Controlled release formulation of divalproex sodium

Details Controlled release formulation of divalproex sodium Controlled release formulation of divalproex sodium

A - Human Necessities

61

K

A61K 9/22 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 31/16 (2006.01) A61K 31/19 (2006.01) A61P 25/08 (2006.01)

Patent

CA 2330480

A controlled release tablet formulation which permits once daily dosing in the treatment of epilepsy comprises from about 50 weight percent to about 55 weight percent of an active ingredient selected from the group consisting of valproic acid, a pharmaceutically acceptable salt or ester of valproic acid, divalproex sodium, and valpromide; from about 20 weight percent to about 40 weight percent hydroxypropyl methylcellulose; from about 5 weight percent to about 15 weight percent lactose, from about 4 weight percent to about 6 weight percent microcrystalline cellulose, and from about 1 weight percent to about 5 weight percent silicon dioxide having an average particle size ranging between about 1 micron and about 10 microns; all weight percentages based upon the total weight of the tablet dosage form. Also disclosed are pre-tableting granular formulations, methods of making the granular formulations and tablets, and a method of treating epilepsy employing the controlled release tablet formulations of the invention.

L'invention porte sur la formule d'un comprimé à libération contrôlée permettant l'administration d'une dose quotidienne unique pour le traitement de l'épilepsie et dont la composition comprend: d'environ 50 à environ 55 % en poids d'un principe actif choisi parmi l'acide valproïque, un sel ou un ester pharmacocompatible de l'acide valproïque, du divalproex sodium, et du valpromide; d'environ 20 à environ 40 % en poids d'hydroxypropylméthylcellulose; d'environ 5 à environ 15 % en poids de lactose, d'environ 4 à environ 6 % en poids de cellulose microcristalline, d'environ 1 à environ 5 % en poids de dioxyde de silicium, et dont la taille moyenne des particules est comprise entre environ 1 et environ 10 microns, tous les poids étant exprimés en % du poids total de la dose du comprimé. L'invention porte également sur des formules de granulés précurseurs, leurs procédés d'élaboration et sur un procédé de traitement de l'épilepsie à l'aide des comprimés de l'invention.

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