Pharmaceutical composition

• US 20030125347A1
• Filed: 11/04/2002
• Published: 07/03/2003
• Est. Priority Date: 11/02/2001
• Status: Abandoned Application

• Current Assignee: Elan Corporation PLC (Perrigo Company PLC)
• Original Assignee: Elan Corporation PLC (Perrigo Company PLC)
• Inventors: Slavitt, Joshua R., Anderson, Kirsten A., Hoch, James M., Duvall, Jean Marie, Liversidge, Gary
• Application Number:
  US10/288,262
• Publication Number:
  US 20030125347A1
• Time in Patent Office: Days
• US Class Current: 514/282
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/785 Polymers containing nitrogen
• CPC Class Codes: A61K 9/2833 Organic macromolecular compounds
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/36 Opioid-abuse
• 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: A61P 37/00 Drugs for immunological or allergic disorders

Abstract

A pharmaceutical composition and an oral dosage form are disclosed comprising an opiate and an irritant. A method is also described for discouraging abuse of an opiate comprising combining a therapeutically effective amount of an opiate and an irritant into an oral dosage form. A method is also described for treating pain by administering a therapeutically effective amount of an opiate and an irritant in an oral dosage form.

Claims

1. A pharmaceutical composition comprising a therapeutically effective amount of an opiate and an irritant.

2. The composition of claim 1 wherein the irritant is a local irritant.

3. The composition of claim 2 wherein the irritant is a capsaicinoid.

4. The composition of claim 3 wherein the capsaicinoid is capsaicin.

5. The composition of claim 1 wherein the irritant is a systemic irritant.

6. The composition of claim 1 wherein the irritant is capable of causing significant discomfort to the gastrointestinal system of a human.

7. The composition of claim 1 wherein the irritant is an emetic.

8. The composition of claim 1 wherein the systemic irritant is capable of causing significant discomfort to the immune system of a human.

9. The composition of claim 1 wherein the irritant is a histamine.

10. The composition of claim 1 wherein the opiate comprises from about 0.1 to about 40 percent by weight and the irritant comprises from about 0.001 to about 85 percent by weight of the composition.

11. The composition of claim 1 wherein the opiate is selected from the group consisting of codeine, hydrocodone, hydromorphone, levorphanol, meperidine, morphine, oxycodone, and pharmaceutically acceptable salts thereof and the irritant is a local irritant.

12. The composition of claim 1 wherein the opiate is selected from the group consisting of codeine, hydrocodone, hydromorphone, levorphanol, meperidine, morphine, oxycodone, and pharmaceutically acceptable salts thereof and the irritant is a systemic irritant.

13. The composition of claim 1 wherein the irritant is sequestered.

14. The composition of claim 13 wherein the irritant is coated by a material that is substantially indigestible.

15. The composition of claim 13 wherein the irritant is chemically bound to a material that renders the irritant biologically unavailable.

16. An oral dosage form comprising the composition of claim 1.

17. The oral dosage form of claim 16 wherein the irritant is present in a sub-clinical amount.

18. The oral dosage form of claim 17 wherein the opiate is provided in immediate-release form.

19. The oral dosage form of claim 16 wherein the opiate is provided in modified-release form and the irritant is sequestered.

20. The oral dosage form of claim 16 wherein the dosage is in tablet form.

21. The oral dosage form of claim 16 wherein the dosage is in a multiparticulate form.

22. A method of deterring abuse of an opiate comprising combining a therapeutically effective amount of an opiate and an irritant into an oral dosage formulation.

23. The method of claim 22 wherein the irritant is provided in a sub-clinical amount.

24. The method of claim 23 wherein the opiate is provided in immediate-release form.

25. The method of claim 22 wherein the opiate is provided in modified-release form and the irritant is sequestered.

26. A method of treating pain comprising orally administering to an individual a therapeutically effective amount of an opiate and an irritant.

27. The method of claim 26 wherein the irritant is provided in a sub-clinical amount.

28. The method of claim 27 wherein the opiate is provided in immediate-release form.

29. The method of claim 26 wherein the opiate is provided in modified-release form and the irritant is sequestered.