Stable pharmaceutical composition and methods of using same

• US 10,449,172 B2
• Filed: 06/04/2018
• Issued: 10/22/2019
• Est. Priority Date: 04/29/2009
• Status: Active Grant

• Current Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Original Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Inventors: Manku, Mehar, Osterloh, Ian, Wicker, Pierre, Braeckman, Rene, Soni, Paresh
• Primary Examiner(s): Sasan, Aradhana
• Application Number:
  US15/996,901
• Publication Number:
  US 20180280334A1
• Time in Patent Office: 505 Days
• Field of Search: None
• CPC Class Codes: A61K 31/202 having three or more double bonds, e.g. linolenic eicosanoids, e.g. leukotrienes A61K31/557
• CPC Class Codes: A61K 31/232 having three or more double bonds, e.g. etretinate
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/48 Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• CPC Class Codes: A61K 9/4825 Proteins, e.g. gelatin gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816
• CPC Class Codes: A61K 9/4858 Organic compounds
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 7/10 Antioedematous agents; Diuretics
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/04 Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• CPC Class Codes: A61P 9/06 Antiarrhythmics
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/12 Antihypertensives

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.

Claims

1. A pharmaceutical composition comprising eicosapentaenoic acid and docosapentaenoic acid, wherein the eicosapentaenoic acid is present in an amount of about 70% to about 90%, by weight, of all fatty acids present in the pharmaceutical composition, the docosapentaenoic acid is present in an amount of up to about 10%, by weight, of all fatty acids in the pharmaceutical composition and the pharmaceutical composition is substantially free of docosahexaenoic acid.

2. The pharmaceutical composition of claim 1, wherein the docosapentaenoic acid is present in an amount up to about 5%, by weight, of all fatty acids present in the pharmaceutical composition.

3. The pharmaceutical composition of claim 1, wherein the docosapentaenoic acid is present in an amount of about 5%, by weight, of all fatty acids present in the pharmaceutical composition.

4. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is free of docosahexaenoic acid.

5. The pharmaceutical composition of claim 1 further comprising heneicosapentaenoic acid.

6. The pharmaceutical composition of claim 5, wherein the pharmaceutical composition is encapsulated in a capsule shell.

7. The pharmaceutical composition of claim 2 further comprising heneicosapentaenoic acid.

8. The pharmaceutical composition of claim 7, wherein the pharmaceutical composition is encapsulated in a capsule shell.