METHODS OF TREATING PAIN
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 method of treating pain comprising:
administering to a human a pharmaceutical dosage form comprising from about 10 mg to about 320 mg of an active pharmaceutical ingredient comprising oxycodone, 8α,14-dihydroxy-7,8-dihydrocodeinone and less than 25 ppm 14-hydroxycodeinone.
81 . The method of claim 80 , wherein the pharmaceutical dosage form is administered orally.
82 . The method of claim 81 , wherein the pharmaceutical dosage form is administered twice daily.
83 . The method of claim 80 , wherein the pharmaceutical dosage form is a tablet.
84 . The method of claim 80 , wherein the pharmaceutical dosage form is a capsule.
85 . The method of claim 80 , wherein the pharmaceutical dosage form comprises powders or granules.
86 . The process of claim 80 , wherein the active pharmaceutical ingredient comprises less than 10 ppm 14-hydroxycodeinone.
87 . The method of claim 80 , wherein the active pharmaceutical ingredient comprises 0.25 ppm or more 14-hydroxycodeinone.
88 . The method of claim 87 , wherein the active pharmaceutical ingredient comprises 1 ppm or more 14-hydroxycodeinone.
89 . The method of claim 80 , wherein the active pharmaceutical ingredient is oxycodone hydrochloride.
90 . The method of claim 82 , wherein the pharmaceutical dosage form is an immediate release tablet.
91 . The method of claim 82 , wherein about 5 mg of the active pharmaceutical ingredient is administered.
92 . The method of claim 82 , wherein about 10 mg of the active pharmaceutical ingredient is administered.
93 . The method of claim 82 , wherein about 15 mg of the active pharmaceutical ingredient is administered.
94 . The method of claim 82 , wherein about 20 mg of the active pharmaceutical ingredient is administered.
95 . The method of claim 82 , wherein about 30 mg of the active pharmaceutical ingredient is administered.
96 . The method of claim 82 , wherein about 40 mg of the active pharmaceutical ingredient is administered.
97 . The method of claim 82 , wherein about 50 mg of the active pharmaceutical ingredient is administered.
98 . The method of claim 82 , wherein about 60 mg of the active pharmaceutical ingredient is administered.
99 . The method of claim 82 , wherein about 80 mg of the active pharmaceutical ingredient is administered.
100 . The method of claim 82 , wherein about 100 mg of the active pharmaceutical ingredient is administered.
101 . The method of claim 82 , wherein about 160 mg of the active pharmaceutical ingredient is administered.
102 . The method of claim 81 , wherein the pharmaceutical dosage form is administered once daily.
103 . The method of claim 102 , wherein about 60 mg of the active pharmaceutical ingredient is administered.
104 . The method of claim 102 , wherein about 80 mg of the active pharmaceutical ingredient is administered.
105 . The method of claim 102 , wherein about 100 mg of the active pharmaceutical ingredient is administered.
106 . The method of claim 102 , wherein about 160 mg of the active pharmaceutical ingredient is administered.
107 . The method of claim 102 , wherein about 320 mg of the active pharmaceutical ingredient is administered.
108 . The process of claim 80 , wherein the active pharmaceutical ingredient is oxycodone salt active pharmaceutical ingredient.
109 . The process of claim 108 , wherein the oxycodone active pharmaceutical ingredient is an oxycodone hydrochloride.