Opioid formulations having reduced potential for abuse

• US 20030091635A1
• Filed: 09/25/2002
• Published: 05/15/2003
• Est. Priority Date: 09/26/2001
• Status: Abandoned Application

• Current Assignee: Endo Pharmaceuticals Incorporated (Endo International PLC)
• Original Assignee: Endo Pharmaceuticals Incorporated (Endo International PLC)
• Inventors: Woodcock, Paul M., Baichwal, Anand R., McCall, Troy
• Application Number:
  US10/254,207
• Publication Number:
  US 20030091635A1
• Time in Patent Office: Days
• US Class Current: 424/468
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 9/2009 Inorganic compounds
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/2018 Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• CPC Class Codes: A61K 9/2027 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/205 Polysaccharides, e.g. alginate, gums; Cyclodextrin
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids

Abstract

The invention provides opioid formulations having reduced potential for abuse, and having reduced potential for illegal sale and distribution. The opioid formulations of the invention comprise at least one opioid and a sustained release delivery system.

Claims

1. A sustained release formulation comprising at least one abuse-potential drug and a sustained release delivery system, wherein the sustained release delivery system comprises at least one hydrophilic compound, at least one cross-linking agent and at least one pharmaceutical diluent.

2. The sustained release formulation of claim 1, wherein the sustained release delivery system further comprises at least one hydrophobic polymer.

3. The sustained release formulation of claim 1, wherein the sustained release delivery system further comprises at least one cationic cross-linking compound.

4. The sustained release formulation of claim 1, further comprising an outer coating, wherein the outer coating comprises at least one hydrophobic polymer.

5. The sustained release formulation of claim 1, further comprising an outer coating, wherein the outer coating comprises at least one plasticizer.

6. The sustained release formulation of claim 1, wherein the abuse-potential drug is an opioid.

7. The sustained release formulation of claim 1, wherein the sustained release formulation has reduced potential for abuse compared to conventional opioid formulations.

8. A method for treating a patient suffering from pain comprising administering an effective amount of the sustained release formulation of claim 1.

9. A method for reducing the potential of opioid abuse comprising administering a patient the sustained release formulation of claim 1 for pain.

10. A method for reducing the potential of opioid abuse comprising prescribing to a patient the sustained release formulation of claim 1 for pain.

11. A kit for reducing the potential of opioid abuse comprising the sustained release formulation of claim 1.

12. A method for making the sustained release formulation of claim 1 comprising:

mixing the at least one hydrophilic compound, the at least one cross-linking agent and the at least one pharmaceutical diluent to form granules;

mixing the granules with at least one abuse-potential drug to form a granulated composition; and

applying pressure to the granulated composition to make the formulation.

13. The method of claim 12, further comprising applying an outer coating onto at least part of the sustained release formulation.

14. The method of claim 12 wherein the abuse-potential drug is an opioid.

15. A sustained release formulation comprising at least one abuse-potential drug and a sustained release delivery system;

wherein the sustained release delivery system comprises at least one hydrophilic compound, at least one cationic cross-linking compound, and at least one pharmaceutical diluent.

16. The sustained release formulation of claim 15, wherein the sustained release delivery system further comprises at least one hydrophobic polymer.

17. The sustained release formulation of claim 15, further comprising an outer coating, wherein the outer coating comprises at least one hydrophobic polymer.

18. The sustained release formulation of claim 15, further comprising an outer coating, wherein the outer coating comprises at least one plasticizer.

19. The sustained release formulation of claim 15, wherein the abuse-potential drug is an opioid.

20. The sustained release formulation of claim 15, wherein the sustained release formulation has reduced potential for abuse compared to conventional opioid formulations.

21. A method for treating a patient suffering from pain comprising administering an effective amount of the sustained release formulation of claim 15.

22. A method for reducing the potential of opioid abuse comprising administering a patient the sustained release formulation of claim 15 for pain.

23. A method for reducing the potential of opioid abuse comprising prescribing to a patient the sustained release formulation of claim 15 for pain.

24. A kit for reducing the potential of opioid abuse comprising the sustained release formulation of claim 15.

25. A method for making the sustained release formulation of claim 15 comprising:

mixing the at least one hydrophilic compound, the at least one cationic cross-linking compound and the at least one pharmaceutical diluent to form granules;

mixing the granules with at least one abuse-potential drug or a pharmaceutically acceptable salt thereof to form a granulated composition; and

applying pressure to the granulated composition to make the formulation.

26. The method of claim 25, further comprising applying an outer coating onto at least part of the sustained release formulation.

27. The method of claim 25, wherein the abuse-potential drug is an opioid.

28. A sustained release formulation comprising an inner core and an outer coating, wherein the inner core comprises at least one opioid and the outer coating comprises at least one hydrophobic polymer.

29. The sustained release formulation of claim 28, wherein the abuse-potential drug is an opioid.

30. The sustained release formulation of claim 28, wherein the outer coating further comprises at least one plasticizer.

31. The sustained release formulation of claim 28, wherein the outer coating further comprises at least one water soluble compound.

32. The sustained release formulation of claim 28, wherein the sustained release formulation has reduced potential for abuse compared to conventional opioid formulations.

33. A method for treating a patient suffering from pain comprising administering an effective amount of the sustained release formulation of claim 28.

34. A method for reducing the potential of opioid abuse comprising administering a patient the sustained release formulation of claim 28 for pain.

35. A method for reducing the potential of opioid abuse comprising prescribing to a patient the sustained release formulation of claim 28 for pain.

36. A kit for reducing the potential of opioid abuse comprising the sustained release formulation of claim 28.