US2013330404A1PendingUtilityA1

Extended release composition containing tramadol

47
Individually held — no corporate assignee on recordPriority: Apr 11, 2002Filed: Apr 17, 2012Published: Dec 12, 2013
Est. expiryApr 11, 2022(expired)· nominal 20-yr term from priority
Inventors:Arthur DeboeckFrancis VanderbistAntonio Sereno
A61P 29/00A61K 31/137A61K 31/135A61K 9/5084
47
PatentIndex Score
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Claims

Abstract

An oral tramadol pharmaceutical composition for once daily administration, containing an effective amount of tramadol or a pharmaceutically-acceptable salt thereof, providing in vivo, a time of tramadol peak plasma concentration (T max ) greater than 10 hours and a peak tramadol plasma concentration (C max ) which is less than three times a plasma concentration obtained 24 hours after administration (C 24h ) of a single dose of the composition.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An oral tramadol pharmaceutical composition for once daily administration, comprising an effective amount of tramadol or a pharmaceutically-acceptable salt thereof, providing in vivo, a time of tramadol peak plasma concentration (T max ) greater than 10 hours and a peak tramadol plasma concentration (C max ) which is less than three times a plasma concentration obtained 24 hours after administration (C 24h ) of a single dose of the composition. 
     
     
         2 . The composition of  claim 1 , wherein the composition provides after repeated once daily administration in vivo, a time of tramadol peak plasma concentration (T max ) greater than 10 hours, and a peak tramadol plasma concentration (C max ) which is not more than three times the plasma concentration obtained 24 hours after administration. 
     
     
         3 . The composition of  claim 1 , wherein said composition provides, after single administration in vivo, o-demethyl tramadol peak plasma concentration (C max ) which is not more than twice the plasma concentration obtained 24 hours after administration (C 24h ). 
     
     
         4 . The composition of  claim 1 , wherein said composition provides, after repeated daily administrations, o-demethyl tramadol peak plasma concentration (C max ) which is not more than twice the plasma concentration obtained 24 hours after administration (C 24h ). 
     
     
         5 . The composition of  claim 1 , wherein said composition provides, after single administration in vivo, a time of o-demethyl tramadol peak plasma concentration (T max ) greater than 10 hours. 
     
     
         6 . The composition of  claim 1 , wherein said composition provides, after repeated once daily administrations in vivo, a time of o-demethyl tramadol peak plasma concentrations (T max) greater than 10 hours. 
     
     
         7 . The composition of  claim 1 , which exhibits an in vitro biphasic dissolution profile. 
     
     
         8 . The composition of  claim 1 , which comprises individual tramadol-containing units which each release tramadol at a different rate. 
     
     
         9 . The composition of  claim 8 , which comprises at least one individual unit from which about 80% of tramadol is released within about 6 hours. 
     
     
         10 . The composition of  claim 8 , which comprises at least one individual unit from which about 80% of tramadol is released within 1 hour. 
     
     
         11 . The composition of  claim 1 , which comprises sustained-release beads covered by layers containing tramadol from which the tramadol is released at a different rate than from the sustained-release beads. 
     
     
         12 . The composition of  claim 11 , which comprises layers containing tramadol from which at least 80% of tramadol is released within about 6 hours. 
     
     
         13 . The composition of  claim 11 , which comprises layers containing tramadol from which at least 80% of tramadol is released within about 1 hour. 
     
     
         14 . The composition of  claim 1 , wherein a rapid rise in tramadol plasma concentration occurs in vivo within about 0.5 to 3 hours after administration. 
     
     
         15 . The composition of  claim 14 , wherein a peak plasma concentration (T max ) from said rapid rise in tramadol plasma concentration is less than the peak concentration (C max ) measured between successive administration. 
     
     
         16 . The composition of  claim 1 , which comprises multiple tramadol-containing units contained in a capsule. 
     
     
         17 . The composition of  claim 1 , which comprises multiple tramadol-containing units compressed in a tablet. 
     
     
         18 . The composition of  claim 1 , which exhibits a biphasic absorption profile in vivo under both fed and fasted administration conditions. 
     
     
         19 . The composition of  claim 1 , which comprises a fast release tablet containing tramadol, and slow release beads containing tramadol, wherein a C max  obtained from the fast release tablet is less than a C max  from the slow release beads. 
     
     
         20 . A method of managing post-surgery pain control, which comprises a step of administering the composition of  claim 1 , to a patient in need thereof, wherein said administering is once daily and effective under both fed and fasted conditions.

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