Claims for Patent: 12,060,361

Summary for Patent: 12,060,361

Title:	Process for preparing oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
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.
Inventor(s):	Robert Chapman, Lonn S. Rider, Qi Hong, Donald Kyle, Robert Kupper
Assignee:	Rhodes Technologies Inc , Purdue Pharma LP
Application Number:	US18/330,932
Patent Claims:	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.