Patent ID: 8110219

Claim:
A controlled release oral dosage form comprising: a) a core, wherein said core comprises: i) an effective amount of metformin hydrochloride, and ii) one or more first pharmaceutically acceptable excipients, and b) a stable controlled release monolithic coating surrounding the core, 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, wherein the stable controlled release coating hydrates when placed into water, and wherein the one or more first pharmaceutically acceptable excipients comprises cross-linked polyvinylpyrrolidone.