Pharmaceutical composition comprising a reduced concentration of cholesterol

Abstract

The invention relates to a process for decreasing the amount of cholesterol in a mixture comprising a marine oil, the marine oil containing the cholesterol, which process comprises the steps of adding a volatile working fluid to the mixture, where the volatile working fluid comprises at least one of a fatty acid ester, a fatty acid amide and a hydrocarbon, and subjecting the mixture with the added volatile working fluid to at least one stripping processing step, in which an amount of cholesterol present in the marine oil in free form is separated from the mixture together with the volatile working fluid. The present invention also relates to a volatile cholesterol decreasing working fluid and a health supplement and a pharmaceutical, based on a marine oil, prepared according to the process mentioned above.

1 - 24 . (canceled) 
     
     
         25 . A pharmaceutical composition comprising a lowered-cholesterol-content marine oil, the marine oil comprising eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and cholesterol in free form, wherein the pharmaceutical composition is not a health supplement and the amount of cholesterol in the marine oil is reduced by:
 a) adding a volatile working fluid to the marine oil, wherein the volatile working fluid comprises at least one fluid chosen from fatty acid esters, fatty acid amides, and hydrocarbons; and   b) subjecting the mixture of marine oil and volatile working fluid from step (a) to at least one stripping processing step, wherein an amount of the cholesterol present in the marine oil in free form is separated from the mixture together with the volatile working fluid.   
     
     
         26 . The composition according to  claim 25 , wherein the marine oil comprises at least one fatty acid chosen from saturated fatty acids in the form of triglycerides and unsaturated fatty acids in the form of triglycerides, and wherein the marine oil is obtained from fish, shellfish, sea mammals, or any combination thereof. 
     
     
         27 . The composition according to  claim 26 , wherein the marine oil is fish oil. 
     
     
         28 . The composition according to  claim 25 , wherein the amount of cholesterol in free form in the marine oil is less than 3 mg/g. 
     
     
         29 . The composition according to  claim 25 , wherein the amount of cholesterol in free form in the marine oil is less than 1.4 mg/g. 
     
     
         30 . The composition according to  claim 25 , wherein the amount of cholesterol in free form ranges from 0.2 mg/g to 1.4 mg/g. 
     
     
         31 . The composition according to  claim 25 , wherein the amount of cholesterol in free form ranges from 1.4 mg/g to 3 mg/g. 
     
     
         32 . The composition according to  claim 31 , wherein the marine oil is fish oil. 
     
     
         33 . The composition according to  claim 25 , wherein the marine oil further comprises cholesterol in bound form, and wherein the at least one stripping processing step of step (b) is followed by:
 c) subjecting the stripped marine oil to at least one trans-esterification reaction with a C1-C6 alcohol under substantially anhydrous conditions, and   d) subjecting the transesterified marine oil from step (c) to at least one distillation process that yields a distillate marine oil fraction and a residue marine oil fraction, wherein the distillate marine oil fraction has concentrations of both free and bound cholesterol lower than in the residue fraction.   
     
     
         34 . The composition according to  claim 33 , wherein the marine oil is fish oil.