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MODIFIED RELEASE TAMSULOSIN TABLETS

机译:改良的释放坦索罗宁片

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.
机译:本发明涉及一种药物片剂,其包含其中分散有0.1至10mg的坦索罗辛或其药学上可接受的盐的片剂基质,并且任选地在所述基质上具有肠溶衣,其中所述片剂是调释片剂并且具有溶出曲线因此,在每种介质SIF,FaSSIF和FeSSIF中,使用500 ml所述介质以50-100 rpm的桨叶速度,在USP 2设备中经过2小时后,所述片剂释放不超过60%的坦洛新。用于治疗或改善病症的单位剂型的单片药物片剂,其包含0.1至10 mg坦洛新或其药学上可接受的盐,10 wt%-90 wt%羟丙基甲基纤维素,总片剂重量为10至300 mg包括有效量的一种或多种上述片剂的良性前列腺增生的方法,以及治疗良性前列腺增生的症状的方法,包括向有需要的患者施用一种或多种上述片剂。

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