Soft shell gelatin capsules containing non-steroidal anti-inflammatories

Abstract

The present invention provides a pharmaceutical formulation suitable for filling softgel capsules comprising: (a) a therapeutically effective amount of a non-steroidal anti-inflammatory drug selected from the group consisting of selected from the group consisting of (1) the propionic acid derivatives; (2) the acetic acid derivatives; (3) the fenamic acid derivatives; (4) the biphenylcarboxylic acid derivatives; and (5) the oxicams; as well as Cox 2 inhibitors and mixtures thereof; and (b) a solvent system comprising 40% to 60% by weight a polyoxyethylene ether of the formula: wherein n=1 to 6; 15% to 35% by weight of glycerin and 15% to 35% by weight water. In the case of compositions containing an NSAID having carboxyl function an alkaline hydroxide may be added to neutralize said hydroxide function.

What is being claimed is:  
     
         1 . A pharmaceutical formulation suitable for filling softgel capsules comprising: 
 (a) a therapeutically effective amount of a non-steroidal anti-inflammatory drug selected from the group consisting of (1) the propionic acid derivatives; (2) the acetic acid derivatives; (3) the fenamic acid derivatives; (4) the biphenylcarboxylic acid derivatives; and (5) the oxicams; and    (b) a solvent system comprising 40% to 60% by weight a polyoxyethylene ether of the formula:                          wherein n=1 to 6; 15% to 35% by weight of glycerin and 15% to 35% by weight water.    
     
     
         2 . The formulation of  claim 1  further comprising an effective amount not to exceed the molar equivalent of the carboxylic acid function of an alkaline metal hydroxide selected from the group consisting of sodium hydroxide and potassium hydroxide.  
     
     
         3 . The formulation of  claim 1  wherein said propionic acid derivative is ibuprofen.  
     
     
         4 . The formulation of  claim 2  wherein said propionic acid derivative is ibuprofen.  
     
     
         5 . The formulation of  claim 1  wherein said propionic acid derivative is naproxen.  
     
     
         6 . A pharmaceutical soft gelatin capsule in unit dosage form with a filling comprising a therapeutically effective amount of non-steroidal anti-inflammatory drug selected from the group consisting of (1) the propionic acid derivatives; (2) the acetic acid derivatives; (3) the fenamic acid derivatives; (4) the biphenylcarboxylic acid derivatives; and (5) the oxicams; and a solvent system comprising 40% to 60% by weight a polyoxyethylene ether of the formula:  
       
         
           
           
               
               
           
         
       
       wherein n=1 to 6; 15% to 35% by weight of glycerin and 15% to 35% by weight water.  
     
     
         7 . The formulation of  claim 6  further comprising an effective amount not to exceed the molar equivalent of the carboxylic acid function of an alkaline metal hydroxide selected from the group consisting of sodium hydroxide and potassium hydroxide.  
     
     
         8 . The formulation of  claim 6  wherein said propionic acid derivative is ibuprofen.  
     
     
         9 . The formulation of  claim 6  wherein said propionic acid derivative is naproxen.  
     
     
         10 . A pharmaceutical formulation for oral administration having increased stability and bioavailability of an analgesic or anti-inflammatory agent containing a carboxylic acid function, comprising a soft gelatin capsule which essentially contains a therapeutically active amount of said analgesic or anti-inflammatory agent dissolved in a composition comprising: 40% to 60% by weight glycofurol; 15% to 35% by weight of glycerin; 15% to 35% by weight water and an effective amount not to exceed the molar equivalent of the carboxylic acid function of an alkaline metal hydroxide selected from the group consisting of sodium hydroxide and potassium hydroxide.  
     
     
         11 . The pharmaceutical formulation of  claim 10  wherein said anti-inflammatory agent is ibuprofen.  
     
     
         12 . The pharmaceutical formulation of  claim 10  wherein said anti-inflammatory agent is naproxen.  
     
     
         13 . A pharmaceutical formulation for oral administration having increased stability and bioavailability comprising a soft gelatin capsule which contains a therapeutically active amount of a Cox2 inhibitor dissolved in a composition comprising: 40% to 80% by weight glycofurol; 15% to 35% by weight of glycerin; 5% to 15% by weight water.  
     
     
         14 . The formulation of  claim 13  wherein said Cox 2 inhibitor is Rofecoxib.  
     
     
         15 . The formulation of  claim 13  wherein said Cox 2 inhibitor is Valdecoxib.  
     
     
         16 . The formulation of  claim 13  wherein said Cox 2 inhibitor is Celecoxib.  
     
     
         17 . The formulation of  claim 13  wherein said Cox 2 inhibitor is Parecoxib.