US2019029985A1PendingUtilityA1

Dpa-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form

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Assignee: OMTHERA PHARMACEUTICALS INCPriority: Jan 6, 2012Filed: Oct 3, 2018Published: Jan 31, 2019
Est. expiryJan 6, 2032(~5.5 yrs left)· nominal 20-yr term from priority
Inventors:Timothy J. MainesBernardus N. MachielseBharat M. MehtaGerald L. WislerMichael H. DavidsonPeter Ralph Wood
A61P 3/06A61P 43/00A61P 9/00A61K 9/4825A61K 45/06A61K 31/366A61K 31/202A61K 2300/00A61K 9/4891A61K 9/48A61K 47/32A61K 31/27A61K 31/22A61K 31/201
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Claims

Abstract

DPA-enriched pharmaceutical compositions of polyunsaturated fatty acids in free acid form, therapeutic methods for their use, and processes for refining the compositions from fish oil are presented.

Claims

exact text as granted — not AI-modified
1 - 68 . (canceled) 
     
     
         69 . A method of treating a patient with elevated pre-treatment serum or plasma triglycerides, the method comprising orally administering to the patient a pharmaceutical composition comprising:
 eicosapentaenoic acid (EPA), in an amount of 50% to 60% by weight;   docosahexaenoic acid (DHA), in an amount of 17% to 23% by weight; and   docosapentaenoic acid (C22:5 n-3) (DPA), in an amount of 1% to 8% by weight;   wherein at least 90% by weight of the polyunsaturated fatty acid in the composition is present in the free acid form; and   wherein the composition is administered in an amount and for a duration effective to:
 a) reduce arachidonic acid (AA) concentration in plasma by at least about 5%; 
 b) reduce plasma AA concentration by at least about 50 μg/mL; 
 c) increase plasma EPA:AA ratio to at least about 0.25; and/or 
 d) reduce serum or plasma ApoCIII from pre-treatment levels. 
   
     
     
         70 . The method of  claim 69 , wherein DPA is present in the composition in an amount of at least about 2% by weight. 
     
     
         71 . The method of  claim 69 , wherein DPA is present in the composition in an amount of at least about 2.5% by weight. 
     
     
         72 . The method of  claim 69 , wherein DPA is present in the composition in an amount of at least about 3% by weight. 
     
     
         73 . The method of  claim 69 , wherein DPA is present in the composition in an amount of at least about 3.5% by weight. 
     
     
         74 . The method of  claim 69 , wherein DPA is present in the composition in an amount of at least about 4% by weight. 
     
     
         75 . The method of  claim 69 , wherein DPA is present in the composition in an amount of at least about 4.5% by weight. 
     
     
         76 . The method of  claim 69 , wherein EPA is present in the composition in an amount of at least about 51% by weight. 
     
     
         77 . The method of  claim 69 , wherein EPA is present in the composition in an amount of at least about 52% by weight. 
     
     
         78 . The method of  claim 69 , wherein EPA is present in the composition in an amount of at least about 53% by weight. 
     
     
         79 . The method of  claim 69 , wherein EPA is present in the composition in an amount of at least about 54% by weight. 
     
     
         80 . The method of  claim 69 , wherein DHA is present in the composition in an amount of at least about 16% by weight. 
     
     
         81 . The method of  claim 69 , wherein DHA is present in the composition in an amount of at least about 17% by weight. 
     
     
         82 . The method of  claim 69 , wherein:
 EPA is present in the composition in an amount of about 55% to about 56% by weight;   DHA is present in the composition in an amount of about 19% to about 20% by weight; and   DPA is present in the composition in an amount of about 4% to about 5% by weight.   
     
     
         83 . The method of  claim 69 , wherein the composition is administered in an amount and for a duration effective to reduce plasma AA concentration by at least about 10% below pre-treatment levels. 
     
     
         84 . The method of  claim 69 , wherein the composition is administered in an amount and for a duration effective to reduce plasma AA concentration by at least about 20% below pre-treatment levels. 
     
     
         85 . The method of  claim 69 , wherein the composition is administered in an amount and for a duration effective to reduce plasma arachidonic acid concentration by at least about 75 μg/mL. 
     
     
         86 . The method of  claim 69 , wherein the composition is administered for an amount and for a duration effective to increase plasma EPA:AA ratio to at least about 0.50. 
     
     
         87 . The method of  claim 69 , wherein the composition is administered in an amount and for a duration effective to increase plasma EPA:AA ratio to at least about 0.65. 
     
     
         88 . The method of  claim 69 , wherein the composition comprises a unit dose of at least 500 mg of the composition. 
     
     
         89 . The method of  claim 69 , wherein the composition comprises a unit dose of about 1 gram of the composition. 
     
     
         90 . The method of  claim 69 , wherein the composition is administered at a dose of 2-4 grams per day. 
     
     
         91 . The method of  claim 90 , wherein the dose is 2 grams per day. 
     
     
         92 . The method of  claim 90 , wherein the dose is 4 grams per day.

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