Patent ID: 7955622

Claim:
A controlled-release dosage formulation, comprising: a core consisting of a core coating layer of 5 wt % to 50 wt % of a water insoluble polymer and 0.1 wt % to 25 wt % of a plastizer, based on the weight of the core coating layer, in admixture with galantamine as the active ingredient, wherein the core coating layer is deposited onto a core substrate to form the core, wherein the core is free of a water soluble excipient; and a release rate controlling coating substantially surrounding the core, wherein the release rate controlling coating comprises 30 wt % to 90 wt % of a release retarding polymer; and a pore forming excipient comprising a water soluble polymer in an amount of 20:1 to 1:10 release retarding polymer: pore forming excipient; and 0.1 wt % to 30 wt % of a plasticizer, wherein the formulation exhibits a dissolution profile such that at 1 hour about 4 to about 9% of the galantamine is released, at 2 hours about 15 to about 25% of the galantamine is released, at 4 hours about 40 to about 55% of the galantamine is released, and at 8 hours about 80 to about 100% of the galantamine is released after combining the dosage formulation with 900 ml of pH 6.5 phosphate buffer at 37° C. in USP Type 1 Apparatus (USP, <711> Dissolution), at a paddle speed of 100 rpm.