Stable pharmaceutical composition and methods of using same

  • US 8,298,554 B2
  • Filed: 04/29/2010
  • Issued: 10/30/2012
  • Est. Priority Date: 04/29/2009
  • Status: Active Grant
First Claim
Patent Images

1. A pharmaceutical composition comprising at least 95%, by weight of total fatty acids present, eicosapentaenoic acid or ester thereof enclosed in a capsule shell, wherein:

  • (a) the composition has a baseline peroxide value not greater than 5 meq/kg and upon storage of the composition at 25°

    C. and 60% RH for a period of 6 months, the composition has a second peroxide value not greater than 8 meq/kg (b) the capsule shell is free of succinated gelatin and comprises a film-forming material, a hygroscopic plasticizer selected from glycerin, sorbitol and alkylene glycols, and a non-hygroscopic plasticizer selected from maltitol, lactitol, xylitol, hydrogenated starch hydrolysate and glucose syrup, wherein the hygroscopic plasticizer and non-hygroscopic plasticizer are present in a weight ratio of about 2;

    1 to about 6;

    1, and (c) if the capsule shell comprises glycerin and the film-forming material comprises gelatin, the capsule shell has a gelatin;

    glycerin weight ratio greater than 5;

    1.

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