Omega 3 fatty acid for use as a prescription medical food and omega 3 fatty acid diagnostic assay for the dietary management of cardiovascular patients with cardiovascular disease (CVD) who are deficient in blood epa and DHA levels

a technology of omega 3 fatty acid and diagnostic assay, which is applied in the direction of biocide, plant growth regulator, pharmaceutical non-active ingredients, etc., can solve the problems of failing to teach or suggest the provision of companion diagnostic assays in the early art, and achieves enhanced vascular protective potential, reduced risk factors, and greater relaxation

Inactive Publication Date: 2015-09-03
PIVOTAL THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a new composition that can be used to reduce the risk factors associated with cardiovascular disease. The composition contains a specific ratio of EPA to DHA, which is important because EPA is a more potent endothelium-dependent vasorelaxant agonist than DHA. The ratio of EPA to DHA in commercial omega-3 preparations is typically 6:1. The composition can be formulated as an orally administerable unit dosage form and has been shown to be effective in treating various risk factors associated with CVD. The composition can be used to improve heart health and reduce the risk factors associated with cardiovascular disease in humans and animals. The patent also provides a diagnostic assay to monitor the progress of treatment. The composition has a sustained vasodilatory effect, which is beneficial for cardiovascular health.

Problems solved by technology

The prior art fails to teach or suggest the provision of a companion diagnostic assay in conjunction with the formulation.

Method used

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  • Omega 3 fatty acid for use as a prescription medical food and omega 3 fatty acid diagnostic assay for the dietary management of cardiovascular patients with cardiovascular disease (CVD) who are deficient in blood epa and DHA levels
  • Omega 3 fatty acid for use as a prescription medical food and omega 3 fatty acid diagnostic assay for the dietary management of cardiovascular patients with cardiovascular disease (CVD) who are deficient in blood epa and DHA levels
  • Omega 3 fatty acid for use as a prescription medical food and omega 3 fatty acid diagnostic assay for the dietary management of cardiovascular patients with cardiovascular disease (CVD) who are deficient in blood epa and DHA levels

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Embodiment Construction

[0044]The prescription medical food formulation provides a long chain fatty acid composition that includes a formulation containing a minimum of about 90% omega 3 fatty acids by weight having a combination of Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 5.7 to 6.3, wherein the sum of the EPA, DHA and DPA is about 82% by weight of the total formulation and about 92% of the total omega 3 fatty acid content of the composition. EPA+DHA are about 80% of the total formulation and about 89% of the total omega 3 fatty acid content of the composition. The fatty acids of the present invention are understood to include biologically active glyceride forms, e.g. triglycerides, biologically active ester forms, e.g. ethyl ester forms, and biologically active phospholipid forms, their derivatives, conjugates, precursors, and pharmaceutically acceptable salts and mixtures thereof.

[0045]The pharmaceutical formulation of the instant invention is conte...

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Abstract

The present invention provides a kit for the dietary management of cardiovascular patients with cardiovascular disease who are deficient in blood Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) levels, said kit including a diagnostic assay for determining blood levels of EPA, DHA and Docosapentaenoic acid (DPA) and a pharmaceutical grade prescription medical food omega-3 fatty acid formulation containing about 90% or more omega 3 fatty acids by weight including a combination of EPA, DPA and DHA in a weight ratio of EPA:DHA of from 5.7 to 6.3, wherein the sum of the EPA, DHA and DPA are about 82% by weight of the total formulation and about 92% of the total omega 3 fatty acid content of the composition.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. application Ser. No. 13 / 584,428, filed Aug. 13, 2012, now U.S. Pat. No. ______, issued ______, which is a continuation-in-part of PCT / US2012 / 025010, filed Feb. 14, 2012, which claims benefit of priority to U.S. Provisional Patent Application Ser. No. 61 / 457,270, filed Feb. 16, 2011, the contents of which are incorporated herein by reference in their entireties.FIELD OF THE INVENTION[0002]The present invention provides a pharmaceutical grade prescription medical food formulation which is used for the dietary management of cardiovascular disease (CVD) patients or any patient who has been found to be deficient in blood omega-3 fatty acids, specifically Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA) and Docosapentaenoic acid (DPA) levels, in combination with a diagnostic assay for determining blood levels of EPA, DPA and DHA.BACKGROUND OF THE INVENTION[0003]In accordance with the findings of...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/202G01N33/92A61K47/22A61K31/232A61K31/66
CPCA61K31/202A61K31/232G01N2800/32A61K47/22G01N33/92A61K31/66A61K45/06A61P9/00A61K2300/00
Inventor JACKOWSKI, GEORGEMACSWEENEY, RACHELLESHAIKH, NISAR AHMADYANTHA, JASONSCHINI-KERTH, VALERIE B.
Owner PIVOTAL THERAPEUTICS
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