Self-emulsifying composition of omega3 fatty acid

Abstract

A self-emulsifying composition contains: 70 to 90% by weight in total of one or more compounds selected from the group consisting of ω3 polyunsaturated fatty acids and their pharmaceutically acceptable salts and esters; 1 to 29% by weight of an emulsifying agent selected from among a polyoxyethylene sorbitan fatty acid ester, a sorbitan fatty acid ester, a glycerin fatty acid ester and a polyoxyl castor oil; and 0.5 to 6% by weight of water when the composition is defined to be 100% by weight as a whole. 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 self-emulsifying composition comprising, when the self-emulsifying composition is defined to be 100% by weight as a whole:
 a) 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,   b) 0.5 to 6% by weight of water,   c) 1 to 29% by weight of an emulsifying agent comprising
 i) a polyoxyethylene sorbitan fatty acid ester or 
 ii) at least two members selected from the group consisting of a sorbitan fatty acid ester, a glycerin fatty acid ester and a polyoxyethylene castor oil; or 
   1 to 29% by weight of an emulsifying agent comprising
 i) a polyoxyethylene sorbitan fatty acid ester and 
 ii) at least one member selected from the group consisting of a sorbitan fatty acid ester, a glycerin fatty acid ester and a polyoxyethylene castor oil, wherein 
   d) a content of ethanol is up to 4% by weight,   e) a content of polyhydric alcohol is up to 4% by weight, and   f) a content of lecithin is lower than 2.1% by weight,   wherein the self-emulsifying composition has a non-separated or non-cloudy appearance and has a transparent appearance when stored in the environment of 5° C. or 40° C. for 12 hours.   
     
     
         2 . The self-emulsifying composition according to  claim 1 , wherein a content of lecithin in the composition is 0 parts by weight in relation to 100 parts by weight of the at least one compound selected from the group consisting of ω3 polyunsaturated fatty acids and their pharmaceutically acceptable salts and esters. 
     
     
         3 . The self-emulsifying composition according to  claim 1 , wherein the ω3 polyunsaturated fatty acids and their pharmaceutically acceptable salts and esters comprise at least one member selected from the group consisting of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and their pharmaceutically acceptable salts and esters. 
     
     
         4 . The self-emulsifying composition according to  claim 1 , wherein the polyhydric alcohol is propylene glycol or glycerin. 
     
     
         5 . The self-emulsifying composition according to  claim 1 , wherein the content of the polyhydric alcohol is up to 1% by weight of the composition. 
     
     
         6 . The self-emulsifying composition according to  claim 1 , wherein the content of the ethanol is up to 1% by weight of the composition. 
     
     
         7 . The self-emulsifying composition according to  claim 1 , wherein the mean droplet diameter when the composition is dispersed in water is up to 2 μm. 
     
     
         8 . A capsulated self-emulsifying preparation comprising a capsule which comprises a liquid self-emulsifying composition, with the self-emulsifying composition comprising, when the self-emulsifying composition is defined to be 100% by weight as a whole:
 a) 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,   b) 0.5 to 6% by weight of water,   c) 1 to 29% by weight of an emulsifying agent comprising
 i) a polyoxyethylene sorbitan fatty acid ester or 
 ii) at least two members selected from the group consisting of a sorbitan fatty acid ester, a glycerin fatty acid ester and a polyoxyethylene castor oil; or 
   1 to 29% by weight of an emulsifying agent comprising
 i) a polyoxyethylene sorbitan fatty acid ester and 
 ii) at least one member selected from the group consisting of a sorbitan fatty acid ester, a glycerin fatty acid ester and a polyoxyethylene castor oil, 
   d) an ethanol content which is up to 4% by weight of the composition, and   e) a polyhydric alcohol content which is up to 4% by weight of the composition, wherein the composition comprises essentially no lecithin, and   f) a content of lecithin is lower than 2.1% by weight of the composition,   wherein the self-emulsifying composition has a non-separated or non-cloudy appearance and has a transparent appearance when stored in the environment of 5° C. or 40° C. for 12 hours, and   wherein the capsule is a hard capsule or a soft capsule.   
     
     
         9 . The capsulated self-emulsifying preparation according to  claim 8 , wherein the capsule is a soft capsule and a capsule film of the soft capsule comprises gelatin. 
     
     
         10 . The capsulated self-emulsifying preparation according to  claim 8 , wherein a content of lecithin in the self-emulsifying composition is 0 parts by weight in relation to 100 parts by weight of the at least one compound selected from the group consisting of ω3 polyunsaturated fatty acids and their pharmaceutically acceptable salts and esters. 
     
     
         11 . The capsulated self-emulsifying preparation according to  claim 8 , wherein the ω3 polyunsaturated fatty acids and their pharmaceutically acceptable salts and esters comprise at least one member selected from the group consisting of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and their pharmaceutically acceptable salts and esters. 
     
     
         12 . The capsulated self-emulsifying preparation according to  claim 8 , wherein the polyhydric alcohol is propylene glycol or glycerin. 
     
     
         13 . The capsulated self-emulsifying preparation according to  claim 8 , wherein the content of the polyhydric alcohol is up to 1% by weight of the composition. 
     
     
         14 . The capsulated self-emulsifying preparation according to  claim 8 , wherein the content of the ethanol is up to 1% by weight of the composition.