Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone

• US 7,683,072 B2
• Filed: 01/16/2007
• Issued: 03/23/2010
• Est. Priority Date: 03/30/2004
• Status: Active Grant

• Current Assignee: Purdue Pharma L.P.
• Original Assignee: Purdue Pharma L.P.
• Inventors: Hong, Qi, Kyle, Donald, Chapman, Robert, Kupper, Robert, Rider, Lonn S.
• Primary Examiner(s): AULAKH, CHARANJIT
• Application Number:
  US11/653,529
• Publication Number:
  US 20070117829A1
• Time in Patent Office: 1,162 Days
• Field of Search: 546/45, 546/44, 514/282
• US Class Current: 514/282
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 9/14 Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51
• CPC Class Codes: A61K 9/20 Pills, tablets, discs, rods A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00
• CPC Class Codes: A61K 9/48 Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• CPC Class Codes: A61K 9/4833 Encapsulating processes; Filling of capsules mechanical aspects A61J3/07
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: C07D 489/02 with oxygen atoms attached in positions 3 and 6, e.g. morphine, morphinone
• CPC Class Codes: C07D 489/04 Salts; Organic complexes
• CPC Class Codes: C07D 489/08 Oxygen atom

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.

Claims

1. 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.

2. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1, wherein the 14-hydroxycodeinone is derived solely from the 8α

, 14-dihydroxy-7,8-dihydrocodeinone.

3. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1 having less than 5 ppm 14-hydroxycodeinone.

4. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1 having less than 15 ppm 14-hydroxycodeinone.

5. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1 having less than 10 ppm 14-hydroxycodeinone.

6. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1 having less than 0.25 ppm 14-hydroxycodeinone.

7. The oxycodone hydrochloride active pharmaceutical ingredient of claim 4, having a lower limit of 14-hydroxycodeinone of 0.25 ppm.

8. The oxycodone hydrochloride active pharmaceutical ingredient of claim 4, having a lower limit of 14-hydroxycodeinone of 0.5 ppm.

9. The oxycodone hydrochloride active pharmaceutical ingredient of claim 4, having a lower limit of 14-hydroxycodeinone of 1 ppm.

10. The oxycodone hydrochloride active pharmaceutical ingredient of claim 4, having a lower limit of 14-hydroxycodeinone of 2 ppm.

11. The oxycodone hydrochloride active pharmaceutical ingredient of claim 4, having a lower limit of 14-hydroxycodeinone of 5 ppm.

12. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1 having less than 2 ppm 14-hydroxycodeinone.

13. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1 having less than 1 ppm 14-hydroxycodeinone.

14. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1 having less than 0.5 ppm 14-hydroxycodeinone.