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Compositions containing omega-3 oil and uses thereof

a technology of compositions and omega-3 oil, applied in the field of pharmaceutical compositions containing omega-3 oil, can solve the problems of limiting the ability of many patients, compliance and swallowing difficulties, and difficulty in ingesting enough gel capsules to achieve this dosage, so as to reduce the likelihood of developing

Inactive Publication Date: 2016-04-07
MAINE NATURAL HEALTH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The enhanced absorption rates result in increased plasma concentrations of EPA and DHA, improved patient compliance, reduced triglyceride and LDL cholesterol levels, decreased nausea, and increased omega-3 oil incorporation into cell membranes, while potentially lowering the dosage of therapeutic agents required.

Problems solved by technology

It is difficult to ingest enough gel capsules to achieve this dosage.
Compliance and swallowing difficulties limit the ability of many patients from consistently taking an amount of omega-3 oil sufficient to elicit a therapeutic effect.
High grade liquid oils are available that allow patients to take these quantities of oils, but the dose volume, taste, and costs are negative factors.
Costs become prohibitive when chemically-altered or refined omega-3 oils from the natural state are used.
The weakness in the available oil products is that these compositions have not been optimized for absorption.
Despite the high quality of omega-3 oil contained within these products, the absorption efficiencies (time to maximum plasma concentration, t1 / 2 for absorption) of the products are not optimal.
The other marketed omega-3 products are also not optimized for absorption.
The conditions for dissolution and absorption are not optimal for these products, and thus, the efficiency of integration into cell membranes and triglyceride storage forms is not optimal.
The gel caps are inferior to Lovaza / Omacor (described above) and also suffer from a reduced efficiency of absorption.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Pharmaceutical Compositions Containing Omega-3 Oil

[0082]In order to increase the absorption efficiency of omega-3 oils in mammals (e.g., humans), a series of omega-3 compositions containing one or more adsorption enhancers were developed. An example of a pharmaceutical composition containing omega-3 oil with an increased absorption rate is shown below.

Formula I:

[0083]

WeightComponentPercentageNatural Fish Oil (25% to 38% combined EPA and DHA)75% Coconut Oil (medium chain triglyceride mix)5%Polytocopherol (source of vitamin E)1%Absolute Ethanol5%Span 20, NF4%Cremaphor ELO, NF10% 

[0084]An example of a pharmaceutical composition containing omega-3 oil and an additional therapeutic organic molecule is shown below.

Formula II:

[0085]

WeightComponentPercentageNatural Fish Oil (25% to 38% combined EPA and DHA)70% Coconut Oil (medium chain triglyceride mix)5%Polytocopherol (source of vitamin E)1%Absolute Ethanol5%Span 20, NF4%Cremaphor ELO, NF5%One or more therapeutic organic molecule(s)10% 

[00...

example 2

The Provided Omega-3 Oil-Containing Pharmaceutical Compositions Demonstrate an Increased Rate of Absorption in Humans

[0088]Experiments were performed to determine the absorption rate of one of the pharmaceutical compositions provided herein (Formula I shown in Example 1). Six human volunteers were treated once a day for one month with a natural source of omega-3 oils containing 3.5 grams of EPA and DHA combined in a 10 mL dose (Group I). Eight human volunteers (Group 2) were treated once a day for one month with the composition of Formula I (shown above). For both groups, the starting omega-3 fatty acid content in whole blood was between 0.6% and 1.1% (baseline of 0.8% for EPA and DHA in red blood cell fatty acids) (Table 1).

[0089]After one month of dosing on a daily basis, the omega-3 oil fatty acid content of EPA and DHA was measured in each volunteer (Table 1). These data demonstrate that the absorption enhancers in Formula I result in a 1.8-fold increase in the absorption of EPA...

example 3

Analyses of the Absorption Rate of Pharmaceutical Compositions Containing Omega-3 Oil and an Additional Therapeutic Organic Molecule

[0090]Additional experiments to test the absorption rate of the different omega-3 oil-containing pharmaceutical compositions described herein was illustrated in a mouse model. In these experiments, mice (4 / group) were administered 25 mg / kg ibuprofen in the composition of Formula II, in 100% natural fish oil, or in saline. The time to reach Cmax and Tmax for ibuprofen was determined from mouse tail vein samples (Table 2).

[0091]The data for this experiment show that natural fish oil is an absorption enhancer and that a further increase in absorption rate and Cmax is achieved when one or more additional absorption enhancers are used (e.g., the additional absorption enhancers in Formula II).

TABLE 2CmaxT1 / 2Ibuprofen in saline10 μg / mL60 minIbuprofen in omega 3 / Formula 214 μg / mL35 min

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Abstract

The invention provides pharmaceutical compositions containing omega-3 oil and a non-hydrophilic co-solvent that have an increased absorption rate. The pharmaceutical compositions may further contain one or more pharmaceutical organic molecules. The invention further provides kits containing these pharmaceutical compositions, methods for formulating pharmaceutical compositions containing omega-3 oil, and methods for decreasing the likelihood of developing cardiovascular disease, decreasing triglyceride or LDL cholesterol levels, decreasing pain or inflammation, treating diabetes, chronic pulmonary diseases, or irritable bowel syndrome, decreasing symptoms of an autoimmune disease or allergic conditions.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is a Continuation of U.S. application Ser. No. 13 / 822,517, filed Apr. 12, 2013, which is the U.S. National Stage of International Application No. PCT / US2011 / 51698, filed Sep. 15, 2011, which claims benefit of U.S. Provisional Application No. 61 / 383,972, filed Sep. 17, 2010, each of which is hereby incorporated by reference.FIELD OF THE INVENTION[0002]The present invention relates to the field of pharmacology and molecular medicine. More specifically, the invention relates to pharmaceutical compositions containing omega-3 oil in co-solvents that are useful for treating, e.g., cardiovascular conditions, and / or as vehicles for delivering other therapeutic agents.BACKGROUND OF THE INVENTION[0003]Omega-3 oil is widely regarded as having certain therapeutic benefits primarily associated with cardiovascular disease. As the scientific community has become more comfortable with the safety and efficacy of omega-3 oils, the recommen...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/23A61K45/06A61K31/192A61K31/202
CPCA61K31/23A61K31/192A61K45/06A61K31/202A61K31/20A61K31/355A61K31/726A61K31/7008
Inventor LEIGHTON, HARRY J.
Owner MAINE NATURAL HEALTH
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