Patent ID: 8765178

Claim:
A sustained release oral dosage pharmaceutical tablet, comprising: a. a first layer consisting of: i. a first active agent comprising hydrocodone or a pharmaceutically acceptable salt thereof to be released over a sustained period of time; ii. a carrier selected from the group consisting of lactose, starch, sucrose, glucose, dextrose, kaolin, microcrystalline cellulose, ethyl cellulose, methyl cellulose, stearic acid, magnesium stearate, dicalcium phosphate, gums, calcium sulfate, calcium carbonate, magnesium carbonate, sodium carbonate, sodium chloride, calcium phosphate, mannitol, sorbitol, inositol, talc, polyethylene glycol, polyvinylpyrrolidone, carboxyalkyl cellulose and combinations thereof; and iii. carnauba wax; b. at least two adjacent controlled release layers wherein at least one of said two adjacent controlled release layers consists of: i. at least one second active agent comprising acetaminophen; ii. a carrier selected from the group consisting of lactose, starch, sucrose, glucose, dextrose, kaolin, microcrystalline cellulose, ethyl cellulose, methyl cellulose, stearic acid, magnesium stearate, dicalcium phosphate, gums, calcium sulfate, calcium carbonate, magnesium carbonate, sodium carbonate, sodium chloride, calcium phosphate, mannitol, sorbitol, inositol, talc, polyethylene glycol, polyvinylpyrrolidone, carboxyalkyl cellulose and combinations thereof; iii. copolymers of acrylate and methacrylates; and iv. carnauba wax; said at least two adjacent layers being configured to regulate fluid access to a portion of the first layer, thereby controlling release of the first active agent from the first layer over the sustained period of time, wherein the configuration of the first layer and the two adjacent controlled release layers provides a T max hydrocodone serum concentration occurring at from about 3 hours to about 8 hours after administration of the tablet to the subject and a T max acetaminophen serum concentration occurring at from about 2 hours to about 8 hours after administration of the tablet to the subject; and wherein fluid access is regulated in an amount sufficient to release the first active agent at a rate of from about 30% to about 45% after about 1 hour, from about 43% to about 75% after about 2 hours, and from about 80% to about 100% after about 4 hours.