Compositions for deterring abuse of opioid containing dosage forms
View Patent ↗This invention relates to an abuse deterrent dosage form of opioid analgesics, wherein an analgesically effective amount of opioid analgesic is combined with a polymer to form a matrix.
1. A therapeutic pharmaceutical composition comprising: a mixture including
(a) an opioid;
(b) a gel-forming polymer in an amount of about 3 to about 40 wt %;
(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 susceptible to abuse 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, β-hydroxy-3-methylfentanyl, levo-α-acetylmethadol, levorphanol, lofentanil, meperidine, methadone, morphine, nalbuphine, oxycodone, oxymorphone, pentazocine, pethidine, propoxyphene, remifentanil, sufentanil, tilidine, tramadol, and pharmaceutically acceptable salts thereof;
(b) a gel-forming polymer in an amount of about 3 to about 40 wt %;
(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) a gel-forming polymer in an amount of about 3 to about 40 wt %;
(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.