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 dosage form comprising an active pharmaceutical ingredient comprising oxycodone, 8α,14-dihydroxy-7,8-dihydrocodeinone and less than 25 ppm of 14-hydroxycodeinone.
81 . The dosage form of claim 80 , which is a tablet.
82 . The dosage form of claim 80 , which is a capsule.
83 . The dosage form of claim 80 , which is a sustained release dosage form.
84 . The dosage form of claim 80 , which comprises particles of the active pharmaceutical ingredient.
85 . The dosage form of claim 84 , wherein the particles have a diameter of from about 0.1 mm to about 2.5 mm.
86 . The dosage form of claim 85 , wherein the particles have a diameter of from about 0.5 mm to about 2 mm.
87 . The dosage form of claim 80 , wherein the active pharmaceutical ingredient is oxycodone hydrochloride.
88 . The dosage form of claim 87 , which comprises from about 10 mg to about 320 mg of oxycodone hydrochloride.
89 . The dosage form of claim 80 , which contains about 5 mg, about 10 mg, about 15 mg, about 20 mg, about 30 mg, about 40 mg, about 50 mg, about 60 mg, about 80 mg, about 100 mg, or about 160 mg of the active pharmaceutical ingredient.
90 . A dosage form comprising an active pharmaceutical ingredient comprising oxycodone, 8α,14-dihydroxy-7,8-dihydrocodeinone, less than 5 ppm of codeinone, and less than 25 ppm of 14-hydroxycodeinone.
91 . The dosage form of claim 90 , which is a tablet.
92 . The dosage form of claim 90 , which is a capsule.
93 . The dosage form of claim 90 , which is a sustained release dosage form.
94 . The dosage form of claim 90 , which comprises particles of the active pharmaceutical ingredient.
95 . The dosage form of claim 94 , wherein the particles have a diameter of from about 0.1 mm to about 2.5 mm.
96 . The dosage form of claim 95 , wherein the particles have a diameter of from about 0.5 mm to about 2 mm.
97 . The dosage form of claim 90 , wherein the active pharmaceutical ingredient is oxycodone hydrochloride.
98 . The dosage form of claim 97 , which comprises from about 10 mg to about 320 mg of oxycodone hydrochloride.
99 . The dosage form of claim 90 , which contains about 5 mg, about 10 mg, about 15 mg, about 20 mg, about 30 mg, about 40 mg, about 50 mg, about 60 mg, about 80 mg, about 100 mg, or about 160 mg of the active pharmaceutical ingredient.