Patent ID: 8545880

Claim:
A once-a-day composition comprising: (a) an immediate release component comprising bupropion or a pharmaceutically acceptable salt thereof wherein the immediate release component is a powder, a granule or an uncoated active pellet; (b) a first pellet comprising a first core containing a pharmaceutically acceptable salt of bupropion and an enteric coating applied to the first core wherein the enteric coating consists of: (i) a pH dependent coating polymer selected from the group consisting of shellac, methacrylic acid copolymers, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, polyvinyl acetate phthalate and mixtures thereof; (ii) a plasticizer; and (iii) a lubricant; and wherein the first pellet releases bupropion in the upper gastrointestinal tract of a human patient; and (c) a second pellet comprising a second core containing a pharmaceutically acceptable salt of bupropion and a sustained release coating applied to the second core wherein the sustained release coating comprises a mixture of: (i) a water insoluble polymer; (ii) a methyl acrylic acid copolymer; (iii) a plasticizer; and (iv) an antisticking agent and wherein the second pellet releases bupropion in the lower gastrointestinal tract of a human patient, wherein said composition is a tablet or capsule that contains 75 to 450 mg of bupropion or a pharmaceutically acceptable salt thereof, and the ratio of first pellet to second pellet is about 30:70 to about70:30 and provides an in vivo plasma profile selected from: (a) a mean C max of at least 50.0 ng/ml; (b) a mean AUC 0-inf of greater than approximately 500.0 ng·hr/ml; and (c) a mean T max of between approximately 5.0 hours and 8.5 hours based upon a single dose administration of a composition containing 150 mg of bupropion or a pharmaceutically acceptable salt.