Methods and compositions relating to emulsions comprising fish oil and/or omega-3 fatty acids

Patent metadata

Field	Value
Publication number	US-11324697-B2
Application number	US-201816634194-A
Country	US
Kind code	B2
Filing date	Aug 10, 2018
Priority date	Aug 10, 2017
Publication date	May 10, 2022
Grant date	May 10, 2022

Abstract

Described herein are emulsion compositions comprising fish oil and medium-chain triglycerides (MCT) and/or omega-3 fatty acids and medium-chain triglycerides (MCT). In some embodiments, the compositions further comprise, e.g., alpha-tocopherol, or one or more fatty acids. Further provided herein are methods of using the compositions, e.g., to provide nutrion, e.g., parenteral nutrition to a subject and/or to treat or prevent certain conditions described herein.

First claim

What is claimed herein is:

1. An emulsion composition comprising:
fish oil and medium-chain triglycerides (MCT) at a ratio between, but not inclusive of, 30:70 to about 70:30; or
omega-3 fatty acids and medium-chain triglycerides (MCT) at a ratio of about 30:70 to about 70:30;
wherein the total triglyceride+diglyceride content of the fish oil and/or omega-3 fatty acids comprises no more than 10% diglyceride.

2. The emulsion composition of claim 1 , comprising:
fish oil and medium-chain triglycerides (MCT) at a ratio of about 40:60 to about 60:40; or
omega-3 fatty acids and medium-chain triglycerides (MCT) at a ratio of about 40:60 to about 60:40.

3. The emulsion composition of claim 1 , comprising
fish oil and medium-chain triglycerides (MCT) at a ratio of about 50:50; or
omega-3 fatty acids and medium-chain triglycerides (MCT) at a ratio of about 50:50.

4. The emulsion composition of claim 1 , wherein the composition further comprises alpha-tocopherol.

5. The emulsion composition of claim 4 , wherein the alpha-tocopherol is present at a level of at least 100 mg per liter of the emulsion composition.

6. The emulsion composition of claim 1 , wherein the fish oil and medium-chain triglycerides (MCT) or omega-3 fatty acids and medium-chain triglycerides (MCT) comprise phytosterols.

7. The emulsion composition of claim 1 , wherein the fish oil and medium-chain triglycerides (MCT) or omega-3 fatty acids and medium-chain triglycerides (MCT) comprise phytosterols at a concentration of less than 50 mg per liter of the emulsion composition.

8. The emulsion composition of claim 1 , wherein the fish oil and medium-chain triglycerides (MCT) or omega-3 fatty acids and medium-chain triglycerides (MCT) comprise arachidonic acid at a concentration of at least 900 mg/L of the emulsion composition.

9. The emulsion composition of claim 1 , wherein the fish oil and medium-chain triglycerides (MCT) or omega-3 fatty acids and medium-chain triglycerides (MCT) comprise docosahexaenoic acid at a concentration of at least 13.4 grams/L of the emulsion composition.

10. The emulsion composition of claim 1 , wherein the fish oil and medium-chain triglycerides (MCT) or omega-3 fatty acids and medium-chain triglycerides (MCT) comprise eicosapentaenoic acid at a concentration of at least 11.6 grams/L of the emulsion composition.

11. The emulsion composition of claim 1 , wherein the composition comprises a mixture of an emulsion of a fish oil and/or omega-3 fatty acid oil and an emulsion of MCT.

12. The emulsion composition of claim 1 , wherein the composition comprises an emulsion of a mixture of a fish oil and/or omega-3 fatty acid oil and an MCT.

13. The emulsion composition of claim 1 , wherein the fish oil and/or omega-3 fatty acid oil have not been distilled or re-esterified.

14. The emulsion composition of claim 1 , formulated for parenteral or intravenous administration.

15. The emulsion composition of claim 1 , further comprising an additive of one or more additional fatty acids or a mixture thereof.

16. The emulsion composition of claim 15 , wherein the composition comprises a mixture of a) an emulsion of the additive and b) one or more emulsions of i) the fish oil and/or omega-3 fatty acids and ii) the MCT.

17. The emulsion composition of claim 1 , further comprising one or more of egg phospholipid, glycerin, sodium oleate, and sodium hydroxide.

18. A method comprising administering an emulsion composition of claim 1 to a subject.

19. The method of claim 18 , wherein the patient is a patient in need of treatment for a condition selected from the group consisting of: hepatic steatosis; intestinal failure; parenteral nutrition-associated liver disease (PNALD); sepsis; cystic fibrosis; sickle cell anemia; pancreatitis; inflammatory bowel disease; Crohn's disease; biliary atresia; primary sclerosis cholangitis; an inflammatory infection; an inflammatory condition; systemic inflammatory response syndrome (SIRS); hypertriglyceridemia; severe hypertriglyceridemia; severe hepatic steatosis; retinopathy of prematurity; acute tubular necrosis; IgA nephropathies; ischemia-reperfusion injury; traumatic brain injury; multi-system organ failure; respiratory distress syndrome; acute myocardial infarction; myocardial infarction; status anginosus ; status asthmaticus; status epilepticus; status lacunaris; inflammatory bowel disease; regional enteritis; ulcerative colitis; severe or debilitating arthritis; arthritis; psoriasis; severe psoriasis; burns; third degree burns; pancreatitis; acute pancreatitis; intestinal failure associated liver disease (IFALD), parenteral nutrition associated cholestasis (PNAC), essential fatty acid deficiency (EFAD), parenteral nutrition dependency complicated by soy allergy or allergy to lipid emulsions comprising ingredients other than MCTs and fish oil, omega-3 predominate fatty acid oil, and/or omega-3 fatty acids.

20. The method of claim 18 , wherein the administration is chronic.

21. The emulsion formulation of claim 1 , wherein the fish oil and medium-chain triglycerides (MCT) or omega-3 fatty acids and medium-chain triglycerides (MCT) comprise phytosterols or omega-6 fatty acids at a concentration of less than 100 mg/L of the emulsion composition.

22. The emulsion composition of claim 1 , wherein the omega-3 fatty acids are provided as an omega-3 predominate fatty acid oil which has not undergone re-esterification.

23. The emulsion composition of claim 1 , wherein the fish oil and/or omega-3 fatty acids comprise no diglycerides.

24. The emulsion composition of claim 1 , wherein the composition comprises a) the fish oil and the MCT at a concentration of 10 g to 50 g per 100 mL or b) the omega-3 fatty acids and the MCT at a concentration of 10 g to 50 g per 100 mL.

25. The emulsion composition of claim 1 , wherein the fish oil and medium-chain triglycerides (MCT) or omega-3 fatty acids and medium-chain triglycerides (MCT) comprise omega-6 fatty acids at a concentration of less than 100 mg/mL of the emulsion composition.

26. The emulsion composition of claim 1 , wherein the fish oil and medium-chain triglycerides (MCT) or omega-3 fatty acids and medium-chain triglycerides (MCT) comprise omega-6 fatty acids at a concentration of less than 50 mg/mL of the emulsion composition.

Assignees

• Childrens Medical Ct Corp

Inventors

• Puder Mark
• Gura Kathleen Marie

Classifications

• 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

• A23V2002/00

  Food compositions, function of food ingredients or processes for food or foodstuffs · CPC title

• A61P29/00

  Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] · CPC title

• A61K47/24

  containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids · CPC title

• A61K47/12

  Carboxylic acids; Salts or anhydrides thereof · CPC title