Patent ID: 8252327

Claim:
A controlled release methylphenidate tablet consisting of: (A) an immediate release methylphenidate coating consisting of: (a) 30-60 weight percent based upon the total weight of the immediate release coating of methylphenidate or a pharmaceutically acceptable salt or isomer thereof; (b) 40-70 weight percent based upon the total weight of the immediate release coating of a binder; and (c) 0.005-5 weight percent based upon the total weight of the immediate release coating of an organic acid; (B) a controlled release methylphenidate core tablet consisting of: (a) a compressed mixture consisting of: (i) 5-40 weight percent based upon the total weight of the compressed mixture of methylphenidate or a pharmaceutically acceptable salt or isomer thereof; (ii) 3-40 weight percent based upon the total weight of the compressed mixture of a hydrogel polymer; (iii) 25-90 weight percent based upon the total weight of the compressed mixture of a diluent; and (iv) optionally a lubricant; and (b) an enteric coating surrounding the core tablet consisting of: (i) 10-70 weight percent based upon the total weight of the enteric coating of a methacrylic acid copolymer; (ii) 1-5 weight percent based upon the total weight of the enteric coating of a plasticizer; (iii) an anti-sticking agent; and (iv) optionally a surfactant; and (C) optionally an aesthetic coating; wherein the controlled release methylphenidate tablet exhibits the following dissolution profile when tested in a United States Pharmacopeia type 2 (paddle) apparatus at 50 rpms in 900 ml of phosphate buffer with a pH of 7.5 and at 37° C.: 1-35% of the methylphenidate is released after 1 hour; 5-40% of the methylphenidate is released after 2 hours; and not less than 70% is release after 10 hours; and when administered to humans exhibits a plasma peak for the immediate release layer (T max1 ) between 1 and 5 hours, a plasma peak for the controlled release core (T max2 ) between 4 and 12 hours, and a plasma trough (T min ) between 2 and 7 hours in between the two peak plasma levels; and wherein the immediate release methylphenidate coating (A) is applied to the enteric coating surrounding the core tablet.