Chewable tablet containing phenylephrine

Abstract

A chewable pharmaceutical composition comprising phenylephrine, artificial sweetener, and a substantially aldehyde-free matrix is provided. The composition has phenylephrine stability suitable for a typical commercial product with a two year shelf life. A method of manufacture of the composition and a method of use are also provided.

1 - 38 . (canceled) 
     
     
         39 . A chewable composition comprising:
 a). phenylephrine;   b). an artificial sweetener; and   c). a matrix comprising substantially aldehyde-free excipients and an aldehyde-free flavorant.   
     
     
         40 . The composition of  claim 39  wherein the composition further comprises less than 2.5% wt/wt total isoquinolines and maintains said level of isoquinolines for at least 24 months. 
     
     
         41 . The composition of  claim 39 , wherein the composition further comprises less than 1.5% wt/wt total isoquinolines and maintains said level of isoquinolines for at least 24 months. 
     
     
         42 . The composition of  claim 39 , further comprising at least one second pharmaceutical active. 
     
     
         43 . The composition of  claim 42 , wherein the at least one second active agent is selected from the group consisting of analgesics, decongestants, expectorants, antitussives, antipyretics, anti-inflammatory agents, cough suppressants and antihistamines. 
     
     
         44 . The composition of  claim 43 , wherein the at least one second active agent is selected from the group consisting of ibuprofen, naproxen, ketoprofen, flurbiprofen, fenoprofen, suprofen, fluprofen, fenbufen, tolmetin sodium, zomepirac, sulindac, indomethacin, mefenamic acid, meclofenamate sodium, diflunisal, flufenisal, oxicams, piroxicam, sudoxicam, isoxicam, chlorpheniramine, brompheniramine, dexchlorpheniramine, dexbrompheniramine, triprolidine, chlorcyclizine, diphenhydramine, doxylamine succinate, tripelenamine, cyproheptatine, bromodiphenhydramine, phenindamine, pyrilamine, azatadine, acrivastine, astemizole, azelastine, cetirizine, ebastine, fexofenadine, ketotifen, carbinoxamine, desloratadine, loratadine, pheniramine, thonzylamine, mizolastine, terfenadine, chlophendianol, caramiphen, dextromethorphan, diphenhydramine, codeine, hydrocodone, pseudoephedrine, ephedrine, phenylephrine, phenylpropenolamine, terpin hydrate, guaifenesin, potassium, potassium guaicolsulfonate, Celecoxib, Rofecoxib, Valdecoxib, aspirin, acetaminophen, phenacetin, salicylate salts and combinations thereof. 
     
     
         45 . The composition of  claim 44 , wherein the at least one second active agent is selected from the group consisting of chlorpheniramine, brompheniramine, dextromethorphan, guaifenesin, acetaminophen, chlophendianol, diphenhydramine, loratadine, aspirin, and doxylamine succinate 
     
     
         46 . The composition of  claim 39 , wherein the artificial sweetener is selected from the group consisting of sucralose, saccharine salts, cyclamates, acesulfame K, aspartame and mixtures thereof. 
     
     
         47 . The composition of  claim 46 , wherein the artificial sweetener comprises sucralose. 
     
     
         48 . The composition of  claim 39 , wherein the substantially aldehyde-free flavorant is selected from the group consisting of mints, menthol, chocolate, artificial chocolate, bubblegum, artificial fruit flavors, natural fruit flavors, debittering flavors and combinations thereof. 
     
     
         49 . The composition of  claim 39 , wherein the matrix comprises an antioxidant. 
     
     
         50 . The composition of  claim 49 , wherein the antioxidant is propyl gallate. 
     
     
         51 . The composition of  claim 39 , wherein the matrix comprises mannitol. 
     
     
         52 . A chewable tablet comprising:
 a). phenylephrine;   b). an artificial sweetener;   c). a matrix comprising substantially aldehyde-free excipients; and   d.) optionally aldehyde-free flavorant.   
     
     
         53 . The chewable tablet of  claim 52 , wherein the tablet further comprises
 a.) less than 2.5 % wt/wt total isoquinolines and maintains said level of isoquinolines for at least 24 months; and   b.) wherein the tablet is formed in the absence of liquid water at substantially ambient temperature.   
     
     
         54 . The chewable tablet of  claim 52 , further comprising at least one second pharmaceutical active. 
     
     
         55 . The chewable tablet of  claim 54 , wherein the at least one second active agent is selected from the group consisting of analgesics, decongestants, expectorants, anti-tussives, antipyretics, anti-inflammatory agents, cough suppressants and antihistamines. 
     
     
         56 . The chewable tablet of  claim 55 , wherein the at least one second active agent is selected from the group consisting of ibuprofen, naproxen, ketoprofen, flurbiprofen, fenoprofen, suprofen, fluprofen, fehbufen, tolmetin sodium, zomepirac, sulindac, indomethacin, mefenamic acid, meclofenamate. sodium, diflunisal, flufenisal, oxicams, piroxicam, sudoxicam, isoxicam, chlorpheniramine, brompheniramine, dexchlorpheniramine, dexbrompheniramine, triprolidine, chlorcyclizine, diphenhydramine, doxylamine, tripelenamine, cyproheptatine, romodiphenhydramine, phenindamine, pyrilamine, azatadine, acrivastine, astemizole, azelastine, cetirizine, ebastine; fexofenadine, ketotifen, carbinoxamine, desloratadine, loratadine, pheniramine, thonzylamine, mizolastine, terfenadine, chlophendianol, caramiphen, dextromethorphan, diphenhydramine, codeine, hydrocodone, pseudoephedrine, ephedrine, phenylephrine, phenylpropenolamine, terpin hydrate, guaifenesin, potassium, potassium guaicolsulfonate, Celecoxib, Rofecoxib, Valdecoxib, aspirin; acetaminophen, phenacetin, salicylate salts and combinations thereof. 
     
     
         57 . The chewable tablet of  claim 56 , wherein the at least one second active agent is selected from the group consisting of chlorpheniramine, brompheniramine, dextromethorphan, guaifenesin, acetaminophen, chlophendianol, diphenhydramine, loratadine, aspirin, and doxylamine succinate 
     
     
         58 . The chewable tablet of  claim 52 , wherein the artificial sweetener is selected from the group consisting of sucralose, saccharine salts, cyclamates, acesulfame K, aspartame and mixtures thereof. 
     
     
         59 . The tablet of  claim 52 , wherein the matrix comprises an antioxidant. 
     
     
         60 . The tablet of  claim 59 , wherein the antioxidant is propyl gallate. 
     
     
         61 . The tablet of  claim 53 , wherein the matrix comprises mannitol. 
     
     
         62 . A method of treating an mammal in need of treatment comprising providing an effective amount of a chewable composition comprising phenylephrine, artificial sweetener, and a matrix comprising substantially aldehyde-free excipients and optionally aldehyde-free flavorant, wherein the composition further comprises less than 2.5% wt/wt total isoquinolines and maintains said level of isoquinolines for at least 24 months.