Pharmaceutical composition comprising eicosapentaenoic acid and derivatives thereof and a statin
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.
1. A dosage unit comprising:
a capsule shell having a surface layer comprising rosuvastatin; and
a fill comprising about 1 g of eicosapentaenoic acid (EPA) or a derivative thereof,
wherein:
the fill comprises at least about 96%, by weight, of all fatty acids present in the fill, ethyl eicosapentaenoate and substantially no docosahexaenoic acid (DHA) or derivative thereof; and
if the rosuvastatin is rosuvastatin calcium, a molar ratio of calcium ion and rosuvastatin calcium present in the dosage unit is 1:1.
2. The dosage unit of claim 1 , wherein the rosuvastatin 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 rosuvastatin is present in an amount of about 1 mg to about 160 mg.
5. The dosage unit of claim 1 , wherein the rosuvastatin is rosuvastatin calcium, and a molar ratio of calcium ion and rosuvastatin calcium present in the dosage unit is 1:1.
6. 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 rosuvastatin and a fill comprising about 1 g of eicosapentaenoic acid (EPA) or a derivative thereof,
wherein:
the fill comprises at least about 96%, by weight, of all fatty acids present in the fill, ethyl eicosapentaenoate and substantially no docosahexaenoic acid (DHA) or derivative thereof; and
if the rosuvastatin is rosuvastatin calcium, a molar ratio of calcium ion and rosuvastatin calcium present in the dosage unit is 1:1.
7. The method of claim 6 , wherein the rosuvastatin is present in an amount of about 1 mg to about 160 mg.
8. The method of claim 6 , wherein the rosuvastatin is rosuvastatin calcium, and a molar ratio of calcium ion and rosuvastatin calcium present in the dosage unit is 1:1.