Compositions containing omega-3 oil and uses thereof

Abstract

The invention provides pharmaceutical compositions containing omega-3 oil and a non-hydrophilic co-solvent that have an increased absorption rate. The pharmaceutical compositions may further contain one or more pharmaceutical organic molecules. The invention further provides kits containing these pharmaceutical compositions, methods for formulating pharmaceutical compositions containing omega-3 oil, and methods for decreasing the likelihood of developing cardiovascular disease, decreasing triglyceride or LDL cholesterol levels, decreasing pain or inflammation, treating diabetes, chronic pulmonary diseases, or irritable bowel syndrome, decreasing symptoms of an autoimmune disease or allergic conditions.

What is claimed is: 
     
         1 . A composition comprising omega-3 oil in a non-hydrophilic co-solvent comprising a herbal-based oil, vitamin E, medium chain triglycerides (MCTs), lecithin, and phosphatidylcholine. 
     
     
         2 . The composition of  claim 1 , wherein said composition is formulated as a liquid. 
     
     
         3 . The composition of  claim 1 , wherein the omega-3 oil is from a natural source. 
     
     
         4 . The composition of  claim 3 , wherein the natural source is selected from the group consisting of: salmon, herring, mackerel, and sardines. 
     
     
         5 . The composition of  claim 1 , wherein the omega-3 oil is high grade. 
     
     
         6 . The composition of  claim 5 , wherein the high grade omega-3 oil is OmegaMaine omega-3 oils. 
     
     
         7 . The composition of  claim 1 , wherein the omega-3 oil is an alkyl ester of a fatty acid. 
     
     
         8 . The composition of  claim 1 , wherein the omega-3 oil is an alkyl ester of eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA), or a mixture of EPA and DHA. 
     
     
         9 . The composition of  claim 1 , wherein the omega-3 oils are in the form of triglycerides. 
     
     
         10 . The composition of  claim 1 , wherein the omega-3 oils are a mixture of triglycerides and free fatty acids. 
     
     
         11 . The composition of  claim 2 , wherein said compositions is formulated in a dose containing greater than 3.0 g combined eicosapentaenoic acid and docosahexanoic acid per 10 mL. 
     
     
         12 . The composition of  claim 11 , wherein said composition is formulated in a dose containing greater than 3.0 g combined EPA and DHA per 10 mL. 
     
     
         13 . The composition of  claim 1 , wherein said non-hydrophilic co-solvent is less than 30% of the composition's total mass. 
     
     
         14 . The composition of  claim 1 , wherein said herbal-based oil is 1% to 10% of the composition's total mass. 
     
     
         15 . The composition of  claim 14 , wherein said herbal-based oil is 3% to 5% of the composition's total mass. 
     
     
         16 . The composition of  claim 1 , wherein the herbal-based oil is selected from the group consisting of rosemary oil, basil oil, turmeric oil, and ginger oil. 
     
     
         17 . The composition of  claim 14 , wherein said herbal-based oil is rosemary oil. 
     
     
         18 . The composition of  claim 1 , wherein the amount of vitamin E present in a single dose of said composition is between 13.4 to 134 mg. 
     
     
         19 . The composition of  claim 1 , wherein the amount of vitamin E present is 1.3% to 13.4% of the composition's mass. 
     
     
         20 . The composition of  claim 1 , wherein said MCTs are from coconut oil. 
     
     
         21 . The composition of  claim 1 , wherein said MCTs are between 1% to 10% of the composition's total mass. 
     
     
         22 . The composition of  claim 21 , wherein said MCTs are 5% of the composition's total mass. 
     
     
         23 . The composition of  claim 1 , wherein phosphatidylcholine is 0.5% to 10% of the composition's total mass. 
     
     
         24 . The composition of  claim 23 , wherein said phosphatidylcholine is 2% to 6% of the composition's total mass. 
     
     
         25 . The composition of  claim 1 , further comprising one or more nitric oxide-stimulating or -releasing agent(s). 
     
     
         26 . The composition of  claim 25 , wherein said nitric oxide-stimulating or -releasing agent is selected from the group of arginine, a di-arginine, and citrulline. 
     
     
         27 . The composition of  claim 1 , further comprising glucosamine. 
     
     
         28 . The composition of  claim 27 , wherein said herbal-based oil is rosemary oil. 
     
     
         29 . The composition of  claim 1 , wherein said composition further comprises ethanol. 
     
     
         30 . The composition of  claim 1 , wherein said composition further comprises a Tween surfactant. 
     
     
         31 . The composition of  claim 30 , wherein said Tween surfactant is selected from the group consisting of: Tween-80, Tween-60, Tween-40, and Tween-20. 
     
     
         32 . The composition of  claim 31 , wherein said Tween surfactant is Tween-80. 
     
     
         33 . The composition of  claim 30 , further comprising ethanol. 
     
     
         34 . The composition of  claim 1 , further comprising one or more therapeutic organic molecule(s) with a molecular weight between 100 g/mole and 800 g/mole, a log P value greater than 2, or a melting point below 200° C. 
     
     
         35 . The composition of  claim 33 , further comprising one or more therapeutic organic molecule(s) with a molecular weight between 100 g/mole and 800 g/mole, a log P value greater than 2, or a melting point below 200° C. 
     
     
         36 . The composition of  claim 35 , wherein said therapeutic organic molecule is a non-steroidal anti-inflammatory drug (NSAID) or a disease-modifying anti-rheumatic drug (DMARD). 
     
     
         37 . The composition of  claim 35 , wherein said therapeutic organic molecule is fenofibrate, a statin, or niacin. 
     
     
         38 . The composition of  claim 37 , wherein a dose of said composition contains 5 mg/mL to 20 mg/mL fenofibrate. 
     
     
         39 . The composition of  claim 38 , wherein said dose contains 10 mg/mL to 15 mg/mL fenofibrate. 
     
     
         40 . The composition of  claim 37 , wherein a dose of said composition contains 1 mg/mL to 4 mg/mL of a statin. 
     
     
         41 . The composition of  claim 40 , wherein a dose of said composition contains 0.5 mg/mL to 2 mg/mL of a statin. 
     
     
         42 . The composition of  claim 36 , wherein said NSAID is selected from the group consisting of ketoprofen, ibuprofen, diflunisal, diclofenac, and naproxen. 
     
     
         43 . The composition of  claim 42 , wherein said NSAID is ketoprofen. 
     
     
         44 . The composition of  claim 36 , wherein said DMARD is methotrexate. 
     
     
         45 . The composition of  claim 36 , wherein said herbal-based oil is rosemary oil and said composition further comprises glucosamine. 
     
     
         46 . The composition of  claim 35 , wherein said therapeutic organic molecule is an H-1 antihistamine. 
     
     
         47 . The composition of  claim 46 , wherein the H-1 antihistamine is from the tricyclic class of antihistamines. 
     
     
         48 . The composition of  claim 47 , wherein the tricyclic antihistamine is imipramine or doxepin. 
     
     
         49 . The composition of  claim 46 , wherein the H-1 antihistamine is from the non-tricyclic class of antihistamines. 
     
     
         50 . The composition of  claim 49 , wherein the non-tricyclic antihistamine is diphenhydramine or triporlidine. 
     
     
         51 . The composition of  claim 1 , further comprising one or more agents selected from the group consisting of: phosphatidylserine, phosphatidylethanolamine, phosphatidylinositol, and phosphatidic acid. 
     
     
         52 . The composition of  claim 51  comprising phosphatidylinositol and phosphatidic acid. 
     
     
         53 . The composition of  claim 1 , wherein 10% of the omega-3 oil is in solution and the remaining 90% of the omega-3 oil is in stable suspension form. 
     
     
         54 . The composition of  claim 2 , wherein said composition is formulated for oral administration. 
     
     
         55 . A composition comprising: 70% to 80% w/w of natural fish oil as a source of omega-3 oil; 5% to 15% w/w of coconut oil as a source of medium chain triglycerides; 0.5% to 5% w/w polytocopherol as a source of vitamin E; 1% to 10% w/w absolute ethanol; 1% to 10% w/w sorbital laurate; and 1% to 10% w/w cremaphor. 
     
     
         56 . A composition comprising: 70% to 80% w/w of natural fish oil as a source of omega-3 oil: 5% to 15% w/w coconut oil as a source of medium chain triglycerides; 0.5% to 5% w/w polytocopherol as a source of vitamin E; 1% to 5% w/w absolute ethanol; and 5% to 15% cremaphor. 
     
     
         57 . A composition comprising: 65% to 75% w/w of natural fish oil as a source of omega-3 oil; 1% to 10% w/w of coconut oil as a source of medium chain triglycerides; 0.5% to 5% w/w polytocopherol as a source of vitamin E; 1% to 10% w/w absolute ethanol; 1% to 10% w/w sorbital laurate; 1% to 10% w/w cremaphor; and 1% to 10% w/w of a therapeutic organic molecule. 
     
     
         58 . A composition comprising: 65% to 75% w/w of natural fish oil as a source of omega-3 oil; 1% to 10% w/w of coconut oil as a source of medium chain triglycerides; 0.5% to 5% w/w polytocopherol as a source of vitamin E; 1% to 5% w/w absolute ethanol; 1% to 10% w/w sorbital laurate; 1% to 15% w/w cremaphor; and 1% to 10% w/w of a therapeutic organic molecule. 
     
     
         59 - 142 . (canceled)