US 12,251,475 B2
Solid pharmaceutical formulations of asimadoline
Kosuke Shigeta, Osaka (JP)
Assigned to Tioga Pharmaceuticals, Inc., San Diego, CA (US)
Filed by Tioga Pharmaceuticals, Inc., San Diego, CA (US)
Filed on Jun. 21, 2019, as Appl. No. 16/448,927.
Application 16/448,927 is a continuation of application No. PCT/US2017/067655, filed on Dec. 20, 2017.
Claims priority of provisional application 62/442,803, filed on Jan. 5, 2017.
Claims priority of provisional application 62/437,603, filed on Dec. 21, 2016.
Prior Publication US 2020/0009061 A1, Jan. 9, 2020
Int. Cl. A61K 9/20 (2006.01); A61K 9/28 (2006.01); A61K 31/40 (2006.01)
CPC A61K 9/2018 (2013.01) [A61K 9/2009 (2013.01); A61K 9/2054 (2013.01); A61K 9/2095 (2013.01); A61K 9/2813 (2013.01); A61K 31/40 (2013.01)] 12 Claims
 
1. A pharmaceutical composition comprising a raw tablet comprising asimadoline or a pharmaceutically acceptable salt thereof, lactose monohydrate, croscarmellose sodium, and magnesium stearate, wherein the raw tablet lacks microcrystalline cellulose and hypromellose, wherein the asimadoline or a pharmaceutically acceptable salt thereof and the lactose monohydrate together are about 90 to about 98% by weight of the composition, and wherein the raw tablet exhibits an immediate release profile characterized by at least 80% dissolution within one hour, as determined by USP<711> dissolution testing.