Pharmaceutical resinate compositions and methods of making and using thereof

Abstract

Disclosed herein are pharmaceutical compositions having a mixture of at least one active agent and an ion exchange resin, such that the composition releases about 75% or more of the at least one active agent within about 1 hour as measured by in-vitro dissolution in a USP Apparatus 2 (paddle) at about 50 rpm in about 900 ml 0.1N HCl at about 37° C. and related methods. Also disclosed herein are pharmaceutical compositions having a mixture of a drug susceptible to abuse, a non-opioid analgesic and an ion exchange resin, the composition further including at least one gelling agent and related methods.

1 - 129 . (canceled) 
     
     
         130 . A pharmaceutical composition comprising:
 a mixture comprising a first active agent and an ion exchange resin, wherein the mixture is layered over a plurality of cores; and   at least one second active agent comprised in the mixture, the plurality of cores, or both,   wherein a weight ratio of the ion exchange resin to the at least one active agent is about 1:1 to about 20:1,   wherein the composition provides an immediate release and releases about 75% or more of the at least one active agent within about 1 hour as measured by in-vitro dissolution in a USP Apparatus 2 (paddle) at about 50 rpm in about 900 ml 0.1N HCl at about 37° C.,   wherein the pharmaceutical composition is a compressed tablet comprising the plurality of cores layered with the mixture.   
     
     
         131 . The pharmaceutical composition of  claim 130 , wherein the first active agent comprises a drug susceptible to abuse. 
     
     
         132 . The pharmaceutical composition of  claim 131 , wherein the drug susceptible to abuse comprises dronabinol, derivatives thereof or mixtures thereof. 
     
     
         133 . The pharmaceutical composition of  claim 131 , wherein the drug susceptible to abuse comprises an opioid agonist. 
     
     
         134 . The pharmaceutical composition of  claim 133  wherein the opioid agonist is selected from the group consisting of oxycodone, oxymorphone, hydrocodone, hydromorphone, morphine, codeine, tramadol, tapentadol, fentanyl, pharmaceutically acceptable salts, hydrates thereof, solvates thereof and mixtures thereof. 
     
     
         135 . The pharmaceutical composition of  claim 134 , wherein the opioid agonist is selected from the group consisting of oxycodone hydrochloride, hydrocodone bitartrate, and hydromorphone hydrochloride. 
     
     
         136 . The pharmaceutical composition of  claim 130 , wherein the first active agent comprises at least one of a central nervous system (CNS) stimulant, a CNS depressant, a tranquilizer, a sedative hypnotic, or combinations thereof. 
     
     
         137 . The pharmaceutical composition of  claim 130 , wherein the second active agent comprises a non-opioid analgesic. 
     
     
         138 . The pharmaceutical composition of  claim 137 , wherein the non-opioid analgesic comprises at least one of a non-steroidal anti-inflammatory agents or acetaminophen. 
     
     
         139 . The pharmaceutical composition of  claim 130 , wherein the second active agent comprises an antagonist to the first active agent. 
     
     
         140 . The pharmaceutical composition of  claim 139 , wherein the antagonist comprises at least one of naltrexone, naloxone, nalmefene, cyclazacine, levallorphan, buprenorphine, pharmaceutically acceptable salts, hydrates and solvates thereof, or mixtures thereof. 
     
     
         141 . The pharmaceutical composition of  claim 139 , wherein the antagonist comprises at least one of naltrexone hydrochloride or naloxone hydrochloride. 
     
     
         142 . The pharmaceutical composition of  claim 130 , wherein the first active agent comprises about 2.5 mg to about 10 mg oxycodone or a pharmaceutically acceptable salt thereof, or comprises about 2.5 mg to about 15 mg of hydrocodone or a pharmaceutically acceptable salt thereof. 
     
     
         143 . The pharmaceutical composition of  claim 130 , further comprising at least one abuse deterrent agent. 
     
     
         144 . The pharmaceutical composition  claim 143 , wherein the at least one abuse deterrent agent comprises a gelling agent, a bittering agent, an irritant or combinations thereof. 
     
     
         145 . The pharmaceutical composition of  claim 144 , wherein the gelling agent comprises at least one of sugars, sugar derived alcohols, starch, starch derivatives, cellulose derivatives, attapulgites, bentonites, dextrins, alginates, carrageenan, gums, pectins, gelatin, kaolin, lecithin, magnesium aluminum silicate, carbomers, carbopols, polyvinylpyrrolidone, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, silicon dioxide, curdlan, furcelleran, egg white powder, lacto albumin, soy protein, chitosan, surfactants, emulsifiers, and pharmaceutically acceptable salts thereof or combinations thereof. 
     
     
         146 . The pharmaceutical composition of  claim 130 , wherein the ion exchange resin is present in an amount of about 2.5 mg to about 15,000 mg. 
     
     
         147 . The pharmaceutical composition of  claim 130 , wherein the mixture comprises the first active agent and the ion exchange resin in an admixture. 
     
     
         148 . The pharmaceutical composition of  claim 130 , wherein the mixture comprises a complex of the first active agent and the ion exchange resin. 
     
     
         149 . The pharmaceutical composition of  claim 148 , wherein the mixture comprises about 25% or more of the complex.