# US 10,864,207 B2 · Method of treating endothelial dysfunction

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- Number: US 10,864,207 B2
- Document ID: US10864207B2
- Status: Granted
- Kind: B2
- Application number: 16/733,131
- Filed: 2020-01-02
- Published: 2020-07-16
- Granted: 2020-12-15
- Earliest claimed: 2019-01-02
- Assignees: Celagenex Research (India) Pvt. Ltd.
- Applicants: Celagenex Research (India) Pvt. Ltd.
- Inventors: Dhiraj Dhamane; Rajendra Prasad Tongra
- Web page: https://patentgrep.com/patent/US10864207B2

## CPC

- A61K 31/455: Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 31/5585: having five-membered rings containing oxygen as the only ring hetero atom, e.g. prostacyclin
- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A61K 36/21: Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/06: Antihyperlipidemics
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 7/02: Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 9/12: Antihypertensives
- A61P 9/14: Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
- A61P 13/12: of the kidneys
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention herein discloses potent synergistic compositions of vasoactive mediators enhancers for improving vascular endothelial function. Particularly, the invention relates to synergistic nutritional composition comprising exogenous blend of N1-methyl nicotinamide chloride and standardized red spinach extract enriched with nitrate content along with pharmaceutically acceptable excipients, wherein N1-methyl nicotinamide salt and standardized red spinach extract enriched with nitrate content are present in the ratio of 1:0.5 to 1:8; and N1-methyl nicotinamide chloride and nitrate of standardized red spinach extract, are present in the ratio of 1:0.1 to 1:1. The present synergistic composition is useful for treating endothelial dysfunction such as hypertension, atherosclerosis, thrombosis, myocardial infarction, heart injury.

## Claims

### Claim 1

A method of treatment of endothelial dysfunction in a subject in need thereof, wherein the method comprising, oral administration of a therapeutically effective amount of a nutritional composition comprising a synergistic blend of N-1 methyl nicotinamide chloride and standardized red amaranth extract enriched with 9-12% by weight nitrate content with pharmaceutically acceptable excipients,
wherein the N-1 methyl nicotinamide chloride and the standardized red amaranth extract enriched with nitrate content are present in a weight ratio of 1:1 to 1:6; and the N-1 methyl nicotinamide chloride and the nitrate content of the standardized red amaranth extract are present in a weight ratio of 1:0.1 to 1:0.6.

### Claim 2 (depends on 1)

The method of treatment according to claim 1, wherein the N-1 methyl nicotinamide chloride is present in a range of 5.0% to 50.0% by weight of the total composition.

### Claim 3 (depends on 1)

The method of treatment according to claim 1, wherein the standardized red amaranth extract enriched with nitrate content is present in a range of 30.0% to 90.0% by weight of the total composition.

### Claim 4 (depends on 1)

The method of treatment according to claim 1, wherein the nitrate content of the standardized red amaranth extract is present in the range of 9.0% to 12.0% by weight of the standardized red amaranth extract and 2.0 to 10.0% by weight of the total composition.

### Claim 5 (depends on 1)

The method of treatment according to claim 1, wherein the red amaranth extract is an aqueous extract of Amaranthus cruentus leaves.

### Claim 6 (depends on 1)

The method of treatment according to claim 1, wherein the endothelial dysfunction is selected from the group consisting of arteriosclerosis, chronic kidney disease (CKD), high blood pressure, lipid metabolism, diabetes, ulcer, obesity, metabolic syndrome, coronary artery disease, cerebrovascular disease, disseminated intravascular coagulation syndrome (DIC), aortic diseases, cardiovascular dysfunction, coronary artery disease (CAD), hypertension, microvascular angina, diastolic dysfunction, peripheral vascular disease (PAD), thrombosis, stroke, myocardial ischemia or infarction and dyslipidemia.

### Claim 7 (depends on 1)

The method of treatment according to claim 1, wherein the endothelial dysfunction is myocardial ischemia or infarction.

### Claim 8 (depends on 1)

The method of treatment according to claim 1, wherein the composition exhibits increased level of PGI2 expression by 0.27 folds over control.

### Claim 9 (depends on 1)

The method of treatment according to claim 1, wherein the composition exhibits increased level of eNOS expression by 0.46 folds over control.