IP Library Granted Patent US 12,370,141
Granted Patent B2
US 12,370,141 · App. 18/425,676 · Granted Jul 29, 2025

Pharmaceutical aerosol product for administration by oral or nasal inhalation

Inventors: Helgert Müller (Radolfzell, DE); Renate Engelstätter (Allensbach, DE); Ulrich Bildmann (Hilzingen, DE); Andrea Bauer (North Reading, MA); Paul McGlynn (Northborough, MA)
Assignee: Covis Pharma GmbH
A61K9/124A61K9/008A61K31/58A61M11/04A61M15/0001A61M15/0065A61M15/009
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Quick Facts
Patent No.
US 12,370,141
App. No.
18/425,676
Granted
Jul 29, 2025
Kind
B2
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 (17)

1. A pharmaceutical product comprising an aerosol canister equipped with a metering valve and containing a pharmaceutical composition comprising the following components:

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 pharmaceutical composition is from 0.1 to 0.8 mg per ml.

2. The pharmaceutical product according to claim 1 , wherein the concentration of ciclesonide in the pharmaceutical composition is from 0.4 to 0.6 mg per ml.

3. The pharmaceutical product according to claim 1 , wherein the concentration of ciclesonide in the pharmaceutical composition is 0.5 mg per ml.

4. The pharmaceutical product according to claim 1 , wherein the pharmaceutical concentration is free of surfactant.

5. The pharmaceutical product according to claim 1 , wherein the pharmaceutical concentration has a concentration of ethanol from 30 to 300 mg per ml.

6. The pharmaceutical product according to claim 1 , wherein the pharmaceutical concentration has a concentration of ethanol from 90 to 100 mg per ml.

7. The pharmaceutical product according to claim 1 , wherein the propellant is 1,1,1,2,3,3,3-heptafluoropropane.

8. The pharmaceutical product according to claim 1 , wherein the propellant is 1,1,1,2-tetrafluoroethane.

9. The pharmaceutical product according to claim 1 , further comprising an actuator.

10. A method for treating a respiratory disease in a patient, comprising administering to the patient a dose of a pharmaceutical composition using the pharmaceutical product according to claim 1 .

11. A method for treating nasal symptoms associated with allergic rhinitis in a child, comprising administering to the nose of the child a dose of a composition using the pharmaceutical product according to claim 1 .

12. A pharmaceutical product according to claim 1 for treating nasal symptoms associated with allergic rhinitis in a child.

Assignments (1)
CONFIRMATORY GRANT OF SECURITY INTEREST IN UNITED STATES PATENTS Recorded May 27, 2025
From: COVIS PHARMA GBMH
To: HPS INVESTMENT PARTNERS, LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 071409/0368 →
Priority Claims (1)
EP 11178042 · Aug 19, 2011 · regional
Continuity (4)
Continuation 17319655 · May 13, 2021
Continuation 14238055
Provisional Application 61524803 · Aug 18, 2011
Related Publication 20240226006A1 · Jul 11, 2024
References Cited (37)
US 5290539A · Marecki · 1994 [cited by applicant]
US 5474758A · Kwon · 1995 [cited by applicant]
US 5482934A · Calatayud et al. · 1996 [cited by applicant]
US 5622163A · Jewett · 1997 [cited by applicant]
US 5836299A · Kwon · 1998 [cited by applicant]
US 5871007A · Clark, Jr. · 1999 [cited by applicant]
US 6120752A · Oliver · 2000 [cited by applicant]
US 6264923B1 · Oliver · 2001 [cited by applicant]
US 8371292B2 · Bethke · 2013 [cited by applicant]
US 11007150B2 · Muller · 2021 [cited by applicant]
US 20040023935A1 · Banerjee et al. · 2004 [cited by applicant]
US 20060127323A1 · Dietzel et al. · 2006 [cited by applicant]
US 20060151524A1 · Stradella et al. · 2006 [cited by applicant]
US 20060163275A1 · Stradella et al. · 2006 [cited by applicant]
US 20070029341A1 · Stradella et al. · 2007 [cited by applicant]
US 20070134165A1 · Wurst · 2007 [cited by applicant]
US 20090318397A1 · Lulla et al. · 2009 [cited by applicant]
US 20130095146A1 · Nagano · 2013 [cited by applicant]
US 20130173849A1 · Wurst · 2013 [cited by applicant]
US 20160015634A1 · Brueck-Scheffler · 2016 [cited by applicant]
US 20190290661A1 · Wurst · 2019 [cited by applicant]
WO 9206675A1 · 1992 [cited by applicant]
WO 9211190A2 · 1992 [cited by applicant]
WO 9508484A1 · 1995 [cited by applicant]
WO 9526769A1 · 1995 [cited by applicant]
WO 9603172A1 · 1996 [cited by applicant]
WO 9632150A1 · 1996 [cited by applicant]
WO 9639337A1 · 1996 [cited by applicant]
WO 9852542A1 · 1998 [cited by applicant]
WO 2004110460A1 · 2004 [cited by applicant]
WO 2005025578A1 · 2005 [cited by applicant]
WO 2005060441A2 · 2005 [cited by applicant]
WO 2007103712A2 · 2007 [cited by applicant]
Cunha (eMedicalhealth (2022) 11 pages. [cited by examiner]
Sirand, Christophe, et al., “Aerosol-Filing Equipment for the Preparation of Pressurized Pack Pharmaceutical Formulations”, Pharmaceutical Inhalation Aerosol Technology, 1992, pp. 187-217. [cited by applicant]
Mealy, N.E., et al., “Ciclesonide”, Drugs of the Future 2001, 26(11), pp. 1033-1039. [cited by applicant]
Wilkinon, Anthony, “The Manufacture of Metered Dose Inhalers”, Metered Dose Inhaler Technology, CRC Press 1997, pp. 69-116. [cited by applicant]