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 . 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;   said 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;   said dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.   
   
   
       2 . The controlled release oral dosage form of  claim 1 , wherein said excipient comprises a controlled release material. 
   
   
       3 . The controlled release oral dosage form of  claim 1 , wherein said gelling agent comprises a controlled release material. 
   
   
       4 . The controlled release oral dosage form of  claim 1 , wherein said drug is an opioid analgesic selected from the group consisting of levorphanol, meperidine, dihydrocodeine, dihydromorphine, oxymorphone, pharmaceutically acceptable salts thereof, and mixtures thereof. 
   
   
       5 . The controlled release oral dosage form of  claim 1 , wherein said drug is an opioid analgesic. 
   
   
       6 . The controlled release oral dosage form of  claim 5 , wherein said opioid analgesic is morphine or a pharmaceutically acceptable salt thereof. 
   
   
       7 . The controlled release oral dosage form of  claim 5 , wherein said opioid analgesic is hydromorphone or a pharmaceutically acceptable salt thereof. 
   
   
       8 . The controlled release oral dosage form of  claim 5 , wherein said opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof. 
   
   
       9 . The controlled release oral dosage form of  claim 5 , wherein said opioid analgesic is oxycodone or a pharmaceutically acceptable salt thereof. 
   
   
       10 . The controlled release oral dosage form of  claim 5 , wherein said opioid analgesic is codeine or a pharmaceutically acceptable salt thereof. 
   
   
       11 . The oral dosage form of  claim 1 , wherein said drug is selected from the group consisting of a tranquilizer, a CNS depressant, a CNS stimulant (e.g., methylphenidate or a pharmaceutically acceptable salt thereof), a sedative hypnotic, and combinations thereof. 
   
   
       12 . The controlled release oral dosage form of  claim 1 , wherein said ratio of said gelling agent to said drug is from about 1:40 to about 40:1. 
   
   
       13 . The controlled release oral dosage form of  claim 1 , wherein said ratio of said gelling agent to said drug is from about 1:1 to about 30:1. 
   
   
       14 . The controlled release oral dosage form of  claim 1 , wherein said ratio of said gelling agent to said drug is from about 2:1 to about 10:1. 
   
   
       15 . The controlled release oral dosage form of  claim 1 , wherein said gelling agent is selected from the group consisting of sugars, sugar derived alcohols, cellulose derivatives, gums, surfactants, emulsifying agents, and mixtures thereof. 
   
   
       16 . The controlled release oral dosage form of  claim 1 , wherein said gelling agent is selected from the group consisting of pectin, xanthan gum and combinations thereof. 
   
   
       17 . The controlled release oral dosage form of  claim 1 , wherein said aqueous liquid is water. 
   
   
       18 . The controlled release oral dosage form of  claim 1 , wherein said unsuitable viscosity is attained when about 1 to about 3 ml of aqueous liquid is mixed with the crushed dosage form. 
   
   
       19 . The controlled release oral dosage form of  claim 1 , wherein the addition of from about 0.5 to about 10 ml of said aqueous liquid causes said solubilized mixture to have a viscosity of at least about 10 cP. 
   
   
       20 . The controlled release oral dosage form of  claim 1 , wherein the addition of from about 0.5 to about 10 ml of said aqueous liquid causes said solubilized mixture to have a viscosity of at least about 60 cP. 
   
   
       21 - 40 . (canceled)