# US 12,178,903 B1 · Liquid composition comprising glucose

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- Number: US 12,178,903 B1
- Document ID: US12178903B1
- Status: Granted
- Kind: B1
- Application number: 18/417,312
- Filed: 2024-01-19
- Granted: 2024-12-31
- Earliest claimed: 2022-07-29
- Assignees: Hikma Pharmaceuticals USA Inc.
- Applicants: Hikma Pharmaceuticals USA Inc.
- Inventors: Barbara Fumic; Stipica Tomic
- Web page: https://patentgrep.com/patent/US12178903B1

## CPC

- A61K 9/0029: {Parenteral nutrition; Parenteral nutrition compositions as drug carriers}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 31/7004: Monosaccharides having only carbon, hydrogen and oxygen atoms
- A61K 31/7016: Disaccharides, e.g. lactose, lactulose (lactobionic acid A61K31/7032)
- A61K 47/02: Inorganic compounds
- 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: 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)

## Abstract

The present disclosure relates to an aqueous composition stored in a single unit dosage container, where the aqueous composition consists of glucose, sodium bicarbonate, water, and a pH adjusting agent if needed to adjust the pH, wherein the pH of the composition is from 6.7 to 8.1. Such composition is stable for at least 3 months at room temperature conditions.

## Claims

### Claim 1

An aqueous composition stored in a single unit dosage container, where the aqueous composition consists of glucose in a concentration from 1 mg/ml to 50 mg/ml, sodium bicarbonate in concentration from 4 mg/ml to 15 mg/ml, water, and a pH adjusting agent to adjust the pH, wherein the pH of the composition is from 6.7 to 8.1,
wherein, after storing the composition for 3 months at 30° C., the composition contains less than or equal to 2% of fructose as determined by high pressure liquid chromatography (HPLC).

### Claim 2 (depends on 1)

The aqueous composition according to claim 1, wherein the glucose is selected from anhydrous glucose and glucose monohydrate.

### Claim 3 (depends on 1)

The aqueous composition according to claim 1, wherein the concentration of glucose is from 5 mg/ml to 50 mg/ml.

### Claim 4 (depends on 1)

The aqueous composition according to claim 1, wherein the concentration of glucose is from 15 mg/ml to 40 mg/ml.

### Claim 5 (depends on 1)

The aqueous composition according to claim 1, wherein the concentration of sodium bicarbonate is from 4.2 mg/ml to 12.6 mg/ml.

### Claim 6 (depends on 1)

The aqueous composition according to claim 1, wherein the pH is from 6.7 to 7.7.

### Claim 7 (depends on 1)

The aqueous composition according to claim 1, wherein the pH adjusting agent is CO2.

### Claim 8 (depends on 1)

The aqueous composition according to claim 1, wherein the single unit dosage container is a flexible plastic container.

### Claim 9 (depends on 8)

The aqueous composition according to claim 8, wherein the flexible plastic container is overwrapped with an overwrap.

### Claim 10 (depends on 9)

The aqueous composition according to claim 9, wherein the space between the flexible plastic container and the overwrap is vacuumed.

### Claim 11 (depends on 1)

The aqueous composition according to claim 1, wherein the composition has been aseptically filled into the single unit dosage container.

### Claim 12 (depends on 1)

A method of treating a human having metabolic acidosis, the method comprises:
(i) providing the aqueous composition of claim 1; and
(ii) administering the composition to the human from the single unit dosage container.

### Claim 13

A method of treating a human having metabolic acidosis, wherein the method comprises: (i) preparing an aqueous composition, the composition consisting of glucose in a concentration from 1 mg/ml to 50 mg/ml, sodium bicarbonate in concentration from 4 mg/ml to 15 mg/ml, a pH adjusting agent, water, and a pH control agent to adjust the pH, wherein the pH of the composition is from 6.7 to 8.1; (ii) storing the composition in a unit dosage container for at last 3 months at 30° C. after the preparation; and (iii) after storing, administering the composition to the human; wherein the composition that is administered to the human contains less than or equal to 2% of fructose as determined by HPLC.