发明名称 |
PHARMACEUTICAL FORMULATION FOR THE ACTIVE INGREDIENT BUDESONIDE |
摘要 |
The invention relates to a pharmaceutical formulation containing essentially a) an inner layer which can optionally be applied to a core, with the active substance budesonide, bound with a binding agent; b) a middle layer with a polymer covering agent which is soluble in intestinal juice or retardant; and c) an outer envelope or outer layer which is resistant to stomach juice, said layers being able to contain in a manner known per se other pharmaceutically usual adjutants. The inventive formulation is characterised in that the binding agent is a polymer or a copolymer with acid groups and the formulation of the inner layer without the middle and outer layer releases the bound active ingredient in a release test according to USP XXIII monography <711> dissolution with apparatus 2 (addle) at a rotational speed of 100 / min in a phosphate buffer pH 7.5 after 30 min to a value of more than 80 %. |
申请公布号 |
WO03080032(A2) |
申请公布日期 |
2003.10.02 |
申请号 |
WO2003EP02269 |
申请日期 |
2003.03.06 |
申请人 |
ROEHM GMBH & CO. KG;BECKERT, THOMAS;RUDOLPH, MARKUS;DRESSMAN, JENNIFER |
发明人 |
BECKERT, THOMAS;RUDOLPH, MARKUS;DRESSMAN, JENNIFER |
分类号 |
A61K9/16;A61K9/20;A61K9/50;A61K31/58;A61K31/635;A61K47/32;A61K47/38;A61K47/42;A61P1/00;A61P1/04 |
主分类号 |
A61K9/16 |
代理机构 |
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代理人 |
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主权项 |
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地址 |
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