- wherein the rHDL formulation comprises an apolipoprotein or fragment thereof;
- a lipid;
- and a detergent at a level selected from the group consisting of about 0.5-1.5 g/L and about 0.010-0.030 g/g apolipoprotein.
Dependencies are inferred from the claim text.