发明名称 |
Stabilized sustained release tramadol formulations |
摘要 |
A stabilized sustained release oral solid dosage form which includes an effective amount of tramadol or a pharmaceutically acceptable salt thereof dispersed in a matrix of a hydrophobic material comprising a wax-like substance which was melted or softened during the preparation of the matrix, is cured at a temperature from about 35° C. to about 65° C. for a time period from about 4 to about 72 hours, such that the formulation, when subjected to in-vitro dissolution after exposure to accelerated storage conditions of at least one month at 40° C./75% RH, releases an amount of tramadol which does not vary at any given dissolution time point by more than about 20% of the total amount of tramadol released when compared to in-vitro dissolution conducted prior to subjecting the dosage form to the accelerated storage conditions.
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申请公布号 |
US6306438(B1) |
申请公布日期 |
2001.10.23 |
申请号 |
US19980109615 |
申请日期 |
1998.07.02 |
申请人 |
EURO-CELTIQUE, S.A. |
发明人 |
OSHLACK BENJAMIN;HUANG HUA-PIN;CHASIN MARK;GOLDENHEIM PAUL |
分类号 |
A61K9/20;A61K9/22;A61K9/26;A61K9/42;A61K31/135;A61K31/137;A61K47/06;A61K47/10;A61K47/12;A61K47/14;A61K47/30;A61K47/32;A61K47/38;A61K47/44;A61P25/02;A61P29/00;(IPC1-7):A61K9/22;A61K9/14;A61K9/16 |
主分类号 |
A61K9/20 |
代理机构 |
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