Abuse resistant drug formulation

Abstract

A pharmaceutical composition may include a coated particulate which may include at least one active pharmaceutical ingredient, particularly one susceptible to abuse by an individual. The coated particles may include a fat/wax and have improved controlled release and/or crush resistance. Method of making these coated particulate and dosage forms therewith are also described.

What is claimed: 
     
         1 . A pharmaceutical composition comprising:
 a solid granulate consisting of:
 an opioid or a salt thereof in an amount of about 1-80% by weight of the granulate; 
 a first material that is a natural or synthetic starch, a natural or synthetic cellulose, an acrylic, a vinylic, or a resin; and 
 a second material that is hydroxypropylmethylcellulose; and, 
   a coating on the granulate;   wherein the first material and second material together are provided in an amount from about 0.1 to about 90 percent by weight of the formulation.   
     
     
         2 . The composition of  claim 1 , wherein the opioid is selected from oxycodone, hydrocodone and salts thereof. 
     
     
         3 . The composition of  claim 2 , wherein the opioid is oxycodone, or a salt thereof. 
     
     
         4 . The composition of  claim 3 , wherein the formulation, post-administration, extends release of the oxycodone or salt thereof to a period of from at least about 6 hours to about 24 hours. 
     
     
         5 . The composition of  claim 2 , wherein the opioid is hydrocodone, or a salt thereof. 
     
     
         6 . The composition of  claim 2 , wherein the first material is provided in an amount from about 0.1 wt % to about 40 wt %, based on the total weight percent of the formulation. 
     
     
         7 . The composition of  claim 2 , wherein the second material is provided in an amount from about 1 wt % to about 50 wt %, based on the total weight percent of the formulation. 
     
     
         8 . The composition of  claim 1 , wherein the coating is selected from the group consisting of cellulose polymers, methacrylate ester copolymers, methacrylic acid copolymers, and shellac. 
     
     
         9 . The composition of  claim 8 , wherein the coating is ethylcellulose. 
     
     
         10 . The composition of  claim 8 , wherein the coating further comprises a fat/wax. 
     
     
         11 . The composition of  claim 9 , wherein the fat/wax is provided in an amount between about 5 and about 40% based on the weight of the coated granulate. 
     
     
         12 . An extended release particle, consisting of:
 an opioid or a salt thereof in an amount of about 1-80% by weight of the particle;   a first material that is a natural or synthetic starch, a natural or synthetic cellulose, an acrylic, a vinylic, or a resin; and   a second material that is hydroxypropylmethylcellulose; and,   a coating on the particle;   wherein the first material and second material together are provided in an amount from about 0.1 to about 90 percent by weight of the particle.   
     
     
         13 . The particle of  claim 12 , wherein the opioid is selected from oxycodone, hydrocodone, and salts thereof. 
     
     
         14 . The particle of  claim 12 , wherein the first material is provided in an amount from about 0.1 wt % to about 40 wt %, based on the total weight percent of the particle. 
     
     
         15 . The particle of  claim 12 , wherein the second material is provided in an amount from about 1 wt % to about 50 wt %, based on the total weight of the particle. 
     
     
         16 . The particle of  claim 13 , wherein the opioid is hydroxycodone or a salt thereof. 
     
     
         17 . The composition according to  claim 1 , wherein the first material is at least partially soluble in an alcohol. 
     
     
         18 . The composition according to  claim 17 , wherein the first material is at least partially soluble in ethanol. 
     
     
         19 . The particle according to  claim 12 , wherein the first material is at least partially soluble in an alcohol. 
     
     
         20 . The composition according to  claim 19 , wherein the first material is at least partially soluble in ethanol.