申请人:——
公开号:US20040067252A1
公开(公告)日:2004-04-08
The present invention is directed to a multiparticulate, modified release solid dispersion formulation, comprising a drug substance having a pH-dependent solubility, said drug substance being a compound of the formula I, or a pharmaceutically acceptable salt thereof; a hydrophobic matrix former which is a water-insoluble, non-swelling amphiphilic lipid; and a hydrophilic matrix former which is a meltable, water-soluble excipient; wherein the weight ratio hydrophobic matrix former/hydrophilic matrix former is ≧1; and the particle size is less than 300 &mgr;m. Also a unit dosage of the same, as well as a process for the preparation thereof and the use of the formulation and unit dosage is claimed.
本发明涉及一种多颗粒、改进释放型固体分散制剂,包括一种溶解度取决于 pH 值的药物,所述药物为式 I 的化合物或其药学上可接受的盐; 疏水基质前体,它是一种不溶于水、无溶胀性的两性脂质;以及亲水基质前体,它是一种可熔化的水溶性赋形剂;其中疏水基质前体/亲水基质前体的重量比为≧1;,粒度小于300&mgr;m。 此外,还要求得到一种相同的单位剂量及其制备工艺,以及该制剂和单位剂量的使用方法。