Enhanced stability of novel liquid compositions

Abstract

The present invention relates to compositions of pharmaceutical agents in combination with additional pharmaceutical agents in a mixture of polyethylene glycol, polyvinylpyrrolidone, and propylene glycol and a process of making the compositions.

1 - 22 . (canceled) 
     
     
         23 . A liquid oral pharmaceutical composition comprising:
 (i) from about 0.1% to about 20% w/v polyvinylpyrrolidone;   (ii) from about 5% to about 70% w/v polyethylene glycol;   (iii) from about 1% to about 30% w/v propylene glycol;   (iv) from about 1% to 10% w/v guaifenesin; and   (v) from about 0.01% to about 1.0% w/v phenylephrine;   further comprising one or more additional pharmaceutical agent selected from the group consisting of analgesics, decongestants, expectorants, antitussives, antipyretics, anti-inflammatory agents, cough suppressants, and antihistamines; and wherein the composition is visually free of guaifenesin precipitation for at least 62 days at 4° C.   
     
     
         24 . The composition of  claim 23 , wherein the one or more additional pharmaceutical agent is an antitussive. 
     
     
         25 . The composition of  claim 24 , wherein the antitussive is dextromethorphan. 
     
     
         26 . The composition of  claim 24 , wherein the antitussive is diphenhydramine. 
     
     
         27 . The composition of  claim 24 , wherein the antitussive is chlophedianol. 
     
     
         28 . The composition of  claim 23 , wherein the one or more additional pharmaceutical agent is an antihistamine. 
     
     
         29 . The composition of  claim 28 , wherein the antihistamine is chlorpheniramine. 
     
     
         30 . The composition of  claim 28 , wherein the antihistamine is brompheniramine. 
     
     
         31 . The composition of  claim 28 , wherein the antihistamine is doxylamine. 
     
     
         32 . The composition of  claim 28 , wherein the antihistamine is loratadine. 
     
     
         33 . The composition of  claim 23 , wherein the one or more additional pharmaceutical agent is an analgesic. 
     
     
         34 . The composition of  claim 33 , wherein the analgesic is acetaminophen. 
     
     
         35 . The composition of  claim 33 , wherein the analgesic is aspirin. 
     
     
         36 . A liquid oral pharmaceutical composition comprising:
 (i) from about 0.1% to about 20% w/v polyvinylpyrrolidone;   (ii) from about 5% to about 70% w/v polyethylene glycol;   (iii) from about 1% to about 30% w/v propylene glycol;   (iv) from about 1% to 10% w/v guaifenesin; and   (v) from about 0.01% to about 1.0% w/v phenylephrine;   further comprising one or more additional pharmaceutical agent selected from the group consisting of analgesics, decongestants, expectorants, antitussives, antipyretics, anti-inflammatory agents, cough suppressants, and antihistamines; and wherein the composition is visually free of guaifenesin precipitation for 14 days at −20° C.