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 is: 
     
         1 . A method for treating pain, and reducing or preventing opioid-induced nausea or vomiting, the method comprising orally administering to a subject in need thereof:
 an antiemetic in a solid matrix formulated for immediate-release, wherein about 90% of the antiemetic is released with about 1 to about 20 minutes following contact of the solid oral pharmaceutical composition with a dissolution fluid of 0.01 N HCl maintained at 37.0±0.5° C. as measured by a USP Apparatus 2 (Paddle Apparatus); and   an opioid analgesic and a non-opioid analgesic in a solid matrix formulated for controlled-release, wherein about 100% of the opioid analgesic is released in about 60 minutes following contact of the solid oral pharmaceutical composition with a dissolution fluid of 0.01 N HCl maintained at 37.0±0.5° C. as measured by a USP Apparatus 2 (Paddle Apparatus),   wherein the opioid analgesic and the non-opioid analgesic are present in an effective amount to treat pain, and wherein the antiemetic is present in an effective amount to reduce or prevent nausea associated with the opioid analgesic or vomiting associated with the opioid analgesic.   
     
     
         2 . The method of  claim 1 , wherein about 100% of the opioid analgesic is released in about 50 minutes following contact of the solid oral pharmaceutical composition with a dissolution fluid of 0.01 N HCl maintained at 37.0±0.5° C. as measured by a USP Apparatus 2 (Paddle Apparatus). 
     
     
         3 . (canceled) 
     
     
         4 . (canceled) 
     
     
         5 . (canceled) 
     
     
         6 . (canceled) 
     
     
         7 . (canceled) 
     
     
         8 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . (canceled) 
     
     
         11 . (canceled) 
     
     
         12 . The method of  claim 1 , wherein the antiemetic is promethazine or a pharmaceutically acceptable salt thereof. 
     
     
         13 . The method of  claim 12 , wherein the promethazine or the pharmaceutically acceptable salt thereof is present in an amount of about 11-14 mg. 
     
     
         14 . The method of  claim 13 , wherein the promethazine or the pharmaceutically acceptable salt thereof is present in an amount of about 12.5 mg. 
     
     
         15 . The method of  claim 12 , wherein the pharmaceutically acceptable salt of the promethazine is promethazine hydrochloride, and is present in an amount of about 12.5 mg. 
     
     
         16 . The method of  claim 12 , wherein the promethazine or the pharmaceutically acceptable salt thereof is present in an amount of about 11 mg. 
     
     
         17 . The method of  claim 12 , wherein the pharmaceutically acceptable salt of the promethazine is promethazine hydrochloride. 
     
     
         18 . (canceled) 
     
     
         19 . (canceled) 
     
     
         20 . (canceled) 
     
     
         21 . (canceled) 
     
     
         22 . The method of  claim 1 , wherein the antiemetic is present in an amount of about 0.5 mg to about 60 mg. 
     
     
         23 . The method of  claim 1 , wherein the antiemetic is aprepitant, dronabinol, perphenazine, palonosetron, trimethyobenzamide, metoclopromide, domperidone, prochlorperazine, promethazine, chlorpromazine, trimethobenzamide, ondansetron, granisetron, hydroxyzine, acetylleucine monoethanolamine, alizapride, azasetron, benzquinamide, bietanautine, bromopride, buclizine, clebopride, cyclizine, dimenhydrinate, diphenidol, dolasetron, meclizine, methallatal, metopimazine, nabilone, oxyperndyl, pipamazine, scopolamine, sulpiride, tetrahydrocannabinol, thiethylperazine, thioproperazine, tropisetron, droperidol, haloperidol, prochloperazine, metoclopramide, diphenhydramine, cannabis, midazolam, lorazepam, hyoscine, dexamethasone, emetrol, propofol, or a pharmaceutically acceptable salt thereof. 
     
     
         24 . The method of  claim 22 , wherein the antiemetic is promethazine or a pharmaceutically acceptable salt thereof, and is present in an amount of about 12.5 mg, about 25 mg, or about 50 mg. 
     
     
         25 . The method of  claim 1 , wherein the solid matrix formulated for immediate-release is a tablet, or wherein the solid matrix formulated for controlled-release is a tablet. 
     
     
         26 . The method of  claim 1 , wherein the solid matrix formulated for immediate-release provides an effective amount of the antiemetic to reduce or prevent nausea associated with the opioid analgesic or vomiting associated with the opioid analgesic for about 4 to about 6 hours. 
     
     
         27 . The method of  claim 1 , wherein the solid matrix formulated for controlled-release provides an effective amount of the opioid analgesic and the non-opioid analgesic to treat pain for about 4 to about 6 hours. 
     
     
         28 . The method of  claim 1 , wherein the opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof, wherein the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof, and wherein the antiemetic is promethazine or a pharmaceutically acceptable salt thereof. 
     
     
         29 . The method of  claim 1 , further comprising orally administering to the subject: an opioid antagonist or an abuse deterrent agent. 
     
     
         30 . The method of  claim 1 , wherein administration of the antiemetic is prior to administration of the opioid analgesic and the non-opioid analgesic. 
     
     
         31 . The method of  claim 1 , wherein about 100% of the opioid analgesic is released in about 40 minutes following contact of the solid oral pharmaceutical composition with a dissolution fluid of 0.01 N HCl maintained at 37.0±0.5° C. as measured by a USP Apparatus 2 (Paddle Apparatus). 
     
     
         32 . The method of  claim 1 , wherein the solid matrix formulated for immediate-release comprises one or more excipients from microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 
     
     
         33 . The method of  claim 1 , wherein the solid matrix formulated for controlled-release comprises one or more excipients from microcrystalline cellulose, hydroxypropyl methylcellulose, croscarmellose sodium, magnesium stearate, or stearic acid.