SHANGHVI, DILIP SHANTILAL,DHARMADHIKARI, NITIN BHALACHANDRA,ZALA, YASHORAJ RUPSINH,KHANNA, SATISH C.
申请号：
ES02733207
公开号：
ES2373873T3
申请日:
2002.04.09
申请国别(地区):
ES
年份:
2012
代理人:
摘要：
A timed pulse release composition comprising: a. a core composition comprising a therapeutically active agent, a swelling agent selected from the group consisting of cross-linked sodium carboxymethyl cellulose, cross-linked polyvinylpyrrolidone, and sodium starch glycolate and, optionally, a water-soluble compound or compounds to induce osmosis , and b. a coating composition comprising one or more film-forming polymers, in which the film-forming polymers in the coating comprise a mixture of a water insoluble polymer and a water soluble polymer, in which the ratio between polymer insoluble in water and water soluble polymer varies from 6: 3 to 9: 3； wherein the water insoluble polymer is ethyl cellulose and the water soluble polymer is hydroxypropyl methyl cellulose； wherein the swelling agent swells considerably but does not form a strong gel and is present in an amount sufficient in the core to provide, after water collection, a swelling pressure above the cohesive force of the coating that surrounds the core, such that after absorbing the surrounding fluid, the core swells and breaks the coating to release, in an impulse, the therapeutically active agent in a reliable manner in approximately a predetermined time, in which The predetermined time is in the range of 1 to 12 hours, in which the reliable manner of breakage comprises the breaking of 36 tablets out of a total of 36 tablets in the predetermined time when tested by subjecting the tablets to the USP dissolution test using a aqueous medium at 37 + - 0.5 ° C, in a USP type I or type II apparatus at a rpm number selected from the range of 50 rpm to 100 rpm.Una composición de liberación por impulso temporizado que comprende: a. una composición de núcleo que comprende un agente terapéuticamente activo, un agente que se hincha seleccionado del grupo que consiste en carboximetil celulosa sódica reticulada, polivinilpirrolidona reticulada, y glicolato sódico de almidón y, opcionalmente, un compuesto o compuestos so
