Patent ID: 7537784
Filing Date: 2009-05-26
Classification: A61K,A61P

Abstract:
1. A modified-release tablet comprising: (i) a core comprising an effective amount of bupropion hydrochloride, polyvinyl alcohol, and glyceryl behenate, wherein said bupropion hydrochloride is present in an amount of at least about 94% by weight of the core dry weight, said polyvinyl alcohol is present in an amount of about 3% by weight of the core dry weight, and said glyceryl behenate is present in an amount of about 3% by weight of each core dry weight; (ii) a control-releasing coat completely surrounding and contacting said core, said control-releasing coat comprising ethyl cellulose grade PR 100, polyethylene glycol 1450, and polyvinylpyrrolidone, wherein said ethyl cellulose grade PR 100 is present in an amount of from about 45% to about 50% by weight of the control-releasing coating dry weight, said polyethylene glycol 1450 is present in an amount of about 12% by weight of the control-releasing coating dry weight, and said polyvinylpyrrolidone is present in an amount of from about 25% to about 50% of the control-releasing coat dry weight, wherein the amount of said control-releasing coat applied is from about 9% to about 15% by weight of the dry tablet core; and (iii) a moisture barrier surrounding said control-releasing coat, said moisture barrier comprising methacrylic acid copolymer, polyethylene glycol 1450, triethyl citrate and silicon dioxide, wherein said methacrylic acid copolymer is present in an amount of about 66% by weight of said moisture barrier dry weight, said polyethylene glycol 1450 and triethyl citrate is present in an amount of about 10% by weight of said moisture barrier dry weight in a proportion of 1 part triethyl citrate to 2 parts polyethylene glycol 1450, and said silicon dioxide is present in an amount of about 25% by weight of said moisture barrier dry weight, wherein the amount of the said moisture barrier applied is no more than about 2.5% of the tablet dry weight, wherein the tablet provides an extended-release of the bupropion hydrochloride such that after about 2 hours about 5% of the bupropion hydrochloride content is released, after about 4 hours about 32% of the bupropion hydrochloride content is released, after about 8 hours about 74% of the bupropion hydrochloride content is released and after about 16 hours no less than about 99% of the bupropion hydrochloride content is released, and wherein the ratio of the ethyl cellulose grade PR 100:polyethylene glycol 1450:polyvinylpyrrolidone is from about 3:1:4 to about 5:1:3.