AU2021263580B2 - Clofazimine composition and method for the treatment or prophylaxis of viral infections - Google Patents

Clofazimine composition and method for the treatment or prophylaxis of viral infections

Info

Publication number
AU2021263580B2
AU2021263580B2 AU2021263580A AU2021263580A AU2021263580B2 AU 2021263580 B2 AU2021263580 B2 AU 2021263580B2 AU 2021263580 A AU2021263580 A AU 2021263580A AU 2021263580 A AU2021263580 A AU 2021263580A AU 2021263580 B2 AU2021263580 B2 AU 2021263580B2
Authority
AU
Australia
Prior art keywords
clofazimine
composition
inhalable
viral infection
salt
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
AU2021263580A
Other languages
English (en)
Other versions
AU2021263580A1 (en
Inventor
John J. Freeman Jr.
Thomas Hofmann
Stefan Ufer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mannkind Corp
Original Assignee
Mannkind Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mannkind Corp filed Critical Mannkind Corp
Publication of AU2021263580A1 publication Critical patent/AU2021263580A1/en
Application granted granted Critical
Publication of AU2021263580B2 publication Critical patent/AU2021263580B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/498—Pyrazines or piperazines ortho- and peri-condensed with carbocyclic ring systems, e.g. quinoxaline, phenazine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Virology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Biochemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
AU2021263580A 2020-05-01 2021-04-30 Clofazimine composition and method for the treatment or prophylaxis of viral infections Active AU2021263580B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063018677P 2020-05-01 2020-05-01
US63/018,677 2020-05-01
PCT/US2021/030155 WO2021222740A1 (en) 2020-05-01 2021-04-30 Clofazimine composition and method for the treatment or prophylaxis of viral infections

Publications (2)

Publication Number Publication Date
AU2021263580A1 AU2021263580A1 (en) 2022-11-24
AU2021263580B2 true AU2021263580B2 (en) 2026-08-06

Family

ID=78332269

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2021263580A Active AU2021263580B2 (en) 2020-05-01 2021-04-30 Clofazimine composition and method for the treatment or prophylaxis of viral infections

Country Status (9)

Country Link
US (1) US20230248722A1 (enExample)
EP (1) EP4142691A4 (enExample)
JP (1) JP7893751B2 (enExample)
KR (1) KR20230005937A (enExample)
CN (1) CN115666510A (enExample)
AU (1) AU2021263580B2 (enExample)
BR (1) BR112022022081A2 (enExample)
CA (1) CA3177438A1 (enExample)
WO (1) WO2021222740A1 (enExample)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023102363A1 (en) * 2021-11-30 2023-06-08 Mannkind Corporation Formulation and method for topical treatment of mycobacterium ulcerans in buruli ulcers
JP2025529312A (ja) * 2022-09-06 2025-09-04 マンカインド コーポレイション 非結核性抗酸菌症を処置するための方法
WO2025091042A1 (en) * 2023-10-27 2025-05-01 Mannkind Corporation Methods for treating non-tuberculous mycobacterial infection

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160220710A1 (en) * 2015-01-30 2016-08-04 The Regents Of The University Of Michigan Compositions and methods for delivering pharmaceutical agents
CN108853106A (zh) * 2017-05-09 2018-11-23 中国食品药品检定研究院 亚胺吩嗪类化合物作为狂犬病病毒抑制剂的用途
WO2019070693A1 (en) * 2017-10-02 2019-04-11 Board Of Regents, The University Of Texas System COMPOSITION FOR INHALING CLOFAZIMINE AND METHODS OF USE
WO2019110099A1 (en) * 2017-12-06 2019-06-13 Qrumpharma Inc. Inhalable clofazimine formulation
US10500159B2 (en) * 2009-11-02 2019-12-10 Mannkind Corporation Apparatus and method for cryogranulating a pharmaceutical composition

Family Cites Families (7)

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Publication number Priority date Publication date Assignee Title
US8071127B2 (en) * 2006-10-24 2011-12-06 Aradigm Corporation Dual action, inhaled formulations providing both an immediate and sustained release profile
US8485180B2 (en) 2008-06-13 2013-07-16 Mannkind Corporation Dry powder drug delivery system
MY155524A (en) 2008-06-13 2015-10-30 Mannkind Corp A dry powder inhaler and system for drug delivery
BR112015023168B1 (pt) * 2013-03-15 2021-08-10 Mannkind Corporation Composição de 3,6-bis(n-fumaril-4-aminobutil)-2,5-dicetopiperazina cristalina, método de produção de partículas de 3,6-bis(n-fumaril-4-aminobutil)-2,5-dicetopiperazina e uso de uma composição de dicetopiperazina cristalina
RU2016143590A (ru) * 2014-04-08 2018-05-11 Арадайм Корпорейшн Липосомальные композиции ципрофлоксацина, обладающие активностью против нетуберкулезных микробактерий
SG11201703307WA (en) * 2014-10-24 2017-05-30 Redhill Biopharma Ltd Therapy for inhibition of single-stranded rna virus replication
CA3109572A1 (en) 2018-08-23 2020-02-27 Mannkind Corporation Compositions of clofazimine, combinations comprising them, processes for their preparation, uses and methods comprising them

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10500159B2 (en) * 2009-11-02 2019-12-10 Mannkind Corporation Apparatus and method for cryogranulating a pharmaceutical composition
US20160220710A1 (en) * 2015-01-30 2016-08-04 The Regents Of The University Of Michigan Compositions and methods for delivering pharmaceutical agents
CN108853106A (zh) * 2017-05-09 2018-11-23 中国食品药品检定研究院 亚胺吩嗪类化合物作为狂犬病病毒抑制剂的用途
WO2019070693A1 (en) * 2017-10-02 2019-04-11 Board Of Regents, The University Of Texas System COMPOSITION FOR INHALING CLOFAZIMINE AND METHODS OF USE
WO2019110099A1 (en) * 2017-12-06 2019-06-13 Qrumpharma Inc. Inhalable clofazimine formulation

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
BANASCHEWSKI B.; et al.: "Clofazimine inhalation suspension for the aerosol treatment of pulmonary nontuberculous mycobacterial infections", Journal of Cystic Fibrosis. 2019, vol 18(5), pg 714-720. *
BRUNAUGH, A. D.; et al.: "Excipient-Free Pulmonary Delivery and Macrophage Targeting of Clofazimine via Air Jet Micronization", Molecular Pharmaceutics. 2017, vol 14(11), pg 4019-4031. *
NGUYEN, D. D.; et al.: "Potentially highly potent drugs for 2019-nCoV", BIORXIV. 2020, 13 pages. *

Also Published As

Publication number Publication date
CA3177438A1 (en) 2021-11-04
AU2021263580A1 (en) 2022-11-24
JP7893751B2 (ja) 2026-07-22
US20230248722A1 (en) 2023-08-10
JP2023524064A (ja) 2023-06-08
CN115666510A (zh) 2023-01-31
BR112022022081A2 (pt) 2022-12-13
WO2021222740A1 (en) 2021-11-04
EP4142691A4 (en) 2024-05-15
EP4142691A1 (en) 2023-03-08
KR20230005937A (ko) 2023-01-10