Pharmaceutical compositions of berberine with epa and dha, and methods thereof

Abstract

The invention provides various novel compositions of berberine in combination with pharmacologically active EPA and DHA, and related methods of their use in treating various diseases or disorders. The pharmaceutical compositions of the invention are useful in treating and/or preventing various diseases or disorders, including metabolic diseases or disorders such as dyslipidemia, hyperglycemia, hypertriglyceridemia, hyperlipidemia, diabetic dyslipidemia, diabetic hyperlipidemia, dyslipidemia in statin-intolerance patients, diabetes, diabetic complications, hypercholesterolemia, or obesity. Additionally, the pharmaceutical compositions of the invention are useful in treating and/or preventing atherosclerosis, heart diseases, neurodegenerative diseases, inflammation, cancers, as well as various liver diseases or disorders, such as fatty liver, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, cholestatic liver diseases or graft-versus-host disease of the liver. Furthermore, the pharmaceutical compositions of the invention are useful in improving liver functions in chronic viral associated liver diseases and alcohol-related liver diseases.

Description

PRIORITY CLAIMS AND RELATED PATENT APPLICATIONS[0001]This application claims the benefit of priority, under 35 U.S.C. §120, from the U.S. designation of International Application No. PCT / CN2016 / 105294, filed on Nov. 10, 2016, which claims benefit of priority from U.S. Provisional Application Ser. No. 62 / 254,739, filed on Nov. 13, 2015, the entire content of each of PCT / CN2016 / 105294 and Ser. No. 62 / 254,739 is incorporated herein by reference in its entirety for all purposes.TECHNICAL FIELD OF THE INVENTION[0002]The invention generally relates to novel compositions and methods of preparation and therapeutic use thereof. In particular, the invention relates to novel pharmaceutical compositions of berberine in combination with omega-3 fatty acids, e.g., eicosapentaenoic acid (EPA) and / or docosahexaenoic acid (DHA), or esters thereof, and methods of their use. The pharmaceutical compositions of the invention are useful in treating and / or preventing various diseases or disorders, includi...

AI Technical Summary

Benefits of technology

[0020]In yet another aspect, the invention generally relates to a method for treating, reducing, or preventing a disease or disorder. The method includes: administering to a subject in need thereof a pharmaceutical composition comprising (a) berberine, in a therapeutically effective amount; (b) one or both of eicosapentaenoic acid, or a pharmaceutically acceptable ester thereof, and docosahexaenoic acid, or a pharmaceutically acceptable ester thereof, in therapeutically effective amounts, and (c) optionally a pharmaceutically acceptable excipient, carrier, or diluent. The disease or disorder is selected from metabolic diseases or disorders, heart diseases or disorders, neurodegenerative diseases or disorders, inflammation, cancers and liver diseases or disorders, or a relate

Problems solved by technology

Hyperglycemia is a potentially serious condition if not treated in time since ketoacidosis, a life-threatening condition, could occur and needs immediate treatment.

Chronic hyperglycemia causes injuries to the heart and is strongly associated with heart attacks and death in subjects with no coronary heart disease or history of heart failure.

Many therapeutic treatments are available for the management of type 2 diabetes, but they are often accompanied by various side effects.

Despite persistent efforts and meaningful progress over the past decades in the understanding and management of diabetes, people with diabetes continue to have an increased risk of, and many do suffer from, a number of serious complications inflicting the heart and blood vessels, eyes, kidneys, and nerves due to high blood glucose, high cholesterol, and high blood pressure.

Diabetic nephropathy caused by damages to small blood vessels in the kidney leads to decreased kidney function or kidney failure altogether.

Despite the development of a number of anti-diabetic agents, there are significant unmet needs for therapeutics that can be used effectively for the treatment and management of diabetic complications.

Metabolic syndrome has been demonstrated to increase the risk of developing cardiovascular diseas

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