Intravenous omega-3 fatty acid compositions and method of use

Patent metadata

Field	Value
Publication number	US-9675572-B2
Application number	US-201113637239-A
Country	US
Kind code	B2
Filing date	Apr 22, 2011
Priority date	Apr 23, 2010
Publication date	Jun 13, 2017
Grant date	Jun 13, 2017

Abstract

The invention encompasses intravenous pharmaceutical compositions containing omega-3 fatty acids and methods of treating traumatic brain injury, traumatic spinal cord injury and/or stroke using these pharmaceutical compositions.

First claim

The invention claimed is:

1. A method of treating a subject suffering from traumatic brain injury, spinal cord injury and/or stroke comprising intravenously administering a pharmaceutical composition in an amount effective to reduce inflammation in the brain and/or spinal cord of the subject, wherein the pharmaceutical composition is a stable intravenous pharmaceutical composition comprising:
a. an oil phase comprising
i. omega-3 essential fatty acids comprising about 5 to about 15 g/L α-linolenic acid (ALA); and about 100 to about 125 g/L of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) combined, and
ii. at least one medium chain triglyceride (MCT),

b. about 12 g/L of egg yolk phospholipids as an emulsifier, and
c. an aqueous phase comprising about 25 g/L of glycerol and about 100 mg/L of α-tocopherol, wherein the oil and aqueous phase form a 20% oil in water emulsion, and
wherein the omega-3 essential fatty acid is in a concentration of about 50% to about 90% by weight of the oil phase, and wherein omega-6 fatty acids are absent.

2. The method according to claim 1 , wherein the pharmaceutical composition is administered with a dosage of about 0.03 g/kg/day to about 0.3 g/kg/day of omega-3 essential fatty acids.

3. The method according to claim 1 , wherein the pharmaceutical composition is administered within about 60 minutes to about 120 minutes of the trauma or injury.

4. The method according to claim 2 , wherein the pharmaceutical composition is initially administered with a dosage of about 0.2 g to about 5 g of the omega-3 essential fatty acids over 1-10 minutes.

5. The method according to claim 1 , wherein the pharmaceutical composition is administered for a minimum of about 5 to about 21 days post trauma or injury.

6. The method according to claim 1 , wherein the subject is human.

7. The method according to claim 6 , wherein the traumatic brain injury is mild, moderate or severe.

8. The method according to claim 6 , wherein the spinal cord injury is incomplete.

9. The method according to claim 6 , wherein the stroke is mild, moderate, or severe.

10. The method according to claim 6 , wherein the stroke is hemorrhagic or ischemic.

11. The method according to claim 1 , wherein the omega-3 fatty acids is in a concentration range of about 105 g/L to about 300 g/L.

12. The method according to claim 1 , wherein the at least one medium chain triglyceride are caprylic acid and capric acid.

13. The method according to claim 12 , wherein the caprylic acid and capric acid are in a ratio range of about 3:2 by weight.

14. A method of treating an adult subject suffering from traumatic brain injury, spinal cord injury and/or stroke comprising intravenously administering a pharmaceutical composition comprising:
a. an oil phase comprising
i. at least one omega-3 essential fatty acid selected from a group consisting of α-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA), and
ii. at least one medium chain triglyceride (MCT),

b. at least one emulsifier in a concentration of 0.5% to 4%, and
c. an aqueous phase, wherein the oil and aqueous phase form a 20% oil in water emulsion, and
wherein the omega-3 essential fatty acid is in a concentration of about 50% to about 90% by weight of the oil phase, and wherein omega-6 fatty acids are absent; and
wherein the composition is initially administered with a dosage of about 2 g to about 5 g of the at least one omega-3 essential fatty acid for a duration of 1-10 minutes, followed by continuous administration to a total dose of about 10 g to about 20 g per day.

Assignees

• Lewis Michael
• Us Army

Inventors

• Lewis Michael

Classifications

• A61K47/14

  Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters · CPC title

• A61K9/107

  Emulsions {; Emulsion preconcentrates; Micelles (composition of emulsions A61K47/00)} · CPC title

• A61K31/201

  having one or two double bonds, e.g. oleic, linoleic acids · CPC title

• A61K9/0019

  Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00) · CPC title

• A61K31/202 Primary

  having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557) · CPC title