Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
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Abstract
In certain embodiments the invention is directed to a process for preparing an oxycodone hydrochloride composition having less than 25 ppm of 14-hydroxycodeinone.
105 Citations
92 Claims
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1-70. -70. (canceled)
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71. An oral dosage form comprising (i) from about 5 mg to about 320 mg of oxycodone hydrochloride having a 14-hydroxycodeinone level of less than 25 ppm;
- and (ii) a pharmaceutically acceptable excipient.
- View Dependent Claims (72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90)
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91. An oral dosage form comprising particles comprising from about 5 mg to about 320 mg oxycodone hydrochloride having 14-hydroxycodeinone level of less than 25 ppm, said particles being coated with a material that permits release of the oxycodone hydrochloride at a sustained rate in an aqueous medium.
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92. An oral dosage form comprising (i) from about 5 mg to about 320 mg of oxycodone hydrochloride having a 14-hydroxycodeinone level of less than 25 ppm;
- and (ii) a sustained release material, wherein the sustained release material is film coated onto said oxycodone hydrochloride.
Specification