AU2019253137B2 - Cyclosporine formulations for use in the treatment of bronchiolitis obliterans syndrome (bos) - Google Patents

Cyclosporine formulations for use in the treatment of bronchiolitis obliterans syndrome (bos) Download PDF

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Publication number
AU2019253137B2
AU2019253137B2 AU2019253137A AU2019253137A AU2019253137B2 AU 2019253137 B2 AU2019253137 B2 AU 2019253137B2 AU 2019253137 A AU2019253137 A AU 2019253137A AU 2019253137 A AU2019253137 A AU 2019253137A AU 2019253137 B2 AU2019253137 B2 AU 2019253137B2
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Prior art keywords
bos
csa
patient
use according
fev1
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AU2019253137A
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AU2019253137A1 (en
Inventor
Gerhard Börner
Oliver Denk
Aldo IACONO
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Breath Therapeutics GmbH
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Breath Therapeutics GmbH
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A61K38/13Cyclosporins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/127Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dispersion Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pulmonology (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Otolaryngology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2019253137A 2018-04-11 2019-04-09 Cyclosporine formulations for use in the treatment of bronchiolitis obliterans syndrome (bos) Active AU2019253137B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201862656226P 2018-04-11 2018-04-11
US62/656,226 2018-04-11
EP18172067 2018-05-14
EP18172067.3 2018-05-14
PCT/EP2019/058958 WO2019197406A1 (en) 2018-04-11 2019-04-09 Cyclosporine formulations for use in the treatment of bronchiolitis obliterans syndrome (bos)

Publications (2)

Publication Number Publication Date
AU2019253137A1 AU2019253137A1 (en) 2020-11-05
AU2019253137B2 true AU2019253137B2 (en) 2025-01-30

Family

ID=66049232

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2019253137A Active AU2019253137B2 (en) 2018-04-11 2019-04-09 Cyclosporine formulations for use in the treatment of bronchiolitis obliterans syndrome (bos)

Country Status (21)

Country Link
US (4) US11484566B2 (https=)
EP (2) EP4400119A3 (https=)
JP (2) JP2021520396A (https=)
CN (1) CN112105374A (https=)
AU (1) AU2019253137B2 (https=)
BR (1) BR112020020564A2 (https=)
CA (1) CA3094891A1 (https=)
CO (1) CO2020013427A2 (https=)
DK (1) DK3773664T3 (https=)
ES (1) ES2980198T3 (https=)
FI (1) FI3773664T3 (https=)
HR (1) HRP20241022T1 (https=)
HU (1) HUE067518T2 (https=)
IL (1) IL277253B2 (https=)
LT (1) LT3773664T (https=)
MX (1) MX2020010738A (https=)
PL (1) PL3773664T3 (https=)
RS (1) RS65713B1 (https=)
SI (1) SI3773664T1 (https=)
SM (1) SMT202400220T1 (https=)
WO (1) WO2019197406A1 (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3069711A1 (en) * 2015-03-16 2016-09-21 PARI Pharma GmbH Cyclosporine formulations for use in the prevention or treatment of pulmonary chronic graft rejection
HRP20241022T1 (hr) * 2018-04-11 2024-11-08 Breath Therapeutics Gmbh Formulacije ciklosporina za upotrebu u liječenju sindroma bronchiolitis obliterans (bos)
US10736847B2 (en) 2018-07-03 2020-08-11 Becton, Dickinson And Company Inverting device for liposome preparation by centrifugation
CN114642677A (zh) * 2020-12-21 2022-06-21 上海凯屹医药科技有限公司 一种稳定的含有苦丁皂苷类化合物的液体药物组合物

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000045834A2 (en) * 1999-02-05 2000-08-10 University Of Pittsburgh Of The Commonwealth System Of Higher Education Use of aerosolized cyclosporine for prevention and treatment of pulmonary disease

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005508220A (ja) 2001-10-24 2005-03-31 パーリ・ゲーエムベーハー 薬用組成物調製用具
DE102006051512A1 (de) 2005-12-06 2007-06-14 Pari GmbH Spezialisten für effektive Inhalation Pharmazeutische Medikamentenzusammensetzungen mit Cyclosporin
EP3069711A1 (en) 2015-03-16 2016-09-21 PARI Pharma GmbH Cyclosporine formulations for use in the prevention or treatment of pulmonary chronic graft rejection
HRP20241022T1 (hr) * 2018-04-11 2024-11-08 Breath Therapeutics Gmbh Formulacije ciklosporina za upotrebu u liječenju sindroma bronchiolitis obliterans (bos)

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000045834A2 (en) * 1999-02-05 2000-08-10 University Of Pittsburgh Of The Commonwealth System Of Higher Education Use of aerosolized cyclosporine for prevention and treatment of pulmonary disease

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
A.T. IACONO ET AL: "Aerosol cyclosporin therapy in lung transplant recipients with bronchiolitis obliterans", EUROPEAN RESPIRATORY JOURNAL, vol. 23, no. 3, 1 March 2004 (2004-03-01), pages 384 - 390, DOI: 10.1183/09031936.04.00058504 *
BEHR J., ET AL, "Lung Deposition of a Liposomal Cyclosporine A Inhalation Solution in Patients after Lung Transplantation", Journal of Aerosol Medicine and Pulmonary Drug Delivery, Jun 2009,121-130, http://doi.org/10.1089/jamp.2008.0714 *
IACONO A ET AL, "Stabilization of lung function and survival improvement by aerosolized liposomal cyclosporine a (L-CSA) for bronchiolitis obliterans syndrome", J. OF HEART AND LUNG TRANSPLANTATION, vol. 37, no. 4, Supp 1, April 2018, p S92 *

Also Published As

Publication number Publication date
US11484566B2 (en) 2022-11-01
HRP20241022T1 (hr) 2024-11-08
CN112105374A (zh) 2020-12-18
PL3773664T3 (pl) 2024-09-02
US20230364182A1 (en) 2023-11-16
CA3094891A1 (en) 2019-10-17
WO2019197406A1 (en) 2019-10-17
US20230128855A1 (en) 2023-04-27
JP2024069355A (ja) 2024-05-21
IL277253B1 (en) 2023-12-01
FI3773664T3 (fi) 2024-07-16
SI3773664T1 (sl) 2024-08-30
LT3773664T (lt) 2024-06-10
IL277253A (en) 2020-10-29
US12178843B2 (en) 2024-12-31
SMT202400220T1 (it) 2024-07-09
CO2020013427A2 (es) 2020-11-10
BR112020020564A2 (pt) 2021-01-12
ES2980198T3 (es) 2024-09-30
RS65713B1 (sr) 2024-08-30
DK3773664T3 (da) 2024-06-17
AU2019253137A1 (en) 2020-11-05
IL277253B2 (en) 2024-04-01
EP4400119A2 (en) 2024-07-17
EP4400119A3 (en) 2024-09-25
JP2021520396A (ja) 2021-08-19
US11701403B2 (en) 2023-07-18
EP3773664A1 (en) 2021-02-17
HUE067518T2 (hu) 2024-10-28
MX2020010738A (es) 2020-11-09
US20210077573A1 (en) 2021-03-18
EP3773664B1 (en) 2024-05-01
US20250090625A1 (en) 2025-03-20

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