Process for preparing oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
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. An oral dosage form comprising oxycodone and 8α,14-dihydroxy-7,8-dihydrocodeinone in a sustained release matrix, wherein the sustained release matrix comprises two or more hydrophobic materials, wherein the ratio of 8α,14-dihydroxy-7,8-dihydrocodeinone to oxycodone is 0.04% or less as measured by HPLC.
2. The oral dosage form of claim 1 , wherein at least one of the hydrophobic materials is a fatty acid.
3. The oral dosage form of claim 1 , wherein at least one of the hydrophobic materials is a C 12 -C 40 long chain fatty acid.
4. The oral dosage form of claim 1 , wherein one of the hydrophobic materials is beeswax.
5. The oral dosage form of claim 1 , wherein one of the hydrophobic materials is carnauba wax.
6. The oral dosage form of claim 1 , wherein one of the hydrophobic materials is beeswax and another hydrophobic material is a fatty acid.
7. The oral dosage form of claim 6 , wherein the fatty acid is a C 12 -C 40 long chain fatty acid.
8. The oral dosage form of claim 1 , wherein one of the hydrophobic materials is carnauba wax and another hydrophobic material is a fatty acid.
9. The oral dosage form of claim 8 , wherein the fatty acid is a C 12 -C 40 long chain fatty acid.
10. The oral dosage form of claim 9 , further comprising beeswax.
11. The oral dosage form of claim 1 , further comprising 14-hydroxycodeinone, wherein the amount of the 14-hydroxycodeinone is less than 100 ppm.
12. The oral dosage form of claim 3 , further comprising 14-hydroxycodeinone, wherein the amount of the 14-hydroxycodeinone is less than 100 ppm.
13. The oral dosage form of claim 4 , further comprising 14-hydroxycodeinone, wherein the amount of the 14-hydroxycodeinone is less than 100 ppm.
14. The oral dosage form of claim 5 , further comprising 14-hydroxycodeinone, wherein the amount of the 14-hydroxycodeinone is less than 100 ppm.
15. The oral dosage form of claim 7 , further comprising 14-hydroxycodeinone, wherein the amount of the 14-hydroxycodeinone is less than 100 ppm.
16. The oral dosage form of claim 9 , further comprising 14-hydroxycodeinone, wherein the amount of the 14-hydroxycodeinone is less than 100 ppm.
17. The oral dosage form of claim 1 , further comprising 14-hydroxycodeinone, wherein the amount of the 14-hydroxycodeinone is less than 25 ppm.
18. The oral dosage form of claim 3 , further comprising 14-hydroxycodeinone, wherein the amount of the 14-hydroxycodeinone is less than 25 ppm.
19. The oral dosage form of claim 4 , further comprising 14-hydroxycodeinone, wherein the amount of the 14-hydroxycodeinone is less than 25 ppm.
20. The oral dosage form of claim 5 , further comprising 14-hydroxycodeinone, wherein the amount of the 14-hydroxycodeinone is less than 25 ppm.
21. The oral dosage form of claim 7 , further comprising 14-hydroxycodeinone, wherein the amount of the 14-hydroxycodeinone is less than 25 ppm.
22. The oral dosage form of claim 9 , further comprising 14-hydroxycodeinone, wherein the amount of the 14-hydroxycodeinone is less than 25 ppm.