Patent ID: 7670627

Claim:
A multi-component controlled release composition comprising: a plurality of solid nano-spheres encapsulated in a pH-sensitive or salt-sensitive micro-sphere, said pH-sensitive or salt-sensitive micro-sphere being formed of a pH-sensitive or salt-sensitive matrix material, and a first pharmaceutical active agent incorporated by dispersion into a hydrophobic matrix forming the core of said plurality of solid nano-spheres or incorporated into both said hydrophobic matrix of said plurality of solid nano-spheres by dispersion and said matrix material of said micro-sphere, wherein said nano-spheres contact said matrix material of said microsphere, wherein said solid nano-spheres are formed of a wax material that has a melting point in the range of between about 25 degrees C. and about 150 degrees C. wherein said first pharmaceutical active agent is incorporated in said hydrophobic matrix of said solid nano-spheres and further comprising a second pharmaceutical active agent homogeneously incorporated in said pH-sensitive or salt-sensitive matrix material of said microsphere wherein said pH-sensitive or salt-sensitive matrix material of said microsphere releases said second active agent upon contact with a solution having a predetermined pH or predetermined salt concentration, wherein said first pharmaceutical active agent and said second pharmaceutical active agent are not the same, wherein said first pharmaceutical active is released continuously thereafter for an extended period of time, and wherein said micro-sphere has a size of from about 20 to about 100 microns and each of said nano-spheres has an average size of about 0.01 to about 5 microns.