Pharmaceutical Formulation Containing Gelling Agent

Abstract

Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.

1 - 40 . (canceled) 
     
     
         41 . A controlled release oral solid dosage form comprising:
 matrix multiparticulates comprising (i) oxycodone base, an organic acid salt of oxycodone, or a combination thereof;   (ii) a gelling agent comprising a surfactant, an emulsifier or a mixture thereof;   (iii) a C 12 -C 40  fatty acid; and   (iv) a wax;   the matrix multiparticulates providing a therapeutic effect for at least about 12 hours when orally administered to a human patient, having a viscosity of at least about 10 cP when subjected to tampering by heating at a temperature greater than about 45° C., and contained in a pharmaceutically acceptable capsule.   
     
     
         42 . The controlled release oral solid dosage form of  claim 41 , wherein the matrix multiparticulates comprise an organic acid salt of oxycodone. 
     
     
         43 . The controlled release oral solid dosage form of  claim 41 , wherein the matrix multiparticulates comprise oxycodone base. 
     
     
         44 . The controlled release oral solid dosage form of  claim 41 , wherein the wax is selected from the group consisting of carnauba wax, beeswax and a combination thereof. 
     
     
         45 . The controlled release oral solid dosage form of  claim 41 , wherein the wax comprises carnauba wax. 
     
     
         46 . The controlled release oral solid dosage form of  claim 41 , wherein the wax comprises beeswax. 
     
     
         47 . The controlled release oral solid dosage form of  claim 41 , wherein the fatty acid comprises C 12  fatty acid. 
     
     
         48 . The controlled release oral solid dosage form of  claim 41 , wherein the fatty acid comprises stearic acid. 
     
     
         49 . The controlled release oral solid dosage form of  claim 41 , wherein the fatty acid comprises C 12  fatty acid and stearic acid. 
     
     
         50 . The controlled release oral solid dosage form of  claim 41 , wherein the matrix multiparticulates are prepared by melting the C 12 -C 40  fatty acid and incorporating oxycodone base therein. 
     
     
         51 . The controlled release oral solid dosage form of  claim 50 , wherein the fatty acid comprises C 12  fatty acid. 
     
     
         52 . The controlled release oral solid dosage form of  claim 50 , wherein the fatty acid comprises stearic acid. 
     
     
         53 . The controlled release oral solid dosage form of  claim 50 , wherein the fatty acid comprises C 12  fatty acid and stearic acid. 
     
     
         54 . The controlled release oral solid dosage form of  claim 41 , wherein the matrix multiparticulates are prepared by combining melted C 12 -C 40  fatty acid, melted wax and oxycodone base. 
     
     
         55 . The controlled release oral solid dosage form of  claim 54 , wherein the wax is selected from the group consisting of carnauba wax, beeswax and a combination thereof. 
     
     
         56 . The controlled release oral solid dosage form of  claim 54 , wherein the wax comprises carnauba wax. 
     
     
         57 . The controlled release oral solid dosage form of  claim 54 , wherein the wax comprises beeswax. 
     
     
         58 . The controlled release oral solid dosage form of  claim 54 , wherein the fatty acid comprises C 12  fatty acid. 
     
     
         59 . The controlled release oral solid dosage form of  claim 54 , wherein the fatty acid comprises stearic acid. 
     
     
         60 . The controlled release oral solid dosage form of  claim 54 , wherein the fatty acid comprises C 12  fatty acid and stearic acid. 
     
     
         61 . A controlled release oral solid dosage form comprising:
 matrix multiparticulates prepared by combining (i) oxycodone base;   (ii) a gelling agent comprising a surfactant, an emulsifier or a mixture thereof;   (iii) a C 12 -C 40  fatty acid; and   (iv) a wax selected from the group consisting of carnauba wax, beeswax and a combination thereof;   the matrix multiparticulates providing a therapeutic effect for at least about 12 hours when orally administered to a human patient, having a viscosity of at least about 10 cP when subjected to tampering by heating at a temperature greater than about 45° C., and contained in a pharmaceutically acceptable capsule.   
     
     
         62 . The controlled release oral solid dosage form of  claim 61 , wherein the fatty acid comprises C 12  fatty acid, stearic acid or a combination thereof. 
     
     
         63 . A controlled release oral solid dosage form comprising:
 matrix multiparticulates comprising (i) oxycodone base, an organic acid salt of oxycodone, or a combination thereof;   (ii) a gelling agent comprising a surfactant, an emulsifier or a mixture thereof;   (iii) a C 12 -C 40  fatty acid; and   (iv) a wax selected from the group consisting of carnauba wax, beeswax and a combination thereof;   the matrix multiparticulates providing a therapeutic effect for at least about 12 hours when orally administered to a human patient, being unsuitable for injection when subjected to tampering by heating at a temperature greater than about 45° C., and contained in a pharmaceutically acceptable capsule.   
     
     
         64 . A controlled release oral solid dosage form comprising:
 matrix multiparticulates comprising (i) oxycodone base, an organic acid salt of oxycodone, or a combination thereof;   (ii) polyglycolized glycerides;   (iii) a C 12 -C 40  fatty acid; and   (iv) a wax;   the matrix multiparticulates providing a therapeutic effect for at least about 12 hours when orally administered to a human patient, having a viscosity of at least about 10 cP when subjected to tampering by heating at a temperature greater than about 45° C., and contained in a pharmaceutically acceptable capsule.   
     
     
         65 . The controlled release dosage form of  claim 41 , wherein the surfactant is polyglycolized glycerides. 
     
     
         66 . The controlled release dosage form of  claim 61 , wherein the surfactant is polyglycolized glycerides. 
     
     
         67 . The controlled release dosage form of  claim 63 , wherein the surfactant is polyglycolized glycerides. 
     
     
         68 . The controlled release dosage form of  claim 41 , further comprising polyethylene glycol.