# US 11,439,634 B2 · Medical skin external preparation

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- Number: US 11,439,634 B2
- Document ID: US11439634B2
- Status: Granted
- Kind: B2
- Application number: 16/465,559
- Filed: 2017-11-30
- Published: 2019-09-19
- Granted: 2022-09-13
- Earliest claimed: 2016-12-01
- Assignees: Maruho Co., Ltd.
- Applicants: Maruho Co., Ltd.
- Inventors: Tomoki Sakaguchi; Masumi Kawaguchi; Ayako Nakamura
- Web page: https://patentgrep.com/patent/US11439634B2

## CPC

- A61K 31/4709: Non-condensed quinolines and containing further heterocyclic rings
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/04: Antipruritics
- A61P 17/10: Anti-acne agents
- A61P 31/04: Antibacterial agents
- 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

## Abstract

An object of the present invention is mainly to provide a medical skin external preparation that is suitable for treating superficial skin infections, in particular, superficial skin infections accompanied by blister or erosion, etc. For example, the present invention can provide a medical skin external preparation containing 1-cyclopropyl-8-methyl-7-[5-methyl-6-(methylamino)-3-pyridyl]-4-oxo-1,4-dihydro-3-quinolinecarboxylic acid and/or a pharmaceutically acceptable salt thereof as an active ingredient, and an alcohol and/or a fatty acid having 12 or more carbon atoms.

## Claims

### Claim 1

A medical skin external preparation consisting essentially of:
about 2 wt % of 1-cyclopropyl-8-methyl-7-[5-methyl-6-(methylamino)-3-pyridyl]-4-oxo-1,4-dihydro-3-quinolinecarboxylic acid and/or a pharmaceutically acceptable salt thereof as an active ingredient;
about 2 wt % of stearic acid;
about 5 wt % of oleyl alcohol;
about 15 wt % of water;
one or more pH adjusting agents; and
white petrolatum, wherein the medical skin external preparation is a cream preparation having a pH of 9 to 13, and wherein the peroxide value is 120 meq/kg or less, wherein each wt % is with respect to the total weight of the preparation.

### Claim 2 (depends on 1)

The medical skin external preparation according to claim 1, consisting of:
1-cyclopropyl-8-methyl-7-[5-methyl-6-(methylamino)-3-pyridyl]-4-oxo-1,4-dihydro-3-quinolinecarboxylic acid and/or a pharmaceutically acceptable salt thereof;
stearic acid;
oleyl alcohol;
water;
the one or more pH adjusting agents; and
white petrolatum.

### Claim 3 (depends on 1)

The medical skin external preparation according to claim 1, wherein the content of a degradation product of the active ingredient is 0.5% or less with respect to the active ingredient.

### Claim 4 (depends on 1)

The medical skin external preparation according to claim 1, wherein the degradation product of the active ingredient is 1-cyclopropyl-3-hydroxy-8-methyl-7-(5-methyl-6-(methylamino)pyridin-3-yl)quinolin-4(1H)-one.

### Claim 5 (depends on 1)

The medical skin external preparation according to claim 1, wherein the peroxide value is 40 meq/kg or less.