FIELD: pharmacology.
SUBSTANCE: invention is a method of treating a cardiovascular disease or condition in a patient comprising administering to said patient, orally or parenterally, a pharmaceutical composition that independently forms micelles upon contact with an aqueous medium to form spherical micelles that have an average diameter of 1 mcm to 10 mcm And ensure the absorption of omega-3 fatty acid esters practically independently of any food influence, or stable micelles pre-formed from mentioned composition in an amount therapeutically effective to reduce one or more of the symptoms of said cardiovascular disease or condition. Mentioned pharmaceutical composition comprises: (a) from 60% (w/w) to 85% (w/w) of at least one omega-3 fatty acid ester selected from the group consisting of an all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acids (EPA), ester (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acids (DHA), hexadecatrienic acid ("NTA" or 16:3 (n-3) or all-Z-7,10,13-hexadecatrienoic acid), α-linolenic acid ("ALA" or 18:3 (n-3) or all-Z-9,12,15-octadecatrienoic acid), stearidonic acid ("SDA" or 18:4 (n-3) or all-Z-6,9,12,15-octadecatetraenoic acid Slots), eicosatrienoic acid ("ETA" or 20:3 (n-3) or all-Z-11,14,17-eicosatrienoic acid), eicosatetraenoic acid ("ETA" or 20:4 (n-3)), ("HPA" or 21:5 (n-3) or all-Z-6,9,12,15,18-geyeykozapentaenoic acid), docosapentaenoic acid ("DPA", or clupanodonic acid, or 22:5 (n-3), or all-Z-7,10,13,16,19-docazapentenoic acid); Tetrakosapentaenoic acid (24:5 (n-3) or all-Z-9,12,15,18,21-tetrakosapentaenoic acid) and tetracosahexaenoic acid (nisic acid or 24:6 (n-3) or all-Z-6 , 9,12,15,18,21-tetracosahexaenoic acid); And (b) a surfactant which contains, in combination, at least one non-ionic polyoxyethylene glycol and sorbitan alkyl ester (polysorbate) selected from the group consisting of polyoxyethylene (20) sorbitan monolaurate (polysorbate 20), polyoxyethylene (20) sorbitan monopalmitate (Polysorbate 40), polyoxyethylene (20) sorbitan monostearate (polysorbate 60), and polyoxyethylene (20) sorbitan monooleate (polysorbate 80); and a block copolymer of polyethylene glycol and polypropylene glycol having the formula [(HO[(HO(C2H4O)64(C3H6O)37(C2H4O)64H] (Poloxamer 237); wherein said polysorbate is present in an amount of 0.5% (wt/wt) to 5% (wt/wt) of smentioned composition. This combination of surfactants is effective for forming said stable micelles upon contact with said aqueous medium, and wherein said composition for the oral or parenteral administration that self-forms micelles when administered to a human in equal dosage provides substantially the same bioavailability when administered with food or without food to the person who needs it. The mentioned composition, which independently forms micelles, independently forms micelles in an aqueous medium, thereby forming spherical micelles having an average diameter of from 1 mcm to 10 mcm, which ensure the absorption of said omega-3 fatty acid esters practically independently of any food effect; and wherein said pharmaceutical composition is administered orally or parenterally in an amount that is therapeutically effective to reduce one or more of the symptoms of said cardiovascular disease or condition..
EFFECT: invention provides compositions that are less influenced by food, have high efficacy at low doses, minimize and eliminate an unpleasant odor, taste or eructation in the patient.
89 cl, 5 ex, 5 tbl, 4 dwg
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Authors
Dates
2017-10-18—Published
2013-03-11—Filed