Liquid dosage forms of sodium naproxen

Abstract

Described herein are oral pharmaceutical compositions comprising liquid dosage forms of sodium naproxen in soft gel capsules. In one embodiment, the pharmaceutical composition comprises sodium naproxen, 0.2-1.0 mole equivalents of a de-ionizing agent per mole of naproxen, polyethylene glycol, and one or more solubilizers such as propylene glycol, polyvinyl pyrrolidone or a combination thereof.

What is claimed: 
     
         1 . A soft gelatin capsule comprising a fill material comprising:
 (a) a naproxen salt;   (b) a deionizing agent comprising lactic acid in an amount of from 0.2 to 1.0 mole equivalents per mole of naproxen salt; and   (c) one or more polyethylene glycols.   
     
     
         2 . The capsule of  claim 1 , wherein the naproxen salt is naproxen sodium. 
     
     
         3 . The capsule of  claim 1 , wherein the one or more polyethylene glycols comprises one or more polyethylene glycols with a molecular weight between 300 and 1500. 
     
     
         4 . The capsule of  claim 1 , wherein the one or more polyethylene glycols are present in an amount from 10% to 80% by weight. 
     
     
         5 . The capsule of  claim 1 , wherein the fill material further comprises one or more solubilizers comprising glycerin, polyvinylpyrrolidone, or propylene glycol. 
     
     
         6 . The capsule of  claim 5 , wherein the one or more solubilizers are present in amount from 1% to 10% by weight. 
     
     
         7 . The capsule of  claim 1 , wherein the fill material further comprises water in an amount from 1% to 18% by weight. 
     
     
         8 . The capsule of  claim 1 , wherein the fill material further comprises one or more excipients comprising plasticizers, crystallization inhibitors, wetting agents, bulk filling agents, bioavailability enhancers, solvents, dyes, preservatives, surfactants, or combinations thereof. 
     
     
         9 . The capsule of  claim 1 , wherein the fill material is liquid. 
     
     
         10 . A method for treating pain, inflammation, or fever comprising administering the capsule of  claim 1  to a patient in need thereof. 
     
     
         11 . A soft gelatin capsule comprising a fill material comprising:
 (a) naproxen sodium;   (b) a deionizing agent comprising lactic acid in an amount of from 0.2 to 1.0 mole equivalents per mole of naproxen sodium; and   (c) one or more polyethylene glycols.   
     
     
         12 . The capsule of  claim 11 , wherein the one or more polyethylene glycols comprises polyethylene glycols with a molecular weight between 300 and 1500. 
     
     
         13 . The capsule of  claim 11 , wherein the one or more polyethylene glycols are present in an amount from 10% to 80% by weight. 
     
     
         14 . The capsule of  claim 11 , wherein the fill material further comprises one or more solubilizers comprising glycerin, polyvinylpyrrolidone, or propylene glycol. 
     
     
         15 . The capsule of  claim 14 , wherein the one or more solubilizers are present in amount from 1% to 10% by weight. 
     
     
         16 . The capsule of  claim 11 , wherein the fill material further comprises water in an amount from 1% to 18% by weight. 
     
     
         17 . The capsule of  claim 11 , further comprising one or more excipients comprising plasticizers, crystallization inhibitors, wetting agents, bulk filling agents, bioavailability enhancers, solvents, dyes, preservatives, surfactants, or combinations thereof. 
     
     
         18 . The capsule of  claim 11 , wherein the fill material is liquid. 
     
     
         19 . A method for treating pain, inflammation, or fever comprising administering the capsule of  claim 11  to a patient in need thereof.