US 12,458,600 B2
Method for producing granules containing a core particle, granules containing a core particle, pharmaceutical composition containing the granules containing the core particle, and preparation containing the pharmaceutical composition
Wataru Izui, Osaka (JP); Kenji Nozawa, Osaka (JP); Hiroyuki Yamamoto, Osaka (JP); Ryota Kimata, Osaka (JP); and Naoki Yoshihara, Osaka (JP)
Assigned to SAWAI PHARMACEUTICAL Co., Ltd., Osaka (JP)
Filed by SAWAI PHARMACEUTICAL Co., Ltd., Osaka (JP)
Filed on Feb. 8, 2021, as Appl. No. 17/169,807.
Claims priority of application No. 2020-025556 (JP), filed on Feb. 18, 2020.
Prior Publication US 2021/0251904 A1, Aug. 19, 2021
Int. Cl. A61K 9/16 (2006.01); A61K 31/13 (2006.01); A61K 31/137 (2006.01); A61K 31/343 (2006.01)
CPC A61K 9/1694 (2013.01) [A61K 9/1623 (2013.01); A61K 9/1635 (2013.01); A61K 9/1652 (2013.01); A61K 9/167 (2013.01); A61K 31/13 (2013.01); A61K 31/137 (2013.01); A61K 31/343 (2013.01)] 15 Claims
OG exemplary drawing
 
1. A method for producing granules comprising:
spraying granulation liquid to a mixture containing a drug substance particle and a core particle to granulate the mixture and cause the drug substance particle to be arranged on a surface of the core particle to obtain the granules, wherein the mixture further contains particles of one or more pharmaceutically acceptable additive agents or the mixture is free from having the particles of one or more pharmaceutically acceptable additive agents,
wherein the core particle is one selected from a group consisting of a partly pregelatinized starch, a thickening polysaccharide and a carboxy vinyl polymer,
the drug substance is a needle crystal or a plate crystal, and
the granulation liquid has a mist diameter (D50) of 90% or less relative to a particle size (D50) of the core particle.