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DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form

A technology of unsaturated fatty acids and compositions, which is applied in the direction of drug combinations, active ingredients of anhydrides/acids/halides, medical preparations of non-active ingredients, etc., and can solve problems such as the increase of ethyl carbamate

Inactive Publication Date: 2015-01-28
OMTHERA PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, excess urea can lead to concentrations of unwanted components and has the potential to lead to increased production of urethane at any given temperature and reaction time, and urethane is not allowed to exceed certain specified lower limits carcinogen
However, other difficulties exist in existing alternatives to urea complexation

Method used

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  • DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
  • DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
  • DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 7

[0094] Example 7 presents the results of the ECLIPSE clinical trial, an open-label, single-dose, randomized 4-way crossover study of The bioavailability of the DPA-enriched pharmaceutical composition (hereinafter referred to as ) bioavailability were compared. 1 gram each according to FDA-approved product label The capsules contain at least 900 mg of ethyl esters of omega-3 fatty acids derived from fish oil, mainly eicosapentaenoic acid (EPA, approximately 465 mg) and docosahexaenoic acid (DHA, approximately 375mg) of the combination of ethyl esters. used in this test The batch contained 57.3% (a / a) EPA, 19.6% (a / a) DHA, and 6.2% (a / a) DPA, each substantially in the free acid form.

[0095] During the high-fat diet period, use The baseline-adjusted changes in the total EPA+DHA and individual EPA and DHA absorption curves (AUC) (with omega-3 PUFA in the free acid form) were significantly greater than those using (omega-3-PUFA ethyl esters) and was significantly bett...

Embodiment 8

[0097] The results from the 14-day bioavailability study are presented in Example 8, showing that the increase in bioavailability observed in the single-dose ECLIPSE trial was maintained, and even enhanced, over the 2-week dosing period. In addition, disaggregated subject-specific data suggest that Subjects with minimal responses still had the same Subjects with the best response compared to greater 14-day EPA+DHAC max .

Embodiment 10

[0098] Example 10 presents the results of the EVOLVE trial, a 12-week, double-blind, Controlled study of olive oil. The primary study endpoint was the percent change in plasma triglyceride levels from baseline to end of treatment (EOT). The secondary study endpoint was the percent change in plasma non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to EOT.

[0099] As seen in Figures 20-23, using The 12-week treatment of ® resulted in a significant increase in the plasma levels of EPA, DHA and DPA.

[0100] The increase in plasma levels of EPA, DHA, and DPA was accompanied by a significant decrease in plasma AA levels, and the 4g dosing regimen achieved an 18% mean reduction, a 25.9% median reduction, and a least squares (LS) mean of 23.2% decline. These plasma arachidonic acid levels were observed to decrease despite the administration of exogenous arachidonic acid, the arachidonic acid used in this trial It exists at the content of 2.446% (a / a) in the b...

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Abstract

DPA-enriched pharmaceutical compositions of polyunsaturated fatty acids in free acid form, therapeutic methods for their use, and processes for refining the compositions from fish oil are presented. Also provided are methods of treating hypertriglyceridemia (200 mg / dL-500 mg / dL) by adjunctive administration of a statin and the pharmaceutical compositions described herein. Further treatment methods include, inter alia, treatments to increase plasma EPA:AA ratios, treatments to decrease ApoCIII levels, and treatments to reduce or prevent resistance to platelet aggregation inhibitors.

Description

[0001] 1. Cross-references to related applications [0002] Pursuant to 35 U.S.C. § 119(e), this application claims U.S. Provisional Patent Application 61 / 583,796 filed January 6, 2012, U.S. Provisional Patent Application 61 / 664,047 filed June 25, 2012, July 10, 2012 U.S. Provisional Patent Application 61 / 669,940 filed on August 7, 2012; The benefit of filed US Provisional Patent Application 61 / 713,388, which is hereby incorporated by reference in its entirety. 2. Background technology [0003] Pharmaceutical compositions enriched in omega-3 (omega-3 or n-3) polyunsaturated fatty acids (PUFAs) are being developed for the treatment of various clinical indications. [0004] These products obtained from natural sources (usually fish oils) are heterogeneous compositions and contain various types of omega-3 PUFAs, omega-6 PUFAs and other minor components including monounsaturated and saturated fatty acids. The observed clinical effects are generally attributed to the composition ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/19A61P9/00
CPCA61K31/366A61K31/202A61K9/4825A61K45/06A61K9/4891A61K2300/00A61P3/06A61P43/00A61P9/00A61K31/201A61K31/27A61K47/32A61K31/22A61K9/48
Inventor T.J.迈恩斯B.N.M.马基尔斯B.M.梅塔G.维斯勒M.戴维森P.R.伍德
Owner OMTHERA PHARMA
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