CPC A61K 31/135 (2013.01) [A61K 9/2013 (2013.01); A61K 9/2054 (2013.01); A61K 9/0053 (2013.01)] | 8 Claims |
1. An oral tablet dosage form comprising:
from 35 wt % to 55 wt % of ((((S)-1-(2-chlorophenyl)-2-oxocyclohexyl)(methyl)carbamoyl)oxy)methyl dimethyl-L-valinate or a pharmaceutically acceptable salt thereof;
from 0.5 wt % to 1.5 wt % of hydroxypropylmethyl cellulose E3;
from 20 wt % to 40 wt % of a controlled release polymer, wherein the controlled release polymer comprises:
from 50 wt % to 100 wt % of a hydroxypropylmethyl cellulose characterized by a methoxyl content from 22% to 24%; a pH in a 2% water at 25° C. from 5 to 8; a hydroxypropoxyl content 7.5% to 9.5%; a Brookfield viscosity from 80 mPa-s to 120 mPa-s as a 2% aqueous solution at 20° C.; and
from 0 wt % to 50 wt % of a hydroxypropylmethyl cellulose characterized by a methoxyl content from 22% to 24%; a pH in 2% water at 25° C. from 5 to 8; a hydroxypropoxyl content 7.5% to 9.5%; a Brookfield viscosity from 2,600 mPa-s to 5,000 mPa-s as a 2% aqueous solution at 20° C.;
wherein wt % is based on the total weight of the controlled release polymer;
from 10 wt % to 20 wt % of microcrystalline cellulose;
from 5 wt % to 15 wt % of sodium lauryl sulfate; and
from 0.1 wt % to 1.0 wt % of magnesium stearate,
wherein wt % is based on the total weight of the oral tablet dosage form.
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