Pharmaceutical compositions

Abstract

Methods and compositions are provided which comprise effective amounts of an analgesic to treat a subject, including reducing or eliminating an adverse effect associated with the analgesic.

What is claimed: 
     
         1 . A solid oral pharmaceutical composition, comprising:
 a) a first plurality of particulates, wherein each particulate of the first plurality of particulates comprises an opioid analgesic, wherein the opioid analgesic is tramadol or a pharmaceutically acceptable salt thereof; and   b) a second plurality of particulates, wherein each particulate of the second plurality of particulates comprises an antiemetic, wherein the second plurality of particulates is formulated for immediate release, and wherein the antiemetic reduces or eliminates an adverse effect of the opioid analgesic.   
     
     
         2 . The solid oral pharmaceutical composition of  claim 1 , wherein the adverse effect of the opioid analgesic is nausea or vomiting. 
     
     
         3 . The solid oral pharmaceutical composition of  claim 1 , wherein the tramadol or the pharmaceutically acceptable salt thereof is present in an amount of about 1 mg to about 100 mg. 
     
     
         4 . The solid oral pharmaceutical composition of  claim 1 , wherein the tramadol or the pharmaceutically acceptable salt thereof is present in an amount of 37.5 mg, 50 mg, or 100 mg. 
     
     
         5 . The solid oral pharmaceutical composition of  claim 1 , wherein the pharmaceutically acceptable salt of the tramadol is tramadol hydrochloride. 
     
     
         6 . The solid oral pharmaceutical composition of  claim 1 , wherein the antiemetic is promethazine or a pharmaceutically acceptable salt thereof, or ondansetron or a pharmaceutically acceptable salt thereof. 
     
     
         7 . The solid oral pharmaceutical composition of  claim 6 , wherein the promethazine or the pharmaceutically acceptable salt thereof is present in an amount of about 0.5 mg to about 60 mg. 
     
     
         8 . The solid oral pharmaceutical composition of  claim 6 , wherein the promethazine or the pharmaceutically acceptable salt thereof is present in an amount of about 6.25, about 10 mg, about 12.5 mg, or about 25 mg. 
     
     
         9 . The solid oral pharmaceutical composition of  claim 6 , wherein the promethazine is present in an amount of about 5.5 mg, about 11 mg, or about 22 mg. 
     
     
         10 . The solid oral pharmaceutical composition of  claim 6 , wherein the pharmaceutically acceptable salt of the promethazine is promethazine hydrochloride. 
     
     
         11 . The solid oral pharmaceutical composition of  claim 6 , wherein the pharmaceutically acceptable salt of the ondansetron is ondansetron hydrochloride. 
     
     
         12 . The solid oral pharmaceutical composition of  claim 1 , wherein the opioid analgesic and the antiemetic are the only two active agents in the solid oral pharmaceutical composition. 
     
     
         13 . The solid oral pharmaceutical composition of  claim 1 , wherein the solid oral pharmaceutical composition comprises more than one antiemetic. 
     
     
         14 . The solid oral pharmaceutical composition of  claim 1 , wherein the solid oral pharmaceutical composition comprises one or more excipients. 
     
     
         15 . The solid oral pharmaceutical composition of  claim 14 , wherein the one or more excipients comprises: carnauba wax, crospovidone, diacetylated monoglycerides, ethylcellulose, hydroxypropyl methylcellulose, 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, hypromellose, croscarmellose sodium, magnesium stearate, stearic acid, sodium starch glycolate, or yellow ferric oxide. 
     
     
         16 . The solid oral pharmaceutical composition of  claim 1 , wherein the solid oral pharmaceutical composition is in a capsule dosage form. 
     
     
         17 . The solid oral pharmaceutical composition of  claim 1 , wherein the solid oral pharmaceutical composition is in a tablet form. 
     
     
         18 . The solid oral pharmaceutical composition of  claim 1 , wherein the solid oral pharmaceutical composition comprises one or more excipients, and wherein about 90% to about 100% of the opioid analgesic and about 90% to about 100% of the antiemetic are released in about 60 minutes following contact with a dissolution fluid as measured by a USP apparatus 2 (Paddle Apparatus). 
     
     
         19 . A method for treatment of pain and reduction or prevention of an adverse effect of an opioid analgesic, comprising administering to a subject in need thereof the solid oral pharmaceutical composition of  claim 1 . 
     
     
         20 . The method of  claim 19 , wherein the solid oral pharmaceutical composition is administered once, twice, or three times daily.