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 pharmaceutical dosage form comprising:
 a mixture comprising (i) buprenorphine or a pharmaceutically acceptable salt thereof; and   (ii) a gelling agent comprising polyethylene oxide, the gelling agent in an effective amount to impart a viscosity of at least about 10 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid;   the dosage form providing an immediate release upon administration to a human patient.   
     
     
         42 . The pharmaceutical dosage form of  claim 41 , further comprising buprenorphine hydrochloride. 
     
     
         43 . The pharmaceutical dosage form of  claim 41 , further comprising hydroxypropylmethylcellulose 
     
     
         44 . The pharmaceutical dosage form of  claim 41 , further comprising a sugar derived alcohol. 
     
     
         45 . The pharmaceutical dosage form of  claim 41 , wherein the gelling agent is in an effective amount to impart a viscosity of at least about 60 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid. 
     
     
         46 . The pharmaceutical dosage form of  claim 41 , wherein the gelling agent is in an effective amount to impart a viscosity of at least about 120 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid. 
     
     
         47 . The pharmaceutical dosage form of  claim 41 , wherein the gelling agent is in an effective amount to impart a viscosity of at least about 375 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid. 
     
     
         48 . The pharmaceutical dosage form of  claim 41 , wherein the gelling agent is in an effective amount to impart a viscosity of at least about 2,000 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid. 
     
     
         49 . The pharmaceutical dosage form of  claim 41 , wherein the gelling agent is in an effective amount to impart a viscosity from about 120 cP to about 5,000 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid. 
     
     
         50 . The pharmaceutical dosage form of  claim 41 , wherein the viscosity is measured using a Brookfield Synchro-Lectric Viscometer. 
     
     
         51 . The pharmaceutical dosage form of  claim 41 , wherein the ratio of gelling agent to buprenorphine or pharmaceutically acceptable salt thereof is from about 1:40 to about 40:1. 
     
     
         52 . The pharmaceutical dosage form of  claim 41 , wherein the aqueous liquid is water. 
     
     
         53 . The pharmaceutical dosage form of  claim 41 , wherein the viscosity is imparted when the dosage form is subjected to tampering by dissolution in about 1 to about 3 ml of aqueous liquid. 
     
     
         54 . The pharmaceutical dosage form of  claim 41 , wherein the viscosity is obtained when the dosage form is subjected to tampering by dissolution in the aqueous liquid with heating greater than 45° C. 
     
     
         55 . The pharmaceutical dosage form of  claim 42 , further comprising hydroxypropylmethylcellulose 
     
     
         56 . The pharmaceutical dosage form of  claim 42 , further comprising a sugar derived alcohol. 
     
     
         57 . The pharmaceutical dosage form of  claim 42 , wherein the gelling agent is in an effective amount to impart a viscosity of at least about 60 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid. 
     
     
         58 . The pharmaceutical dosage form of  claim 42 , wherein the gelling agent is in an effective amount to impart a viscosity of at least about 120 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid. 
     
     
         59 . The pharmaceutical dosage form of  claim 42 , wherein the gelling agent is in an effective amount to impart a viscosity of at least about 375 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid. 
     
     
         60 . The pharmaceutical dosage form of  claim 42 , wherein the gelling agent is in an effective amount to impart a viscosity of at least about 2,000 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid. 
     
     
         61 . The pharmaceutical dosage form of  claim 42 , wherein the gelling agent is in an effective amount to impart a viscosity from about 120 cP to about 5,000 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid. 
     
     
         62 . The pharmaceutical dosage form of  claim 42 , wherein the viscosity is measured using a Brookfield Synchro-Lectric Viscometer. 
     
     
         63 . The pharmaceutical dosage form of  claim 42 , wherein the ratio of gelling agent to buprenorphine or pharmaceutically acceptable salt thereof is from about 1:40 to about 40:1. 
     
     
         64 . The pharmaceutical dosage form of  claim 42 , wherein the aqueous liquid is water. 
     
     
         65 . The pharmaceutical dosage form of  claim 42 , wherein the viscosity is imparted when the dosage form is subjected to tampering by dissolution in about 1 to about 3 ml of aqueous liquid. 
     
     
         66 . The pharmaceutical dosage form of  claim 42 , wherein the viscosity is obtained when the dosage form is subjected to tampering by dissolution in the aqueous liquid with heating greater than 45° C. 
     
     
         67 . The pharmaceutical dosage form of  claim 41 , comprising polyethylene oxide having a weight average molecular weight of 50,000 daltons to 1,000,000 daltons. 
     
     
         68 . The pharmaceutical dosage form of  claim 41 , comprising polyethylene oxide having a weight average molecular weight of 100,000 daltons. 
     
     
         69 . The pharmaceutical dosage form of  claim 41 , comprising polyethylene oxide having a weight average molecular weight of 200,000 daltons. 
     
     
         70 . A pharmaceutical dosage form comprising:
 a mixture comprising (i) buprenorphine or a pharmaceutically acceptable salt thereof; and   (ii) a gelling agent comprising polyethylene oxide, hydroxypropylmethylcellulose and sugar derived alcohol; the gelling agent in an effective amount to impart a viscosity of at least about 10 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid;   the dosage form providing an immediate release upon administration to a human patient.