Patent ID: 6528090
Filing Date: 2003-03-04
Classification: A61K

Abstract:
An oral hydrophilic matrix formulation suitable for once-a-day administration comprising:a) from about 40 to about 80 w/w% of divalproex sodium, which is in admixture with; b) a pharmaceutically acceptable hydrophilic polymer in which said hydrophilic polymer is present in the quantity of from about 20% to about 50%, by weight of the formulation, and said hydrophilic polymer is selected from the group consisting of polyvinylpyrrolidine, hydroxypropylcellulose, hydroxypropylmethyl cellulose, methyl cellulose, vinyl acetate copolymers, polysaccharides, polyethylene oxide, methacrylic acid copolymers, and maleic anhydride/methyl vinyl ether copolymers, and; c) when said formulation is ingested orally by healthy human subjects: i. said formulation produces a Cmax that is statistically significantly lower than the Cmax produced by a delayed release enteric coated divalproex sodium tablet given twice daily, when each is determined at steady state in a healthy fasting population, ii. a Cmin that is not statistically significantly different from the Cmin produced by said delayed release divalproex sodium tablet, when each Cmin is determined at steady state in a healthy fasting population, and; iii. said formulation produces an AUC value that is equivalent to the AUC value generated by said divalproex sodium delayed release tablet, when each AUC is determined at steady state in a healthy fasting population.