主权项 |
1. A soft gelatin capsule consisting of a shell with a gastro-resistant and enteric-soluble coating enclosing a filling material, wherein:
the filling material consists of a solution of a poorly water-soluble or water-insoluble active ingredient in an oily solvent phase, the shell contains a cyclodextrin which is thus maintained separated from the active ingredient in the filling material, the shell of the capsule is prepared from a mix containing, by weight: from 0.7 to 20% of hydroxypropyl-β-cyclodextrin, or β-cyclodextrin, from 20 to 50% by weight of gelatin, from 1 to 25% by weight to a plasticizer, from 20 to 50% by weight of water, where the active ingredient is selected from the group consisting of non-steroid anti-inflammatory drugs having aromatic rings. |