Patent ID: 8728522

Claim:
A pharmaceutical composition in the form of a bi-layer tablet comprising: (1) an immediate release layer comprising: (a) about 5 mgs to about 20 mgs of promethazine or a pharmaceutically acceptable salt thereof, (b) about 75 mgs to about 150 mgs of silicified microcrystalline cellulose, (c) about 5 mgs to about 20 mgs of croscarmellose sodium, and (d) about 0.2 mgs to about 5 mgs of magnesium stearate; and (2) a controlled release layer comprising: (a) about 250 mgs to about 400 mgs of acetaminophen, or a pharmaceutically acceptable salt thereof, (b) about 2 mgs to about 15 mgs of hydrocodone, or a pharmaceutically acceptable salt thereof, (c) about 100 mgs to about 250 mgs of silicified microcrystalline cellulose, (d) about 5 mgs to about 30 mgs of hydroxypropyl methylcellulose, (e) about 0.5 mgs to about 5 mgs of magnesium stearate, and (f) about 0.5 mgs to about 10 mgs of stearic acid, wherein the bi-layer tablet provides an effective amount of the hydrocodone and the acetaminophen, or pharmaceutically acceptable salts thereof, for about 4 to about 6 hours following administration, and provides an effective amount of the promethazine or pharmaceutically acceptable salt thereof to reduce or eliminate an adverse effect associated with administration of the hydrocodone or pharmaceutically acceptable salt thereof, and wherein at least about 90% of the promethazine or pharmaceutically acceptable salt thereof is released within the first 10 minutes following administration, and 25% to 60% of the hydrocodone or pharmaceutically acceptable salt thereof is released within the first 5 minutes following administration.