Patent ID: 9387177
Filing Date: 2016-07-12
CPC Classification: A61K,A61P

Claim Text:
1. A method for treating pain, and reducing or preventing opioid-induced nausea or vomiting, the method comprising administering a tablet comprising two layers to a subject in need thereof, the tablet comprising: a) a first layer formulated for controlled-release comprising an opioid analgesic and a non-opioid analgesic, wherein: b) a second layer formulated for immediate-release comprising an antiemetic, 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, microcrystalline cellulose, croscarmellose sodium, stearic acid, or yellow ferric oxide, wherein the tablet demonstrates the following dissolution profile: wherein the tablet provides an effective amount of the promethazine or the pharmaceutically acceptable salt thereof to reduce or prevent 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 or the hydrocodone or the pharmaceutically acceptable salt thereof to treat pain for about 4 to about 6 hours following administration to the subject.