Process for preparing oxycodone compositions

Abstract

In certain embodiments the invention is directed to a process for preparing an oxycodone hydrochloride composition having less than 25 ppm of 14-hydroxycodeinone.

1 - 79 . (canceled) 
     
     
         80 . A process for preparing an oxycodone composition comprising:
 subjecting a first oxycodone composition comprising a first amount of 14-hydroxycodeinone to chromatographic separation to preferentially remove 14-hydroxycodeinone as compared to oxycodone; and   recovering a second oxycodone composition comprising a second amount of 14-hydroxycodeinone;   wherein the second amount of 14-hydroxycodeinone is lower than the first amount of 14-hydroxycodeinone.   
     
     
         81 . The process of  claim 80 , wherein the second amount is less than 100 ppm. 
     
     
         82 . The process of  claim 81 , wherein the second amount is less than 25 ppm. 
     
     
         83 . The process of  claim 82 , wherein the second amount is less than 10 ppm. 
     
     
         84 . The process of  claim 83 , wherein the second amount is less than 5 ppm. 
     
     
         85 . The process of  claim 81 , wherein the second amount is 0.25 ppm or more. 
     
     
         86 . The process of  claim 85 , wherein the second amount is 1 ppm or more. 
     
     
         87 . The process of  claim 80 , wherein the chromatographic separation is a simulated moving bed. 
     
     
         88 . The process of  claim 80 , wherein the process is for preparing an oxycodone hydrochloride composition. 
     
     
         89 . The process of  claim 80 , wherein the process is for preparing an oxycodone hydrochloride active pharmaceutical ingredient composition. 
     
     
         90 . The process of  claim 80 , wherein the process is for preparing an oxycodone hydrochloride active pharmaceutical ingredient composition comprising less than 25 ppm 14-hydroxycodeinone.