Stable pharmaceutical composition and methods of using same
AssigneeAmarin Pharmaceuticals Ireland Limited
InventorMehar Manku
Life of this patent
Estimating the term…
Abstract
The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.
Claims31
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.
A pharmaceutical composition comprising at least about 95%, by weight of total fatty acids present, ethyl eicosapentaenoate enclosed in a capsule shell, wherein the composition has a baseline peroxide value not greater than 5 meq/kg and upon storage of the composition at 30° C. and 65% RH for a period of 6 months, the composition has a second peroxide value not greater than 5 meq/kg wherein the capsule shell comprises a film-forming material free of chemically modified gelatin, a hygroscopic plasticizer selected from glycerol, sorbitol and alkylene glycols, and a non-hygroscopic plasticizer selected from maltitol, lactitol, xylitol, hydrogenated starch hydrolysate and glucose syrup, the capsule shell having a weight ratio of hygroscopic plasticizer to non-hygroscopic plasticizer of about 2:1 to about 6:1, and wherein if the capsule shell comprises glycerol and the film-forming material comprises gelatin, the capsule shell has a gelatin:glycerol weight ratio greater than 5:1.
A pharmaceutical composition comprising at least about 95%, by weight of total fatty acids present, ethyl eicosapentaenoate encapsulated in a capsule shell comprising gelatin, a hygroscopic plasticizer selected from glycerol, sorbitol and alkylene glycols, and a non-hygroscopic plasticizer selected from maltitol, lactitol, xylitol, hydrogenated starch hydrolysate and glucose syrup, wherein the capsule shell has a weight ratio of gelatin to total plasticizer of about 1.75:1 to about 5:1 and a weight ratio of hygroscopic plasticizer to non-hygroscopic plasticizer of about 3:1 to about 5:1 and is free of chemically modified gelatin, the composition has a baseline peroxide value not greater than 5 meg/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 and if the film-forming material comprises gelatin, the capsule shell has a gelatin:glycerol weight ratio greater than 5:1.
Dependencies are inferred from the claim text.