Pharmaceutical formulation containing irritant

Abstract

Disclosed in certain embodiments is an oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse; and an effective amount of an irritant to impart an irritating sensation to an abuser upon administration of said dosage form after tampering.

1 - 27 . (canceled) 
     
     
         28 : A method of preventing abuse of an oral dosage form of a drug susceptible to abuse comprising:
 preparing the dosage form with a therapeutically effective amount of a drug susceptible to abuse; and   an irritant in an effective amount to impart an irritating sensation to an abuser upon administration of the dosage form after tampering.   
     
     
         29 : The method of  claim 28 , wherein said drug is an opioid analgesic. 
     
     
         30 : The method of  claim 28 , wherein said irritant comprises capsaicin. 
     
     
         31 : A controlled release oral dosage form comprising:
 coated beads comprising a therapeutically effective amount of a drug susceptible to abuse and a hydrophobic material; and   coated beads comprising an effective amount of an aversive agent to cause an irritating sensation to an abuser upon administration of said dosage form after tampering.   
     
     
         32 : The dosage form of  claim 31 , wherein said hydrophobic material comprises an acrylic polymer. 
     
     
         33 : The dosage form of  claim 31 , wherein said drug susceptible to abuse comprises an opioid analgesic. 
     
     
         34 : The dosage form of  claim 33 , wherein said opioid analgesic comprises hydrocodone or a pharmaceutically acceptable salt thereof. 
     
     
         35 : The dosage form of  claim 33 , wherein said opioid analgesic comprises oxycodone or a pharmaceutically acceptable salt thereof. 
     
     
         36 : The dosage form of  claim 31 , wherein said irritant comprises capsaicin. 
     
     
         37 : The dosage form of  claim 31 , wherein said coated beads comprise inert beads. 
     
     
         38 : The dosage form of  claim 37 , wherein said inert beads are coated with said hydrophobic material. 
     
     
         39 : The oral dosage form of  claim 31 , wherein said aversive agent provides a burning sensation to an abuser upon injection of said dosage form after tampering comprising crushing, shearing, grinding, chewing, dissolution in a solvent, heating, or any combination thereof. 
     
     
         40 : The oral dosage form of  claim 31 , wherein said aversive agent provides a burning sensation to an abuser upon inhalation of said dosage form after tampering comprising crushing, shearing, grinding, chewing, dissolution in a solvent, heating, or any combination thereof. 
     
     
         41 : The dosage form of  claim 31 , wherein said aversive agent comprises a surfactant. 
     
     
         42 : An oral dosage form comprising:
 coated beads comprising a therapeutically effective amount of a drug susceptible to abuse; and   coated beads comprising an effective amount of an aversive agent comprising a surfactant to cause an irritating sensation to an abuser upon administration of said dosage form after tampering.   
     
     
         43 : The dosage form of  claim 42 , wherein said drug susceptible to abuse comprises a CNS stimulant. 
     
     
         44 : The dosage form of  claim 42 , wherein said drug susceptible to abuse comprises oxycodone. 
     
     
         45 : The dosage form of  claim 42 , wherein said coated beads comprising the therapeutically effective amount of said drug susceptible to abuse further comprise inert beads. 
     
     
         46 : The dosage form of  claim 45 , wherein said inert beads are coated with a hydrophobic material comprising an acrylic polymer. 
     
     
         47 : The oral dosage form of  claim 42 , wherein said aversive agent provides a burning sensation to an abuser upon inhalation of said dosage form after tampering comprising crushing, shearing, grinding, chewing, dissolution in a solvent, heating, or any combination thereof. 
     
     
         48 : The oral dosage form of  claim 42 , wherein said aversive agent provides a burning sensation to an abuser upon injection of said dosage form after tampering comprising crushing, shearing, grinding, chewing, dissolution in a solvent, heating, or any combination thereof.