# US 12,214,073 B2 · Nutritional compositions for the management of hyponatremia

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- Number: US 12,214,073 B2
- Document ID: US12214073B2
- Status: Granted
- Kind: B2
- Application number: 17/713,134
- Filed: 2022-04-04
- Published: 2022-07-21
- Granted: 2025-02-04
- Earliest claimed: 2019-10-03
- Assignees: Nephcentric, LLC
- Applicants: Nephcentric, LLC
- Inventors: Lee Souders; Bhupinder Singh
- Web page: https://patentgrep.com/patent/US12214073B2

## CPC

- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A23L 29/294: Inorganic additives, e.g. silica
- A23L 33/10: using additives (addition of substantially indigestible substances A23L33/21)
- A23L 33/125: containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates (indigestible substances A23L33/21)
- A61K 31/17: having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine (isoureas, isothioureas A61K31/155; sulfonylureas A61K31/64)
- A61K 31/715: Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K 31/718: Starch or degraded starch, e.g. amylose, amylopectin
- A61K 33/06: Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay}
- A61K 47/02: Inorganic compounds
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61P 7/08: Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock (artificial tears A61P27/04)
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- 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)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention involves novel urea compositions for oral administration, that are useful for treatment or management of hyponatremia. Also disclosed are novel methods of making the urea compositions.

## Claims

### Claim 1

A powder composition for treatment of hyponatremia comprising:
(a) 60-80 wt % urea;
(b) 7-12 wt % maltodextrin; and
(c) 5 wt % calcium silicate, wherein the powder composition is effective for treatment of hyponatremia.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the composition comprises about 9.7 wt % maltodextrin.

### Claim 3 (depends on 1)

The composition of claim 1, further comprising a flavoring agent.

### Claim 4 (depends on 1)

The composition of claim 1, further comprising citric acid, sucralose, and a flavoring agent.

### Claim 5 (depends on 1)

A method of treating hyponatremia comprising administering the composition of claim 1 to a patient suffering from hyponatremia.

### Claim 6 (depends on 5)

The method of claim 5, wherein the composition is administered by dispersing or dissolving the composition in water prior to consumption.

### Claim 7 (depends on 1)

The method of claim 1, wherein the composition is administered by mixing the composition with food prior to consumption.