| 摘要 |
PROBLEM TO BE SOLVED: To provide a granule that can advantageously be used in the manufacture of pharmaceutical dosage units for transmucosal delivery which allows a pharmaceutically active substance to be absorbed in a body via a mucosa.SOLUTION: The granule has a volume weighted mean diameter of 1-200 μm and contains: at least 0.1 wt.% of a pharmaceutically active substance; at least 10 wt.% of an emulsifier selected from a group consisting of sugar fatty acid esters, mono-glycerides, di-glycerides, diacetyl tartaric acid esters of monoglyceride, diacetyl tartaric acid esters of diglyceride, polyglycerol esters, calcium stearoyl lactate, sodium stearoyl lactate and combinations thereof; and 0-89.9 wt.% of a water-dispersible saccharide, the combination of the pharmaceutically active substance, the emulsifier, and the water-dispersible saccharide together representing at least 60 wt.% of the granule, wherein the granule is monophasic or the granule comprises a dispersed phase containing the pharmaceutically active substance, and the dispersed phase has a volume weighted mean diameter of less than 300 nm. |
