Self-emulsifying formulations of fenofibrate and/or fenofibrate derivatives with improved oral bioavailability and/or reduced food effect

A method of treating a subject suffering from endogenous hyperlipidaemia, hypercholesterolaemia and/or hypertriglyceridaemia, comprising administering to the subject a self-emulsifying oral pharmaceutical formulation with improved bioavailability, wherein said formulation consists essentially of:

• a therapeutically effective amount of fenofibrate or a fenofibrate derivative;
• at least one surfactant;
• about 20% to about 80% one or more fibrate solubilizers selected from N-alkyl derivative of 2-pyrrolidone, monoethylene glycol monoethers, diethylene glycol monoethers, higher-ethylene glycol monoethers, polyethylene glycol monoethers, C8-12 fatty acid mono- or diesters of propylene glycol, and combinations thereof;
• and
• up to about 30% one or more stabilizers;
• wherein the fibrate to solubilizer weight ratio is between about 1:1 and about 1:100 and the saturation factor is between about 1.05 and about 2.5 and the stabilizer is present in sufficient amounts to prevent crystal growth.

A method of treating a subject suffering from endogenous hyperlipidaemia, hypercholesterolaemia and/or hypertriglyceridaemia, comprising administering to the subject a fibrate formulation, wherein said formulation consists essentially of a fibrate dissolved in at least one fibrate solubilizer, at least one surfactant and, at least one stabilizer,

• wherein said at least one fibrate solubilizer is selected from the group consisting of N-alkyl derivative of 2-pyrrolidone, monoethylene glycol monoethers, diethylene glycol monoethers, higher-ethylene glycol monoethers, polyethylene glycol monoethers, C8-12 fatty acid mono- or diesters of propylene glycol, and combinations thereof;
• wherein said at least one surfactant is selected from the group consisting of at least one ionic or non-ionic surfactant and combinations thereof;
• and
• wherein the fibrate is between about 5 W/W % and about 40 W/W %, the fibrate solubilizer is between about 20 W/W % and about 80 W/W %;
• the surfactant is between about 2 W/W %, and about 25 W/W %;
• and stabilizer is between about 0 W/W % and 30 W/W %;
• and the stabilizer is present in an amount sufficient to prevent the crystal growth of the fibrate.