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Details for Patent: 7,727,557

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Details for Patent: 7,727,557

Title:Pharmaceutical formulation containing irritant
Abstract: Disclosed in certain embodiments is an oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse; and an effective amount of an irritant to impart an irritating sensation to an abuser upon administration of said dosage form after tampering.
Inventor(s): Sackler; Richard (Greenwich, CT)
Assignee: Purdue Pharma LP (Stanford, CT)
Filing Date:Sep 22, 2006
Application Number:11/525,395
Claims:1. An oral dosage form consisting of: a therapeutically effective amount of a drug susceptible to abuse, an irritant, a modified or a sustained release carrier, and one or more pharmaceutical excipients, wherein the irritant is coated with the modified or the sustained release carrier and is in an effective amount to impart an irritating sensation to an abuser upon administration of said dosage form after tampering.

2. The oral dosage form of claim 1, wherein the irritant is selected from the group consisting of capsaicin, a capsaicin analog, and mixtures thereof.

3. The oral dosage form of claim 1, wherein the irritant is a capsaicin analog selected from the group consisting of resiniferatoxin, tinyatoxin, heptanoylisobutylamide, heptanoyl guaiacylamide, other isobutylamides or guaiacylamides, dihydrocapsaicin, homovanillyl octylester, nonanoyl vanillylamide, and mixtures thereof.

4. The oral dosage form of claim 1, wherein the irritant is capsaicin.

5. The oral dosage form of claim 1, wherein the irritant is vanillylamide.

6. The oral dosage form of claim 1, wherein the irritant is in a sequestered form.

7. The oral dosage form of claim 1, wherein said drug is an opioid analgesic.

8. The oral dosage form of claim 7, wherein said opioid analgesic is morphine, codeine, tramadol, or a pharmaceutically acceptable salts thereof.

9. The oral dosage form of claim 7, wherein said opioid analgesic is hydromorphone or a pharmaceutically acceptable salt thereof.

10. The oral dosage form of claim 7, wherein said opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof.

11. The oral dosage form of claim 7, wherein said opioid analgesic is oxycodone or a pharmaceutically acceptable salt thereof.

12. The oral dosage form of claim 1, wherein said drug is selected from the group consisting of a tranquilizer, a CNS depressant, a CNS stimulant, a sedative hypnotic or a combination thereof.

13. The oral dosage form of claim 1, wherein said administration is oral administration.

14. The oral dosage form of claim 1, wherein said administration is nasal administration.

15. The oral dosage form of claim 1, wherein said administration is parenteral administration.

16. The oral dosage form of claim 1, wherein the irritant is in an amount of about 0.00125% to about 50% by weight of the dosage form.

17. The oral dosage form of claim 1, wherein the irritant is in an amount of about 1 to about 7.5% by weight of the dosage form.

18. The oral dosage form of claim 1, wherein the irritant is in an amount of about 1 to about 5% by weight of the dosage form.

19. The oral dosage form of claim 12, wherein the CNS stimulant is methylphenidate or a pharmaceutically acceptable salt thereof.

20. The oral dosage form of claim 1, wherein the modified or the sustained release carrier renders the irritant substantially non-releasable from said dosage form that has been administered intact.

21. The oral dosage form of claim 1, wherein the carrier is a sustained release carrier.

22. The oral dosage form of claim 1, wherein the carrier is a modified release carrier.

23. The oral dosage form of claim 22, wherein the modified release carrier is an enteric carrier.

24. The oral dosage form of claim 1, wherein the tampering is by crushing, shearing, grinding, chewing, dissolution in a solvent, heating or any combination thereof.
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