PROCESS FOR PREPARING OXYCODONE COMPOSITIONS
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.