加熱溶融混練押出法と噴霧乾燥法によって製造した固体分散体の溶出特性

抄録

Solid dispersion particles were prepared using an indomethacin (IND) as a model insoluble drug, poly-(vinylpyrrolidone-co-vinyl acetate) (VA64) as a water-soluble polymer and mannitol (Man) as an excipient. In case of hot-melt extrusion (HME) preparation, dissolution profile of every composition without Man was the same as others. The dissolution profile of composition including Man was much improved than others without Man. By contrast, the effect of Man addition was not recognized in case of spray drying (SD) preparation. Surface energy of the solid dispersion particles was measured by using an inverse gas chromatography surface analyzer (iGC-SEA). The surface energy of solid dispersion particles including Man prepared by the HME is much smaller than that without Man. However, in the SD preparation, there was no clear difference in the surface energy of solid dispersion particles with and without Man. The characteristic of the solid dispersion particles by the different manufacturing methods implied the difference of the dissolution improvement, in spite of the same composition.