Patent ID: 9011912
Filing Date: 2015-04-21
Classification: A61K,A61P

Abstract:
1. An extended-release oral dosage form for poorly soluble amine compounds comprising, (a) a core having an ionizable compound, wherein the ionizable compound is an organic acid, wherein the organic acid is selected from the group consisting of citric acid, maleic acid and combinations thereof; (b) a barrier layer coating the core; (c) a mantle of a matrix having a poorly soluble amine compound and at least one amphiphilic polymer, wherein the amphiphilic polymer is selected from the group consisting of polyethylene glycol 6000/vinylcaprolactam/vinyl acetate 13/57/30, d-α-tocopheryl polyethyleneglycol 1000 succinate (Vitamin E-TPGS), and combinations thereof; and (d) a release-rate controlling layer coating the mantle; wherein the ionizable compound and the amphiphilic polymer are in amounts sufficient to provide synergistic solubility effect.