首页> 外国专利> MULTIPARTICULATED PHARMACEUTICAL FORM SUITABLE FOR UNIFORM RELEASE OF AN ACTIVE PHARMACEUTICAL INGREDIENT IN THE SMALL INTESTINE AND THE BIG INTESTINE, ITS PRODUCTION PROCESS AND ITS USE

MULTIPARTICULATED PHARMACEUTICAL FORM SUITABLE FOR UNIFORM RELEASE OF AN ACTIVE PHARMACEUTICAL INGREDIENT IN THE SMALL INTESTINE AND THE BIG INTESTINE, ITS PRODUCTION PROCESS AND ITS USE

机译:适用于小肠和大肠内活性药物成分统一释放的多药制剂形式,其生产过程和用途

摘要

"multiparticulate drug form comprising at least two differently coated pellet forms". the invention relates to a multiparticulate drug form for uniform release of an active pharmaceutical ingredient in the small intestine and large intestine, comprising at least two forms of pellets a and b comprising an active pharmaceutical ingredient in the core and having different polymer coatings that determine the release of the active ingredient at different pH values, characterized by the fact that the pellet form a is supplied with an internal polymer coating, and has an external enteric coating that quickly dissolves above the pH around 5.5, and the pellet form b is supplied with a polymer coating which, in the usp release test, releases less than 20% of the active ingredient at 6.8 ph in 6 hours and releases more than 50% of the active ingredient in ph of 7.2 in 6 hours. the invention further relates to a process for producing the multiparticulate drug form and the use of pellet forms a and b to produce the drug form.
机译:“包含至少两种不同包衣的丸剂形式的多颗粒药物形式”。本发明涉及一种用于在小肠和大肠中均匀释放活性药物成分的多颗粒药物形式,包括至少两种形式的小丸a和b,其在芯中包含活性药物成分并且具有决定该药物作用的不同聚合物包衣。活性成分在不同pH值下的释放,其特征在于:颗粒a带有内部聚合物包衣,并具有外部肠溶衣,可在5.5左右的pH值以上迅速溶解,并且颗粒b带有一种聚合物涂层,在usp释放测试中,在6小时内在6.8 ph下释放少于20%的活性成分,在6小时内以7.2 ph释放超过50%的活性成分。本发明还涉及制备多颗粒药物形式的方法,以及使用小丸形式a和b来制备药物形式。

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