| 摘要 |
PURPOSE: A process for preparing a beta-cyclodextrin possessing high compressibility and stable over time in order to use it as direct compression excipient-binder is provided, and a directly compressible beta-cyclodextrin thus obtained is provided. CONSTITUTION: The process for preparing beta-cyclodextrin which is of high compressibility and which is stable over time comprises a step of dehydrating hydrated beta-cyclodextrin to a water content of less than 6%, preferably less than 4% and more preferably still less than or equal to 2% by weight, followed by forced rehydration to a water content greater than 10%, preferably greater than 12% and more preferably still greater than or equal to 13% by weight, wherein the dehydration is carried out on a fluidized air bed dryer-granulator, the rehydration is carried out on a fluidized air bed granulator, and the rehydration is carried out by spraying water at a temperature of less than 60 deg.C, preferably less than 40 deg.C. Beta-cyclodextrin has a compressibility greater than 70 N expressed in a C test, wherein beta-cyclodextrin has a specific surface area according to the BET method greater than or equal to 1 m/g for a particle size fraction of between 100 and 160 micrometers, a mean particle diameter greater than 80 micrometers and an apparent mass density greater than or equal to 0.45 g/ml, and preferably greater than or equal to 0.50 g/ml, for a particle size fraction of between 100 and 315 micrometers, and beta-cyclodextrin exhibits a stability greater than six months at room temperature.
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