Solvent system for enhancing solubility

Abstract

A pharmaceutically acceptable solution with a medicament suitable for filling a soft gelatin capsule is made from a solvent. The solvent contains a polymer, such as polyethylene glycol, and an acid salt of a compound having 3 or more carbon atoms, and a salt such as sodium propionate. The solvent may optionally contain a cosolvent, such as dimethyl isosorbide. The medicament may preferably comprise an analgesic such as aspirin or naproxen.

We claim:  
     
         1 . A pharmaceutically acceptable solution comprising a medicament and a solvent system, wherein said solvent system comprises a low molecular weight polymeric material and a salt of an organic acid containing at least three carbon atoms.  
     
     
         2 . The solution of  claim 1 , wherein said medicament is capable of forming a zwitterion.  
     
     
         3 . The solution of  claim 2 , wherein said medicament is acetaminophen.  
     
     
         4 . The solution of  claim 1 , wherein said medicament comprises at least about 25% by weight of said solution.  
     
     
         5 . The solution of  claim 1 , wherein said polymeric material is selected from the group consisting of polymers of alkylene glycols, copolymers thereof, polymers of vinyl pyrollidones, copolymers thereof, glycerin, propylene glycol and mixtures and analogs thereof.  
     
     
         6 . The solution of  claim 1 , wherein said polymeric material is selected from the group consisting of polymers and copolymers of ethylene glycol.  
     
     
         7 . The solution of  claim 6 , wherein said polymeric material has an average molecular weight of less than about 1,500 daltons.  
     
     
         8 . The solution of  claim 1 , wherein said polymeric material comprises from about 10% to about 70% by weight of the solution.  
     
     
         9 . The solution of  claim 1 , wherein said salt is an alkali propionate.  
     
     
         10 . The solution of  claim 1 , wherein said salt comprises from about 2% by weight to about 40% by weight of the solution.  
     
     
         11 . The solution of  claim 1 , further comprising a cosolvent.  
     
     
         12 . A gelcap for administering a medicament comprising an outer shell comprising gelatin fully or partially enclosing a solution comprising a medicament and a solvent system, wherein said solvent system comprises a low molecular weight polymeric material and a salt of an organic acid containing at least three carbon atoms.  
     
     
         13 . The gelcap of  claim 12 , wherein said medicament is an analgesic.  
     
     
         14 . The gelcap of  claim 13 , wherein said medicament is acetaminophen.  
     
     
         15 . The gelcap of  claim 12 , wherein said medicament comprises at least about 25% by weight of said solution.  
     
     
         16 . The gelcap of  claim 12 , wherein said polymeric material is selected from the group consisting of polymers of alkylene glycols, copolymers thereof, polymers of vinyl pyrollidones, copolymers thereof, glycerin, propylene glycol and mixtures and analogs thereof.  
     
     
         17 . The gelcap of  claim 12 , wherein said polymeric material is selected from the group consisting of polymers and copolymers of ethylene glycol.  
     
     
         18 . The gelcap of  claim 17 , wherein said polymeric material has a molecular weight of less than about 1,500 daltons.  
     
     
         19 . The gelcap of  claim 12 , wherein said polymeric material comprises from about 10% to about 70% by weight of the solution.  
     
     
         20 . The gelcap of  claim 12 , wherein said salt is an alkali propionate.  
     
     
         21 . The gelcap of  claim 12 , wherein said salt comprises from about 2% by weight to about 40% by weight of the solution.  
     
     
         22 . The gelcap of  claim 12 , further comprising a cosolvent.  
     
     
         23 . A method of making a solution comprising the steps of: (a) preparing a solvent comprising a low molecular weight polymeric material; (b) adding a medicament to said solvent system to form a solution; and (c) blending a salt of an organic acid containing at least three carbon atoms with said polymeric material to form a solvent system.  
     
     
         24 . The method of  claim 23 , further comprising the step of heating at least one of said solvent, said solvent system or said solution.