Fatty acid formulations and methods of use thereof

• US 9,687,016 B2
• Filed: 04/04/2012
• Issued: 06/27/2017
• Est. Priority Date: 02/22/2007
• Status: Active Grant

• Current Assignee: Children's Hospital & Research Center At Oakland
• Original Assignee: Children's Hospital & Research Center At Oakland
• Inventors: Morris, Claudia R.
• Primary Examiner(s): Landau, Sharmila G.
• Assistant Examiner(s): MACAULEY, SHERIDAN R
• Application Number:
  US13/439,192
• Publication Number:
  US 20120190737A1
• Time in Patent Office: 1,910 Days
• Field of Search: 514739
• 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 method of treating apraxia and/or autism spectrum disorder, the method comprising orally administering to an individual in need thereof an effective amount of a formulation comprising:

a) eicosapentaenoic acid (EPA);

b) docosohexaenoic acid (DHA);

c) α

-tocopherol;

d) γ

-tocopherol;

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

1 to about 5;

1,

wherein the α

-tocopherol is present in an amount of from about 500 mg to about 3000 mg per unit dose,

wherein the γ

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

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

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

2. The method of claim 1, wherein the formulation is administered three times daily.

3. The method of claim 1, wherein the formulation is administered twice daily.

4. The method of claim 1, wherein the formulation is administered once daily.

5. The method of claim 1, 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.

6. The method of claim 1, wherein the formulation further comprises carnitine in an amount of from about 200 mg to about 3000 mg per unit dose.

7. The method of claim 1, wherein the formulation further comprises vitamin K in an amount of from about 100 μ

g to about 2 mg per unit dose.

8. The method of claim 1, wherein the formulation further comprises γ

-linolenic acid in an amount of from about 50 mg to about 75 mg per unit dose.

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

10. The method of claim 1, wherein the individual is a human of from about 1 month to about 19 years of age.

11. The method of claim 1, wherein the individual is a human adult.