| 摘要 |
<p>A solid pharmaceutical formulation suitable for oral administration is described. The formulation is in the form of beads and contains a therapeutically effective amount of an hydrophobic active pharmaceutical ingredient (API), vitamin E TPGS, a filler/spheronization agent, a binder and a superdisintegrant. Processes for preparing the formulation are also described. One process involves wetting a dry mixture comprising the API, the filler/spheronization agent, the binder and the superdisintegrant with a solution of vitamin E TPGS in a granulation fluid (e.g., water optionally mixed with an alcohol), granulating the wetted mixture, extruding the resulting granulated mass, spheronizing the extrudate to provide beads, and drying the beads. Another process involves wet granulating a dry blend of API, spray-dried granules of vitamin E TPGS, filler/spheronization agent, binder and superdisintegrant, extruding the wet granulate, spheronizing the extrudate to beads, and drying the beads.</p> |
