Nanoparticle isoflavone compositions and methods of making and using the same

Abstract

The present invention is directed to formulations of genistein and methods for making and using, the same. In particular embodiments, the formulations described herein include suspension formulations of nanoparticulate genistein.

1 - 64 . (canceled) 
     
     
         65 . A method of preparing a genistein formulation suitable for oral administration, comprising:
 combining genistein with a pharmaceutically acceptable suspension medium, the pharmaceutically acceptable suspension medium comprising a water soluble polymer;   forming a suspension of the genistein in the pharmaceutically acceptable suspension medium; and   isolating a solid dispersion comprising genistein and the water soluble polymer, wherein the solid dispersion is suitable for oral administration.   
     
     
         66 . The method of  claim 65 , wherein isolating the solid dispersion comprises at least one of spray drying, lyophilizing, milling, microprecipitation, evaporative precipitation, or antisolvent precipitation. 
     
     
         67 . The method of  claim 66 , wherein isolating the solid dispersion comprises spray drying the suspension. 
     
     
         68 . The method of  claim 66 , wherein isolating the solid dispersion comprises lyophilizing the suspension. 
     
     
         69 . The method of  claim 66 , wherein isolating the solid dispersion comprises milling. 
     
     
         70 . The method of  claim 65 , further comprising:
 forming particles of the solid dispersion.   
     
     
         71 . The method of  claim 65 , further comprising:
 packaging the solid dispersion.   
     
     
         72 . The method of  claim 65 , wherein the water soluble polymer comprises polyvinylpyrrolidone (PVP). 
     
     
         73 . The method of  claim 65 , wherein the suspension further comprises a pharmaceutically acceptable sweetening agent. 
     
     
         74 . The method of  claim 65 , wherein the solid dispersion comprises up to 65% w/w genistein. 
     
     
         75 . A method of preparing a genistein formulation suitable for oral administration, comprising:
 combining genistein with a pharmaceutically acceptable suspension medium, the pharmaceutically acceptable suspension medium comprising a water soluble polymer comprising polyvinylpyrrolidone;   forming a suspension of the genistein in the pharmaceutically acceptable suspension medium;   isolating a solid dispersion comprising genistein and the water soluble polymer, wherein the solid dispersion is suitable for oral administration; and   packaging the solid dispersion.   
     
     
         76 . The method of  claim 75 , wherein isolating the solid dispersion comprises at least one of spray drying, lyophilizing, milling, microprecipitation, evaporative precipitation, or antisolvent precipitation. 
     
     
         77 . The method of  claim 76 , wherein isolating the solid dispersion comprises spray drying the suspension. 
     
     
         78 . The method of  claim 76 , wherein isolating the solid dispersion comprises lyophilizing the suspension. 
     
     
         79 . The method of  claim 76 , wherein isolating the solid dispersion comprises milling. 
     
     
         80 . The method of  claim 75 , wherein the solid dispersion comprises up to 65% w/w genistein. 
     
     
         81 . A genistein formulation suitable for oral administration, comprising:
 a solid dispersion comprising genistein and a pharmaceutically acceptable suspension medium, the pharmaceutically acceptable suspension medium comprising a water soluble polymer comprising polyvinylpyrrolidone;   wherein the solid dispersion is in particulate form.   
     
     
         82 . The formulation of  claim 81 , wherein the solid dispersion comprises up to about 65% w/w genistein. 
     
     
         83 . The formulation of  claim 81 , wherein the solid dispersion is dehydrated. 
     
     
         84 . The formulation of  claim 83 , wherein the solid dispersion is spray dried or lyophilized.