发明名称 |
DOSAGE FORM CONTAINING THE ACTIVE INGREDIENT CHOLYLSARCOSINE |
摘要 |
The invention relates to a dosage form, containing the active ingredient cholylsarcosine, in the form of pellets, which are provided with a polymer coating that is resistant to gastric juices. The invention is characterised in that it discloses pellets comprising an active ingredient, which contain between 50 and 80 wt. % of the active ingredient cholylsarcosine and between 50 and 20 wt. % of one or more conventional pharmaceutical adjuvants as binding agents, whereby at least 90 wt. % of said adjuvants are water-soluble and the size of at least 80 % of the pellets comprising an active ingredient is between 800 and 2,500 µm. The granulates containing an active ingredient are coated with an anionic, film-forming polymer coating agent, which dissolves in a 0.07M sodium phosphate buffer with a pH value of 5.5 at a dissolution rate of at least 10 mg/min*g and whose dissolution rate in a 0.07M sodium phosphate buffer with a pH value of 6.0 is at least 200 mg/min*g. The polymer coating amounts to between 5 and 15 wt. % of the pellet weight. The invention also relates to a method for producing said dosage form. |
申请公布号 |
WO2005120467(A3) |
申请公布日期 |
2006.06.08 |
申请号 |
WO2005EP05157 |
申请日期 |
2005.05.12 |
申请人 |
ROEHM GMBH & CO. KG;DRESSMAN, JENNIFER;STEIN, HANS-JUERGEN;FUERST, THOMAS;BOTT, CHRISTIANE |
发明人 |
DRESSMAN, JENNIFER;STEIN, HANS-JUERGEN;FUERST, THOMAS;BOTT, CHRISTIANE |
分类号 |
A61K9/50;A61K31/575;A61K38/00;A61P1/16 |
主分类号 |
A61K9/50 |
代理机构 |
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