Abstract: The present invention is directed to a formulation comprising a lipid-regulating agent dissolved in one or more non-aqueous and/or water-miscible solvents, or optionally, in a premix of one or more solvents and one or more surfactants.

Abstract: The present invention is directed to a semi-solid formulation comprising a lipid-regulating agent. Said formulation is prepared by solubilizing said lipid-regulating agent in one or more liquid components to form a clear liquid solution, then solidifying said solution by adding one or more solid or semi-solid components to said solution to form a semi-solid formulation. Said formulation can melt or dissolve upon mixing with a bulk aqueous medium. The resulting formulation results in an increase in drug solubility and oral bioavailability, and an improved dissolution rate.

Abstract: The present invention relates to a stabilized self-emulsifying system, comprising a therapeutically effective amount of o-(chloroacetylcarbamoyl)fumigillol, a pharmaceutically acceptable carrier and a stabilizing component, wherein the pharmaceutically acceptable carrier comprises an oily constituent and at least one surfactant. The stabilizing component comprises from about 1% to about 15% water relative to the weight of the self-emulsifying system, an acid, an adsorbent, or a complex-forming agent.

Abstract: The present invention relates to a stabilized self-emulsifying system, comprising a therapeutically effective amount of o-(chloroacetylcarbamoyl)fumigillol, a pharmaceutically acceptable carrier and a stabilizing component, wherein the pharmaceutically acceptable carrier comprises an oily constituent and at least one surfactant. The stabilizing component comprises from about 1% to about 15% water relative to the weight of the self-emulsifying system, an acid, an adsorbent, or a complex-forming agent.

Abstract: The present invention relates to a stabilized self-emulsifying system, comprising a therapeutically effective amount of o-(chloroacetylcarbamoyl)fumigillol, a pharmaceutically acceptable carrier and a stabilizing component, wherein the pharmaceutically acceptable carrier comprises an oily constituent and at least one surfactant. The stabilizing component comprises from about 1% to about 15% water relative to the weight of the self-emulsifying system, an acid, an adsorbent, or a complex-forming agent.

Abstract: The present invention is directed to a semi-solid formulation comprising a lipid-regulating agent. Said formulation is prepared by solubilizing said lipid-regulating agent in one or more liquid components to form a clear liquid solution, then solidifying said solution by adding one or more solid or semi-solid components to said solution to form a semi-solid formulation. Said formulation can melt or dissolve upon mixing with a bulk aqueous medium. The resulting formulation results in an increase in drug solubility and oral bioavailability, and an improved dissolution rate.

Abstract: The present invention is directed to a process for preparing a formulation comprising a lipid-regulating agent dissolved in a supercritical fluid, spraying the solution through a nozzle to form small particles of the lipid-regulating agent, forming a suspension of the particles of said lipid-regulating agent in a liquid, and collecting the particles.

Abstract: The present invention is directed to a formulation comprising a lipid-regulating agent dissolved in one or more non-aqueous and/or water-miscible solvents, or optionally, in a premix of one or more solvents and one or more surfactants.