Second Generation Fatty Acid Compositions, Formulations, and Methods of Use and Synthesis Thereof

Abstract

An orally administered fatty acid composition for the treatment of cardiovascular diseases, and a method of treating same, are provided. The compound includes 5Z,8Z,11Z,14Z,17Z-eicosapentaenoic ethanolamide (EPA ethanolamide), 4Z,7Z,10Z,13Z,16Z,19Z-docosahexaenoic ethanolamide (DHA ethanolamide), and at least one tocotrienol. The EPA ethanolamide and the DHA ethanolamide are preferably each substantially in a range of 100-900 mg per dosage form. The at least one tocotrienol is substantially in a range of 10-500 mg per dosage form. The at least one tocotrienol includes at least one of α-tocotrienol, β-tocotrienol, γ-tocotrienol, or δ-tocotrienol and is preferably substantially tocopherol-free. The composition may take the form of a medical food or a pharmaceutical preparation. A preferred formulation of the composition includes approximately 525 mg EPA ethanolamide, approximately 315 mg DHA ethanolamide, and approximately 50 mg δ-tocotrienol. The EPA and DHA ethanolamides may be synthesized from fatty acid triglycerides.

1 . An orally administered fatty acid composition, comprising:
 5Z,8Z,11Z,14Z,17Z-eicosapentaenoic ethanolamide (EPA ethanolamide);   4Z,7Z,10Z,13Z,16Z,19Z-docosahexaenoic ethanolamide (DHA ethanolamide); and   at least one tocotrienol,   wherein said composition has a total aerobic plate count per g/mL of less than 20,000 cfu.   
     
     
         2 . An orally administered fatty acid composition according to  claim 1 , wherein said EPA ethanolamide is substantially in a range of 100 mg to 900 mg per dosage form. 
     
     
         3 . An orally administered fatty acid composition according to  claim 1 , wherein said DHA ethanolamide is substantially in a range of 100 mg to 900 mg per dosage form. 
     
     
         4 . An orally administered fatty acid composition according to  claim 1 , wherein said at least one tocotrienol is substantially in a range of 10 mg to 500 mg per dosage form. 
     
     
         5 . An orally administered fatty acid composition according to  claim 1 , wherein said at least one tocotrienol includes at least one of α-tocotrienol, β-tocotrienol, γ-tocotrienol, or δ-tocotrienol. 
     
     
         6 . An orally administered fatty acid composition according to  claim 1 , wherein said at least one tocotrienol is substantially tocopherol-free. 
     
     
         7 . An orally administered fatty acid composition according to  claim 1 , wherein said composition comprises a medical food. 
     
     
         8 . An orally administered fatty acid composition according to  claim 1 , wherein said composition comprises a pharmaceutical preparation. 
     
     
         9 . An orally administered fatty acid composition according to  claim 1 , wherein said composition comprises a capsule having approximately 525 mg of said EPA ethanolamide, approximately 315 mg of said DHA ethanolamide, and approximately 50 mg of δ-tocotrienol. 
     
     
         10 . An orally administered fatty acid composition according to  claim 9 , wherein said capsule has a gelatin base. 
     
     
         11 . An orally administered fatty acid composition according to  claim 1 , wherein at least one of said EPA ethanolamide or said DHA ethanolamide is synthesized from a respective fatty acid triglyceride. 
     
     
         12 . A method of treating cardiovascular diseases, comprising the step of orally administering a therapeutically effective amount of a composition comprising 5Z,8Z,11Z,14Z,17Z-eicosapentaenoic ethanolamide (EPA ethanolamide), 4Z,7Z,10Z,13Z,16Z,19Z-docosahexaenoic ethanolamide (DHA ethanolamide), and at least one tocotrienol. 
     
     
         13 . A method of treating cardiovascular diseases according to  claim 12 , wherein the EPA ethanolamide is substantially in a range of 100-900 mg per dosage form, the DHA ethanolamide is substantially in a range of 100-900 mg per dosage form, and the at least one tocotrienol is substantially in a range of 10-500 mg per dosage form. 
     
     
         14 . A method of treating cardiovascular diseases according to  claim 12 , wherein the at least one tocotrienol includes at least one of α-tocotrienol, β-tocotrienol, γ-tocotrienol, or δ-tocotrienol and is substantially tocopherol-free. 
     
     
         15 . A method of treating cardiovascular diseases according to  claim 12 , wherein the composition comprises a medical food. 
     
     
         16 . A method of treating cardiovascular diseases according to  claim 12 , wherein the composition comprises a pharmaceutical preparation. 
     
     
         17 . A method of treating cardiovascular diseases according to  claim 12 , wherein the composition comprises a capsule having approximately 525 mg of the EPA ethanolamide, approximately 315 mg of the DHA ethanolamide, and approximately 50 mg of δ-tocotrienol. 
     
     
         18 . A method of treating cardiovascular diseases according to  claim 12 , further comprising the step of providing the EPA ethanolamide, the DHA ethanolamide, and the at least tocotrienol in a capsule having a gelatin base. 
     
     
         19 . A method of treating cardiovascular diseases according to  claim 12 , further comprising the step of synthesizing at least one of said EPA ethanolamide or said DHA ethanolamide from a respective fatty acid triglyceride.