CPC A61K 31/5377 (2013.01) [A61K 9/0053 (2013.01); A61K 9/2013 (2013.01); A61K 9/2018 (2013.01); A61K 9/2027 (2013.01); A61K 9/2054 (2013.01); A61K 9/2059 (2013.01); A61K 9/2077 (2013.01); A61K 9/2095 (2013.01); A61K 9/2846 (2013.01); A61K 9/2893 (2013.01); A61P 35/00 (2018.01); A61K 9/2004 (2013.01)] | 62 Claims |
1. A method of treating a solid tumor or B cell lymphoma, comprising administering to a human subject in need thereof a solid pharmaceutical formulation comprising, in each case relative to the total weight of the solid pharmaceutical formulation, N-((4,6-dimethyl-2-oxo-1,2-dihydropyridin-3 -yl) methyl)-5-(ethyl(tetrahydro-2H-pyran-4-yl)amino)-4-methyl-4′-(morpholinomethyl)-[1,1′-biphenyl]-3-carboxamide:
![]() in an amount of about 40-60 wt. %, or a pharmaceutically acceptable salt of Compound 1 in an amount equivalent to about 40-60 wt. % of Compound 1, or a combination of Compound 1 and a pharmaceutically acceptable salt of Compound 1 wherein the combination is present in an amount equivalent to about 40-60 wt. % of Compound 1;
a diluent comprising lactose monohydrate;
a disintegrant in an amount of about 15-25 wt. % comprising low-substituted hydroxypropyl cellulose, sodium starch glycolate, or a combination thereof;
a binder in an amount of about 1-10 wt. % comprising hydroxypropyl cellulose; and
a lubricant in an amount of about 0.5-5 wt. % comprising magnesium stearate; wherein the solid pharmaceutical formulation provides a maximum plasma concentration of Compound 1 at a median Tmax of from about 1 hour to about 2 hours after multiple dosing for 15 days.
|