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 hydrochloride composition comprising
combining hydrochloric acid and an oxycodone base composition comprising 8α,14-dihydroxy-7,8-dihydrocodeinone to form a solution comprising oxycodone base, 8α,14-dihydroxy-7,8-dihydrocodeinone and 14-hydroxycodeinone; and
lyophilizing the solution to generate an oxycodone hydrochloride composition comprising 8α,14-dihydroxy-7,8-dihydrocodeinone and less than 25 ppm 14-hydroxycodeinone.
81 . A process for preparing an oxycodone hydrochloride composition comprising
combining hydrochloric acid and an oxycodone base composition comprising 8α,14-dihydroxy-7,8-dihydrocodeinone to form a solution comprising oxycodone base, 8α,14-dihydroxy-7,8-dihydrocodeinone and 14-hydroxycodeinone; and
spray drying the solution to generate an oxycodone hydrochloride composition comprising 8α,14-dihydroxy-7,8-dihydrocodeinone and less than 25 ppm 14-hydroxycodeinone.
82 . A solution comprising oxycodone base, 8α,14-dihydroxy-7,8-dihydrocodeinone and 14-hydroxycodeinone, wherein the solution comprises less than 25 parts of the 14-hydroxycodeinone per 1 million parts of the oxycodone base.
83 . The solution of claim 82 , wherein the solution comprises an alcohol.
1 - 79 . (canceled)
80 . A process for preparing an oxycodone hydrochloride composition comprising
combining hydrochloric acid and an oxycodone base composition comprising 8α,14-dihydroxy-7,8-dihydrocodeinone to form a solution comprising hydrochlorides of oxycodone, 8α,14-dihydroxy-7,8-dihydrocodeinone and 14-hydroxycodeinone; and
lyophilizing the solution to generate an oxycodone hydrochloride composition comprising oxycodone, 8α,14-dihydroxy-7,8-dihydrocodeinone and less than 25 ppm 14-hydroxycodeinone.
81 . A process for preparing an oxycodone hydrochloride composition comprising
combining hydrochloric acid and an oxycodone base composition comprising 8α,14-dihydroxy-7,8-dihydrocodeinone to form a solution comprising hydrochlorides of oxycodone, 8α,14-dihydroxy-7,8-dihydrocodeinone and 14-hydroxycodeinone; and
spray drying the solution to generate an oxycodone hydrochloride composition comprising oxycodone, 8α,14-dihydroxy-7,8-dihydrocodeinone and less than 25 ppm 14-hydroxycodeinone.
82 . A solution comprising salts of oxycodone, 8α,14-dihydroxy-7,8-dihydrocodeinone and 14-hydroxycodeinone, wherein the solution comprises less than 25 parts of the 14-hydroxycodeinone per 1 million parts of the oxycodone.
83 . The solution of claim 82 , wherein the solution comprises an alcohol.