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Controlled release dosage forms enclosed resistant to tampering
专利权人:
PURDUE PHARMA L.P.
发明人:
申请号:
ARP110104910
公开号:
AR084575A1
申请日:
2011.12.22
申请国别(地区):
AR
年份:
2013
代理人:
摘要:
A controlled release Solid dosage form comprises a Core comprising a first portion of an opioid Analgesic First dispersed in a Matrix material.And a cover enclosing the core and includes a second portion of the opioid Analgesic dispersed in a Second Matrix material; where the amount of active Agent release from the dosage form is proportional within 20% of the elapsed time from 8 to 24 hours.As measured by an in vitro Dissolution apparatus (USP basket in a 1 to 100 rpm) in 900 ml of simulated gastric Fluid (SGF), i.e. without Enzymes.29: the claim of controlled release Solid dosage form according to the claim 28 wherein the opioid Analgesic is selected from the group consisting of codeine, hydrocodone, hydromorphone, morphine, oxycodone, tramadol, pharmaceutically acceptable salts of S, the same of hydrates, solvates thereof, and mixtures thereof.Claim 130: a method for preparing a controlled release Solid dosage form, characterized as comprising: preparing a Core comprising a first portion of an opioid Analgesic First dispersed in a Matrix material; and the lock Core cover Q EU comprises a second portion of the opioid Analgesic dispersed in a Second Matrix material; LThe amount of Opioid Analgesic released from the dosage form is proportional within 20% of the elapsed time from 8 to 24 hours, as measured by an in vitro Dissolution apparatus (USP basket in a 1 to 100 rpm) in 900 ml of simulated gastric Fluid (SGF), i.e. without Enzymes.Una forma de dosis de liberación controlada sólida que comprende: un núcleo que comprende una primera porción de un analgésico opioide dispersado en un primer material de matriz, y una cubierta que encierra el núcleo y que comprende una segunda porción del analgésico opioide dispersado en un segundo material de matriz; donde la cantidad de agente activo liberado de la forma de dosis es proporcional dentro de un 20% al tiempo transcurrido de 8 a 24 horas, según se mide mediante una disolución in vitro en un Aparato 1 USP (cestillo) a 1
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中国工程科技知识中心
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