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 salt composition comprising:
 reacting an oxycodone base composition comprising 8α, 14-dihydroxy-7,8-dihydrocodeinone with boronated polystyrene resin in a suitable solvent to provide a modified oxycodone base composition; and   converting the modified oxycodone base composition to an oxycodone salt composition.   
     
     
         81 . The process of  claim 80 , wherein the oxycodone salt composition is substantially free of 14-hydroxycodeinone. 
     
     
         82 . The process of  claim 81 , wherein the oxycodone salt composition comprises less than 100 ppm 14-hydroxycodeinone. 
     
     
         83 . The process of  claim 82 , wherein the oxycodone salt composition comprises less than 25 ppm 14-hydroxycodeinone. 
     
     
         84 . The process of  claim 83 , wherein the oxycodone salt composition comprises less than 10 ppm 14-hydroxycodeinone. 
     
     
         85 . The process of  claim 84 , wherein the oxycodone salt composition comprises less than 5 ppm 14-hydroxycodeinone. 
     
     
         86 . The process of  claim 82 , wherein the oxycodone salt composition comprises 0.25 ppm or more 14-hydroxycodeinone. 
     
     
         87 . The process of  claim 86 , wherein the oxycodone salt composition comprises 1 ppm or more 14-hydroxycodeinone. 
     
     
         88 . The process of  claim 80 , wherein the reacting is at a temperature below about 20 degrees C. 
     
     
         89 . The process of  claim 80 , wherein the process is for preparing an oxycodone hydrochloride composition. 
     
     
         90 . The process of  claim 83 , wherein the process is for preparing an oxycodone hydrochloride active pharmaceutical ingredient composition. 
     
     
         91 . 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.