US 12,083,226 B2
Stabilizer-containing solid drug formulation
Hiroaki Arai, Tokyo (JP); Shinji Yoshinaga, Tokyo (JP); and Yurika Ozaki, Tokyo (JP)
Assigned to DAIICHI SANKYO COMPANY, LIMITED, Tokyo (JP)
Appl. No. 17/264,563
Filed by DAIICHI SANKYO COMPANY, LIMITED, Tokyo (JP)
PCT Filed Jul. 29, 2019, PCT No. PCT/JP2019/029580
§ 371(c)(1), (2) Date Jan. 29, 2021,
PCT Pub. No. WO2020/027019, PCT Pub. Date Feb. 6, 2020.
Claims priority of application No. 2018-142885 (JP), filed on Jul. 30, 2018.
Prior Publication US 2021/0330592 A1, Oct. 28, 2021
Int. Cl. A61K 9/20 (2006.01); A61K 9/28 (2006.01); A61K 31/195 (2006.01)
CPC A61K 9/2013 (2013.01) [A61K 9/28 (2013.01); A61K 31/195 (2013.01)] 9 Claims
 
1. A tablet comprising:
[(1R,5S,6S)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl]acetic acid monobenzenesulfonate of formula (I):

OG Complex Work Unit Chemistry
D-mannitol;
carmellose calcium;
citric acid anhydride or citric acid hydrate, wherein the citric acid anhydride or citric acid hydrate is present at 1.125 to 2.9% by weight of the total weight of the uncoated tablet; and
α-tocopherol, wherein the α-tocopherol is present at 0.005 to 0.5% by weight of the total weight of the uncoated tablet.