Compositions and methods of making rapidly dissolving ionically masked formulations

Abstract

The present invention includes compositions and methods for reduce the taste of the drug in the drug resin complex. The composition may include one or more drug-resin complexes and a highly compressible, free-flowing pharmaceutical excipient. The resin is present in an amount effective to reduce the taste of the drug in the drug resin complex relative to an otherwise identical pharmaceutical composition without the resin; and wherein the highly compressible, free-flowing pharmaceutical excipient causes release of the drug-resin complex in the mouth.

1 - 17 . (canceled) 
     
     
         18 . A compressed, controlled release taste-masked pharmaceutical composition comprising: a pharmaceutically active coated drug-ion-exchange resin complex and a directly compressible, free-flowing pharmaceutical excipient, wherein said composition is in the form of a compressed tablet. 
     
     
         19 . The composition of  claim 18 , wherein the pharmaceutically active drug-ion-exchange-resin complex comprises polistirex, polacrilex or combinations thereof. 
     
     
         20 - 28 . (canceled) 
     
     
         29 . The composition of  claim 18 , wherein the directly compressible, free-flowing pharmaceutical excipient aids in the rapid breakdown of the compressed tablet in the mouth by chewing. 
     
     
         30 . The composition of  claim 18 , wherein the resin in the drug-ion-exchange resin complex comprises one or more cationic exchange resins. 
     
     
         31 . The composition of  claim 18 , wherein the composition comprises a hardness of between about 5 and about 15 kPa. 
     
     
         32 . The composition of  claim 18 , wherein said controlled release coating comprises a diffusion barrier coating. 
     
     
         33 . The composition of  claim 18 , wherein said controlled release coating comprises a delayed release coating. 
     
     
         34 . The composition of  claim 18 , wherein the drug in said drug-ion-exchange resin complex comprises an analgesic drug, anti-inflammatory drug, central nervous system agent, anti-hypertensive drug, or an anti-hyperactive drug. 
     
     
         35 . The composition of  claim 18 , wherein the drug in said drug-ion-exchange resin complex comprises amphetamine. 
     
     
         36 . The composition of  claim 18 , wherein said composition is in the form of a chewable tablet. 
     
     
         37 . The composition of  claim 18 , wherein said drug-ion-exchange resin complex is slowly released when the tablet is chewed, and the tablet slowly dissociates when the tablet is chewed, so as to completely dissociate thereafter once swallowed. 
     
     
         38 . The composition of  claim 18 , wherein the thickness of the coating on said coated drug-ion-exchange resin complex is sufficient to remain intact until the desired site of topical delivery in the lower intestinal tract is reached. 
     
     
         39 . The composition of  claim 18 , wherein, when said tablet becomes thixotropic as it is chewed but not fully dissolving for at least 30 seconds and rapidly disintegrates during chewing but prevents the release of the ionic drug until after the complex is swallowed. 
     
     
         40 . The composition of  claim 18 , wherein said pharmaceutically active coated drug-ion-exchange resin complex is in a free-flowing form. 
     
     
         42 . A chewable, sustained-release formulation pharmaceutical composition comprising a pharmaceutically active coated drug-ion-exchange resin complex and a mixture of sugar, syrup, starch, citric acid, and a carrier. 
     
     
         43 . The composition of  claim 42 , wherein unpleasant taste associated with delivery of the drug is effectively masked. 
     
     
         44 . The composition of  claim 42 , wherein the pharmaceutically active drug-ion-exchange resin complex comprises polistirex, polacrilex or combinations thereof. 
     
     
         45 . The composition of  claim 42 , wherein the drug-ion-exchange resin complex comprises a divinylbenzene sulfonic acid cationic exchange resin. 
     
     
         46 . The composition of  claim 42 , wherein the drug in said drug-ion-exchange resin complex comprises an analgesic drug, anti-inflammatory drug, central nervous system agent, anti-hypertensive drug, or an anti-hyperactive drug. 
     
     
         47 . The composition of  claim 42 , wherein the drug in said drug-ion-exchange resin complex comprises amphetamine.