Patent ID: 8323692

Claim:
A controlled release oral dosage form comprising: a) a core, wherein said core comprises: i) an effective amount of metformin hydrochloride, and ii) at least one first pharmaceutically acceptable excipients, and b) a stable controlled release monolithic coating surrounding the core, wherein said dosage form provides a T max of said metformin hydrochloride of from about 6 hours to about 12 hours after administration to a patient; and/or provides an in-vitro release rate of the metformin hydrochloride when tested by the USP Apparatus I (Basket Apparatus) method at 100 rpm, in 900 mL simulated gastric fluid and at about 37° C., such that not more than 37% of the metformin hydrochloride is released after about 2 hours and not more than 61% of the metformin hydrochloride is released after about 4 hours, wherein the stable controlled release coating hydrates when placed into water, and wherein the at least one first pharmaceutically acceptable excipient comprises cross-linked polyvinylpyrrolidone, and wherein the stable controlled release coating is formed by a process comprising: coating the core with a coating composition to form a coated core, and curing the coated core to form the stable controlled release coating, wherein the coating composition comprises i) an aqueous dispersion of a neutral ester copolymer without any functional groups; ii) a poly glycol having a melting point of at least about 55° C., and iii) one or more second pharmaceutically acceptable excipients; and wherein the curing is conducted at a temperature at least equal to or greater than the melting point of the poly glycol.