# US 10,869,845 B1 · Ephedrine compositions and methods

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- Number: US 10,869,845 B1
- Document ID: US10869845B1
- Status: Granted
- Kind: B1
- Application number: 16/749,378
- Filed: 2020-01-22
- Granted: 2020-12-22
- Earliest claimed: 2020-01-22
- Assignees: Nevakar Inc.
- Applicants: Nevakar Inc.
- Inventors: Irfan Ali Mohammed; Tushar Hingorani; Kumaresh Soppimath
- Web page: https://patentgrep.com/patent/US10869845B1

## CPC

- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- 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 47/02: Inorganic compounds
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- 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

Disclosed herein are storage-stable ephedrine single-phase solution compositions, comprising 4 mg/mL to 6 mg/mL of ephedrine, a pH adjuster comprising acetic acid, and water, wherein the composition has a pH between 4.5 and 5.0; and wherein the pH drift of the composition is less than 0.5 after storage over at least two months at 25° C. and 60% relative humidity. Also disclosed herein are methods of making and using the same.

## Claims

### Claim 1

A storage-stable, sterile ephedrine ready-to-use solution composition, comprising:
about 5 mg/mL of ephedrine or a pharmaceutically acceptable salt thereof;
about 9 mg/mL of sodium chloride;
a pH adjuster comprising acetic acid; and
water,
wherein the initial adjusted pH of the composition is in the range of 4.6 to 4.8;
wherein the pH drift of the composition is less than 0.5 after storage for 6 months at 25° C. and 60% relative humidity; and
wherein the composition contains about 5% or less total impurities after storage for 6 months at 25° C. and 60% relative humidity as determined by HPLC.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the initial adjusted pH of the composition is 4.7.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the composition is substantially free of a preservative.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the composition is provided in a vial or a syringe.

### Claim 5 (depends on 4)

The composition of claim 4, wherein the composition is provided in a polypropylene syringe.

### Claim 6 (depends on 4)

The composition of claim 4, wherein the composition is provided in a glass vial.

### Claim 7 (depends on 1)

The composition of claim 1, wherein the ephedrine comprises ephedrine sulfate.

### Claim 8 (depends on 1)

The composition of claim 1, wherein the composition is sterilized by a process comprising sterile filtration.

### Claim 9 (depends on 1)

The composition of claim 1, wherein the composition is sterilized by a process comprising autoclaving.

### Claim 10

A storage-stable, sterile ephedrine ready-to-use solution composition having pH drift of less than 0.5 after storage for 6 months at 25° C. and 60% relative humidity, and wherein the composition contains about 5% or less total impurities after storage for 6 months at 25° C. and 60% relative humidity as determined by HPLC, wherein the composition is prepared by a process comprising the steps of:
formulating an aqueous solution comprising about 5 mg/mL of ephedrine and about 9 mg/mL of sodium chloride;
adjusting the pH of the solution to between 4.6-4.8 with a pH adjuster comprising acetic acid.

### Claim 11 (depends on 10)

The composition of claim 10, wherein the initial adjusted pH of the composition is 4.7.

### Claim 12 (depends on 10)

The composition of claim 10, wherein the composition is substantially free of a preservative.