# US 10,117,862 B2 · Remifentanil injection

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- Number: US 10,117,862 B2
- Document ID: US10117862B2
- Status: Granted
- Kind: B2
- Application number: 15/457,142
- Filed: 2017-03-13
- Published: 2017-06-29
- Granted: 2018-11-06
- Earliest claimed: 2014-09-12
- Assignees: Terumo Kabushiki Kaisha
- Applicants: Terumo Kabushiki Kaisha
- Inventors: Aiko Horiuchi; Shigeru Suzuki
- Web page: https://patentgrep.com/patent/US10117862B2

## CPC

- A61K 31/4468: having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
- 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 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone}
- A61K 31/445: Non condensed piperidines, e.g. piperocaine
- A61K 31/55: having seven-membered rings, e.g. azelastine, pentylenetetrazole
- 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

A remifentanil injection solution formulation contains remifentanil and or physiologically acceptable salts thereof, water, and a stabilizer, the remifentanil injection solution formulation contains said water at a rate of 0.007 to 0.025 mL per 1 mg of said remifentanil.

## Claims

### Claim 1

A remifentanil injection solution formulation comprising
water, a stabilizer and remifentanil and/or physiologically acceptable salts thereof,
wherein said stabilizer is polyethylene glycol or propylene glycol,
said remifentanil injection solution formulation contains said water at a rate of 0.007 to 0.025 mL per 1 mg of said remifentanil, and
a content ratio between said water and said stabilizer is set to 2:23 to 2:198 in a volume ratio.

### Claim 2 (depends on 1)

A remifentanil injection solution formulation according to claim 1, as a content of said remifentanil and/or said physiologically acceptable salts thereof to be contained in said remifentanil injection solution formulation, 1 to 10 mg of said remifentanil is contained in said remifentanil injection solution formulation per 1 mL thereof.

### Claim 3 (depends on 1)

A remifentanil injection solution formulation according to claim 1, wherein said remifentanil injection solution formulation has a survival rate of remifentanil not less than 95% after the remifentanil injection solution formulation was stored at 60 degrees C. for one week.

### Claim 4 (depends on 1)

A remifentanil injection solution formulation according to claim 1, wherein said stabilizer is polyethylene glycol, said remifentanil and/or physiologically acceptable salts thereof is remifentanil hydrochloride, said remifentanil injection solution formulation contains said water at a rate of 0.007 to 0.025 mL per 1 mg of said remifentanil hydrochloride, and a content ratio between said water and said polyethylene glycol is set to 2:23 to 2:198 in a volume ratio.

### Claim 5 (depends on 1)

A remifentanil injection solution formulation according to claim 1, wherein said remifentanil injection solution formulation contains a colorant.

### Claim 6

A prefilled syringe filled a remifentanil injection solution formulation and subjected to high-pressure steam sterilization,
wherein said remifentanil injection solution formulation comprises water, a stabilizer and remifentanil and/or physiologically acceptable salts thereof,
said stabilizer is polyethylene glycol or propylene glycol,
said remifentanil injection solution formulation contains said water at a rate of 0.007 to 0.025 mL per 1 mg of said remifentanil, and
a content ratio between said water and said stabilizer is set to 2:23 to 2:198 in a volume ratio.

### Claim 7 (depends on 6)

A prefilled syringe according to claim 6, wherein said prefilled syringe comprises a gasket made of butyl rubber and syringe body made of cyclic polyolefin.

### Claim 8 (depends on 7)

A prefilled syringe according to claim 7, wherein said syringe body has a capacity of 1 mL.