Fatty acid formulations and methods of use thereof

• US 10,300,034 B2
• Filed: 02/19/2008
• Issued: 05/28/2019
• Est. Priority Date: 02/22/2007
• Status: Active Grant

• Current Assignee: Children's Hospital & Research Center At Oakland
• Original Assignee: Children's Hospital of Eastern Ontario Research Institute
• Inventors: Morris, Claudia R.
• Primary Examiner(s): Shen, Bin
• Application Number:
  US12/033,431
• Publication Number:
  US 20080213239A1
• Time in Patent Office: 4,116 Days
• Field of Search: 424 941
• CPC Class Codes: A23L 33/12 Fatty acids or derivatives thereof
• CPC Class Codes: A23L 33/15 Vitamins
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2200/304 having a modulation effect on allergy and risk of allergy
• CPC Class Codes: A23V 2200/306 having an effect on bone mass, e.g. osteoporosis prevention
• CPC Class Codes: A23V 2200/314 having an effect on lung or respiratory system
• CPC Class Codes: A23V 2200/318 having an effect on skin health and hair or coat
• CPC Class Codes: A23V 2200/322 having an effect on the health of the nervous system or on mental function
• CPC Class Codes: A23V 2200/326 having effect on cardiovascular health
• CPC Class Codes: A23V 2200/328 having effect on glycaemic control and diabetes
• CPC Class Codes: A23V 2250/026 Alpha lipoic acid, thioctic acid
• CPC Class Codes: A23V 2250/0612 Carnitine
• CPC Class Codes: A23V 2250/1626 Selenium
• CPC Class Codes: A23V 2250/1642 Zinc
• CPC Class Codes: A23V 2250/1846 Phosphatidyl Choline
• CPC Class Codes: A23V 2250/1868 Docosahexaenoic acid
• CPC Class Codes: A23V 2250/187 Eicosapentaenoic acid
• CPC Class Codes: A23V 2250/1874 Linolenic acid
• CPC Class Codes: A23V 2250/188 Oleic acid
• CPC Class Codes: A23V 2250/708 Vitamin C
• CPC Class Codes: A23V 2250/712 : Vitamin E
• CPC Class Codes: A23V 2250/7142 : Vitamin K1
• CPC Class Codes: A23V 2250/7144 : Vitamin K2
• CPC Class Codes: A61K 31/122 : having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
• CPC Class Codes: A61K 31/201 : having one or two double bonds, e.g. oleic, linoleic acids
• CPC Class Codes: A61K 31/202 : having three or more double bonds, e.g. linolenic eicosanoids, e.g. leukotrienes A61K31/557
• CPC Class Codes: A61K 31/205 : Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
• CPC Class Codes: A61K 31/355 : Tocopherols, e.g. vitamin E
• CPC Class Codes: A61K 31/375 : Ascorbic acid, i.e. vitamin C; Salts thereof
• CPC Class Codes: A61K 31/385 : having two or more sulfur atoms in the same ring
• CPC Class Codes: A61K 31/593 : 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
• CPC Class Codes: A61K 31/661 : Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion or mevinphos
• CPC Class Codes: A61K 33/30 : Zinc; Compounds thereof
• CPC Class Codes: A61K 38/43 : Enzymes; Proenzymes; Derivatives thereof
• CPC Class Codes: A61K 45/06 : Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0053 : Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/48 : Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• CPC Class Codes: A61P 25/00 : Drugs for disorders of the nervous system
• CPC Class Codes: A61P 37/08 : Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention provides dietary formulations comprising polyunsaturated fatty acids and vitamin E. The present invention further provides methods of treating various conditions, generally involving administering to an individual in need thereof an effective amount of a subject dietary formulation.

Claims

1. A dietary formulation suitable for treating an autism spectrum disorder and/or apraxia, the formulation comprising:

a) eicosapentaenoic acid (EPA);

b) docosohexaenoic acid (DHA);

c) α

-tocopherol;

d) γ

-tocopherol;

e) vitamin K1;

f) vitamin K2; and

g) γ

-linolenic acid (GLA),

wherein the ratio of EPA to DHA is in a range of from 1.5;

1 to 5;

1,

wherein the α

-tocopherol is present in an amount of from 300 mg to 3000 mg per unit dose,

wherein the γ

-tocopherol is present in an amount of from 200 mg to 1000 mg per unit dose,

wherein the EPA is present in an amount of from 500 mg to 3000 mg per unit dose,

wherein the DHA is present in an amount of from 100 mg to 400 mg per unit dose,

wherein the vitamin K1 is present in an amount of from 100 μ

g to 10 mg,

wherein the vitamin K2 is present in an amount of from 100 μ

g to 2 mg; and

wherein the GLA is present in an amount of from 50 mg to 75 mg.

2. The formulation of claim 1, further comprising α

-lipoic acid in an amount of from 50 mg to 600 mg per unit dose.

3. The formulation of claim 1, further comprising carnitine in an amount of from 200 mg to 3000 mg per unit dose.

4. The formulation of claim 1, further comprising an omega-9 fatty acid.

5. The formulation of claim 4, wherein the omega-9 fatty acid is oleic acid.

6. The formulation of claim 1, further comprising vitamin C in an amount of from 200 mg to 500 mg.

7. The formulation of claim 1, further comprising phosphocholine.

8. The formulation of claim 1, further comprising zinc.

9. The formulation of claim 1, further comprising one or more additional components selected from coenzyme Q, selenium, vitamin A, vitamin B₁, riboflavin, vitamin B₆, vitamin B₁₂, vitamin D, arginine, calcium, magnesium, vitamin B₇, vitamin B₉, vitamin B₅, tetrahydrobiopterin, and vitamin B₃.

10. The formulation of claim 1, further comprising a pancreatic enzyme.

11. The formulation of claim 1, further comprising a leukotriene inhibitor.

12. The formulation of claim 1, wherein the formulation is in a dosage form selected from a tablet, a capsule, a powder, a gel, and a liquid.

13. The formulation of claim 1, further comprising one or more food-grade components.

14. The formulation of claim 1, further comprising an anti-oxidant.

15. The formulation of claim 1, further comprising an anti-inflammatory agent.

16. The formulation of claim 1, further comprising an amino acid.

17. The formulation of claim 16, wherein the formulation further comprises arginine.

18. The formulation of claim 1, further comprising an anti-fungal agent.

19. The formulation of claim 1, further comprising one or more of β

-tocopherol, δ

-tocopherol, α

-tocotrienol, β

-tocotrienol, γ

-tocotrienol, and δ

-tocotrienol.

20. The formulation of claim 1, wherein a unit dose of the formulation is effective to treat an autism spectrum disorder and/or apraxia.

21. A method of treating apraxia and/or autism spectrum disorder, the method comprising orally administering to an individual in need thereof an effective amount of the formulation of claim 1.

22. The method of claim 21, wherein the formulation is administered three times daily.

23. The method of claim 21, wherein the formulation is administered twice daily.

24. The method of claim 21, wherein the formulation is administered once daily.

25. The method of claim 21, wherein said administration is effective to increase the percentile score of at least one of oral movement score, simple phonemic/syllabic score, complex phonemic/syllabic score, and spontaneous length and complexity score, by at least about 10 percentile points.

26. A method of treating an allergic disorder, the method comprising orally administering to an individual in need thereof an effective amount of the formulation of claim 1.

27. The method of claim 26, wherein the disorder is selected from celiac disease, sprue, gluten sensitivity, a malabsorption syndrome, asthma, food allergy, leaky gut syndrome, and/or eczema.

28. A method of treating an inflammatory condition, the method comprising orally administering to an individual in need thereof an effective amount of the formulation of claim 1, wherein the inflammatory condition is rheumatic arthritis, diabetes, or cardiovascular disease.