Pharmaceutical Compositions for the Deterrence and/or Prevention of Abuse

Abstract

Provided herein is a pharmaceutical composition comprising an antagonist, an agonist, a seal coat, and a sequestering polymer, wherein the antagonist, agonist, seal coat and at least one sequestering polymer are all components of a single unit, and wherein the seal coat forms a layer physically separating the antagonist from the agonist from one another. Methods for manufacturing such a pharmaceutical composition are also provided.

1 - 79 . (canceled) 
     
     
         80 . A composition comprising a plurality of multi-layer pellets comprising:
 a. a water-soluble core;   b. an opioid antagonist comprising layer coating the core, wherein the opioid antagonist is naltrexone or a pharmaceutically acceptable salt thereof;   c. a sequestering polymer layer coating the opioid antagonist comprising layer;   d. an opioid agonist wherein the opioid agonist is selected from the group consisting of morphine, oxycodone, hydrocodone, hydromorphone dihydrocodeine, codeine, dihydromorphine, buprenorphine, salts of these molecules, and combinations thereof; and   e. a controlled release layer coating the opioid agonist;
 wherein the sequestering polymer layer comprises copolymers of acrylic and methacrylic acid esters with quaternary ammonium groups, a surfactant in an amount from 1.6% to 6.3% of the copolymers of acrylic and methacrylic acid esters with quaternary ammonium groups on a weight-to-weight basis, 
   
     
     
         81 . The composition of  claim 80 , wherein the surfactant is selected from the group consisting of sodium lauryl sulfate, sodium docusate, dioctyl sodium sulphosuccinate, sodium lauryl sarcosinate, sodium methyl cocyl taurate, magnesium lauryl sulfate, dioctyl sodium sulfosuccinate, sodium dodecylbenzene sulfonate, and combinations thereof. 
     
     
         82 . The composition of  claim 81 , wherein the surfactant is sodium lauryl sulfate. 
     
     
         83 . The composition of  claim 80 , wherein the opioid agonist is morphine sulfate.