US2015004240A1PendingUtilityA1

Compositions and methods of making rapidly dissolving ionically masked formulations

61
Assignee: NEOS THERAPEUTICS LPPriority: Oct 21, 2005Filed: Sep 15, 2014Published: Jan 1, 2015
Est. expiryOct 21, 2025(expired)· nominal 20-yr term from priority
Inventors:Mark TenglerRussell Mcmahen
A61P 9/00A61P 35/00A61P 29/00A61P 31/00A61P 25/16A61K 9/0056A61K 9/0002A61K 47/26A61P 11/00A61P 21/02A61K 31/46A61K 47/585A61K 31/74A61K 47/59A61K 31/137A61K 31/785A61K 31/4402A61K 47/58A61K 47/48192A61K 47/48176
61
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Claims

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.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A taste-masked pharmaceutical composition comprising:
 a drug-resin complex and a highly compressible, free-flowing pharmaceutical excipient, wherein the resin is present in an amount effective to reduce the taste of the drug in the drug resin complex by more than about 15 percent relative to an otherwise identical pharmaceutical composition without the resin; and wherein the highly compressible, free-flowing pharmaceutical excipient aids release of the drug-resin complex in the mouth.   
     
     
         2 . The composition of  claim 1 , wherein the composition comprises a chewable tablet, a solid, a dissolvable or disintegrating tablet, a liquid, a gel, a tab, a capsule, a powder, a lotion, a cream, a gum, a lozenge and combinations thereof. 
     
     
         3 . The composition of  claim 1 , wherein the drug in the drug-resin complex comprises dextromethorphan, codeine, morphine, hydrocodone, hyoscyamine, moguisteine, pseudoephedrine, chlorpheniramine, phenylpropanolamine, pharmaceutically acceptable salts of the same and combinations thereof. 
     
     
         4 . The composition of  claim 1 , wherein the pharmaceutical composition is suitable for oral administration. 
     
     
         5 . The composition of  claim 1 , further comprising one or more flavorants, sweeteners, coolants, dyes, or combinations and mixtures thereof. 
     
     
         6 . The composition of  claim 1 , further comprising one or more excipients, one or more binders or combinations and mixtures thereof. 
     
     
         7 . The pharmaceutical of  claim 1 , wherein the drug-resin complex comprises polistirex, polyacrilex and combinations thereof. 
     
     
         8 . The pharmaceutical of  claim 1 , wherein the drug-resin complex comprises pseudoephedrine polistirex and chlorpheniramine polyacrilex. 
     
     
         9 . The pharmaceutical of  claim 1 , wherein the resin in the drug-resin complex comprises one or more cationic exchange resins. 
     
     
         10 . The pharmaceutical of  claim 1 , wherein the drug-resin complex comprises a divinylbenzene sulfonic acid cationic exchange resin. 
     
     
         11 . The pharmaceutical of  claim 1 , wherein the composition comprises a hardness of between about 5 and about 15 kPa. 
     
     
         12 . The pharmaceutical of  claim 1 , wherein the composition has at least about 20 percent better mouth-feel. 
     
     
         13 . The pharmaceutical of  claim 1 , wherein the drug-resin complex comprises a diffusion barrier coating. 
     
     
         14 . The pharmaceutical of  claim 13 , wherein the diffusion barrier coating is a time release coating. 
     
     
         15 . A rapidly dissolving or disintegrating, taste-masked pharmaceutical composition comprising:
 a drug-resin complex and a compressible, free-flowing, pharmaceutical, taste-masking excipient, wherein 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.   
     
     
         16 . The pharmaceutical of  claim 15 , wherein the drug-resin complex comprises polistirex, polyacrilex and combinations thereof. 
     
     
         17 . The pharmaceutical of  claim 15 , wherein the drug-resin complex comprises pseudoephedrine polistirex and chlorpheniramine polyacrilex. 
     
     
         18 . A chewable tablet comprising:
 a pharmaceutically active drug-resin complex, whereby the pharmaceutically active ingredient is slowly released when the tablet is chewed, the tablet becoming thixotropic when chewed but not fully dissociating for at least 30 seconds when chewed, and the tablet slowly dissociates when the tablet is chewed, so as to completely dissociate thereafter once swallowed; and   one or more amorphous sugars.   
     
     
         19 . The pharmaceutical of  claim 18 , wherein the pharmaceutically active drug-resin complex comprises polistirex, polyacrilex and combinations thereof. 
     
     
         20 . The pharmaceutical of  claim 18 , wherein the pharmaceutically active drug-resin complex comprises pseudoephedrine polistirex and chlorpheniramine polyacrilex. 
     
     
         21 . The composition of  claim 18 , further comprising one or more flavorants, sweeteners, coolants, dyes, or combinations and mixtures thereof. 
     
     
         22 . The composition of  claim 18 , further comprising one or more excipients, one or more binders or combinations and mixtures thereof. 
     
     
         23 . A taste-masked chewable pseudoephedrine and chlorpheniramine pharmaceutical composition comprising:
 a pseudoephedrine-resin complex;   a chlorpheniramine-resin complex;   one or more amorphous sugars; and   a compressible, free-flowing, pharmaceutical, taste-masking excipient, wherein the highly compressible, free-flowing pharmaceutical excipient aids release of the drug-resin complex in the mouth.   
     
     
         24 . The pharmaceutical of  claim 23 , wherein the pseudoephedrine-resin complex, chlorpheniramine-resin complex or both comprise a polistirex resin, a polyacrilex resin and combinations thereof. 
     
     
         25 . A rapidly dissolving, taste-masked hyoscyamine pharmaceutical composition comprising:
 a hyoscyamine-resin complex, whereby the hyoscyamine is released when the tablet disintegrates; and   one or more amorphous sugars; and   a compressible, free-flowing, pharmaceutical, taste-masking excipient.   
     
     
         26 . The composition of  claim 25 , further comprising one or more flavorants, sweeteners, coolants, dyes, or combinations and mixtures thereof. 
     
     
         27 . The composition of  claim 25 , further comprising one or more excipients, one or more binders or combinations and mixtures thereof. 
     
     
         28 . A taste-masked chewable pseudoephedrine and chiorpheniramine pharmaceutical composition comprising:
 a pseudoephedrine-resin complex;   a chlorpheniramine-resin complex;   one or more amorphous sugars; and   a compressible, free-flowing, pharmaceutical, taste-masking excipient, whereby the pseudoephedrine and the chlorpheniramine are slowly released when the composition is chewed, the composition becoming thixotropic when chewed but not fully dissociating for at least 10 seconds when chewed, and the composition slowly dissociates when the composition is chewed, so as to fully dissociate after the mixture is swallowed.

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