发明名称 Dosage form comprising lopinavir and ritonavir
摘要 The present invention relates to an oral dosage form comprising crystalline lopinavir and crystalline ritonavir. The invention further relates to methods of preparing said oral dosage forms containing the above pharmaceutical active agents.
申请公布号 US9370578(B2) 申请公布日期 2016.06.21
申请号 US201314382499 申请日期 2013.03.06
申请人 ratiopharm GmbH 发明人 Meergans Dominique;Holfinger Konstantin
分类号 A61K47/30;B01F3/12;B01F3/08;A61K47/38;A61K38/55;A61K31/513;A61K9/20;A61K31/427 主分类号 A61K47/30
代理机构 Milstein Zhang & Wu LLC 代理人 Milstein Zhang & Wu LLC
主权项 1. An oral dosage form comprising 10 to 35 wt % of crystalline lopinavir being present in a mixture with 10 to 50 wt % of a brittle vehicle, 2 to 9 wt % of crystalline ritonavir, 0 to 4 wt % of glidant, 10 to 35 wt % of filler, 3 to 17 wt % of disintegrant, 2 to 15 wt % of surfactant, and 0.3 to 2.5 wt % of lubricant, based on the total weight of the dosage form wherein the crystalline lopinavir comprises hydrated polymorphic Form I of lopinavir; the average particle diameter (D50-value) of the crystalline lopinavir is from about 0.1 μm to about 50 μm; the crystalline ritonavir comprises polymorphic Form I of ritonavir, and lopinavir is 95 to 99.9% by weight of crystalline lopinavir and 0.1 to 5% by weight of non-crystalline lopinavir and ritonavir is 95 to 99.9% by weight of crystalline ritonavir and 0.1 to 5% by weight of non-crystalline ritonavir.
地址 Ulm DE