Pharmaceutical composition comprising low concentrations of environment pollutants

Abstract

The invention relates to a process for decreasing the amount of environmental pollutants in a mixture comprising a fat or an oil, being edible or for use in cosmetics, the fat or oil containing the environmental pollutants, 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, a free fatty acid and a hydro-carbon, and subjecting the mixture with the added volatile working fluid to at least one stripping processing step, in which an amount of environmental pollutant present in the fat or oil, being edible or for use in cosmetics, is separated from the mixture together with the volatile working fluid. The present invention also relates to a volatile environmental pollutants decreasing working fluid, for use in decreasing an amount of environmental pollutants present in a fat or oil, being edible or for use in cosmetics. In addition, the present invention relates to a health supplement, a pharmaceutical and an animal feed product prepared according to the process mentioned above.

1 - 31 . (canceled) 
     
     
         32 . A pharmaceutical composition comprising eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester from a marine oil in a pharmaceutically effective concentration, wherein the concentration of BDE 47 in the marine oil is less than 12.2 ng/g, and wherein the pharmaceutical composition is not a health supplement. 
     
     
         33 . The composition according to  claim 32 , wherein the concentration of BDE 99 is less than 0.3 ng/g. 
     
     
         34 . The composition according to  claim 32 , wherein the total concentration of at least one PCDD and at least one PCDF in the marine oil is less than 4.65 pg/g (TE/WHO). 
     
     
         35 . The composition according to  claim 34 , wherein the at least one PCDD is chosen from tetrachlorodibenzodioxins, pentachlorodibenzodioxins, hexachlorodibenzodioxins, heptachlorodibenzodioxins, and octachlorodibenzodioxins; and the at least one PCDF is chosen from tetrachlorodibenzofurans, pentachlorodibenzofurans, hexachlorodibenzofurans, heptachlorodibenzofurans, and octachlorodibenzofurans. 
     
     
         36 . The composition according to  claim 32 , wherein the total concentration of at least one TE-PCB in the marine oil is less than 22.6 pg/g (TE/WHO). 
     
     
         37 . The composition according to  claim 36 , wherein the at least one TE-PCB is chosen from 3,3′,4,4′-tetrachlorobiphenyl, 3,4,4′,5-tetrachlorobiphenyl, 3,3′,4,4′,5-pentachlorobiphenyl, and 3,3′,4,4′,5,5′-hexachlorobiphenyl. 
     
     
         38 . The composition according to  claim 32 , wherein the concentration of hexachlorobenzene is less than 27.5 ng/g. 
     
     
         39 . The composition according to  claim 32 , wherein the sum of the concentrations of DDE, DDD, and DDT in the marine oil is less than 170 ng/g. 
     
     
         40 . The composition according to  claim 32 , wherein the concentration of dieldrin in the marine oil is less than 60 ng/g. 
     
     
         41 . The composition according to  claim 32 , wherein the marine oil is derived from at least one of fish, shellfish, and sea mammal. 
     
     
         42 . The composition according to  claim 41 , wherein the marine oil is a fish oil. 
     
     
         43 . The composition according to  claim 42 , wherein the fish oil is chosen from sardine oil and anchovy oil. 
     
     
         44 . A pharmaceutical composition comprising eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester from a marine oil in a pharmaceutically effective concentration, wherein the concentration of BDE 47 in the marine oil is 0.58 ng/g or ranges from 0.58 ng/g to 12.2 ng/g, and wherein the pharmaceutical composition is not a health supplement. 
     
     
         45 . The composition according to  claim 44 , wherein the concentration of BDE 99 is less than 0.17 ng/g or ranges from 0.17 ng/g to 0.3 ng/g. 
     
     
         46 . The composition according to  claim 44 , wherein the total concentration of at least one PCDD and at least one PCDF in the marine oil is 0.46 pg/g or ranges from 0.46 pg/g to 4.65 pg/g (TE/WHO). 
     
     
         47 . The composition according to  claim 46 , wherein the at least one PCDD is chosen from tetrachlorodibenzodioxins, pentachlorodibenzodioxins, hexachlorodibenzodioxins, heptachlorodibenzodioxins, and octachlorodibenzodioxins; and the at least one PCDF is chosen from tetrachlorodibenzofurans, pentachlorodibenzofurans, hexachlorodibenzofurans, heptachlorodibenzofurans, and octachlorodibenzofurans. 
     
     
         48 . The composition according to  claim 44 , wherein the total concentration of at least one TE-PCB in the marine oil is 0.09 pg/g or ranges from 0.09 pg/g to 22.6 pg/g (TE/WHO). 
     
     
         49 . The composition according to  claim 48 , wherein the at least one TE-PCB is chosen from 3,3′,4,4′-tetrachlorobiphenyl, 3,4,4′,5-tetrachlorobiphenyl, 3,3′,4,4′,5-pentachlorobiphenyl, and 3,3′,4,4′,5,5′-hexachlorobiphenyl. 
     
     
         50 . The composition according to  claim 44 , wherein the concentration of hexachlorobenzene is 0.25 ng/g or ranges from 0.25 ng/g to 27.5 ng/g. 
     
     
         51 . The composition according to  claim 44 , wherein the sum of the concentrations of DDE, DDD, and DDT in the marine oil is less than 4.02 ng/g or ranges from 4.02 ng/g to 170 ng/g. 
     
     
         52 . The composition according to  claim 44 , wherein the concentration of dieldrin in the marine oil is less than 3.20 ng/g or ranges from 3.20 ng/g to 60 ng/g. 
     
     
         53 . The composition according to  claim 44 , wherein the marine oil is derived from at least one of fish, shellfish, and sea mammal. 
     
     
         54 . The composition according to  claim 53 , wherein the marine oil is a fish oil. 
     
     
         55 . The composition according to  claim 54 , wherein the fish oil is chosen from sardine oil and anchovy oil. 
     
     
         56 . A pharmaceutical composition comprising eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester from a marine oil in a pharmaceutically effective concentration, wherein the concentration of BDE 47 in the marine oil is less than 0.58 ng/g, and wherein the pharmaceutical composition is not a health supplement. 
     
     
         57 . A pharmaceutical composition comprising eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester from a marine oil in a pharmaceutically effective concentration, wherein the concentration of BDE 47 in the marine oil is less than 5.3 μg/kg, and wherein the pharmaceutical composition is not a health supplement. 
     
     
         58 . The composition according to  claim 57 , wherein the concentration of BDE 99 in the marine oil is less than 1.2 μg/kg. 
     
     
         59 . The composition according to  claim 57 , wherein the concentration of BDE 100 in the marine oil is less than 1.0 μg/kg. 
     
     
         60 . The composition according to  claim 57 , wherein the concentration of dieldrin is less than 22 μg/kg. 
     
     
         61 . The composition according to  claim 57 , wherein the concentration of hexachlorobenzene is less than 12 μg/kg. 
     
     
         62 . The composition according to  claim 57 , wherein the sum of the concentrations of at least two hexochlorocyclohexane (HCH) compounds chosen from α-HCH, β-HCH, and γ-HCH is less than 14.1 μg/kg. 
     
     
         63 . The composition according to  claim 57 , wherein the concentration of DDE is less than 38 μg/kg. 
     
     
         64 . The composition according to  claim 57 , wherein the concentration of DDD is less than 15 μg/kg. 
     
     
         65 . The composition according to  claim 57 , wherein the total concentration of PCBs in the marine oil is less than 67.8 μg/kg. 
     
     
         66 . The composition according to  claim 65 , wherein the PCBs are chosen from CB 28, CB 52, CB 101, CB 118, CB 153, CB 105, CB 138, CB 156, and CB 180. 
     
     
         67 . The composition according to  claim 57 , wherein the marine oil is derived from at least one of fish, shellfish, and sea mammal. 
     
     
         68 . The composition according to  claim 67 , wherein the marine oil is a fish oil. 
     
     
         69 . The composition according to  claim 68 , wherein the fish oil is chosen from sardine oil and anchovy oil. 
     
     
         70 . A pharmaceutical composition comprising eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester from a marine oil in a pharmaceutically effective concentration, wherein the sum of the concentrations of at least two brominated flame retardants chosen from BDE 47, BDE 99, and BDE 100 in the marine oil is less than 7.5 μg/kg, and wherein the pharmaceutical composition is not a health supplement. 
     
     
         71 . A pharmaceutical composition comprising eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester from a marine oil in a pharmaceutically effective concentration, wherein the concentration of BDE 47 in the marine oil is less than 0.2 μg/kg or ranges from 0.2 μg/kg to 5.3 μg/kg, and wherein the pharmaceutical composition is not a health supplement. 
     
     
         72 . The composition according to  claim 71 , wherein the concentration of BDE 99 in the marine oil is less than 0.2 μg/kg or ranges from 0.2 μg/kg to 1.2 μg/kg. 
     
     
         73 . The composition according to  claim 71 , wherein the concentration of BDE 100 in the marine oil is less than 0.2 μg/kg or ranges from 0.2 μg/kg to 1.0 μg/kg. 
     
     
         74 . The composition according to  claim 71 , wherein the concentration of dieldrin is less than 0.4 μg/kg or ranges from 0.4 μg/kg to 22 μg/kg. 
     
     
         75 . The composition according to  claim 71 , wherein the concentration of hexachlorobenzene is less than 1 μg/kg or ranges from 1 μg/kg to 12 μg/kg. 
     
     
         76 . The composition according to  claim 71 , wherein the sum of the concentrations of at least two hexochlorocyclohexane (HCH) compounds chosen from α-HCH, β-HCH, and γ-HCH is less than 8 μg/kg. 
     
     
         77 . The composition according to  claim 71 , wherein the concentration of DDE is less than 3 μg/kg or ranges from 3 μg/kg to 38 μg/kg. 
     
     
         78 . The composition according to  claim 71 , wherein the concentration of DDD is less than 3 μg/kg or ranges from 3 μg/kg to 15 μg/kg. 
     
     
         79 . The composition according to  claim 71 , wherein the total concentration of PCBs in the marine oil is less than 46 μg/kg. 
     
     
         80 . The composition according to  claim 79 , wherein the PCBs are chosen from CB 28, CB 52, CB 101, CB 118, CB 153, CB 105, CB 138, CB 156, and CB 180. 
     
     
         81 . The composition according to  claim 71 , wherein the marine oil is derived from at least one of fish, shellfish, and sea mammal. 
     
     
         82 . The composition according to  claim 81 , wherein the marine oil is a fish oil. 
     
     
         83 . The composition according to  claim 82 , wherein the fish oil is chosen from sardine oil and anchovy oil. 
     
     
         84 . A pharmaceutical composition comprising eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester from a marine oil in a pharmaceutically effective concentration, wherein the sum of the concentrations of at least two brominated flame retardants chosen from BDE 47, BDE 99, and BDE 100 in the marine oil is less than 0.6 μg/kg, and wherein the pharmaceutical composition is not a health supplement. 
     
     
         85 . A pharmaceutical composition comprising eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester from a marine oil in a pharmaceutically effective concentration, wherein the marine oil is a fish oil chosen from sardine oil and anchovy oil, wherein:
 the concentration of BDE 47 is less than 12.2 ng/g;   the total concentration of at least one PCDD and at least one PCDF is less than 4.65 pg/g (TE/WHO);   the total concentration of at least one TE-PCB is less than 22.6 pg/g (TE/WHO);   the sum of the concentrations of DDE, DDD, and DDT is less than 170 ng/g; and   the concentration of hexachlorobenzene is less than 27.5 ng/g;   wherein pharmaceutical composition is not a health supplement.   
     
     
         86 . A pharmaceutical composition comprising eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester from a marine oil in a pharmaceutically effective concentration, wherein the marine oil is a fish oil chosen from sardine oil and anchovy oil, wherein:
 the concentration of BDE 47 is 0.58 ng/g or ranges from 0.58 ng/g to 12.2 ng/g;   the total concentration of at least one PCDD and at least one PCDF is 0.46 pg/g or ranges from 0.46 pg/g to 4.65 pg/g (TE/WHO);   the total concentration of at least one TE-PCB is 0.09 pg/g or ranges from 0.09 pg/g to 22.6 pg/g (TE/WHO);   the sum of the concentrations of DDE, DDD, and DDT is less than 4.02 ng/g or ranges from 4.02 ng/g to 170 ng/g; and   the concentration of hexachlorobenzene is 0.25 ng/g or ranges from 0.25 ng/g to 27.5 ng/g;   wherein pharmaceutical composition is not a health supplement.   
     
     
         87 . A pharmaceutical composition comprising eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester from a marine oil in a pharmaceutically effective concentration, wherein the marine oil is a fish oil wherein:
 the sum of the concentrations of at least two brominated flame retardants chosen from BDE 47, BDE 99, and BDE 100 in the marine oil is less than 7.5 μg/kg;   the concentration of DDE is less than 38 μg/kg;   the concentration of DDD is less than 15 μg/kg; and   the concentration of hexachlorobenzene is less than 12 μg/kg;   the total concentration of PCBs is less than 67.9 μg/kg;   wherein pharmaceutical composition is not a health supplement.   
     
     
         88 . A pharmaceutical composition comprising eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester from a marine oil in a pharmaceutically effective concentration, wherein the marine oil is a fish oil wherein:
 the sum of the concentrations of at least two brominated flame retardants chosen from BDE 47, BDE 99, and BDE 100 in the marine oil is less than 0.6 μg/kg;   the concentration of DDE is less than 3 μg/kg or ranges from 3 μg/kg to 38 μg/kg;   the concentration of DDD is less than 3 μg/kg or ranges from 3 μg/kg to 15 μg/kg; and   the concentration of hexachlorobenzene is less than 1 μg/kg or ranges from 1 μg/kg to 12 μg/kg;   the total concentration of PCBs is less than 46 μg/kg;   wherein pharmaceutical composition is not a health supplement.   
     
     
         89 . A method of treating at least one condition in a patient in need thereof, comprising administering to the subject a pharmaceutical composition comprising eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester from a marine oil in a pharmaceutically effective concentration, wherein:
 the concentration of BDE 47 in the marine oil is 0.58 ng/g or less than 0.58 ng/g,   the at least one condition is chosen from cardiovascular diseases, cardiovascular risk factors, inflammatory diseases, and kidney disease; and   the pharmaceutical composition is not a health supplement.   
     
     
         90 . The method according to  claim 89 , wherein the at least one condition is chosen from hypertriglyceridaemia, hypertension, myocardial infarction, and atherosclerosis. 
     
     
         91 . A pharmaceutical composition comprising at least one of eicosapentaenoic acid (EPA) ethyl ester and docosahexaenoic acid (DHA) ethyl ester from a marine oil, wherein the pharmaceutical composition is prepared by
 reducing the concentration of BDE 47 in the marine oil by at least 95%; and   increasing the concentration of at least one of the EPA and DHA to a pharmaceutically effective concentration;   wherein the pharmaceutical composition is not a health supplement.   
     
     
         92 . The composition according to  claim 91 , comprising a pharmaceutically-effective amount of EPA. 
     
     
         93 . A pharmaceutical composition comprising eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester from a marine oil in a pharmaceutically effective concentration, wherein the sum of the concentrations of BDE 28, BDE 47, BDE 71, BDE 99, BDE 100, and BDE 154 in the marine oil is less than 8.5 μg/kg, and wherein the pharmaceutical composition is not a health supplement. 
     
     
         94 . The composition according to  claim 93 , wherein the sum of the concentrations of BDE 28, BDE 47, BDE 71, BDE 99, BDE 100, and BDE 154 in the marine oil is 0.6 μg/kg or ranges from 0.6 μg/kg to 8.5 μg/kg. 
     
     
         95 . The composition according to  claim 65 , wherein the sum of the concentrations of CB 28, CB 52, CB 101, CB 118, CB 153, and CB 180 is less than 61.8 μg/kg. 
     
     
         96 . The composition according to  claim 79 , wherein the sum of the concentrations of CB 28, CB 52, CB 101, CB 118, CB 153, and CB 180 is less than 40 μg/kg.