# US 11,992,556 B2 · Pharmaceutical aerosol product for administration by oral or nasal inhalation

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- Number: US 11,992,556 B2
- Document ID: US11992556B2
- Status: Granted
- Kind: B2
- Application number: 17/319,655
- Filed: 2021-05-13
- Published: 2021-09-02
- Granted: 2024-05-28
- Earliest claimed: 2011-08-18
- Assignees: Covis Pharma GmbH
- Applicants: Covis Pharma GmbH
- Inventors: Helgert Müller; Renate Engelstätter; Ulrich Bildmann; Andrea Bauer; Paul McGlynn
- Web page: https://patentgrep.com/patent/US11992556B2

## CPC

- A61K 9/124: {characterised by the propellant}
- A61K 9/008: {comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]}
- A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048})
- A61M 11/04: operated by the vapour pressure of the liquid to be sprayed or atomised {(air-humidification, e.g. "room humidifiers" F24F6/00)}
- A61M 15/0001: {Details of inhalators; Constructional features thereof}
- A61M 15/0065: {Inhalators with dosage or measuring devices (A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52)}
- A61M 15/009: {using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08)}
- 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)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

This invention relates to a pharmaceutical aerosol product suitable for administration by oral or nasal inhalation and its use in the treatment of respiratory diseases, in particular in the treatment of children. The aerosol composition comprises ciclesonide, ethanol and either 1, 1, 1, 2-tetrafluoroethane, or 1, 1, 1, 2, 3, 3, 3-heptafluoropropane.

## Claims

### Claim 1

A method for preparing a pharmaceutical composition, the method comprising:
combining:
(a) ciclesonide,
(b) a propellant selected from 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane and a mixture thereof, and
(c) ethanol in an amount effective to solubilize the ciclesonide and
(d) optionally a surfactant,
wherein the concentration of ciclesonide in the composition is from 0.1 to 0.8 mg per ml, wherein the pharmaceutical composition is contained in an aerosol canister equipped with a metering valve.

### Claim 2 (depends on 1)

The method of claim 1, wherein the ciclesonide is solubilized by the ethanol.

### Claim 3 (depends on 1)

The method of claim 1, wherein the concentration of ciclesonide in the composition is from 0.4 to 0.5 mg per ml.

### Claim 4 (depends on 1)

The method of claim 1, wherein the concentration of ethanol in the composition is from 30 to 300 mg per ml.

### Claim 5 (depends on 1)

The method of claim 1, wherein the propellant is 1,1,1,2-tetrafluoroethane.

### Claim 6 (depends on 1)

The method of claim 1, wherein the propellant is 1,1,1,2,3,3,3-heptafluoropropane.

### Claim 7 (depends on 1)

The method of claim 1, wherein the concentration of propellant in the composition is from 1000 to 1400 mg per ml.

### Claim 8 (depends on 1)

The method of claim 1, wherein the combining comprises mixing the ciclesonide and ethanol to form a concentrate, and then adding and mixing the propellant to the concentrate.

### Claim 9 (depends on 1)

The method of claim 1, wherein the combining comprises mixing the ciclesonide and ethanol to form a concentrate.

### Claim 10 (depends on 9)

The method of claim 9, further comprising adding the concentrate into the aerosol canister.

### Claim 11 (depends on 10)

The method of claim 10, further comprising adding the propellant to the aerosol vial while under pressure.

### Claim 12 (depends on 1)

The method of claim 1, wherein the ciclesonide is the sole drug in the pharmaceutical composition.