PROBLEM TO BE SOLVED: To provide a spherical granulated material aggregate of sugar alcohol which has a small mean particle diameter, can reduce oral graininess when using in an orally disintegrating tablet, has a low reactivity with a drug, and further has a sharp particle size distribution, and to provide an efficient method for producing the same, as well as to provide a tablet using the spherical granulated material aggregate of sugar alcohol.SOLUTION: The invention provides a spherical granulated material aggregate of sugar alcohol whose mean particle diameter is less than 100 μm, and whose value of σg obtained by a particle size distribution is 1.1-1.5 and a method for producing spherical granulated material aggregate of sugar alcohol comprising rolling crystal particles of sugar alcohol with a mean particle diameter of from more than 15 μm to less than 50 μm in a centrifugal rolling device, and granulating under the absence of a sugar alcohol powder, while spraying a sugar alcohol solution.COPYRIGHT: (C)2015,JPO&INPIT【課題】平均粒子径が小さく、口腔内崩壊錠に用いた場合に口腔内でのざらつきを低減することができ、また、薬物との反応性が低く、更には粒度分布がシャープな糖アルコール球形造粒物集合体、及びその効率的な製造方法、並びに該糖アルコール球形造粒物集合体を用いた錠剤を提供すること。【解決手段】平均粒子径が100μm未満であり、粒度分布により得られるσgの値が1.1~1.5である糖アルコール球形造粒物集合体、及び平均粒子径が15μm超50μm未満である糖アルコールの結晶粒子を遠心転動装置内で転動させ、糖アルコール粉末の非存在下で、糖アルコール溶液を噴霧しながら造粒する糖アルコール球形造粒物集合体の製造方法である。【選択図】なし
