ABUSE DETERRENT COMPOSITIONS AND METHODS OF MAKING SAME
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.
1 - 22 . (canceled)
23 . A therapeutic pharmaceutical composition comprising: (1) an immediate release mixture including: (a) a first water soluble drug; (b) a gel forming polymer at about 3 to about 40 wt % of the composition; (c) a disintegrant; (d) a surfactant, (e) an emetic, and (f) an opioid analgesic agonistic to the kappa-receptor; wherein the disintegrant is present in an amount sufficient to cause the immediate release mixture to exhibit an immediate release profile; and, (2) an extended release mixture including: (a) a second water soluble drug and (b) a polymer that provides extended release of the second water soluble drug, wherein 80% to 95% of the second water soluble drug contained in the extended release mixture is released after 10 hours.
24 . The therapeutic pharmaceutical composition of claim 23 , wherein the pharmaceutical composition is in unit dose form.
25 . The therapeutic pharmaceutical composition of claim 23 , wherein the pharmaceutical composition is in suppository, capsule, caplet, pill, gel, soft gelatin capsule, or layered, coated or compressed tablet form.
26 . The therapeutic pharmaceutical composition of claim 23 , wherein the first water soluble drug is a drug that is susceptible to abuse and is an opioid and is present in an amount of 0.5 to about 25 wt % of the composition.
27 . The therapeutic pharmaceutical composition of claim 23 , wherein the disintegrant is present in an amount of about 2 to about 25 wt % of the composition.
28 . The therapeutic pharmaceutical composition of claim 23 , wherein the surfactant is present in an amount of about 1 to about 10 wt % of the composition.
29 . The therapeutic pharmaceutical composition of claim 23 , wherein the first water soluble drug is different from the second water soluble drug.
30 . The therapeutic pharmaceutical composition of claim 23 , wherein the disintegrant is selected from the group consisting of sodium starch glycolate, crospovidone, and croscarmellose sodium.
31 . The therapeutic pharmaceutical composition of claim 23 further comprising naloxone.
32 . A therapeutic pharmaceutical composition comprising: an extended release mixture comprising (a) a water soluble drug; (b) a polymer in an amount of about 3 to about 40 wt % of the composition; (c) a disintegrant; (d) a surfactant; (e) an emetic; and (f) an opioid analgesic agonistic to the kappa-receptor, wherein 80% to 95% of the water soluble drug is released after 10 hours.
33 . The therapeutic pharmaceutical composition of claim 32 , wherein the pharmaceutical composition is in unit dose form and the dose includes 5 to 500 mg of the water soluble drug.