# US 11,998,565 B2 · Trace element compositions, methods of making and use

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- Number: US 11,998,565 B2
- Document ID: US11998565B2
- Status: Granted
- Kind: B2
- Application number: 18/124,391
- Filed: 2023-03-21
- Published: 2023-09-28
- Granted: 2024-06-04
- Earliest claimed: 2020-07-02
- Assignees: American Regent, Inc.
- Applicants: American Regent, Inc.
- Inventors: Gopal Anyarambhatla; Richard Lawrence; Jasmina Marinkovic
- Web page: https://patentgrep.com/patent/US11998565B2

## CPC

- A61K 33/30: Zinc; Compounds thereof
- A61K 47/02: Inorganic compounds
- A61K 9/0029: {Parenteral nutrition; Parenteral nutrition compositions as drug carriers}
- A61K 31/7004: Monosaccharides having only carbon, hydrogen and oxygen atoms
- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A61K 33/04: Sulfur, selenium or tellurium; Compounds thereof
- A61K 33/06: Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay}
- A61K 33/22: Boron compounds
- A61K 33/24: Heavy metals; Compounds thereof
- A61K 33/32: Manganese; Compounds thereof
- A61K 33/34: Copper; Compounds thereof
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/20: containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
- A61P 3/02: Nutrients, e.g. vitamins, minerals
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Injectable compositions that can be added to parenteral nutrition are provided. In particular, a stable injectable composition is provided which includes water, and at least one of about 800 μg to about 4,000 μg of zinc, about 40 μg to about 400 μg of copper, from about 4 μg to about 90 μg of selenium, or from about 1 μg to about 80 μg of manganese per 1 mL of the injectable composition. Methods of preparing and using of the stable injectable composition are also provided.

## Claims

### Claim 1

An injectable composition comprising water, 6 μg or 60 μg of selenium, no chromium or chromium in an amount not to exceed 1 μg, no aluminum or aluminum in an amount not to exceed 6 μg, no iron or iron in an amount up to 10 μg, and fluoride in an amount of 0.0001 μg to 2.7 μg per 1 mL of the injectable composition.

### Claim 2 (depends on 1)

The injectable composition of claim 1, wherein the injectable composition comprises 60 μg of selenium per 1 mL of the injectable composition.

### Claim 3 (depends on 1)

The injectable composition of claim 1, wherein the injectable composition comprises 6 μg of selenium per 1 mL of the injectable composition.

### Claim 4 (depends on 1)

The injectable composition of claim 1, wherein the injectable composition contains 0.0001 μg to 0.6 μg of aluminum per 1 mL of the injectable composition.

### Claim 5 (depends on 1)

The injectable composition of claim 1, wherein the injectable composition contains 0.0001 μg to 10 μg of iron per 1 mL of the injectable composition.

### Claim 6 (depends on 1)

The injectable composition of claim 1, wherein the injectable composition is suitable for administration to an adult or pediatric patient when added to parenteral nutrition.

### Claim 7 (depends on 1)

The injectable composition of claim 1, wherein the injectable composition contains iodine in an amount of 0.0001 μg to 0.2 μg per 1 mL of the injectable composition.

### Claim 8 (depends on 1)

The injectable composition of claim 1, wherein the injectable composition has a pH of 1.8 to 2.4.

### Claim 9 (depends on 1)

The injectable composition of claim 1, wherein the injectable composition further comprises nitric acid.

### Claim 10 (depends on 1)

The injectable composition of claim 1, wherein the selenium is elemental selenium from selenious acid.

### Claim 11 (depends on 2)

The injectable composition of claim 2, wherein the selenium is elemental selenium from selenious acid.

### Claim 12 (depends on 3)

The injectable composition of claim 3, wherein the selenium is elemental selenium from selenious acid.

### Claim 13 (depends on 1)

The injectable composition of claim 1, wherein the injectable composition contains 0.0001 μg/mL to 0.25 μg/mL of chromium.

### Claim 14 (depends on 1)

The injectable composition of claim 1, wherein the injectable composition contains 1 ppm to 6 μg/mL of aluminum.

### Claim 15

An injectable composition comprising water, 6 μg or 60 μg of selenium, no chromium or chromium in an amount not to exceed 1 μg, no aluminum or aluminum in an amount not to exceed 6 μg, no iron or iron in an amount up to 10 μg, and iodine in an amount of 0.0001 μg to 0.2 μg per 1 mL of the injectable composition.

### Claim 16 (depends on 1)

The injectable composition of claim 1, wherein the injectable composition comprises 0.0001 μg to 0.25 μg of chromium; 0.0001 μg to 0.6 μg of aluminum; 0.0001 μg to 10 μg of iron; 0.0001 μg to 0.2 μg of iodine; and 0.0001 μg to 100 μg of silicon per mL of the injectable composition.

### Claim 17 (depends on 15)

The injectable composition of claim 15, wherein the injectable composition is suitable for administration to an adult or pediatric patient.

### Claim 18 (depends on 3)

The injectable composition of claim 3, wherein the injectable composition is suitable for administration to a pediatric or neonatal patient when added to parenteral nutrition.

### Claim 19 (depends on 15)

The injectable composition of claim 15, wherein the selenium is elemental selenium from selenious acid.

### Claim 20 (depends on 15)

The injectable composition of claim 15, wherein the injectable composition comprises 60 μg of selenium per 1 mL of the injectable composition.

### Claim 21 (depends on 15)

The injectable composition of claim 15, wherein the injectable composition comprises 6 μg of selenium per 1 mL of the injectable composition.

### Claim 22 (depends on 1)

The injectable composition of claim 1, wherein the injectable composition is in a volume that fills a 1 mL, 2 mL, 3 mL, 5 mL or 10 mL vial.

### Claim 23 (depends on 15)

The injectable composition of claim 15, wherein the injectable composition comprises 0.0001 μg to 0.25 μg of chromium; 0.0001 μg to 0.6 μg of aluminum; 0.0001 μg to 10 μg of iron; 0.0001 μg to 2.7 μg of fluoride; and 0.0001 μg to 100 μg of silicon per mL of the injectable composition.

### Claim 24 (depends on 1)

The injectable composition of claim 1, wherein the injectable composition contains less than 0.25 μg/mL of chromium.

### Claim 25 (depends on 1)

The injectable composition of claim 1, wherein permitted daily limits (PDL) of the injectable composition do not exceed 0.4 μg/day of cadmium, 0.5 μg/day of lead, 1.5 μg/day of arsenic, 0.4 μg/day of mercury, 1 μg/day of cobalt, about 2 μg/day of vanadium, 4 μg/day of nickel, 1.6 μg/day of thallium, 20 μg/day of gold, 2 μg/day of palladium, 2 μg/day of iridium, 2 μg/day of osmium, 2 μg/day of rhodium, 2 μg/day of ruthenium, 2 μg/day of silver, 2 μg/day of platinum, 50 μg/day of lithium, 18 μg/day of antimony, 140 μg/day of barium, 300 μg/day of molybdenum, 120 μg/day of tin, 1 μg/day of chromium, 6 μg/day of aluminum, 50 μg/day of boron, 50 μg/day of calcium, 10 μg/day of iron, 94,000 μg/day of potassium, 50 μg/day of magnesium, 24,000 μg/day of sodium, 1 μg/day of tungsten, and/or 100 μg/day of silicon.

### Claim 26

An injectable composition consisting essentially of water, nitric acid, selenious acid 98 μg, no chromium or chromium in an amount not to exceed 1 μg, no aluminum or aluminum in an amount not to exceed 6 μg, no iron or iron in an amount up to 10 μg, and fluoride in an amount of 0.0001 μg to 2.7 μg or iodine in an amount of 0.0001 μg to 0.2 μg per 1 mL of the injectable composition.

### Claim 27

An injectable composition consisting essentially of water, nitric acid, selenious acid 9.8 μg, no chromium or chromium in an amount not to exceed 1 μg, no aluminum or aluminum in an amount not to exceed 6 μg, no iron or iron in an amount up to 10 μg, and fluoride in an amount of 0.0001 μg to 2.7 μg or iodine in an amount of 0.0001 μg to 0.2 μg per 1 mL of the injectable composition.

### Claim 28 (depends on 1)

The injectable composition of claim 1, wherein the injectable composition is in a glass vial or ampule and has a silicon impurity in an amount of not more than 100 μg/mL.

### Claim 29 (depends on 15)

The injectable composition of claim 15, wherein the injectable composition further comprises nitric acid and has a pH of 1.8 to 2.4.