Methods and 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) at least one opioid analgesic 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-acetylmethadol, levorphanol, lofentanil, meperidine, methadone, morphine, nalbuphine, oxycodone, oxymorphone, pentazocine, pethidine, propoxyphene, remifentanil, sufentanil, tilidine, tramadol and a pharmaceutically acceptable salt thereof;
(b) gel forming polyethylene oxide;
(c) at least one disintegrant wherein the disintegrant is selected from the group consisting of crospovidone, sodium starch glycolate, and croscarmellose sodium; and
(d) a surfactant.
2. The therapeutic pharmaceutical composition of claim 1 , further comprising an emetic.
3. The therapeutic pharmaceutical composition of claim 1 , wherein the gel forming polyethylene oxide has an average molecular weight ranging from about 300,000 to about 5,000,000.
4. The therapeutic pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is in unit dose form.
5. The therapeutic pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is in a suppository, capsule, caplet, pill, gel, soft gelatin capsule, or compressed tablet form.
6. The therapeutic pharmaceutical composition of claim 1 , wherein the analgesic is present in an amount of about 0.5 to about 25 percent by weight.
7. The therapeutic pharmaceutical composition of claim 1 , wherein the analgesic is oxycodone or a pharmaceutically acceptable salt thereof.
8. A therapeutic pharmaceutical composition comprising:
a mixture including
(a) at least one opioid analgesic 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-acetylmethadol, levorphanol, lofentanil, meperidine, methadone, morphine, nalbuphine, oxycodone, oxymorphone, pentazocine, pethidine, propoxyphene, remifentanil, sufentanil, tilidine, tramadol and a pharmaceutically acceptable salt thereof
(b) gel forming polyethylene oxide;
(c) at least one disintegrant at about 2 to 25 percent by weight wherein the disintegrant is selected from the group consisting of crospovidone, sodium starch glycolate, and croscarmellose sodium; and
(d) sodium lauryl sulfate.
9. The therapeutic pharmaceutical composition of claim 8 , further comprising an emetic.
10. The therapeutic pharmaceutical composition of claim 8 , wherein the gel forming polyethylene oxide has an average molecular weight ranging from about 300,000 to about 5,000,000.
11. The therapeutic pharmaceutical composition of claim 8 , wherein the pharmaceutical composition is in unit dose form.
12. The therapeutic pharmaceutical composition of claim 8 , wherein the pharmaceutical composition is in a suppository, capsule, caplet, pill, gel, soft gelatin capsule, or compressed tablet form.
13. The therapeutic pharmaceutical composition of claim 8 , wherein the analgesic is present in an amount of about 0.5 to about 25 percent by weight.
14. The therapeutic pharmaceutical composition of claim 8 , wherein the analgesic is oxycodone or a pharmaceutically acceptable salt thereof.
15. A therapeutic pharmaceutical composition comprising:
a mixture including
(a) at least one opioid analgesic 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-acetylmethadol, levorphanol, lofentanil, meperidine, methadone, morphine, nalbuphine, oxycodone, oxymorphone, pentazocine, pethidine, propoxyphene, remifentanil, sufentanil, tilidine, tramadol and a pharmaceutically acceptable salt thereof;
(b) gel forming polyethylene oxide;
(c) at least one disintegrant wherein the disintegrant is selected from the group consisting of crospovidone, sodium starch glycolate, and croscarmellose sodium; and
(d) sodium lauryl sulfate at about 1 to 10 percent by weight.
16. The therapeutic pharmaceutical composition of claim 15 , further comprising an emetic.
17. The therapeutic pharmaceutical composition of claim 15 , wherein the gel forming polyethylene oxide has an average molecular weight ranging from about 300,000 to about 5,000,000.
18. The therapeutic pharmaceutical composition of claim 15 , wherein the pharmaceutical composition is in unit dose form.
19. The therapeutic pharmaceutical composition of claim 15 , wherein the pharmaceutical composition is in a suppository, capsule, caplet, pill, gel, soft gelatin capsule, or compressed tablet form.
20. The therapeutic pharmaceutical composition of claim 15 , wherein the analgesic is oxycodone or a pharmaceutically acceptable salt thereof.