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. A composition comprising:
a core comprising:
10 to 80 mg oxycodone hydrochloride;
a detectable amount of 14-hydroxycodeinone that is less than 10 ppm;
a detectable amount of codeinone that is less than 5 ppm; and
a polyalkylene oxide having a weight-average molecular weight of about 1,000,000 to about 10,000,000.
2. The composition of claim 1 , wherein the polyalkylene oxide is a polyethylene oxide.
3. The composition of claim 2 , wherein the polyethylene oxide has a weight-average molecular weight of about 1,000,000 to about 7,000,000.
4. The composition of claim 2 , further comprising a first coating surrounding the core.
5. The composition of claim 4 , wherein the first coating comprises hydroxypropylmethylcellulose.
6. The composition of claim 5 , wherein the core further comprises a lubricant.
7. The composition of claim 6 , wherein the lubricant is magnesium stearate.
8. The composition of claim 6 , further comprising a second coating.
9. The composition of claim 8 , wherein the second coating comprises an alkylcellulose.
10. The composition of claim 9 , wherein the second alkylcellulose is hydroxypropylmethylcellulose.
11. The composition of claim 10 , wherein the second coating further comprises titanium dioxide.
12. A composition comprising:
a core comprising:
10 to 80 mg oxycodone hydrochloride;
less than 10 ppm of 14-hydroxycodeinone;
less than 5 ppm of codeinone; and
a polyalkylene oxide having a weight-average molecular weight of about 1,000,000 to about 10,000,000.
13. The composition of claim 12 , wherein the polyalkylene oxide is a polyethylene oxide.
14. The composition of claim 13 , wherein the polyethylene oxide has a weight-average molecular weight of about 1,000,000 to about 7,000,000.
15. The composition of claim 14 , wherein the polyethylene oxide has a weight-average molecular weight of about 1,000,000 to about 5,000,000.
16. The composition of claim 13 , further comprising a first coating surrounding the core.
17. The composition of claim 16 , wherein the first coating comprises hydroxypropylmethylcellulose.
18. The composition of claim 17 , wherein the core further comprises a lubricant.
19. The composition of claim 18 , wherein the core comprises up to 7.5 mg of the lubricant.
20. The composition of claim 18 , wherein the lubricant is magnesium stearate.
21. The composition of claim 18 , further comprising a second coating.
22. The composition of claim 21 , wherein the second coating comprises an alkylcellulose.
23. The composition of claim 22 , wherein the second alkylcellulose is hydroxypropylmethylcellulose.
24. The composition of claim 23 , wherein the second coating further comprises titanium dioxide.
25. The composition of claim 24 , wherein the second coating further comprises a plasticizer.
26. The composition of claim 25 , wherein the plasticizer is polyethylene glycol.
27. The composition of claim 26 , wherein the core comprises 10 to 60 mg oxycodone hydrochloride.
28. A method of treating pain comprising administering to a patient a composition, the composition comprising:
a core comprising:
10 to 80 mg oxycodone hydrochloride;
less than 10 ppm of 14-hydroxycodeinone;
less than 5 ppm of codeinone; and
a polyalkylene oxide having a weight-average molecular weight of about 1,000,000 to about 10,000,000.
29. The composition of claim 12 , wherein the 14-hydroxycodeinone is detected by a process comprising high-performance liquid chromatography (HPLC), and wherein HPLC parameters include a C18 column and a mobile phase comprising a carbonate buffer or a phosphate buffer.