Novel tablets incorporating isoflavone plant extracts and methods of manufacturing water soluble polymer-based rapidly dissolving tablets and production processes thereof
AssigneesJohnson & Johnson Consumer Companies, Inc., Indena S.p.A.
InventorsMin Michael He, Fang-Yu Liu, Joseph A. Fix, Martin Link, Maria L. Kang, Ezio Bombardelli
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Abstract
The invention is directed to novel tablets comprising isoflavone-containing plant extract and water-insoluble polysaccharides, and methods of manufacturing them.
Claims37
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.
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.
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.
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.
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.
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.
Dependencies are inferred from the claim text.