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Last Updated: April 23, 2024

Details for Patent: 9,492,443


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Title:Abuse deterrent compositions and methods of making same
Abstract: This invention relates a therapeutic pharmaceutical composition comprising: a mixture including an opioid; polyethylene oxide in an amount of about 3 to about 40 wt % of the composition; a disintegrant; and a surfactant; wherein the disintegrant is present in an amount sufficient to cause the pharmaceutical composition to exhibit an immediate release profile.
Inventor(s): Kumar; Vijai (Morris Plains, NJ), Dixon; David (Woodside, NY), Tewari; Divya (West Chester, PA), Wadgaonkar; Dilip B. (Suffern, NY)
Assignee: ACURA PHARMACEUTICALS, INC. (Palatine, IL)
Filing Date:Jul 23, 2014
Application Number:14/339,143
Claims:1. A therapeutic pharmaceutical composition comprising: a mixture including (a) an opioid; (b) polyethylene oxide in an amount of about 3 to about 40 wt % of the composition; (c) a disintegrant; and (d) a surfactant; wherein the disintegrant is present in an amount sufficient to cause the pharmaceutical composition to exhibit an immediate release profile.

2. The therapeutic pharmaceutical composition of claim 1, wherein the pharmaceutical composition is in unit dose form.

3. The therapeutic pharmaceutical composition of claim 1, wherein the pharmaceutical composition is in suppository, capsule, caplet, pill, gel, soft gelatin capsule, or compressed tablet form.

4. The therapeutic pharmaceutical composition of claim 1, wherein the opioid is present in an amount of 0.5 to about 25 wt % of the composition.

5. The therapeutic pharmaceutical composition of claim 1, wherein the disintegrant is present in an amount of about 2 to about 25 wt % of the composition.

6. The therapeutic pharmaceutical composition of claim 1, wherein the surfactant is present in an amount of about 1 to about 10 wt % of the composition.

7. The therapeutic pharmaceutical composition of claim 1, wherein the disintegrant is selected from the group consisting of sodium starch glycolate, crospovidone, and croscarmellose sodium.

8. A therapeutic pharmaceutical composition comprising: a mixture including (a) an opioid selected from the group consisting of alfentanil, buprenorphine, butorphanol, carfentanil, codeine, dezocine, diacetylmorphine, dihydrocodeine, dihydromorphine, diprenorphine, etorphine, fentanyl, hydrocodone, hydromorphone, .beta.-hydroxy-3-methylfentanyl, levo-.alpha.-acetylmethadol, levorphanol, lofentanil, meperidine, methadone, morphine, nalbuphine, oxycodone, oxymorphone, pentazocine, pethidine, prepoxyphene, remifentanil, sufentanil, tilidine, tramadol, and pharmaceutically acceptable salts thereof; (b) polyethylene oxide in an amount of about 3 to about 40 wt % of the composition; (c) a disintegrant; and (d) a surfactant; wherein the disintegrant is present in an amount sufficient to cause the pharmaceutical composition to exhibit an immediate release profile.

9. The therapeutic pharmaceutical composition of claim 8, wherein the pharmaceutical composition is in unit dose form.

10. The therapeutic pharmaceutical composition of claim 8, wherein the pharmaceutical composition is in suppository, capsule, caplet, pill, gel, soft gelatin capsule, or compressed tablet form.

11. The therapeutic pharmaceutical composition of claim 8, wherein the opioid is present in an amount of 0.5 to about 25 wt % of the composition.

12. The therapeutic pharmaceutical composition of claim 8, wherein the disintegrant is present in an amount of about 2 to about 25 wt % of the composition.

13. The therapeutic pharmaceutical composition of claim 8, wherein the surfactant is present in an amount of about 1 to about 10 wt % of the composition.

14. The therapeutic pharmaceutical composition of claim 8, wherein the disintegrant is selected from the group consisting of sodium starch glycolate, crospovidone, and croscarmellose sodium.

15. A therapeutic pharmaceutical composition comprising: a mixture including (a) oxycodone hydrochloride; (b) polyethylene oxide in an amount of about 3 to about 40 wt % of the composition; (c) a disintegrant; and (d) a surfactant; wherein the disintegrant is present in an amount sufficient to cause the pharmaceutical composition to exhibit an immediate release profile.

16. The therapeutic pharmaceutical composition of claim 15, wherein the pharmaceutical composition is in unit dose form.

17. The therapeutic pharmaceutical composition of claim 15, wherein the pharmaceutical composition is in suppository, capsule, caplet, pill, gel, soft gelatin capsule, or compressed tablet form.

18. The therapeutic pharmaceutical composition of claim 15, wherein the oxycodone hydrochloride is present in an amount of 0.5 to about 25 wt % of the composition.

19. The therapeutic pharmaceutical composition of claim 15, wherein the disintegrant is present in an amount of about 2 to about 25 wt % of the composition.

20. The therapeutic pharmaceutical composition of claim 15, wherein the surfactant is present in an amount of about 1 to about 10 wt % of the composition.

21. The therapeutic pharmaceutical composition of claim 15, wherein the disintegrant is selected from the group consisting of sodium starch glycolate, crospovidone, and croscarmellose sodium.

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