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Oral solid tamsulozine hydrochloride preparation with prolonged release and method for its manufacture
Oral solid tamsulozine hydrochloride preparation with prolonged release and method for its manufacture
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机译:口服缓释型盐酸坦苏鲁嗪固体制剂及其制备方法
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摘要
Taught herein is a solid, oral, controlled-release pharmaceutical composition of tamsulosin hydrochloride in the form of an enteric-coated tablet, wherein tamsulosin hydrochloride is homogenously dispersed within a matrix consisting of a mixture of a fatty component and a hydrophilic component, together with at least one diluent, and optionally other pharmaceutically acceptable excipients, exhibiting the following dissolution profile of tamsulosin hydrochloride, as measured in a Type II paddle apparatus in accordance with the dissolution testing method specified in the European Pharmacopoeia, i.e., at 37±0.5° C. and 100 rpm in a 0.1 N HCl buffer for 2 hours, followed by pH 7.2 buffer for the rest of the test: 10-40% dissolution during first 2 hours (in HCl), 35-70% dissolution after 3 h (in pH 7.2 buffer system), not less than 70% dissolution of the declared content after 5 h (in pH 7.2 buffer system).
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机译:本文教导了呈肠溶片形式的盐酸坦洛新的固体口服口服控释药物组合物,其中盐酸坦洛新均匀地分散在由脂肪组分和亲水组分的混合物组成的基质中,以及根据欧洲药典规定的溶出度测试方法,在II型桨式装置中测得的至少一种稀释剂和(可选)其他药学上可接受的赋形剂,表现出下列盐酸坦洛新的溶出曲线,即在37±0.5°C下在0.1 N HCl缓冲液中以100 rpm的速度搅拌2小时,然后在其余的测试中用pH 7.2缓冲液:在最初2个小时的溶出度为10-40%(在HCl中),在3小时的溶出度为35-70%(在HCl中) pH 7.2缓冲液系统),5小时后不低于所声明含量的70%溶解(在pH 7.2缓冲液系统中)。
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