➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Johnson and Johnson
Moodys
Medtronic
Colorcon

Last Updated: September 21, 2021

DrugPatentWatch Database Preview

Claims for Patent: 9,907,793


Email this page to a colleague

« Back to Dashboard

Summary for Patent: 9,907,793
Title:Pharmaceutical preparation containing oxycodone and naloxone
Abstract: The invention concerns a storage stable pharmaceutical preparation comprising oxycodone and naloxone for use in pain therapy, with the active compounds being released from the preparation in a sustained, invariant and independent manner.
Inventor(s): Brogmann; Bianca (Ulm, DE), Muhlau; Silke (Biberach, DE), Spitzley; Christof (Elbtal, DE)
Assignee: Purdue Pharma L.P. (Stamford, CT)
Application Number:15/399,487
Patent Claims: 1. An oral sustained release pharmaceutical formulation comprising: 10 to 30 mg of oxycodone or a pharmaceutically acceptable salt thereof; and naloxone or a pharmaceutically acceptable salt thereof; wherein the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof are present in the pharmaceutical formulation in a weight ratio of 2:1 and are released from the pharmaceutical formulation in a sustained manner; wherein the formulation comprises a tablet, a multi-layer tablet, a pill, a capsule, granules, or powder.

2. The pharmaceutical formulation of claim 1, wherein the oxycodone is present in the form of a pharmaceutically acceptable salt thereof.

3. The pharmaceutical formulation of claim 1, wherein the oxycodone is present in the form of oxycodone hydrochloride.

4. The pharmaceutical formulation of claim 1, wherein the naloxone is present in the form of a pharmaceutically acceptable salt thereof.

5. The pharmaceutical formulation of claim 1, wherein the naloxone is present in the form of naloxone hydrochloride.

6. The pharmaceutical formulation of claim 1, wherein the oxycodone is present in the form of oxycodone hydrochloride, and the naloxone is present in the form of naloxone hydrochloride.

7. The pharmaceutical formulation of claim 1, wherein the oxycodone or pharmaceutically acceptable salt thereof is present in an amount of 10 mg.

8. The pharmaceutical formulation of claim 1, wherein the oxycodone or pharmaceutically acceptable salt thereof is present in an amount of 12 mg.

9. The pharmaceutical formulation of claim 1, wherein the oxycodone or pharmaceutically acceptable salt thereof is present in an amount of 20 mg.

10. The pharmaceutical formulation of claim 1, wherein the oxycodone or pharmaceutically acceptable salt thereof is present in an amount of 30 mg.

11. The pharmaceutical formulation of claim 1, wherein the formulation comprises a multi-layer tablet, a pill, a capsule, granules, or powder.

12. The pharmaceutical formulation of claim 1, wherein the formulation is formulated to release the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof over 2 to 24 hours.

13. The pharmaceutical formulation of claim 1, wherein the formulation is formulated to release the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof over 2 to 16 hours.

14. The pharmaceutical formulation of claim 1, wherein the formulation is formulated to release the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof over 2 to 12 hours.

15. The pharmaceutical formulation of claim 1, wherein the formulation is formulated to release 40% to 80% of the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof by 2 hours.

16. The pharmaceutical formulation of claim 1, wherein the formulation is formulated to release 70% to 100% of the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof by 4 hours.

17. The pharmaceutical formulation of claim 1, wherein the formulation is formulated to release 70% to 100% of the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof by 7 hours.

18. The pharmaceutical formulation of claim 1, wherein the formulation is formulated to release 85% to 100% of the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof by 12 hours.

19. The pharmaceutical formulation of claim 1, wherein the formulation is formulated to release the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof in equal percent amounts per unit time.

20. The pharmaceutical formulation of claim 1, wherein the formulation is formulated to release the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof such that the percent released of the oxycodone or pharmaceutically acceptable salt thereof deviates from the percent released of the naloxone or pharmaceutically acceptable salt by not more than 20%, and the percent released of the naloxone or pharmaceutically acceptable salt thereof deviates from the percent released of the oxycodone or pharmaceutically acceptable salt by not more than 20%.

21. The pharmaceutical formulation of claim 1, wherein the formulation comprises a sustained release matrix that contains and releases the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof.

22. The pharmaceutical formulation of claim 21, wherein the oxycodone is present in the form of oxycodone hydrochloride, and the naloxone is present in the form of naloxone hydrochloride; the matrix is formulated to release 85% to 100% of the oxycodone hydrochloride and the naloxone hydrochloride by 12 hours; and the matrix is formulated to release the oxycodone hydrochloride and the naloxone hydrochloride in equal percent amounts per unit time.

23. A method of treating pain comprising administering to a subject in need thereof the pharmaceutical composition of claim 1.

24. An oral sustained release pharmaceutical formulation comprising: oxycodone or a pharmaceutically acceptable salt thereof; and 1 to 10 mg of naloxone or a pharmaceutically acceptable salt thereof; wherein the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof are present in the pharmaceutical formulation in a weight ratio of 2:1 and are released from the pharmaceutical formulation in a sustained manner; wherein the formulation comprises a tablet, a multi-layer tablet, a pill, a capsule, granules, or powder.

25. The pharmaceutical formulation of claim 24, wherein the oxycodone is present in the form of a pharmaceutically acceptable salt thereof.

26. The pharmaceutical formulation of claim 24, wherein the oxycodone is present in the form of oxycodone hydrochloride.

27. The pharmaceutical formulation of claim 24, wherein the naloxone is present in the form of a pharmaceutically acceptable salt thereof.

28. The pharmaceutical formulation of claim 24, wherein the naloxone is present in the form of naloxone hydrochloride.

29. The pharmaceutical formulation of claim 24, wherein the oxycodone is present in the form of oxycodone hydrochloride, and the naloxone is present in the form of naloxone hydrochloride.

30. The pharmaceutical formulation of claim 24, wherein the oxycodone or pharmaceutically acceptable salt thereof is present in an amount of 5 mg.

31. The pharmaceutical formulation of claim 24, wherein the formulation comprises a multi-layer tablet, a pill, a capsule, granules, or powder.

32. The pharmaceutical formulation of claim 24, wherein the formulation is formulated to release the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof over 2 to 24 hours.

33. The pharmaceutical formulation of claim 24, wherein the formulation is formulated to release the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof over 2 to 16 hours.

34. The pharmaceutical formulation of claim 24, wherein the formulation is formulated to release the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof over 2 to 12 hours.

35. The pharmaceutical formulation of claim 24, wherein the formulation is formulated to release 40% to 80% of the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof by 2 hours.

36. The pharmaceutical formulation of claim 24, wherein the formulation is formulated to release 70% to 100% of the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof by 4 hours.

37. The pharmaceutical formulation of claim 24, wherein the formulation is formulated to release 70% to 100% of the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof by 7 hours.

38. The pharmaceutical formulation of claim 24, wherein the formulation is formulated to release 85% to 100% of the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof by 12 hours.

39. The pharmaceutical formulation of claim 24, wherein the formulation is formulated to release the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof in equal percent amounts per unit time.

40. The pharmaceutical formulation of claim 24, wherein the formulation is formulated to release the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof such that the percent released of the oxycodone or pharmaceutically acceptable salt thereof deviates from the percent released of the naloxone or pharmaceutically acceptable salt by not more than 20%, and the percent released of the naloxone or pharmaceutically acceptable salt thereof deviates from the percent released of the oxycodone or pharmaceutically acceptable salt by not more than 20%.

41. The pharmaceutical formulation of claim 24, wherein the formulation comprises a sustained release matrix that contains and releases the oxycodone or pharmaceutically acceptable salt thereof and the naloxone or pharmaceutically acceptable salt thereof.

42. The pharmaceutical formulation of claim 41, wherein the oxycodone is present in the form of oxycodone hydrochloride, and the naloxone is present in the form of naloxone hydrochloride; the matrix is formulated to release 85% to 100% of the oxycodone hydrochloride and the naloxone hydrochloride by 12 hours; and the matrix is formulated to release the oxycodone hydrochloride and the naloxone hydrochloride in equal percent amounts per unit time.

43. A method of treating pain comprising administering to a subject in need thereof the pharmaceutical composition of claim 24.

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Dow
McKinsey
Harvard Business School
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.