US 11,786,472 B2
Preparation containing saxagliptin and method for producing the same
Kenji Nozawa, Osaka (JP); Wataru Izui, Osaka (JP); Ayane Natsume, Osaka (JP); and Daiki Birukawa, Osaka (JP)
Assigned to SAWAI PHARMACEUTICAL CO., LTD., Osaka (JP)
Filed by SAWAI PHARMACEUTICAL Co., Ltd., Osaka (JP)
Filed on Jun. 22, 2021, as Appl. No. 17/354,167.
Claims priority of application No. 2020-107612 (JP), filed on Jun. 23, 2020.
Prior Publication US 2021/0393532 A1, Dec. 23, 2021
Int. Cl. A61K 9/20 (2006.01); A61K 31/403 (2006.01)
CPC A61K 9/2086 (2013.01) [A61K 9/2009 (2013.01); A61K 9/2018 (2013.01); A61K 9/2054 (2013.01); A61K 9/2059 (2013.01); A61K 31/403 (2013.01)] 18 Claims
 
1. A preparation containing saxagliptin comprising:
a plain tablet part containing one or more first additive agent selected from a group consisting of D-mannitol, lactose, anhydrous lactose, and anhydrous dibasic calcium phosphate, the plain tablet part containing less than 35% by weight of crystalline cellulose with respect to 100% by weight of the plain tablet part; and
a film coating part in direct contact with the plain tablet part and containing saxagliptin, a salt thereof, or a hydrate thereof;
wherein the film coating part contains 40% by weight or more of polyvinyl alcohol with respect to 100% by weight of the film coating part excluding the saxagliptin.