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 packaged oxycodone hydrochloride composition comprising a pharmaceutically acceptable package containing at least 1 kg of an oxycodone hydrochloride active pharmaceutical ingredient having less than 25 ppm 14-hydroxycodeinone, wherein at least a portion of the 14-hydroxycodeinone is derived from 8α,14-dihydroxy-7,8-dihydrocodeinone during conversion of oxycodone free base to oxycodone hydrochloride.
2. The packaged oxycodone hydrochloride composition of claim 1 , wherein the 14-hydroxycodeinone is derived solely from 8α,14-dihydroxy-7,8-dihydrocodeinone.
3. The packaged oxycodone hydrochloride composition of claim 1 , wherein the oxycodone hydrochloride active pharmaceutical ingredient has less than 15 ppm 14-hydroxycodeinone.
4. The packaged oxycodone hydrochloride composition of claim 1 , wherein the oxycodone hydrochloride active pharmaceutical ingredient has less than 10 ppm 14-hydroxycodeinone.
5. The packaged oxycodone hydrochloride composition of claim 1 , wherein the oxycodone hydrochloride active pharmaceutical ingredient has a lower limit of 14-hydroxycodeinone of 0.25 ppm.
6. The packaged oxycodone hydrochloride composition of claim 1 , wherein the oxycodone hydrochloride active pharmaceutical ingredient has a lower limit of 14-hydroxycodeinone of 0.5 ppm.
7. The packaged oxycodone hydrochloride composition of claim 1 , wherein the oxycodone hydrochloride active pharmaceutical ingredient has a lower limit of 14-hydroxycodeinone of 1 ppm.
8. The packaged oxycodone hydrochloride composition of claim 1 , wherein the oxycodone hydrochloride active pharmaceutical ingredient has a lower limit of 14-hydroxycodeinone of 2 ppm.
9. The packaged oxycodone hydrochloride composition of claim 1 , wherein the oxycodone hydrochloride active pharmaceutical ingredient has a lower limit of 14-hydroxycodeinone of 5 ppm.
10. The packaged oxycodone composition of claim 1 , wherein the oxycodone hydrochloride active pharmaceutical ingredient has less than 5 ppm 14-hydroxycodeinone.
11. The packaged oxycodone hydrochloride composition of claim 1 , wherein the amount of the oxycodone hydrochloride active pharmaceutical ingredient in the pharmaceutically acceptable package is between about 10 kg and about 500 kg.
12. The packaged oxycodone hydrochloride composition of claim 1 , wherein the amount of the oxycodone hydrochloride active pharmaceutical ingredient in the pharmaceutically acceptable package is between about 20 kg and about 100 kg.
13. The packaged oxycodone hydrochloride composition of claim 1 , wherein the amount of the oxycodone hydrochloride active pharmaceutical ingredient in the pharmaceutically acceptable package is between about 20 kg and about 50 kg.
14. The packaged oxycodone hydrochloride composition of claim 1 , wherein the pharmaceutically acceptable package is a corrugated box container.
15. The packaged oxycodone hydrochloride composition of claim 1 , wherein the pharmaceutically acceptable package is a drum.
16. The packaged oxycodone hydrochloride composition of claim 1 , wherein the pharmaceutically acceptable package is a flexible intermediate bulk container.
17. The packaged oxycodone hydrochloride composition of claim 1 , comprising a liner between the pharmaceutically acceptable package and the oxycodone hydrochloride active pharmaceutical ingredient.