PROCESS FOR PREPARING OXYCODONE DOCAGE FORM
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 a pharmaceutical dosage form comprising:
combining (i) an active pharmaceutical ingredient comprising oxycodone, 8α,14-dihydroxy-7,8-dihydrocodeinone and less than 25 ppm 14-hydroxycodeinone and (ii) pharmaceutically acceptable excipients in a pharmaceutical dosage form.
81 . The process of claim 80 , wherein one of the pharmaceutically acceptable excipients comprises a pharmaceutically acceptable carrier.
82 . The process of claim 80 , wherein the process is for preparing an oral pharmaceutical dosage form.
83 . The process of claim 80 , wherein the active pharmaceutical ingredient comprises less than 10 ppm 14-hydroxycodeinone.
84 . The process of claim 83 , wherein the active pharmaceutical ingredient comprises less than 5 ppm 14-hydroxycodeinone.
85 . The process of claim 80 , wherein the active pharmaceutical ingredient comprises 0.25 ppm or more 14-hydroxycodeinone.
86 . The process of claim 85 , wherein the active pharmaceutical ingredient comprises 1 ppm or more 14-hydroxycodeinone.
87 . The process of claim 80 , wherein the active pharmaceutical ingredient is oxycodone hydrochloride.
88 . The process of claim 80 , wherein the process is for preparing a pharmaceutical dosage form comprising from about 10 mg to about 320 mg of the active pharmaceutical ingredient.
89 . A process for preparing a pharmaceutical dosage form comprising:
mixing (i) an active pharmaceutical ingredient comprising oxycodone, 8α,14-dihydroxy-7,8-dihydrocodeinone and less than 25 ppm 14-hydroxycodeinone and (ii) pharmaceutically acceptable excipients, and
making a tablet.
90 . The process of claim 89 , wherein one of the pharmaceutically acceptable excipients is a lubricant.
91 . The process of claim 89 , wherein one of the pharmaceutically acceptable excipients is a binding agent.
92 . The process of claim 89 , wherein the tablet is a sustained release tablet and at least one of the pharmaceutically acceptable excipients is a sustained release material.
93 . The process of claim 89 , wherein the tablet is an immediate release tablet.
94 . The process of claim 89 , wherein the tablet comprises from about 10 mg to about 320 mg of the active pharmaceutical ingredient.
95 . The process of claim 94 , wherein the active pharmaceutical ingredient is oxycodone hydrochloride.
96 . The process of claim 89 , wherein the active pharmaceutical ingredient comprises less than 10 ppm 14-hydroxycodeinone.
97 . The process of claim 89 , wherein the active pharmaceutical ingredient comprises 0.25 ppm or more 14-hydroxycodeinone.
98 . The process of claim 97 , wherein the active pharmaceutical ingredient comprises 1 ppm or more 14-hydroxycodeinone.
99 . A process for preparing a pharmaceutical dosage form comprising:
incorporating an active pharmaceutical ingredient comprising oxycodone, 8α,14-dihydroxy-7,8-dihydrocodeinone and less than 25 ppm 14-hydroxycodeinone into a capsule.
100 . The process of claim 99 , wherein the capsule comprises from about 10 mg to about 320 mg of the active pharmaceutical ingredient.
101 . The process of claim 99 , wherein the active pharmaceutical ingredient is oxycodone hydrochloride active pharmaceutical ingredient.
102 . The process of claim 99 , wherein the active pharmaceutical ingredient comprises less than 10 ppm 14-hydroxycodeinone.
103 . The process of claim 99 , wherein the active pharmaceutical ingredient comprises 0.25 ppm or more 14-hydroxycodeinone.
104 . The process of claim 99 , wherein the active pharmaceutical ingredient comprises 1 ppm or more 14-hydroxycodeinone.
105 . A process for preparing a pharmaceutical dosage form comprising:
forming particles comprising at least one pharmaceutically acceptable excipient and an active pharmaceutical ingredient comprising oxycodone, 8α,14-dihydroxy-7,8-dihydrocodeinone and less than 25 ppm 14-hydroxycodeinone, and
incorporating the particles into a pharmaceutical dosage form.
106 . The process of claim 105 , wherein the particles have a diameter from about 0.1 mm to about 2.5 mm.
107 . The process of claim 105 , wherein the pharmaceutical dosage form is a capsule or a tablet.
108 . The process of claim 105 , wherein the active pharmaceutical ingredient is an oxycodone salt active pharmaceutical ingredient.
109 . The process of claim 105 , wherein the oxycodone active pharmaceutical ingredient is oxycodone hydrochloride.