Oxycodone compositions
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 oxycodone HCl composition comprising oxycodone HCl and 8α,14-dihydroxy-7,8-dihydrocodeinone, wherein the ratio of 8α,14-dihydroxy-7,8-dihydrocodeinone to oxycodone HCl is 0.04% or less as measured by HPLC.
2. The oxycodone HCl composition of claim 1 , wherein the oxycodone HCl is crystalline.
3. The oxycodone HCl composition of claim 1 , wherein at least 1 kg of the oxycodone HCl is prepared.
4. A pharmaceutically acceptable formulation comprising oxycodone HCl and 8α,14-dihydroxy-7,8-dihydrocodeinone, wherein the ratio of 8α,14-dihydroxy-7,8-dihydrocodeinone to oxycodone HCl is 0.04% or less as measured by HPLC.
5. The pharmaceutically acceptable formulation of claim 4 , wherein the oxycodone HCl is crystalline.
6. The pharmaceutically acceptable formulation of claim 5 , wherein the oxycodone HCl is incorporated into an oral dosage form.
7. The pharmaceutically acceptable formulation of claim 6 , further comprising a sustained released matrix.
8. The pharmaceutically acceptable formulation of claim 7 , wherein the sustained release matrix is prepared by melt-extrusion or melt-granulation.
9. The pharmaceutically acceptable formulation of claim 7 , wherein the sustained release matrix comprises melt-extruded multiparticulates.
10. The pharmaceutically acceptable formulation of claim 5 , wherein said crystalline oxycodone HCl is formulated in a homogeneous core surrounded by a semipermeable wall.
11. The pharmaceutically acceptable formulation of claim 10 , wherein the homogeneous core comprises polyethylene oxide.
12. An oxycodone HCl composition comprising oxycodone HCl, 8α,14-dihydroxy-7,8-dihydrocodeinone and less than 100 ppm of 14-hydroxycodeinone, wherein the ratio of 8α,14-dihydroxy-7,8-dihydrocodeinone to oxycodone HCl is 0.04% or less as measured by HPLC.
13. The oxycodone HCl composition of claim 12 , comprising less than 25 ppm of 14-hydroxycodeinone.
14. The oxycodone HCl composition of claim 12 , comprising less than 15 ppm of 14-hydroxycodeinone.
15. The oxycodone HCl composition of claim 12 , comprising less than 10 ppm of 14-hydroxycodeinone.
16. The oxycodone HCl composition of claim 12 , wherein the oxycodone HCl is crystalline.
17. The oxycodone HCl composition of claim 12 , wherein at least 1 kg of the oxycodone HCl is prepared.
18. A pharmaceutically acceptable formulation comprising oxycodone HCl, 8α,14-dihydroxy-7,8-dihydrocodeinone and less than 100 ppm of 14-hydroxycodeinone, wherein the ratio of 8α,14-dihydroxy-7,8-dihydrocodeinone to oxycodone HCl is 0.04% or less as measured by HPLC.
19. The pharmaceutically acceptable formulation of claim 18 , comprising less than 25 ppm of 14-hydroxycodeinone.
20. The pharmaceutically acceptable formulation of claim 18 , comprising less than 15 ppm of 14-hydroxycodeinone.
21. The pharmaceutically acceptable formulation of claim 18 , comprising less than 10 ppm of 14-hydroxycodeinone.
22. The pharmaceutically acceptable formulation of claim 18 , wherein the oxycodone HCl is crystalline.
23. The pharmaceutically acceptable formulation of claim 22 , wherein the oxycodone HCl is incorporated into an oral dosage form.
24. The pharmaceutically acceptable formulation of claim 23 , further comprising a sustained released matrix.
25. The pharmaceutically acceptable formulation of claim 24 , wherein the sustained release matrix is prepared by melt-extrusion or melt-granulation.
26. The pharmaceutically acceptable composition of claim 24 , wherein the sustained release matrix comprises melt-extruded multiparticulates.
27. The pharmaceutically acceptable formulation of claim 22 , wherein said crystalline oxycodone HCl is formulated in a homogeneous core surrounded by a semipermeable wall.
28. The pharmaceutically acceptable formulation of claim 27 , wherein the homogeneous core comprises polyethylene oxide.