# US 11,077,075 B2 · Methods of stabilizing epinephrine

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- Number: US 11,077,075 B2
- Document ID: US11077075B2
- Status: Granted
- Kind: B2
- Application number: 16/242,101
- Filed: 2019-01-08
- Published: 2019-07-11
- Granted: 2021-08-03
- Earliest claimed: 2018-01-10
- Assignees: Hikma Pharmaceuticals USA Inc.
- Applicants: Insys Development Company, Inc.
- Inventors: Eshwaran Narayanan; Rajesh Wakaskar; Chandeshwari Chilampalli; Thrimoorthy Potta; Venkat R. Goskonda
- Web page: https://patentgrep.com/patent/US11077075B2

## CPC

- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61J 1/00: Containers specially adapted for medical or pharmaceutical purposes (capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00)
- A61K 9/0043: {Nose}
- A61K 47/02: Inorganic compounds
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/186: {Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide}
- 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)
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE

## Abstract

The present invention is directed to methods of stabilizing a pharmaceutical composition comprising epinephrine containing the steps filling a container, capping the container, assembling the container and placing the assembled capped container (assembled device) in a secondary packaging system.

## Claims

### Claim 1

A method of stabilizing a pharmaceutical composition comprising from about 1% to about 12% w/w epinephrine, from about 10% to about 60% w/w ethanol, from about 2% to about 20% w/w propylene glycol, from about 0.001% to about 0.02% w/w benzalkonium chloride and from about 0.01% to about 0.1% w/w edetate disodium dihydrate comprising the steps of:
a. filling a container with the pharmaceutical composition under a vacuum or a gas overlay;
b. closing the container;
c. placing the closed container in a holder and actuator to create an assembled device;
d. placing the assembled device in a secondary packaging system under one or more conditions selected from the group consisting of under a gas overlay, with an oxygen absorbing means and with oxygen indicator; and
e. sealing the secondary packaging system,
wherein the container is selected from the group consisting of a glass vial, a plastic vial, a glass bottle and a plastic bottle and the secondary packaging system is selected from the group consisting of a pouch and a blister package and wherein w/w denotes weight to total weight of the composition.

### Claim 2 (depends on 1)

The method of claim 1, wherein the gas is selected from the group consisting of helium, neon, argon, krypton, xenon, radon and nitrogen.

### Claim 3 (depends on 2)

The method of claim 2, wherein the gas is nitrogen.

### Claim 4 (depends on 1)

The method of claim 1, wherein the assembled device comprises a glass vial, a rubber stopper, a vial holder and an actuator.

### Claim 5 (depends on 1)

The method of claim 1, wherein the secondary packaging system contains an oxygen absorbing means.

### Claim 6 (depends on 5)

The method of claim 5, wherein the oxygen absorbing means is provided by one or more walls of the secondary packaging system.

### Claim 7 (depends on 5)

The method of claim 5, wherein the oxygen absorbing means is provided by an auxiliary oxygen absorber displaced between two or more walls of the secondary packaging system.

### Claim 8 (depends on 7)

The method of claim 7, wherein the oxygen absorbing means is in a form selected from the group consisting of a pellet, a strip, a sheet and a packet.

### Claim 9 (depends on 7)

The method of claim 7, wherein the auxiliary oxygen absorber is iron based or polymer based.

### Claim 10 (depends on 9)

The method of claim 9, wherein the auxiliary oxygen absorber is iron based.

### Claim 11 (depends on 10)

The method of claim 10, wherein the iron based auxiliary oxygen absorber provides absorption of from about 1 to about 3,000 cubic centimeters of oxygen.

### Claim 12 (depends on 10)

The method of claim 10, wherein the iron based auxiliary oxygen absorber provides absorption of from about 10 to about 1,000 cubic centimeters of oxygen.

### Claim 13 (depends on 10)

The method of claim 10, wherein the iron based auxiliary oxygen absorber provides absorption of from about 50 to about 500 cubic centimeters of oxygen.

### Claim 14 (depends on 10)

The method of claim 10, wherein the iron based auxiliary oxygen absorber provides absorption of about 100 cubic centimeters of oxygen.

### Claim 15 (depends on 1)

The method of claim 1, wherein the secondary packaging system contains an oxygen indicator.

### Claim 16 (depends on 15)

The method of claim 15, comprising an oxygen indicator in a form of a pellet, a strip, a sheet and a packet.