PROBLEM TO BE SOLVED: To provide a method for producing a formulation in which the concentration in blood and elution rate of the formulation are equal to the formulation and the elution rate of the conventional ones, also, capable of achieving the improvement of taking properties and further capable of preventing the generation of tableting trouble or the like while reducing an additive.SOLUTION: The method for producing a formulation including a physiologically active medicine includes charging a mixture obtained by uniformly dispersing a physiologically active medicine and an additive to a fluidized bed granulation device, while fluidizing the same at a prescribed fluidization wind velocity, at first, spray-adding water, and next spray-adding the solution or the dispersion-suspension liquid of a polymer binder, thus moistening, sticking and flocculating the powder in the fluid bed to produce a granule. In the production method, the wind velocity of a perforated-plate part is varied, in accordance with the powder physical properties such as particle diameter, particle shape, mass or the like of the physiologically active medicine, and, further, in accordance with the conditions of particle growth, to a stage 1: the time of fluidization start (0.7 to 1.4 m/sec), a stage 2 (0.4 to 1.3 m/sec), a stage 3 (0.6 to 1.2 m/sec) and a stage 4 (0.4 to 0.8 m/sec), also, the spray velocity of the solution or dispersion-suspension liquid of the polymer binder is the one controlled to an amount balanced with the moisture, sticking, flocculation and evaporation heating value.COPYRIGHT: (C)2014,JPO&INPIT【課題】薬剤の血中濃度や溶出率は従来と同等で、且つ、服用性の改善を計ることができ、更に添加剤を低減しながら打錠障害等の発生を防止できるような製剤の製造方法を提供すること。【解決手段】生理活性薬物と添加剤とを均一分散させた混合物を、流動層造粒装置に仕込み、所定の流動化風速にて流動化させながら、まず水をスプレー添加し、次いで高分子結合剤の溶液または分散・懸濁液をスプレー添加することによって、流動層内の粉末を湿潤、付着、凝集することで造粒物を製造することを含む、生理活性薬物を含有する製剤の製造方法において、目皿板部の風速を生理活性薬物の粒子径、粒子形状、質量等の粉体物性に応じ、さらに、粒子成長の状況に応じて、ステージ1流動化開始時(0.7~1.4 m/sec)、ステージ2(0.4~1.3 m/sec)、ステージ3(0.6~1.2 m/sec)、ステージ4(0.4~
