Methods and compositions relating to emulsions comprising fish oil and/or omega-3 fatty acids
View Patent ↗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.
1 . An emulsion composition comprising:
a) fish oil and-medium-chain triglycerides (MCT) at a ratio between, but not inclusive of, 30:70 to 70:30, wherein the fish oil has not been re-esterified, and wherein the concentration of fish oil and MCT is 10 g to 50 g per 100 mL; or
b) omega-3 fatty acids and medium-chain triglycerides (MCT) at a ratio of 30:70 to 70:30, wherein the omega-3 fatty acids have not been re-esterified, and wherein the concentration of omega-3 fatty acids and MCT is 10 g to 50 g per 100 mL.
2 . The emulsion composition of claim 1 , comprising
fish oil and medium-chain triglycerides (MCT) at a ratio of 50:50; or
omega-3 fatty acids and medium-chain triglycerides (MCT) at a ratio of 50:50.
3 . The emulsion composition of claim 1 , further comprising phytosterols.
4 . The emulsion composition of claim 3 , wherein the phytosterols are at a concentration of less than 50 mg per liter of the emulsion composition.
5 . The emulsion composition of claim 1 , further comprising arachidonic acid at a concentration of at least 900 mg/L.
6 . 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.
7 . 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.
8 . The emulsion composition of claim 1 , formulated for parenteral or intravenous administration.
9 . The emulsion composition of claim 1 , further comprising an additive of one or more additional fatty acids or a mixture thereof.
10 . The emulsion composition of claim 1 , 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.
11 . The emulsion composition of claim 1 , further comprising one or more of egg phospholipid, glycerin, sodium oleate, and sodium hydroxide.
12 . The emulsion composition of claim 1 , wherein phytosterols or omega-6 fatty acids are present in the emulsion at a concentration of less than 100 mg/L.
13 . A method comprising administering an emulsion composition of claim 1 to a subject.
14 . The method of claim 13 , 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.
15 . The emulsion composition of claim 1 , wherein the concentration of fish oil and the MCT is 20 g to 40 g per 100 mL or the concentration of omega-3 fatty acids and the MCT is 20 g to 40 g per 100 mL.
16 . The emulsion composition of claim 1 , wherein the omega-3 fatty acid is eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and the MCT is caprylic acid, capric acid, lauric acid, and caproic acid.
17 . The emulsion composition of claim 1 , wherein the omega-3 fatty acid is eicosapentaenoic acid (EPA) and the MCT is caprylic acid, capric acid, lauric acid, and caproic acid.
18 . The emulsion composition of claim 1 , wherein the omega-3 fatty acid is docosahexaenoic acid (DHA) and the MCT is caprylic acid, capric acid, lauric acid, and caproic acid.
19 . The emulsion composition of claim 1 , wherein the emulsion does not comprise long chain fatty acids obtained from a plant source.
20 . The emulsion composition of claim 1 , wherein the emulsion does not comprise predominantly omega-6 fatty acids.
21 . 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.
22 . The emulsion composition of claim 1 , wherein omega-6 fatty acids are present in the emulsion at a concentration of less than 100 mg/L.
23 . The emulsion composition of claim 1 , wherein omega-6 fatty acids are present in the emulsion at a concentration of less than 50 mg/L.
24 . A kit comprising:
a) a container; and
b) an emulsion composition comprising:
i) fish oil and medium-chain triglycerides (MCT) at a ratio between, but not inclusive of, 30:70 to 70:30, wherein the fish oil has not been re-esterified, and wherein the concentration of fish oil and MCT is 10 g to 50 g per 100 mL; or
ii) omega-3 fatty acids and medium-chain triglycerides (MCT) at a ratio of 30:70 to 70:30, wherein the omega-3 fatty acids have not been re-esterified, and wherein the concentration of omega-3 fatty acids and MCT is 10 g to 50 g per 100 mL.
25 . The kit of claim 24 , wherein the container is glass.
26 . The kit of claim 24 , wherein the container is DEHP free plastic.
27 . The kit of claim 24 , wherein the container is nitrogen filled.
28 . The kit of claim 24 , further comprising an overwrap.
29 . The kit of claim 24 , further comprising an overwrap and a dessicant.