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COMPRIMES DE TAMSULOSINE A LIBERATION MODIFIEE
专利权人:
Synthon B.V.
发明人:
申请号:
EP02780143.0
公开号:
EP1441713B2
申请日:
2002.11.06
申请国别(地区):
EP
年份:
2018
代理人:
摘要:
The invention relates to a pharmaceutical tablet comprising a tablet matrix having dispersed therein 0.1 to 10 mg of tamsulosin or a pharmaceutically acceptable salt thereof, and optionally having an enteric coating over said matrix, wherein said tablet is a modified release tablet and has a dissolution profile such that in each of the media SIF, FaSSIF, and FeSSIF, said tablet releases not more than 60% of said tamsulosin at 2 hours elapsed time in USP 2 apparatus using 500 ml of said media at 50-100 rpm paddle speed, to a monolithic pharmaceutical tablet, comprising 0.1 to 10 mg of tamsulosin or a pharmaceutically acceptable salt thereof, 10 wt% - 90 wt% hydroxypropyl methylcellulose, and a total tablet weight of 10 to 300 mg, to a unit dosage form for treating or ameliorating the conditions of benign prostatic hyperplasia comprising an effective amount of one or more tablets as mentioned above, and to a method for treating the symptoms of benign prostatic hyperplasia, which comprises administering to a patient in need thereof one or more tablets as mentioned above.
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