US2017360772A1PendingUtilityA1

Pharmaceutical compositions

Assignee: CHARLESTON LABORATORIES INCPriority: Jan 9, 2008Filed: Aug 14, 2017Published: Dec 21, 2017
Est. expiryJan 9, 2028(~1.5 yrs left)· nominal 20-yr term from priority
A61P 43/00A61P 39/00A61P 9/00A61P 7/02A61P 29/00A61P 25/04A61P 25/08A61P 29/02A61P 25/06A61P 1/08A61K 9/2013A61K 9/2054A61K 31/515A61K 45/06A61K 31/5415A61K 31/454A61K 31/522A61K 31/437A61K 31/4196A61K 31/165A61K 31/403A61K 9/209A61K 9/1694A61K 9/0024A61K 31/167A61K 31/485A61K 31/24A61K 47/36A61K 9/5084A61K 9/2027A61K 31/422A61K 9/4808A61K 31/404A61K 9/2086A61K 9/0056
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Claims

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.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A solid oral pharmaceutical composition in the form of a capsule that comprises only two active ingredients and one or more pharmaceutically acceptable excipients, wherein the solid oral pharmaceutical composition comprises:
 a second plurality of particulates that comprises a serotonin receptor agonist; and   a second plurality of particulates that comprises an antiemetic, wherein the plurality of second particulates is formulated for rapid release.   
     
     
         2 . The solid oral pharmaceutical composition of  claim 1 , wherein the serotonin receptor agonist comprises buspirone, cisapride, or lysergic acid diethylamide. 
     
     
         3 . The solid oral pharmaceutical composition of  claim 1 , wherein the serotonin receptor comprises a triptan, and wherein the antiemetic comprises promethazine or a pharmaceutically acceptable salt thereof. 
     
     
         4 . The solid oral pharmaceutical composition of  claim 3 , wherein the triptan is sumatriptan or a pharmaceutically acceptable salt thereof. 
     
     
         5 . The solid oral pharmaceutical composition of  claim 4 , wherein the sumatriptan or the pharmaceutically acceptable salt thereof is present in an amount of: from about 25 mg to about 100 mg. 
     
     
         6 . The solid oral pharmaceutical composition of  claim 4 , wherein the pharmaceutically acceptable salt of sumatriptan is sumatriptan succinate. 
     
     
         7 . The solid oral pharmaceutical composition of  claim 1 , wherein the antiemetic is promethazine or a pharmaceutically acceptable salt thereof. 
     
     
         8 . The solid oral pharmaceutical composition of  claim 7 , wherein the promethazine or the pharmaceutically acceptable salt thereof is provided in an amount of: from about 12.5 mg to about 50 mg. 
     
     
         9 . The solid oral pharmaceutical composition of  claim 7 , wherein the promethazine or the pharmaceutically acceptable salt thereof is provided in an amount of from about 0.5 mg to about 60 mg. 
     
     
         10 . The solid oral pharmaceutical composition of  claim 7 , wherein the promethazine is present in an amount of about 44 mg. 
     
     
         11 . The solid oral pharmaceutical composition of  claim 7 , wherein the pharmaceutically acceptable salt of promethazine is promethazine hydrochloride. 
     
     
         12 . The solid oral pharmaceutical composition of  claim 11 , wherein the promethazine hydrochloride is present in an amount of about 25 mg or about 50 mg. 
     
     
         13 . The solid oral pharmaceutical composition of  claim 1 , wherein the first plurality of particulates or the second plurality of particulates are beads, spheres, or pellets. 
     
     
         14 . The solid oral pharmaceutical composition of  claim 1  that further comprises polyvinyl alcohol. 
     
     
         15 . The solid oral pharmaceutical composition of  claim 1  that further comprises hydroxypropyl methylcellulose. 
     
     
         16 . The solid oral pharmaceutical composition of  claim 15 , wherein the hydroxypropyl methylcellulose is hydroxypropyl methylcellulose 2910. 
     
     
         17 . The solid oral pharmaceutical composition of  claim 3 , wherein the triptan is naratriptan or a pharmaceutically acceptable salt thereof. 
     
     
         18 . The solid oral pharmaceutical composition of  claim 3 , wherein the triptan is almotriptan or a pharmaceutically acceptable salt thereof. 
     
     
         19 . The solid oral pharmaceutical composition of  claim 3 , wherein the triptan is zolmitriptan or a pharmaceutically acceptable salt thereof. 
     
     
         20 . The solid oral pharmaceutical composition of  claim 3 , wherein the triptan is frovatriptan or a pharmaceutically acceptable salt thereof. 
     
     
         21 . The solid oral pharmaceutical composition of  claim 3 , wherein the triptan is rizatriptan or a pharmaceutically acceptable salt thereof. 
     
     
         22 . The solid oral pharmaceutical composition of  claim 1 , wherein about 90% to about 100% of the serotonin receptor agonist is released by about 60 minutes in a dissolution test as measured with a USP Apparatus 2 (Paddle Apparatus), and about 90% to about 100% of the antiemetic is released by about 40 minutes in a dissolution test as measured with a USP Apparatus 2 (Paddle Apparatus). 
     
     
         23 . A method of treating or preventing pain in a subject, comprising administering to the subject the solid oral pharmaceutical composition of  claim 1 . 
     
     
         24 . The method of  claim 23 , wherein the pain is a headache. 
     
     
         25 . The method of  claim 24 , wherein the headache is a migraine headache, a cluster headache, a hemicrania continua headache, a chronic headache, a tension headache, a chronic tension headache, or any combination thereof. 
     
     
         26 . The method of  claim 24 , wherein the headache is a migraine headache with or without an aura. 
     
     
         27 . The method of  claim 24 , wherein the headache is acute. 
     
     
         28 . The method of  claim 23 , wherein the solid oral pharmaceutical composition reduces nausea or vomiting. 
     
     
         29 . The method of  claim 23 , wherein the solid oral pharmaceutical composition prevents nausea or vomiting. 
     
     
         30 . A method of treating or preventing photophobia in a subject, comprising administering to the subject the solid oral pharmaceutical composition of  claim 1 . 
     
     
         31 . The method of  claim 30 , wherein the photophobia is associated with a migraine headache.

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