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Details for Patent: 8,652,497

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Details for Patent: 8,652,497

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 L.P. (Stamford, CT)
Filing Date:Apr 20, 2010
Application Number:12/763,898
Claims:1. An oral dosage form consisting of: a therapeutically effective amount of a drug susceptible to abuse; and a modified or a sustained release carrier, an effective amount of an irritant to impart an irritating sensation to an abuser upon administration of said dosage form after tampering, and one or more pharmaceutical excipients, wherein the modified or the sustained release carrier is selected from the group consisting of gums, cellulose ethers, acrylic resins, protein derived materials, waxes, shellac, oils and mixtures of any of the foregoing materials, and the irritant is coated with the modified or the sustained release carrier or is dispersed in a matrix of the modified or the sustained release carrier.

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 6, wherein said irritant is dispersed in said matrix, and the modified or the sustained release carrier is in the amount that substantially prevents the release of said irritant from the dosage form which is administered intact.

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

9. The oral dosage form of claim 8, wherein said opioid analgesic is morphine, codeine, tramadol, or a pharmaceutically acceptable salt of any of the foregoing.

10. The oral dosage form of claim 8, wherein said opioid analgesic is hydromorphone or a pharmaceutically acceptable salt thereof.

11. The oral dosage form of claim 8, wherein said opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof.

12. The oral dosage form of claim 8, wherein said opioid analgesic is oxycodone or a pharmaceutically acceptable salt thereof.

13. 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 combinations thereof.

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

15. The oral dosage form of claim 1, wherein said administration of said dosage form after tampering is nasal administration.

16. The oral dosage form of claim 1, wherein said administration of said dosage form after tampering is parenteral administration.

17. 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.

18. 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.

19. 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.

20. The oral dosage form of claim 1, wherein the drug is selected from the group consisting of phenobarbital, secobarbital, pentobarbital, butabarbital, tabutal, aprobarbital, mephobarbital, butalbital, diazepam, chlordiazepoxide, alprazolam, triazolam, estazolam, clonazepam, flunitrazepam, dextroamphetamine, sibutramine, methylenedioxymethampetamine, marinol, meprobamate, carisoprodol and pharmaceutically acceptable salts thereof.
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