Self-emulsifying composition of omega3 fatty acid

Abstract

A self-emulsifying composition contains: 70 to 90% by weight of at least one compound selected from the group consisting of ω3 polyunsaturated fatty acids and their pharmaceutically acceptable salts and esters; 0.5 to 6% by weight of water; 1 to 29% by weight of a polyoxyethylene sorbitan fatty acid ester as an emulsifier (optionally including a polyoxyl castor oil, and not including lecithin); and lecithin in an amount of 3 to 40 parts by weight in relation to 100 parts by weight of ω3 polyunsaturated fatty acids and the like. The self-emulsifying composition is excellent in self-emulsifying property, composition dispersibility, emulsion stability, and absorbability, is free from ethanol and polyhydric alcohols or only has such an alcohol added thereto at a reduced concentration, and is useful for foods and pharmaceuticals.

1 . A method for reducing the side effects of ω3PUFA wherein at least one compound selected from the group consisting of ω3PUFA and their pharmaceutically acceptable salts and esters and lecithin are administered in combination. 
     
     
         2 . The method for reducing the side effects according to  claim 1 , wherein an emulsifier is further administered in combination. 
     
     
         3 . The method for reducing the side effects according to  claim 2 , wherein the emulsifier includes a polyoxyethylene sorbitan fatty acid ester. 
     
     
         4 . The method for reducing the side effects according to  claim 2 , wherein the emulsifier includes a polyoxyethylene castor oil. 
     
     
         5 . The method for reducing the side effects according to  claim 2 , wherein 5 to 45 parts by weight of the emulsifier is administered in combination in relation to 100 parts by weight of the ω3PUFA. 
     
     
         6 . The method for reducing the side effects according to  claim 1 , wherein up to 120 parts by weight of the polyoxyethylene castor oil is administered in combination in relation to 100 parts by weight of the polyoxyethylene sorbitan fatty acid ester. 
     
     
         7 . The method for reducing the side effects according to  claim 1 , wherein 1 to 25 parts by weight of the lecithin is administered in combination with 100 parts by weight of the ω3PUFA. 
     
     
         8 . The method for reducing the side effects according to  claim 1 , wherein upon administration to a human satisfies at least one of the following (a) to (i) calculated by conducting the correction by subtracting the plasma ω3PUFA concentration before the administration:
 (a) the maximum plasma ω3PUFA concentration is at least 50 μg/mL, 
 (b) the plasma ω3PUFA concentration 2 hours after the administration is at least 20 μg/mL, 
 (c) the time required to reach the maximum plasma ω3PUFA concentration (Tmax) is up to 6 hours, 
 (d) the area under the curve of the plasma ω3PUFA concentration at 0 to 72 hours after the administration is at least 500 μg·hr/mL, and 
 (e) the plasma ω3PUFA concentration 24 hours after the administration is 5 to 100 μg/mL. 
 (f) the area under the curve of the plasma ω3PUFA concentration at 0 to 24 hours after the administration is at least 100 μg·hr/mL, 
 (g) the maximum plasma ω3PUFA concentration in steady state is at least 50 μg/mL, 
 (h) the minimum plasma ω3PUFA concentration in steady state is at least 10 μg/mL, and 
 (i) the average ω3PUFA plasma concentration in steady state is at least 30 μg/mL. 
 
     
     
         9 . The method for reducing the side effects according to  claim 8 , wherein content of the 3PUFA to be administered to human is 500 mg to 10000 mg. 
     
     
         10 . The method for reducing the side effects according to  claim 1 , wherein a self-emulsifying composition containing the compound and lecithin is administered.