CONTROLLED RELEASE FORMULATION OF DIVALPROEX SODIUM
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...
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Sprache: | eng ; slv |
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Zusammenfassung: | 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.
Tabletna formulacija za kontrolirano sproščanje, ki dopušča enkrat na dan doziranje pri zdravljenju epilepsije, ki obsega od pribl. 50 mas.% do pribl 55 mas.% aktivne sestavine, izbrane iz skupine, ki jo sestavljajo valproinska kislina, farmacevtsko sprejemljiva sol ali ester valproinske kisline, divalproeks natrij in valpromid, od pribl. 20 mas.% do pribl. 40 mas.% hidroksipropil metilceluloze, od pribl. 5 mas.% do pribl. 15 mas.% laktoze, od pribl. 4 mas.% do pribl. 6 mas.% mikrokristalinične celuloze in od pribl. 1 mas.% do pribl. 5 mas.% silicijevega dioksida s povprečno velikostjo delcev v območju med pribl. 1 mikrometer in približno 10 mikrometrov, pri čemer so vsi masni odstotki glede na celotno maso tabletne dozirne oblike. Prikazane so tudi predtabletirne granulirane formulacije, postopki za izdelavo granuliranih formulacij in tablet in postopek za zdravljenje epilepsije z uporabo tabletnih formulacij za kontrolirano sproščanje v smislu izuma.ŕ |
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