Abstract: A spherical core containing an esomeprazole compound as an active ingredient and having a median particle diameter (d50) of 50 ?m or more is coated with a coat containing a controlled release layer to prepare a controlled release granule containing a controlled release granule with a median particle diameter (d50) of 350 ?m or less. The spherical core may contain the esomeprazole compound at a proportion of 50% by mass or more relative to the spherical core. The spherical core may be a spherical particle containing the esomeprazole compound as a drug. The spherical core has a median particle diameter (d50) of 50 ?m or more. The spherical core may have a sphericity of 0.6 or more. The coat may be in a multilayer free from an esomeprazole compound as an active ingredient. The controlled release layer may be an enteric coating layer. The proportion of the coat may be 80% by mass or more relative to the whole amount of the preparation.

Abstract: The present invention provides a method of efficiently manufacturing drug-containing particle which has a sharp peak in the particle size distribution, is highly spherical, and good in fluidity. The present invention relates to a manufacturing method of a drug-containing particle, the drug-containing particle comprising a raw material particle and a coating layer on the outside of the raw material particle, the raw material particle and/or the coating layer comprising at least one drug, wherein the manufacturing method comprises a granulation process that agitates a mixture comprising a core particle for powder coating formed by coating the raw material particle with a polymer and a drug and/or pharmaceutically acceptable additive while spraying a solvent which can dissolve the polymer on the mixture.