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 therapeutic pharmaceutical composition comprising: a mixture including (a) an opioid; (b) a gel-forming polymer; (c) a disintegrant; and (d) a surfactant; wherein the pharmaceutical composition exhibits an immediate release profile. 
     
     
         42 . The therapeutic pharmaceutical composition of  claim 41 , wherein the pharmaceutical composition is in unit dose form. 
     
     
         43 . The therapeutic pharmaceutical composition of  claim 41 , wherein the pharmaceutical composition is in suppository, capsule, pill, soft gelatin capsule, or compressed tablet form. 
     
     
         44 . The therapeutic pharmaceutical composition of  claim 41 , wherein the water soluble drug susceptible to abuse is present in an amount of 2.3 to 29.8 wt % of the composition. 
     
     
         45 . The therapeutic pharmaceutical composition of  claim 41 , wherein the disintegrant is present in an amount of 5 to 15 wt % of the composition. 
     
     
         46 . The therapeutic pharmaceutical composition of  claim 41 , wherein the surfactant is present in an amount of 1 to 10 wt % of the composition. 
     
     
         47 . The therapeutic pharmaceutical composition of  claim 41 , wherein the gel-forming polymer is present in an amount of about 3 to about 40 wt % of the composition. 
     
     
         48 . The therapeutic pharmaceutical composition of  claim 41 , wherein the disintegrant is selected from the group consisting of sodium starch glycolate, crospovidone, and croscarmellose sodium. 
     
     
         49 . The therapeutic pharmaceutical composition of  claim 41 , wherein the gel-forming polymer is present in an amount of 3.8 to 39 wt %. 
     
     
         50 . The therapeutic pharmaceutical composition of  claim 41 , wherein the disintegrant is present in an amount sufficient to cause the pharmaceutical composition to exhibit an immediate release profile. 
     
     
         51 . The therapeutic pharmaceutical composition of  claim 47 , wherein the disintegrant is present in an amount sufficient to cause the pharmaceutical composition to exhibit an immediate release profile. 
     
     
         52 . The therapeutic pharmaceutical composition of  claim 49 , wherein the disintegrant is present in an amount sufficient to cause the pharmaceutical composition to exhibit an immediate release profile. 
     
     
         53 . The therapeutic pharmaceutical composition of  claim 41  wherein the opioid is selected from the group consisting of alfentanil, allylprodine, alphaprodine, anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, desomorphine, dextromoramide, dezocine, diampromide, diamorphone, dihydrocodeine, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene, etorphine, dihydroetorphine, fentanyl and derivatives, heroin, hydrocodone, hydromorphone, hydroxypethidine, isomethadone, ketobemidone, levorphanol, levophenacylmorphan, lofentanil, meperidine, meptazinol, metazocine, methadone, metopon, morphine, myrophine, narceine, nicomorphine, norlevorphanol, normethadone, nalorphine, nalbuphene, normorphine, norpipanone, opium, oxycodone, oxymorphone, papaveretum, pentazocine, phenadoxone, phenomorphan, phenazocine, phenoperidine, piminodine, piritramide, propheptazine, promedol, properidine, propoxyphene, sufentanil, tilidine, tramadol, and pharmaceutically acceptable salts thereof. 
     
     
         54 . The therapeutic pharmaceutical composition of  claim 41 , wherein the opioid is selected from the group consisting of alfentanil, buprenorphine, butorphanol, codeine, dihydrocodeine, dihydromorphine, etorphine, fentanyl, hydrocodone, hydromorphone, levorphanol, lofentanil, meperidine, methadone, morphine, nalbuphene, oxycodone, oxymorphone, pentazocine, propoxyphene, sufentanil, tilidine, tramadol and pharmaceutically acceptable salts thereof. 
     
     
         55 . The therapeutic pharmaceutical composition of  claim 41 , wherein the opioid is oxycodone hydrochloride. 
     
     
         56 . The therapeutic pharmaceutical formulation of  claim 41 , wherein the surfactant is sodium lauryl sulfate. 
     
     
         57 . The therapeutic pharmaceutical formulation of  claim 41 , wherein the opioid is the sole active agent in the dosage form.