US2014271841A1PendingUtilityA1

Pharmaceutical composition comprising eicosapentaenoic acid and derivatives thereof and a statin

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Assignee: AMARIN PHARMACEUTICALS IE LTDPriority: Mar 15, 2013Filed: Mar 14, 2014Published: Sep 18, 2014
Est. expiryMar 15, 2033(~6.6 yrs left)· nominal 20-yr term from priority
Inventors:George Grandolfi
A61P 9/12A61P 9/10A61P 9/04A61P 9/00A61K 31/505A61K 31/40A61K 31/202A61K 31/366A61K 31/232A61K 31/22
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Claims

Abstract

The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and a statin and to methods of using the same to treat or prevent cardiovascular-related diseases.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A dosage unit comprising:
 a capsule shell having a surface layer comprising a statin; and   a fill comprising eicosapentaenoate or a derivative thereof.   
     
     
         2 . The dosage unit of  claim 1 , wherein the statin is present in a coating on an exterior surface of the capsule shell. 
     
     
         3 . The dosage unit of  claim 1 , wherein the capsule shell comprises gelatin. 
     
     
         4 . The dosage unit of  claim 1 , wherein the eicosapentaenoate or a derivative thereof is ethyl eicosapentaenoate. 
     
     
         5 . The dosage unit of  claim 1 , wherein the dosage unit comprises at least about 50%, by weight of all fatty acids present, eicosapentaenoate or a derivative thereof. 
     
     
         6 . The dosage unit of  claim 1 , wherein the dosage unit comprises no more than about 20%, by weight of all fatty acids present, docosahexaenoate or ester thereof. 
     
     
         7 . The dosage unit of  claim 1 , wherein the dosage unit comprises no more than about 5%, by weight of all fatty acids present, of any single fatty acid other than eicosapentaenoate or a derivative thereof. 
     
     
         8 . The dosage unit of  claim 1 , wherein the statin is present in an amount of about 1 mg to about 160 mg. 
     
     
         9 . The dosage unit of  claim 1 , wherein the eicosapentaenoate or derivative thereof is present in an amount of about 400 mg to about 2400 mg. 
     
     
         10 . The dosage unit of  claim 1 , wherein the statin is selected from the group consisting of lovastatin, mevastatin, pitavastatin, rosuvastatin, fluvastatin, atorvastatin, simvastatin, and pravastatin. 
     
     
         11 . A dosage unit comprising:
 a capsule shell; and   a fill comprising a statin and eicosapentaenoate or a derivative thereof.   
     
     
         12 . The dosage unit of  claim 11 , wherein the capsule shell has a surface layer comprising a statin. 
     
     
         13 . The dosage unit of  claim 12 , wherein the statin is present in a coating on an exterior surface of the capsule shell. 
     
     
         14 . The dosage unit of  claim 11 , wherein the statin is suspended in the eicosapentaenoate or a derivative thereof. 
     
     
         15 . The dosage unit of  claim 14 , wherein the statin is in the form of a solid dosage unit. 
     
     
         16 . The dosage unit of  claim 15 , wherein the statin is in the form of a tablet. 
     
     
         17 . The dosage unit of  claim 11 , wherein the capsule shell comprises gelatin. 
     
     
         18 . The dosage unit of  claim 11 , wherein the eicosapentaenoate or a derivative thereof is ethyl eicosapentaenoate. 
     
     
         19 . The dosage unit of  claim 11 , wherein the dosage unit comprises at least about 80%, by weight of all fatty acids present, eicosapentaenoate or a derivative thereof. 
     
     
         20 . The dosage unit of  claim 11 , wherein the dosage unit comprises no more than about 10%, by weight of all fatty acids present, docosahexaenoate or ester thereof. 
     
     
         21 . The dosage unit of  claim 11 , wherein the dosage unit comprises no more than about 5%, by weight of all fatty acids present, of any single fatty acid other than eicosapentaenoate or a derivative thereof. 
     
     
         22 . The dosage unit of  claim 11 , wherein the statin is present in an amount of about 1 mg to about 160 mg. 
     
     
         23 . The dosage unit of  claim 11 , wherein the eicosapentaenoate or derivative thereof is present in an amount of about 400 mg to about 2400 mg. 
     
     
         24 . The dosage unit of  claim 11 , wherein the statin is selected from the group consisting of lovastatin, mevastatin, pitavastatin, rosuvastatin, fluvastatin, atorvastatin, simvastatin, and pravastatin. 
     
     
         25 . A method of treating or preventing a cardiovascular-related disease or disorder in a subject, the method comprising administering to the subject a dosage unit comprising a capsule shell having a surface layer comprising a statin and a fill comprising eicosapentaenoate or a derivative thereof. 
     
     
         26 . A method of treating or preventing a cardiovascular-related disease or disorder in a subject, the method comprising administering to the subject a dosage unit comprising a capsule shell and a fill comprising a statin and eicosapentaenoate or a derivative thereof. 
     
     
         27 . The method of  claim 26 , wherein the capsule shell has a surface layer comprising a statin.

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