Hypromellose acetate succinate for use as hot-melt extrusion carrier, hot-melt extrusion composition, and method for producing hot-melt extrudate

摘要

Provided are a hot-melt extrudate excellent in uniform miscibility with a drug; and a method for producing a hot-melt extrudate capable of smoothly feeding a powder in hot-melt extrusion. More specifically, provided are hypromellose acetate succinate (HPMCAS) for use as a hot-melt extrusion carrier having a volume average particle size (D 50 ) of from 70 to 300 µm as measured by dry laser diffraction and a loose bulk density of from 0.25 to 0.40 g/cm 3 ; and a hot-melt extrusion composition comprising the HPMCAS and a drug. Also provided is a method for producing a hot-melt extrudate comprising the steps of: hot-melting the hot-melt extrusion composition at a hot-melt temperature equal to or higher than a melting temperature of the HPMCAS, or at a hot-melt temperature equal to or higher than a temperature at which both of the HPMCAS and the drug become melt; and extruding the hot-melted composition.