Nanoparticulate statin formulations and novel statin combinations

Abstract

The present invention is directed to nanoparticulate compositions comprising statin such as lovastatin or simvastatin. The statin particles of the composition have an effective average particle size of less than about 2000 nm. In another aspect of this invention, novel combinations of statins and other cholesterol lowering agents are described and methods of using same are taught.

Description

FIELD OF THE INVENTION

[0001] The present invention relates to nanoparticulate compositions comprising statin, preferably lovastatin or simvastatin, and novel statin combinations. The nanoparticulate statin particles preferably have an effective average particle size of less than about 2000 nm. In another aspect, this invention includes novel combinations of statins and other cholesterol lowering agents and methods of using the same.BACKGROUND OF THE INVENTION

[0002] I. Background Regarding Nanoparticulate Active Agent Compositions

[0003] Nanoparticulate active agent compositions, first described in U.S. Pat. No. 5,145,684 (“the '684 patent”), are particles consisting of a poorly soluble therapeutic or diagnostic agent having adsorbed onto, or associated with, the surface thereof a non-crosslinked surface stabilizer. Many factors can affect bioavailability including the dosage form and various properties, e.g., dissolution rate of the drug. Poor bioavailability is a significant problem en...