| 主权项 |
1. A tablet comprising two layers and containing a single analgesic for the treatment of acute pain in a subject in need thereof, comprising:
a) a first layer formulated for controlled-release comprising, an opioid analgesic effective to treat acute pain, wherein the opioid analgesic is oxycodone or a pharmaceutically acceptable salt thereof and is present in an amount of about 5 mg, about 7.5 mg, about 10 mg, about 15 mg, about 20 mg, or about 30 mg; and b) a second layer formulated for immediate-release comprising, an antiemetic effective to reduce nausea or vomiting associated with the opioid analgesic, wherein the antiemetic is promethazine or a pharmaceutically acceptable salt thereof and is present in an amount of from about 12.5 mg to about 50 mg, wherein the tablet comprises one or more excipients, wherein the one or more excipients comprise: carnauba wax, crospovidone, diacetylated monoglycerides, ethylcellulose, hydroxypropyl methylcellulose, hypromellose phthalate, magnesium stearate, mannitol, sodium hydroxide, sodium stearyl fumarate, talc, titanium dioxide, glyceryl monostearate 40-50, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, triethyl citrate, or yellow ferric oxide, and wherein: i) about 70% to about 80% of the promethazine or the pharmaceutically acceptable salt thereof is released in about 5 minutes to about 10 minutes following contact of the tablet with a dissolution fluid as measured by USP Apparatus 2 (Paddle), ii) about 30% to about 40% of the opioid analgesic or the pharmaceutically acceptable salt thereof is released within about 5 minutes to about 10 minutes following contact of the tablet with a dissolution fluid as measured by USP Apparatus 2 (Paddle), and iii) the tablet provides an effective amount of the promethazine or the pharmaceutically acceptable salt thereof to reduce nausea or vomiting associated with the opioid analgesic for about 4 to about 6 hours following administration to the subject, and an effective amount of the oxycodone or the pharmaceutically acceptable salt thereof to treat acute pain for about 4 to about 6 hours following administration to the subject. |
