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.

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; and (d) a surfactant; 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, 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; and (d) a surfactant; 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.