Novel tablets incorporating isoflavone plant extracts and methods of manufacturing water soluble polymer-based rapidly dissolving tablets and production processes thereof

Abstract

The invention is directed to novel tablets comprising isoflavone-containing plant extract and water-insoluble polysaccharides, and methods of manufacturing them.

What is claimed is:  
     
         1 . A physiologically acceptable tablet comprising an isoflavone-containing plant extract and a compressed tablet formulation that comprises a water-insoluble polysaccharide, wherein the amount of the water-insoluble polysaccharide in the tablet comprises at least about 15% of the dry weight of the tablet.  
     
     
         2 . The tablet of  claim 1 , wherein the water-insoluble polysaccharide is a plant water-insoluble polysaccharide.  
     
     
         3 . The tablet of  claim 2 , wherein the plant water-insoluble polysaccharide is a soybean plant water-insoluble polysaccharide.  
     
     
         4 . The tablet of  claim 3 , wherein the soybean plant water-insoluble polysaccharide is Emcosoy® polysaccharide.  
     
     
         5 . The tablet of  claim 1 , wherein the amount of the water-insoluble polysaccharide in the tablet comprises between about 15% to about 25% of the dry weight of the tablet.  
     
     
         6 . The tablet of  claim 1 , wherein the amount of the water-insoluble polysaccharide in the tablet comprises about 21% to 22% of the dry weight of the tablet.  
     
     
         7 . The tablet of  claim 1 , wherein the isoflavone-containing plant extract is from a fruit of the Leguminosae family.  
     
     
         8 . The tablet of  claim 7 , wherein the fruit is a soy bean.  
     
     
         9 . The tablet of  claim 1 , wherein the amount of the isoflavone-containing plant extract in the tablet comprises between about 10% to about 85% of the dry weight of the tablet.  
     
     
         10 . The tablet of  claim 9 , wherein the amount of the isoflavone-containing plant extract in the tablet comprises between about 25% to about 70% of the dry weight of the tablet.  
     
     
         11 . The tablet of  claim 10 , wherein the amount of the isoflavone-containing plant extract in the tablet comprises about 45% to about 65% of the dry weight of the tablet.  
     
     
         12 . The tablet of  claim 1 , wherein the tablet can disintegrate in a gastric fluid within at least about 30 minutes.  
     
     
         13 . The tablet of  claim 1 , wherein the tablet further comprises a micronized fatty acid in an amount between about 1% to about 5% of the dry weight of the tablet.  
     
     
         14 . The tablet of  claim 13 , wherein the amount of the micronized fatty acid in the tablet comprises about 2% of the dry weight of the tablet.  
     
     
         15 . The tablet of  claim 13 , wherein the micronized fatty acid is a micronized stearic acid.  
     
     
         16 . The tablet of  claim 1 , wherein the tablet further comprises a silica gel in an amount between about 1% to about 5% of the dry weight of the tablet.  
     
     
         17 . The tablet of  claim 16 , wherein the amount of the silica gel in the tablet comprises about 2% of the dry weight of the tablet.  
     
     
         18 . The tablet of  claim 1 , wherein the tablet is suitable for delivery to a body cavity of the group consisting of the oral, buccal, sublingual, vaginal or rectal cavities.  
     
     
         19 . The tablet of  claim 1 , wherein the formulation further comprises at least one additive agent selected from the group consisting of a disintegrant, a flavorant, an artificial sweetener, a perfume, and a colorant.  
     
     
         20 . A tablet made by a direct compression process comprising the following steps: 
 (a) mixing an initial formulation comprising    an isoflavone-containing plant extract,    a water-insoluble polysaccharide, wherein the amount of the water-insoluble polysaccharide in the tablet comprises at least about 15% the tablet,    a filler, and    a silica gel, wherein the amount of the silica gel in the tablet comprises between about 1% to about 5% of the dry weight of the tablet;    (b) milling the mixed formulation;    (c) mixing into the milled and mixed formulation a micronized stearic acid, wherein the amount of the micronized stearic acid in the tablet comprises between about 1% to about 5% of the dry weight of the tablet; and    (d) pressing the milled formulation into a tablet form, wherein the compression force of the press on the tablet is at least about 15 kilopounds.    
     
     
         21 . The tablet of  claim 20 , wherein the compression force of the press on the tablet is between about 15 to about 30 kilopounds.  
     
     
         22 . The tablet of  claim 21 , wherein the compression force of the press on the tablet is between about 17 to about 23 kilopounds.  
     
     
         23 . The tablet of  claim 20 , wherein the isoflavone-containing plant extract is from the fruit of a Leguminosae family plant.  
     
     
         24 . The tablet of  claim 23 , wherein the fruit is a soy bean.  
     
     
         25 . The tablet of  claim 20 , wherein the direct compression process further comprises a coating process comprising the following steps: 
 (a) coating the pressed tablets with an aqueous dispersion comprising a cellulose-based polymer; and    (b) drying the coated tablets, wherein the drying does not heat the tablet more than about 40° C.    
     
     
         26 . A tablet made by a granulation process comprising the following steps: 
 (a) mixing an initial formulation comprising an isoflavone-containing plant extract and a water-insoluble polysaccharide, wherein the amount of the water-insoluble polysaccharide in the tablet comprises at least about 15% of the dry weight of the tablet;    (b) granulating the mixed formulation using an aqueous solution comprising at least 0.5% cellulose-based polymer;    (c) drying the granulated formulation; and    (d) pressing the dried, granulated formulation into a tablet form.    
     
     
         27 . The tablet of  claim 26 , wherein the isoflavone-containing plant extract is from the fruit of a Leguminosae family plant.  
     
     
         28 . The tablet of  claim 27 , wherein the fruit is a soy bean.  
     
     
         29 . The tablet of  claim 26 , wherein the granulation process further comprises a coating process comprising the following steps: 
 (a) coating the pressed tablets with an aqueous dispersion comprising a cellulose-based polymer; and    (b) drying the coated tablets, wherein the drying does not heat the tablet more than about 40° C.    
     
     
         30 . A direct compression process for producing a tablet comprising the following steps: 
 (a) mixing an initial formulation comprising    an isoflavone-containing plant extract,    a water-insoluble polysaccharide, wherein the amount of the water-insoluble polysaccharide in the tablet comprises at least about 15% the tablet,    a filler, and    a silica gel glidant wherein the amount of the silica gel in the tablet comprises between about 1% to about 5% of the dry weight of the tablet;    (b) milling the mixed formulation;    (c) mixing into the milled and mixed formulation a micronized stearic acid, wherein the amount of the micronized stearic acid in the tablet comprises between about 1% to about 5% of the dry weight of the tablet; and    (d) pressing the milled formulation into a tablet form, wherein the compression force of the press on the tablet is at least about 15 kilopounds.    
     
     
         31 . The direct compression process of  claim 30 , wherein the isoflavone-containing plant extract is from the fruit of a Leguminosae family plant.  
     
     
         32 . The direct compression process of  claim 31 , wherein the fruit is a soy bean.  
     
     
         33 . The direct compression process of  claim 30 , wherein the compression force of the press on the tablet is between about 17 to about 23 kilopounds.  
     
     
         34 . The direct compression process of  claim 30  further comprises a coating process comprising the following steps: 
 (a) coating the pressed tablets with an aqueous dispersion comprising a cellulose-based polymer; and  
 (b) drying the coated tablets, wherein the drying does not heat the tablet more than about 40° C.  
 
     
     
         35 . A granulation process for producing a tablet comprising the following steps 
 (a) mixing an initial formulation comprising an isoflavone-containing plant extract and a water-insoluble polysaccharide, wherein the amount of the water-insoluble polysaccharide in the tablet comprises at least about 15% of the dry weight of the tablet;    (b) granulating the mixed formulation using an aqueous solution comprising at least 0.5% cellulose-based polymer;    (c) drying the granulated formulation; and    (d) pressing the dried, granulated formulation into a tablet form.    
     
     
         36 . The granulation process of  claim 34  further comprises a coating process comprising the following steps: 
 (a) coating the pressed tablets with an aqueous dispersion comprising a cellulose-based polymer;  
 (b) drying the coated tablets, wherein the drying does not heat the tablet more than about 40° C.  
 
     
     
         37 . A physiologically acceptable tablet comprising a compressed tablet formulation that comprises 
 an isoflavone-containing plant extract, wherein the amount of the plant extract in the tablet comprises about 45% to about 65% of the dry weight of the tablet;    a filler,    a micronized stearic acid, wherein the amount of the micronized stearic acid in the tablet comprises between about 1% to about 5% of the dry weight of the tablet;    a silica gel, wherein the amount of the silica gel in the tablet comprises between about 1% to about 5% of the dry weight of the tablet; and    a water-insoluble polysaccharide, wherein the amount of the water-insoluble polysaccharide in the tablet comprises at least about 15% of the dry weight of the tablet,    wherein the tablet can substantially dissolve in a gastric fluid in at least about 30 minutes.