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 that is substantially free of 14-hydroxycodeinone comprising:
contacting an oxycodone base composition having an amount of 8α,14-dihydroxy-7,8-dihydrocodeinone with a substance that preferentially removes 8α,14-dihydroxy-7,8-dihydrocodeinone as compared to the oxycodone base; and
converting the oxycodone base composition to the oxycodone salt composition that is substantially free of 14-hydroxycodeinone.
81 . The process of claim 80 , wherein the oxycodone salt composition comprises less than 100 ppm 14-hydroxycodeinone.
82 . The process of claim 81 , wherein the oxycodone salt composition comprises less than 25 ppm 14-hydroxycodeinone.
83 . The process of claim 82 , wherein the oxycodone salt composition comprises less than 15 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 81 , wherein the oxycodone salt composition comprises 0.5 ppm or more 14-hydroxycodeinone.
87 . The process of claim 80 , wherein the process is for preparing an oxycodone hydrochloride active pharmaceutical ingredient composition.
88 . 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.
89 . The process of claim 80 , wherein the substance that preferentially removes the 8α,14-dihydroxy-7,8-dihydrocodeinone is a gel.
90 . The process of claim 89 , further comprising forming a slurry with the oxycodone base composition and the gel.
91 . The process according to claim 80 , wherein the oxycodone base composition is passed through the substance that preferentially removes the 8α,14-dihydroxy-7,8-dihydrocodeinone.
92 . The process of claim 80 , further comprising controlling an acid catalyzed dehydration consisting of conversion of the 8α,14-dihydroxy-7,8-dihydrocodeinone to 14-hydroxycodeinone during the conversion of the oxycodone base composition to the oxycodone salt composition.
93 . The process of claim 92 , further comprising reducing the rate of dehydration of the 8α,14-dihydroxy-7,8-dihydrocodeinone to 14-hydroxycodeinone during the conversion of the oxycodone base composition to the oxycodone salt composition.
94 . The process of claim 93 , wherein at least some of the 8α,14-dihydroxy-7,8-dihydrocodeinone is dehydrated to 14-hydroxycodeinone during the conversion of the oxycodone base composition to the oxycodone salt composition.
95 . A process for preparing an oxycodone salt composition comprising less than 100 ppm 14-hydroxycodeinone comprising:
contacting an oxycodone base composition having an amount of 8α,14-dihydroxy-7,8-dihydrocodeinone with a substance that preferentially removes 8α,14-dihydroxy-7,8-dihydrocodeinone as compared to the oxycodone base;
converting the oxycodone base composition to an oxycodone salt composition comprising less than 14-hydroxycodeinone; and
isolating the oxycodone salt composition comprising less than 100 ppm 14-hydroxycodeinone.
96 . The process of claim 95 , further comprising controlling an acid catalyzed dehydration consisting of conversion of the 8α,14-dihydroxy-7,8-dihydrocodeinone to 14-hydroxycodeinone during the conversion of the oxycodone base composition to the oxycodone salt composition.
97 . The process of claim 96 , further comprising reducing the rate of dehydration of the 8α,14-dihydroxy-7,8-dihydrocodeinone to 14-hydroxycodeinone during the conversion of the oxycodone base composition to the oxycodone salt composition.
98 . The process of claim 97 , wherein at least some of the 8α,14-dihydroxy-7,8-dihydrocodeinone is dehydrated to 14-hydroxycodeinone during the conversion of the oxycodone base composition to the oxycodone salt composition.
99 . The process of claim 95 , wherein the oxycodone salt composition comprises less than 25 ppm 14-hydroxycodeinone.
100 . The process of claim 99 , wherein the oxycodone salt composition comprises less than 10 ppm 14-hydroxycodeinone.
101 . The process of claim 100 , wherein the oxycodone salt composition comprises less than 5 ppm 14-hydroxycodeinone.
102 . The process of claim 95 , wherein the oxycodone salt composition comprises 0.5 ppm or more 14-hydroxycodeinone.
103 . The process of claim 102 , wherein the oxycodone salt composition comprises 1 ppm or more 14-hydroxycodeinone.
104 . The process of claim 95 , wherein the process is for preparing an oxycodone hydrochloride composition.
105 . The process of claim 95 , wherein the process is for preparing an oxycodone hydrochloride active pharmaceutical ingredient composition.
106 . The process of claim 95 , wherein the process is for preparing an oxycodone hydrochloride active pharmaceutical ingredient composition comprising less than 25 ppm 14-hydroxycodeinone.
107 . The process of claim 95 , wherein the isolated oxycodone salt composition comprises greater than 100 ppm 14-hydroxycodeinone.
108 . The process of claim 107 , further comprising hydrogenating the oxycodone salt composition comprising greater than 100 ppm 14-hydroxycodeinone to decrease the level of 14-hydroxycodeinone.
109 . The process of claim 108 , wherein the level of 14-hydroxycodeinone is decreased to less than 25 ppm.