OXYCODONE DOSAGE FORMS
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 sustained release oral dosage form comprising:
(i) an active pharmaceutical ingredient comprising oxycodone, 8α,14-dihydroxy-7,8-dihydrocodeinone and less than 100 ppm 14-hydroxycodeinone; and
(ii) a material selected from the group consisting of gums, cellulose ethers, acrylic resins, waxes, fatty alcohols, fatty acids, and mixtures thereof.
81 . The dosage form of claim 80 , wherein the material is selected from the group consisting of waxes, fatty alcohols, fatty acids, and mixtures thereof.
82 . The dosage form of claim 81 , wherein the material is a fatty acid.
83 . The dosage form of claim 82 , wherein the fatty acid is selected from the group consisting of lauryl, myristyl, stearyl, cetyl and cetostearyl alcohols.
84 . The dosage form of claim 81 , wherein the material is a wax.
85 . The dosage form of claim 80 , wherein the active pharmaceutical ingredient comprises less than 25 ppm 14-hydroxycodeinone.
86 . The dosage form of claim 80 , wherein the active pharmaceutical ingredient comprises 0.25 ppm or more 14-hydroxycodeinone.
87 . The dosage form of claim 80 , wherein the active pharmaceutical ingredient comprises 1 ppm or more 14-hydroxycodeinone.
88 . The dosage form of claim 80 , wherein the active pharmaceutical ingredient comprises 2 ppm or more 14-hydroxycodeinone.
89 . The dosage form of claim 80 , wherein the active pharmaceutical ingredient comprises 5 ppm or more 14-hydroxycodeinone.
90 . The dosage form of claim 80 , wherein the dosage form is a capsule.
91 . The dosage form of claim 80 , wherein the active pharmaceutical ingredient is an oxycodone salt.
92 . The dosage form of claim 91 , wherein the oxycodone salt is an oxycodone hydrochloride salt.
93 . A sustained release oral dosage form comprising:
(i) an active pharmaceutical ingredient comprising oxycodone and 8α,14-dihydroxy-7,8-dihydrocodeinone; and
(ii) a material selected from the group consisting of gums, cellulose ethers, acrylic resins, waxes, fatty alcohols, fatty acids, and mixtures thereof;
wherein the dosage form comprises from about 10 mg to about 320 mg of the active pharmaceutical ingredient, and the active pharmaceutical ingredient is substantially free of 14-hydroxycodeinone.
94 . The dosage form of claim 93 , wherein the dosage form comprises 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.
95 . The dosage form of claim 94 , wherein the active pharmaceutical ingredient comprises less than 25 ppm 14-hydroxycodeinone.
96 . The dosage form of claim 94 , wherein the active pharmaceutical ingredient is an oxycodone salt.
97 . The dosage form of claim 96 , wherein the oxycodone salt is an oxycodone hydrochloride salt.
98 . The dosage form of claim 94 , wherein the active pharmaceutical ingredient comprises less than 100 ppm 14-hydroxycodeinone.
99 . The dosage form of claim 98 , wherein the active pharmaceutical ingredient comprises 1 ppm or more 14-hydroxycodeinone.
100 . The dosage form of claim 95 , wherein the active pharmaceutical ingredient comprises 1 ppm or more 14-hydroxycodeinone.
101 . The dosage form of claim 95 , wherein the active pharmaceutical ingredient comprises 5 ppm or more 14-hydroxycodeinone.
102 . The dosage form of claim 94 , wherein the dosage form is a multiparticulate formulation.
103 . The dosage form of claim 102 , wherein the multiparticulate formulation comprises granules, spheroids or pellets.
104 . A sustained release oral dosage form comprising:
(i) an active pharmaceutical ingredient comprising oxycodone, 8α,14-dihydroxy-7,8-dihydrocodeinone and less than 100 ppm 14-hydroxycodeinone; and
(ii) a material selected from the group consisting of gums, cellulose ethers, acrylic resins, waxes, fatty alcohols, fatty acids, and mixtures thereof,
wherein the dosage form is a tablet and comprises from about 10 mg to about 320 mg of the active pharmaceutical ingredient.
105 . The dosage form of claim 104 , wherein the active pharmaceutical ingredient is an oxycodone salt.
106 . The dosage form of claim 105 , wherein the oxycodone salt is an oxycodone hydrochloride salt.
107 . The dosage form of claim 106 , wherein the active pharmaceutical ingredient comprises 0.25 ppm or more 14-hydroxycodeinone.
108 . The dosage form of claim 106 , wherein the active pharmaceutical ingredient comprises 1 ppm or more 14-hydroxycodeinone.
109 . The dosage form of claim 106 , wherein the active pharmaceutical ingredient comprises 2 ppm or more 14-hydroxycodeinone.