US2007122478A1PendingUtilityA1

Extended release composition containing tramadol

60
Individually held — no corporate assignee on recordPriority: Apr 11, 2001Filed: Nov 16, 2006Published: May 31, 2007
Est. expiryApr 11, 2021(expired)· nominal 20-yr term from priority
Inventors:Arthur DeboeckFrancis VanderbistAntonio Sereno
A61K 31/137A61K 31/135A61P 29/00A61K 9/5084
60
PatentIndex Score
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Cited by
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References
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Claims

Abstract

The present invention relates to a once daily extended release pharmaceutical preparation of Tramadol or its acceptable pharmaceutical salts. The preparation provides, effective blood concentration for a period of about 24 hours with reduced peak concentrations. It is characterized that effective Tramadol levels appears within the first hours after administration, the time to maximal Tramadol content T max is at least 10 hours and the peak Tramadol concentration is less than three times the concentration obtained after 24 hours of said administration.

Claims

exact text as granted — not AI-modified
1 . Oral Tramadol pharmaceutical composition suitable for once daily administration comprising an effective amount of Tramadol or its pharmaceutically acceptable salts providing in vivo, a time of Tramadol peak plasma concentrations (T max ) greater than 10 hours and a peak Tramadol plasma concentrations (C max ) which are less than three times the plasma concentration obtained 24 hours after administration (C 24th ) of a single does of such composition.  
   
   
       2 . Compositions of  claim 1  wherein said pharmaceutical 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 are not more than three times the plasma concentration obtained 24 hours of administration (C 24th ).  
   
   
       3 . Composition of  claim 1  wherein said pharmaceutical composition provides, after single administration in vivo, o-demethyl Tramadol peak plasma concentrations (C max ) which are not more than twice the plasma concentration obtained 24 hours after administration (C 24th ).  
   
   
       4 . Composition of  claim 1  wherein said pharmaceutical composition provides, after repeated once daily administrations, o-demethyl Tramadol peak plasma concentrations (C max ) which are not more than twice the plasma concentration obtained 24 hours after administration (C 24th ).  
   
   
       5 . Composition of  claim 1  wherein said pharmaceutical composition provides, after single administration in vivo, a time of o-demethyl Tramadol peak plasma concentration (T max ) greater than 10 hours.  
   
   
       6 . Composition of  claim 1  wherein said pharmaceutical 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 . Composition of  claim 1  wherein said pharmaceutical composition exhibit an in vitro dissolution biphasic profile.  
   
   
       8 . Composition of  claim 1  wherein said pharmaceutical composition comprises individual containing Tramadol units from which Tramadol is released at different rates.  
   
   
       9 . Composition of  claim 10  wherein said pharmaceutical composition comprises at least one individual unit from which about 80% of Tramadol is released within about 6 hours.  
   
   
       10 . Composition of  claim 10  wherein said pharmaceutical composition comprises at least one individual unit from which about 80% of Tramadol is released within 1 hour.  
   
   
       11 . Composition of  claim 1  wherein said pharmaceutical composition comprises sustained released beads covered by layers containing Tramadol from which the Tramadol is released at a different rate than from the sustained release beads.  
   
   
       12 . Composition of  claim 13  wherein said pharmaceutical composition comprises layers containing Tramadol from which at least 80% of Tramadol is released within about 6 hours.  
   
   
       13 . Composition of  claim 13  wherein said pharmaceutical composition comprises layers containing Tramadol from which at least 80% of Tramadol is released within about 1 hours.  
   
   
       14 . Composition of  claim 10  wherein said pharmaceutical composition is characterized in vivo, by a rapid rise of Tramadol plasma concentration.  
   
   
       15 . Composition of  claim 16  wherein said rapid Tramadol plasma concentration rise occurs within about 0.5 to 3 hours after administration.  
   
   
       16 . Composition of  claim 16  wherein said rapid Tramadol plasma is less than the peak concentration (C max ) measured between successive administration.  
   
   
       17 . Composition of  claim 1  wherein pharmaceutical composition comprises multiple Tramadol containing units contained in a capsule.  
   
   
       18 . Composition of  claim 1  wherein said pharmaceutical composition comprises multiple Tramadol containing units compressed in a tablet.  
   
   
       19 . Composition of  claim 1  wherein said pharmaceutical composition provides similar pharmaceutical profile when such composition is administered orally with or without food.  
   
   
       20 . Composition of  claim 1  wherein said pharmaceutical composition provides effective pain control in humans during a period of about 24 hours after administration.  
   
   
       21 . Composition of  claim 1  wherein said pharmaceutical composition provides effective pain control in humans, starting at about 1 to 2 hours after administration and lasting for about 24 hours after administration.  
   
   
       22 . A composition of  claim 22  useful for the post surgery pain control.

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