Pharmaceutical Suspension Composition

Abstract

An aqueous oral liquid pharmaceutical composition system with reduced propensity for agglomeration and phase separation which is particularly amendable to the suspension of one or more pharmaceutical actives that are substantially insoluble in water. The oral liquid pharmaceutical composition may further comprise pharmaceutical actives that are soluble in water and dissolve in the aqueous medium. In the composition of the invention both suspended and any dissolved active agents are distributed homogeneously.

1 . An oral liquid pharmaceutical composition comprising:
 a. a suspending system comprising an an aqueous medium, about 0.1 g/100 mL to about 0.5 g/100 mL xanthan gum and about 0.5 g/100 mL to about 3.0 g/100 mL microcrystalline cellulose/carboxymethylcellulose sodium;   b. Ibuprofen;   c. at least one density adjusting agent consisting of sorbitol, glycerin, propylene glycol, or a mixture thereof;   d. wherein said composition is sugar free; and   e. wherein said composition optionally includes one or more soluble pharmaceutical active ingredients dissolved in the aqueous medium.   
     
     
         2 . (canceled) 
     
     
         3 . (canceled) 
     
     
         4 . (canceled) 
     
     
         5 . The pharmaceutical composition of  claim 1  wherein the density adjusting agent comprises 10 g/100 mL to about 50 g/100 mL glycerin and about 10 g/100 mL to about 50 g/100 mL sorbitol. 
     
     
         6 . The pharmaceutical composition of  claim 1  further comprising about 0.1 g/100 mL to about 1.5 g/100 mL of a surface modifying agent. 
     
     
         7 . (canceled) 
     
     
         8 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . (canceled) 
     
     
         11 . (canceled) 
     
     
         12 . The pharmaceutical composition of  claim 6  wherein the surface modifying agent is a polysorbate. 
     
     
         13 . (canceled) 
     
     
         14 . (canceled) 
     
     
         15 . (canceled) 
     
     
         16 . (canceled) 
     
     
         17 . (canceled) 
     
     
         18 . (canceled) 
     
     
         19 . (canceled) 
     
     
         20 . (canceled) 
     
     
         21 . (canceled) 
     
     
         22 . (canceled) 
     
     
         23 . (canceled) 
     
     
         24 . A method for treatment of pain and discomfort associated with at least one of headache, body ache, cold symptoms, flu symptoms, and allergy symptoms in humans comprising the administration to a human of a safe and effective amount of the pharmaceutical composition of  claim 7 . 
     
     
         25 . A method of preparing an oral liquid pharmaceutical composition comprising:
 a. preparing a suspending system, comprising xantham gum, microcrystalline cellulose, carboxymethylcellulose sodium, or combinations thereof in an aqueous medium;   b. optionally dissolving additional sugar free excipients in an aqueous medium;   c. preparing a homogeneous composition by mixing the optional additional excipients into the suspending system;   d. uniformly dispersing at least one substantially insoluble first pharmaceutical active selected from ibuprofen, ketoprofen, naproxen and pharmaceutically acceptable salts thereof in a solution comprising polyols; and   e. mixing the uniformly dispersed first pharmaceutical active in a solution comprising polyols with the homogeneous composition to form a suspension; wherein the polyols are used at a concentration that creates a solution with a specific gravity matching the true density of the at least one substantially insoluble first pharmaceutical active;   f. optionally adding to the suspension at least one soluble additional pharmaceutical active dissolved in a water/polyol mixture.   
     
     
         26 . The method of  claim 25  further comprising de-aerating the composition by subjecting it to vacuum. 
     
     
         27 . (canceled) 
     
     
         28 . The method of  claim 26  further comprising adding a surface modifying agent to the pharmaceutical composition. 
     
     
         29 . A method for treatment of pain and discomfort associated with at least one of headache, body ache, cold symptoms, flu symptoms, and allergy symptoms in humans comprising the administration to a human of a safe and effective amount of the pharmaceutical composition of  claim 25 . 
     
     
         30 . A method for treatment of pain and discomfort associated with at least one of headache, body ache, cold symptoms, flu symptoms, and allergy symptoms in humans comprising the administration to a human of a safe and effective amount of the pharmaceutical composition of  claim 26 .