Omega 3 fatty acid formulations

Abstract

The present invention provides highly purified omega-3 fatty acid formulations. Certain formulations provided herein have contain greater than 85% omega-3 fatty acids by weight. Certain other formulations provided herein contain EPA and DHA in a ratio of from about 4.01:1 to about 5:1. The invention also provides methods of using the dosage forms to treat a variety of cardiovascular, autoimmune, inflammatory, and central nervous system disorders by administering a formulation of the invention to a patient in need thereof.

1 . An pharmaceutical formulation comprising EPA and DHA in a weight to weight ratio from about 3.5:1 to about 6.99 to 1. 
     
     
         2 . The pharmaceutical formulation of  claim 1 , comprising EPA and DHA in a weight to weight ratio from about 4.01:1 to about 6.99:1. 
     
     
         3 . The pharmaceutical formulation of  claim 1  comprising EPA and DHA in a weight to weight ratio from about 4.01:1 to about 5:1. 
     
     
         4 . The pharmaceutical formulation of  claim 1 , wherein the weight to weight ratio of EPA to DHA is approximately 4.1:1. 
     
     
         5 . The pharmaceutical formulation of  claim 1 , wherein a unit dosage form of the formulation comprises at least 50 mg DHA and at least 300 mg EPA. 
     
     
         6 . The pharmaceutical formulation of  claim 1 , wherein a unit dosage form of the formulation comprises at least 100 mg DHA and at least 400 mg EPA. 
     
     
         7 . The pharmaceutical formulation of  claim 1 , wherein a unit dosage form of the formulation comprises at least 125 mg DHA and 600 mg EPA. 
     
     
         8 . The pharmaceutical formulation of  claim 1 , wherein the formulation is in the form of a capsule. 
     
     
         9 . The pharmaceutical formulation of  claim 1 , wherein the formulation additionally comprises a stabilizer. 
     
     
         10 . The pharmaceutical formulation of  claim 1 , wherein the stabilizer is vitamin E. 
     
     
         11 . The pharmaceutical formulation of  claim 1 , wherein the formulation is more than 84% EPA and DHA by weight. 
     
     
         12 . The pharmaceutical formulation of  claim 1 , wherein formulation is more than 90% omega-3 fatty acids by weight by weight. 
     
     
         13 . The pharmaceutical formulation of  claim 1 , wherein the formulation comprises less than 1% cholesterol. 
     
     
         14 . The pharmaceutical formulation of  claim 1 , wherein the formulation comprises less than 10 meq/kg peroxides. 
     
     
         15 . A packaged pharmaceutical formulation, comprising the formulation of  claim 1  together with instructions for using the formulation to treat a cardiovascular disorder, feeding disorder, central nervous system disorder, autoimmune disorder, inflammatory disorder or chronic pain. 
     
     
         16 . The packaged pharmaceutical formulation of  claim 15 , wherein the dosage form is a gel or liquid capsule and is packaged in blister packages of about 20 capsules per sheet. 
     
     
         17 . A method of treating alopecia, Alzheimer's dementia, anxiety disorders, asthma, attention deficit disorder, attention-deficit hyperactivity disorder, atopic dermatitis, autism, bipolar disorder, borderline personality disorder, cardiovascular disease, chronic fatigue syndrome, chronic pain, chronic polyarthritis, cognitive disorders, communication disorders, Crohn's disease, cystic fibrosis, dementia, depression, diabetes, diabetes-related sequelae, diabetic neuropathy, dry eyes, dry skin, dysmenorrhea, eating disorders, eczema, fibromyalgia, gout, learning disorders, lupus, male infertility, metabolic syndrome, melanoma, mild cognitive impairment, migraine, mood disorders, multiple sclerosis, obsessive-compulsive disorder, oppositional-defiant disorder, osteoarthritis, osteoporosis, pervasive developmental disorders, polyarteritis nodosa, psoriasis, psoriatic arthritis, rheumatoid arthritis, schizophrenia, sclerodermia, self-injurious behavior, sickle cell anemia, tic disorders, ulcerative colitis, vasculitic disorders, or weight loss cachexia associated with chemotherapy, by providing the formulation of  claim 1 , to a patient in need thereof. 
     
     
         18 . The method of treatment of  claim 17 , wherein the cardiovascular disease is angina, atherosclerosis, hypercholesterolemia, hypertriglyceridemia, low HDL, high blood pressure, Raynaud's disease, and cardiac arrhythmias. 
     
     
         19 . A method of preventing surgical complications by providing the formulation of  claim 1  to a patient prior to, or after, a cardiovascular surgical procedure being performed on the patient. 
     
     
         20 . The method of  claim 19 , wherein the surgical procedure is cardiotomy. 
     
     
         21 . A method of reducing the risk a second myocardial infarction by providing the pharmaceutical formulation of  claim 1  at least one time per day for at least 60 days following the experience of first myocardial infarction by the patient. 
     
     
         22 . A method of treating or preventing basal cell carcinoma by providing the pharmaceutical formulation of  claim 1 , to a patient in need thereof. 
     
     
         23 . The method of treatment of  claim 17 , wherein 750 to 3000 mg of the formulation are provided daily. 
     
     
         24 . The pharmaceutical formulation of  claim 1  wherein the EPA and DHA are in the ethyl ester form.