Tamper Resistant Pharmaceutical Formulations

Abstract

Disclosed in certain embodiments is a solid oral dosage form comprising a heat-labile gelling agent; a thermal stabilizer; and a drug susceptible to abuse.

1 - 149 . (canceled) 
     
     
         150 . A method of preparing a solid oral dosage form comprising combining a pH-sensitive gelling agent; a pH-modifying agent; and a drug susceptible to abuse to form a unitary or multiparticulate dosage form. 
     
     
         151 . The method of  claim 150 , wherein the drug susceptible to abuse comprises an opioid agonist. 
     
     
         152 . The method of  claim 151 , wherein the opioid agonist is oxycodone or a pharmaceutically acceptable salt thereof. 
     
     
         153 . The method of  claim 150 , wherein the pH-sensitive gelling agent is a polymer. 
     
     
         154 . The method of  claim 153 , wherein the polymer is an anionic polymer in a neutral pH aqueous solution. 
     
     
         155 . The method of  claim 154 , wherein the anionic polymer is a polyacrylic acid. 
     
     
         156 . The method of  claim 155 , wherein the polyacrylic acid is a homopolymer. 
     
     
         157 . The method of  claim 156 , wherein the polyacrylic acid is crosslinked. 
     
     
         158 . The method of  claim 157 , wherein the polyacrylic acid is crosslinked with a polyalcohol allyl ether. 
     
     
         159 . The method of  claim 158 , wherein the polyalcohol allyl ether is selected from the group consisting of an allyl ether pentaerythritol, an allyl ether of sucrose, an allyl ether of propylene and a mixture thereof. 
     
     
         160 . The method of  claim 150 , wherein the pH-modifying agent provides a pH of between about 5.5 and 8.5 to a viscous solution obtained when the dosage form is crushed and mixed with 5 mL of distilled water. 
     
     
         161 . The method of  claim 150 , wherein the pH-modifying agent provides a pH of between 6 and 8. 
     
     
         162 . The method of  claim 150 , wherein the pH-modifying agent provides a pH of between 6.5 and 7.5. 
     
     
         163 . The method of  claim 162 , wherein the pH-modifying agent is sodium bicarbonate. 
     
     
         164 . The method of  claim 150 , wherein the drug susceptible to abuse is oxycodone or a pharmaceutically acceptable salt thereof. 
     
     
         165 . The method of  claim 150 , further comprising combining an irritant into the solid oral dosage form. 
     
     
         166 . The method of  claim 165 , wherein the irritant is a surfactant, capsaicin or a capsaicin analog. 
     
     
         167 . The method of  claim 166 , wherein the surfactant is selected from the group consisting of poloxamer, a sorbitan monoester, a glyceryl monooleate, sodium lauryl sulfate and mixtures thereof. 
     
     
         168 . The method of  claim 164 , further comprising combining acetaminophen. 
     
     
         169 . The method of  claim 150 , wherein the solid dosage form releases at least about 85% of the opioid agonist within 45 minutes as measured by in-vitro dissolution in a USP Apparatus 2 (paddle) at 50 rpm in 500 ml SGF at 37° C. 
     
     
         170 . The method of  claim 150 , wherein the viscosity of the solid oral dosage form after crushing and mixing with from about 0.5 to about 10 ml of distilled water is about 100 cP or more.