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Building IP: AMRN Patent Grant re "Stable pharmaceutical

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JBWIN   Tuesday, 10/19/21 12:52:45 AM
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Building IP: AMRN Patent Grant re "Stable pharmaceutical composition and methods of using same"

United States Patent 11,147,787
Manku , et al. October 19, 2021
Stable pharmaceutical composition and methods of using same

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.

Inventors: Manku; Mehar (Birmingham, GB), Osterloh; Ian (Kent, GB), Wicker; Pierre (Mystic, CT), Braeckman; Rene (Richboro, PA), Soni; Paresh (Mystic, CT)
Name City State Country Type

Amarin Pharmaceuticals Ireland Limited
Assignee: Amarin Pharmaceuticals Ireland Limited (Dublin, IE)
Family ID: 1000005873577
Appl. No.: 16/562,294
Filed: September 5, 2019
Prior Publication Data
Document Identifier Publication Date
US 20200000759 A1 Jan 2, 2020
Related U.S. Patent Documents
Application Number Filing Date Patent Number Issue Date
15996901 Jun 4, 2018 10449172
15415468 Jul 3, 2018 10010517
15092391 Mar 7, 2017 9585856
14709937 May 12, 2015
14259724 Jul 7, 2015 9072715
14084887 Jun 23, 2015 9060982
13685291 Dec 24, 2013 8613945
13614111 Jun 4, 2013 8454994
13458496 May 21, 2013 8445003
12769885 Oct 30, 2012 8298554
61173763 Apr 29, 2009
Current U.S. Class: 1/1
Current CPC Class: A61K 9/48 (20130101); A61P 9/00 (20180101); A61P 9/10 (20180101); A61P 9/06 (20180101); A61P 9/04 (20180101); A61K 31/202 (20130101); A61K 9/4858 (20130101); A61K 31/232 (20130101); A61P 3/06 (20180101); A61K 9/4825 (20130101); A61K 45/06 (20130101)
Current International Class: A61K 31/202 (20060101); A61K 31/232 (20060101); A61K 45/06 (20060101); A61K 9/48 (20060101); A61P 3/06 (20060101); A61P 9/04 (20060101); A61P 9/06 (20060101); A61P 9/10 (20060101); A61P 9/00 (20060101)
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Primary Examiner: Sasan; Aradhana
Attorney, Agent or Firm: Perkins Coie LLP
Parent Case Text


This application is a continuation of U.S. application Ser. No. 15/996,901 filed Jun. 4, 2018 (now allowed), which is a continuation of U.S. application Ser. No. 15/415,468 filed Jan. 25, 2017 (now U.S. Pat. No. 10,010,517), which is a continuation of U.S. application Ser. No. 15/092,391 filed Apr. 6, 2016 (now U.S. Pat. No. 9,585,856), which is a continuation of U.S. application Ser. No. 14/709,937 filed May 12, 2015, which is a continuation of Ser. No. 14/259,724 filed Apr. 23, 2014 (now U.S. Pat. No. 9,072,715), which is a continuation of U.S. application Ser. No. 14/084,887 filed Nov. 20, 2013 (now U.S. Pat. No. 9,060,982), which is a continuation of U.S. application Ser. No. 13/685,291 filed Nov. 26, 2012 (now U.S. Pat. No. 8,613,945), which is a continuation of U.S. application Ser. No. 13/614,111 filed Sep. 13, 2012 (now U.S. Pat. No. 8,454,994), which is a continuation of U.S. application Ser. No. 13/458,496 filed Apr. 27, 2012 (now U.S. Pat. No. 8,445,003), which is a continuation of U.S. application Ser. No. 12/769,885 filed Apr. 29, 2010 (now U.S. Pat. No. 8,298,554), which claims priority to U.S. Provisional Application No. 61/173,763, filed Apr. 29, 2009, the entireties of each of which are incorporated herein by reference and relied upon.

We claim:

1. A pharmaceutical composition, comprising: omega-3 fatty acids in free acid form including (a) eicosapentaenoic acid in an amount selected from about 925 mg, about 950 mg, and about 975 mg; and (b) docosapentaenoic acid in an amount of about 5%, by weight, of total fatty acids in the pharmaceutical composition.

2. The pharmaceutical composition of claim 1, wherein the eicosapentaenoic acid is present in an amount of about 925 mg.

3. The pharmaceutical composition of claim 1, wherein the eicosapentaenoic acid is present in an amount of about 950 mg.

4. The pharmaceutical composition of claim 1, wherein the eicosapentaenoic acid is present in an amount of about 975 mg.

5. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is present in one or more dosage units.

6. The pharmaceutical composition of claim 5, wherein the one or more dosage units comprise capsules.

7. A method of reducing triglycerides in a subject in need thereof comprising, administering to the subject daily the pharmaceutical composition of claim 1.

8. The method of claim 7, wherein the subject has very high serum triglycerides.


Mixed omega-3 fatty acid esters are typically encapsulated in type 2a gelatin capsules containing gelatin (.about.43.4%), glycerol (.about.20%) and water (.about.36.6%) and do not experience stability problems throughout their shelf life. While chemically modified gelatins such as succinated/succinylated gelatin have been used to encapsulate reactive fill ingredients, such gelatin is not approved for use in the U.S. and other markets.


We have unexpectedly found that high purity eicosapentaenoic acid (EPA) is more susceptible to oxidative degradation than mixed omega-3-acid ethyl esters. In various embodiments, the invention provides pharmaceutical compositions comprising a fatty acid or a derivative thereof in a capsule shell that resists, hinders, attenuates, or prevents oxidation of the fatty acid or fatty acid derivative, for example to a greater extent than is provided by a standard type IIa capsule shell. In a related embodiment, the fatty acid comprises eicosapentaenoic acid (EPA) or a derivative of EPA, for example ethyl eicosapentaenoate (ethyl-EPA or E-EPA). In another embodiment, the fatty acid comprises ultra-pure EPA.

In one embodiment, the invention provides a pharmaceutical composition comprising ultra-pure EPA encapsulated in a capsule shell, where the ultra-pure EPA has a baseline peroxide value not greater than about 5 meq/mg and upon storage of the composition at 23.degree. C. and 50% RH for a period of time, that ultra-pure EPA has a second peroxide value not greater than about 20 meq/mg.

In other embodiments, the invention provides a pharmaceutical composition comprising EPA (e.g. E-EPA or ultra-pure E-EPA) encapsulated in a capsule shell comprising a film forming material and a hygroscopic plasticizer, wherein the weight ratio of film-forming material to hygroscopic plasticizer is not less than about 2.5:1. Further, the capsule shell can optionally comprise a non-hygroscopic plasticizer. In one embodiment, the capsule contains no chemically modified gelatin, for example succinated or succinylated gelatin.

In still other embodiments, the present invention provides methods of treating or preventing a cardiovascular-related disease using compositions as described herein.

These and other embodiments of the present invention will be disclosed in further detail herein below.

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