Pharmaceutical or nutraceutical self-emulsifying solid dispersion composition

Abstract

The present invention pertains to a pharmaceutical, or nutraceutical, “self-emulsifying solid dispersion” composition for oral administration which contains (a) a drug or a nutraceutical that is water-insoluble or poorly water-soluble; (b) at least one surfactant; (c) one carrier selected from the group consisting of silicic acid, a silicate, or any combination thereof; and (d) at least one carbohydrate filler.

What is claimed is: 
     
         1 . A pharmaceutical or nutraceutical, self-emulsifying solid dispersion (SESD) composition for oral administration, comprising:
 (a) a drug or a nutraceutical that is water-insoluble or poorly water-soluble (hydrophobic);   (b) at least one surfactant;   (c) one carrier selected from the group consisting of silicic acid, a silicate, or any combination thereof; and   (d) at least one carbohydrate filler.   
     
     
         2 . The pharmaceutical, or nutraceutical, SESD composition of  claim 1 , wherein the drug or the nutraceutical is selected from the group consisting of tocotrienols, tocopherols, vitamins A, D, K and β-carotene or other hydrophobic medicines or extracts. 
     
     
         3 . The pharmaceutical or nutraceutical SESD composition of  claim 2 , wherein the drug or the nutraceutical comprises tocotrienols. 
     
     
         4 . The pharmaceutical or nutraceutical SESD composition of  claim 1 , wherein said surfactant is selected from the group consisting of Polysorbate (Tween), Sorbitan fatty acid ester (Span), Polyethylene glycol (PEG), Polyoxyl 35 castor oil (Kolliphor EL), and any combination thereof. 
     
     
         5 . The pharmaceutical or nutraceutical SESD composition of  claim 1 , wherein said carrier is present in a percentage by weight of 1% to 40%. 
     
     
         6 . The pharmaceutical or nutraceutical SESD composition of  claim 5 , wherein said carrier is present in a percentage by weight of 1% to 20%. 
     
     
         7 . The pharmaceutical or nutraceutical SESD composition of  claim 1 , wherein said carbohydrate filler is present in a percentage by weight of 15% to 90%. 
     
     
         8 . The pharmaceutical or nutraceutical SESD composition of  claim 1 , wherein said carbohydrate filler is selected from the group consisting of lactose, isomalt, cyclodextrin, dextrates, isomaltodextrin, maltodextrins, and any combination thereof. 
     
     
         9 . The pharmaceutical or nutraceutical SESD composition of  claim 8 , wherein said carbohydrate filler is present in a percentage by weight of 40% to 90%. 
     
     
         10 . The pharmaceutical or nutraceutical SESD composition of  claim 1 , further comprising
 (e) at least one binder; and   (f) at least one lubricant.   
     
     
         11 . The pharmaceutical or nutraceutical SESD composition of  claim 1 , further comprising
 (e) at least one binder; or   (f) at least one lubricant.   
     
     
         12 . A delivery system for a water-insoluble or poorly water-soluble (hydrophobic) drug or nutraceutical, which comprises one carrier selected from the group consisting of silicic acid, a silicate, or any combination thereof; at least one surfactant; and at least one carbohydrate filler. 
     
     
         13 . The delivery system of  claim 12 , further comprising at least one binder; and at least one lubricant. 
     
     
         14 . The delivery system of  claim 12 , wherein said surfactant is selected from the group consisting of Polysorbate (Tween), Sorbitan fatty acid ester (Span), Polyethylene glycol (PEG), Polyoxyl 35 castor oil (Kolliphor EL), and any combination thereof. 
     
     
         15 . The delivery system of  claim 14 , wherein said carrier is present in a percentage by weight of 1% to 40%. 
     
     
         16 . The delivery system of  claim 14 , wherein said carrier is present in a percentage by weight of 1% to 20%. 
     
     
         17 . The delivery system of  claim 12 , wherein said carbohydrate filler is selected from the group consisting of lactose, isomalt, cyclodextrin, dextrates, isomaltodextrin, maltodextrins, and any combination thereof. 
     
     
         18 . The delivery system of  claim 17 , wherein said carbohydrate filler is present in a percentage by weight of 15% to 90%. 
     
     
         19 . The delivery system of  claim 18 , wherein said carbohydrate filler is present in a percentage by weight of 40% to 90%. 
     
     
         20 . A composition or pharmaceutical composition for improving delivery and absorption of tocopherol, comprising:
 (a) a compound or substance comprising at least one tocopherol;   (b) at least one surfactant;   (c) a silicic-acid carrier;   (d) a carbohydrate filler;   wherein the silicic-acid carrier is present in a percentage by weight of 0.1%-20%, and the carbohydrate filler in a percentage by weight of 40-90%.   
     
     
         21 . The composition or pharmaceutical composition of  claim 20 , wherein said surfactant is selected form the group consisting of Polysorbate (Tween), Sorbitan fatty acid ester (Span), Polyethylene glycol (PEG), Polyoxyl 35 castor oil (Kolliphor EL), and any combination thereof. 
     
     
         22 . The composition or pharmaceutical composition of  claim 20 , wherein said carbohydrate filler is selected from the group consisting of lactose, isomalt, cyclodextrin, dextrates, isomaltodextrin, maltodextrins, and any combination thereof. 
     
     
         23 . The composition or pharmaceutical composition of  claim 20 , further comprising
 (e) at least one binder; and   (f) at least one lubricant.   
     
     
         24 . The composition or pharmaceutical composition of  claim 20 , further comprising
 (e) at least one binder; or   (f) at least one lubricant.