Titration of Tapentadol

Abstract

The use of tapentadol for the manufacture of a medicament comprising at least one administration unit A containing dose a of tapentadol and at least one administration unit B containing dose b of tapentadol, where dose a<dose b, for the treatment of pain.

1 - 25 . (canceled) 
     
     
         26 . A method of treating pain in a subject in need thereof, said method comprising administering said subject
 dose a of tapentadol during a first administration interval and   dose b of tapentadol during a second administration interval following the first administration interval,   
       where dose a<dose b. 
     
     
         27 . The method according to  claim 26 , where dose a and dose b of tapentadol are administered orally. 
     
     
         28 . The method according to  claim 26 , wherein dose a and dose b of tapentadol are administered once daily (sid), twice daily (bid) or thrice daily (tid). 
     
     
         29 . The method according to  claim 26 , wherein dose a is within the range of from 10 to 90 wt.-% of dose b. 
     
     
         30 . The method according to  claim 26 , further comprising orally administering dose c of tapentadol once daily (sid), twice daily (bid) or thrice daily (tic/) during a third administration interval following the second administration interval, where dose b<dose c. 
     
     
         31 . The method according to  claim 30 , where dose a is within the range of from 10 to 65 wt.-% of dose c and where dose b is within the range of from 35 to 90 wt.-% of dose c. 
     
     
         32 . The method according to  claim 30 , further comprising orally administering dose d of tapentadol once daily (sid), twice daily (bid) or thrice daily (tid) during a fourth administration interval following the third administration interval, where dose c<dose d. 
     
     
         33 . The method according to  claim 32 , where dose a is within the range of from 10 to 55 wt.-% of dose d, where dose b is within the range of from 35 to 75 wt.-% of dose d, and where dose c is within the range of from 60 to 95 wt.-% of dose d. 
     
     
         34 . The method according to  claim 32 , further comprising orally administering dose e of tapentadol once daily (sick, twice daily (bid) or thrice daily (tid) during a fifth administration interval following the fourth administration interval, where dose d<dose e. 
     
     
         35 . The method according to  claim 34 , where dose a is within the range of from 10 to 30 wt.-% of dose e, where dose b is within the range of from 30 to 50 wt.-% of dose e, where dose c is within the range of from 50 to 70 wt.-% of dose e, and where dose d is within the range of from 70 to 90 wt.-% of dose e. 
     
     
         36 . The method according to  claim 26 , wherein dose a, dose b, optional dose c, optional dose d and optional dose e are independently selected so that the daily dose of tapentadol is always within the range of from 20 to 550 mg. 
     
     
         37 . The method according to  claim 26 , comprising orally administering
 (i) dose a of tapentadol twice daily (bid) during a first administration interval of at least α consecutive days,   (ii) dose b of tapentadol twice daily (bid) during a second administration interval of at least β consecutive days following the first administration interval,   (iii) optionally, dose c of tapentadol twice daily (bid) during a third administration interval of at least χ consecutive days following the second administration interval,   (iv) optionally, dose d of tapentadol twice daily (bid) during a fourth administration interval of at least δ consecutive days following the third administration interval, and   (v) optionally, dose e of tapentadol twice daily (bid) during a fifth administration interval of at least ε consecutive days following the fourth administration interval;   
       where a, b, c, d, e and α, β, χ, δ, ε satisfy requirement P, Q, R, or S: 
       
         
           
                 
                 
                 
                 
                 
               
                     
                 
                   [mg]/[days] 
                   P 
                   Q 
                   R 
                   S 
                 
                     
                 
                   (a/α) 
                    (25 ± 5%/≧2) 
                    (50 ± 5%/≧2) 
                   (100 ± 5%/≧2) 
                   (100 ± 5%/≧2) 
                 
                   (b/β) 
                    (50 ± 5%/≧2) 
                   (100 ± 5%/≧2) 
                   (150 ± 5%/≧2) 
                   (150 ± 5%/≧2) 
                 
                   (c/χ) 
                   (100 ± 5%/≧2) 
                   (150 ± 5%/≧0) 
                   (250 ± 5%/≧0) 
                   (200 ± 5%/≧0) 
                 
                   (d/δ) 
                   (150 ± 5%/≧0) 
                   (200 ± 5%/≧0) 
                     
                   (250 ± 5%/≧0) 
                 
                   (e/ε) 
                   (200 ± 5%/≧0) 
                   (250 ± 5%/≧0) 
                 
                     
                 
             
                
                
                
               
               
                
                
                
                
                
                
               
            
           
         
       
     
     
         38 . The method according to  claim 26 , wherein tapentadol is administered in a regimen including at least 30 consecutive days. 
     
     
         39 . The method according to  claim 38 , wherein at the end of the regimen the administration of tapentadol is terminated without drug tapering.