US 11,883,539 B2 · 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.

Claims7

Dependent claims

A softgel capsule having a unit dose of a pharmaceutical composition, wherein the pharmaceutical composition consists of:

(a) berberine (BBR), or a chloride, sulfate or citrate salt thereof;
(b1) eicosapentaenoic acid (EPA), or an ethyl ester thereof;
(b2) docosahexaenoic acid (DHA), or an ethyl ester thereof;
and
(c) a pharmaceutically acceptable excipient, carrier, or diluent,
wherein a weight ratio of the BBR to EPA and DHA is from about 3:1 to about 1:8, and the pharmaceutical composition does not contain any active agent that elicits a biological response, other than said (a), (b1) and (b2).

3 more elements

Dependencies are inferred from the claim text.

Facts

Application

17/744,685Filed 15 May 2022 · continuation

Priority

13 Nov 2015

Published

US 2022/0296528 A122 Sep 2022

Granted

30 Jan 2024

Term ends

Not estimatedThe source records don’t support an estimate.

Classification9 codes

A61K 9/48
Medicinal preparations characterised by special physical form: preparations in capsules, e.g. of gelatin, of chocolate
A61K 31/202
Having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids: having three or more double…
A61K 31/232
Of acids having a carboxyl group bound to a chain of seven or more carbon atoms: having three or more double bonds, e.g. etretinate
A61K 31/4375
Ortho- or peri-condensed with heterocyclic ring systems: the heterocyclic ring system containing a six-membered ring having nitrogen as a ring…

Family

Application62/254,739Us provisional application · filed 13 Nov 2015

PCT/CN2016/105294Parent of this continuation-in-part · filed 10 Nov 2016

Application15/384,943Parent of this division · filed 20 Dec 2016

Application16/857,798Parent of this continuation · filed 24 Apr 2020

US 2022/0296528 A1Pre-grant publication · published 22 Sep 2022

US 11,369,573 B2Parent of this continuation

Application16/857,798Parent of this division

Application15/384,943Parent of this continuation-in-part

US 2017/0135995 A1Published application

US 2020/0405646 A1Published application

US 11,883,539 B2This patent

From the US filing history. Foreign family members aren’t listed.

Pharmaceutical compositions of berberine with EPA and DHA, and methods thereof

Life of this patent

Pharmaceutical compositions of berberine with EPA and DHA, and methods thereof

Life of this patent

Abstract

Claims7