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. |