AU2022228443B2 - Dihydroergotamine dry powder formulations and methods of use - Google Patents

Dihydroergotamine dry powder formulations and methods of use

Info

Publication number
AU2022228443B2
AU2022228443B2 AU2022228443A AU2022228443A AU2022228443B2 AU 2022228443 B2 AU2022228443 B2 AU 2022228443B2 AU 2022228443 A AU2022228443 A AU 2022228443A AU 2022228443 A AU2022228443 A AU 2022228443A AU 2022228443 B2 AU2022228443 B2 AU 2022228443B2
Authority
AU
Australia
Prior art keywords
dhe
dry
weight
powder
less
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
AU2022228443A
Other languages
English (en)
Other versions
AU2022228443A1 (en
Inventor
Hillary T. BERGSON
Aidan K. CURRAN
Aaron C. GONZALEZ NELSON
Dayna F. HANSON
Jason M. PERRY
Eric C. STOLZ
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.)
Pulmatrix Operating Co Inc
Original Assignee
Pulmatrix Operating Co Inc
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 Pulmatrix Operating Co Inc filed Critical Pulmatrix Operating Co Inc
Publication of AU2022228443A1 publication Critical patent/AU2022228443A1/en
Application granted granted Critical
Publication of AU2022228443B2 publication Critical patent/AU2022228443B2/en
Priority to AU2025256073A priority Critical patent/AU2025256073A1/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
    • 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
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/48—Ergoline derivatives, e.g. lysergic acid, ergotamine
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5383—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/06—Antimigraine agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
AU2022228443A 2021-03-03 2022-03-01 Dihydroergotamine dry powder formulations and methods of use Active AU2022228443B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2025256073A AU2025256073A1 (en) 2021-03-03 2025-10-21 Dihydroergotamine dry powder formulations and methods of use

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163156111P 2021-03-03 2021-03-03
US63/156,111 2021-03-03
PCT/US2022/018306 WO2022187222A1 (en) 2021-03-03 2022-03-01 Dihydroergotamine dry power formulations and methods of use

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2025256073A Division AU2025256073A1 (en) 2021-03-03 2025-10-21 Dihydroergotamine dry powder formulations and methods of use

Publications (2)

Publication Number Publication Date
AU2022228443A1 AU2022228443A1 (en) 2023-09-21
AU2022228443B2 true AU2022228443B2 (en) 2025-07-24

Family

ID=80781023

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2022228443A Active AU2022228443B2 (en) 2021-03-03 2022-03-01 Dihydroergotamine dry powder formulations and methods of use
AU2025256073A Pending AU2025256073A1 (en) 2021-03-03 2025-10-21 Dihydroergotamine dry powder formulations and methods of use

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2025256073A Pending AU2025256073A1 (en) 2021-03-03 2025-10-21 Dihydroergotamine dry powder formulations and methods of use

Country Status (11)

Country Link
US (1) US20240033218A1 (https=)
EP (1) EP4301334A1 (https=)
JP (1) JP2024510564A (https=)
KR (1) KR20230152083A (https=)
CN (1) CN117222401A (https=)
AU (2) AU2022228443B2 (https=)
BR (1) BR112023017538A2 (https=)
CA (1) CA3210442A1 (https=)
IL (1) IL305506A (https=)
MX (1) MX2023010120A (https=)
WO (1) WO2022187222A1 (https=)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100081664A1 (en) * 2007-02-11 2010-04-01 Map Pharmaceuticals, Inc. Method of therapeutic administration of dhe to enable rapid relief of migraine while minimizing side effect profile
US20160263101A1 (en) * 2012-12-21 2016-09-15 Map Pharmaceuticals, Inc. 8'-hydroxy-dihydroergotamine compounds and compositions

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4069819A (en) 1973-04-13 1978-01-24 Societa Farmaceutici S.P.A. Inhalation device
IT1228459B (it) 1989-02-23 1991-06-19 Phidea S R L Inalatore con svuotamento regolare e completo della capsula.
AP3138A (en) * 2009-04-24 2015-02-28 Iceutica Pty Ltd Production of encapsulated nanoparticles at high volume fractions
CN103200938B (zh) * 2010-08-30 2018-07-31 普马特里克斯营业公司 干燥粉末配方及用于治疗肺部疾病的方法
PT3470057T (pt) * 2010-09-29 2021-12-03 Pulmatrix Operating Co Inc Pós secos catiónicos compreendendo sais de magnésio
US20140179705A1 (en) * 2012-12-21 2014-06-26 Map Pharmaceuticals, Inc. 8'-hydroxy-dihydroergotamine compounds and compositions
AU2014248455B2 (en) * 2013-04-01 2018-12-06 Pulmatrix Operating Company, Inc. Tiotropium dry powders
IL265913B2 (en) * 2016-10-14 2024-07-01 Pulmatrix Operating Co Inc Respirable Dry Powder Comprising Itraconazole In Crystalline Form And Its Use For Manufacturing A Medicament For Treating Fungal Infection

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100081664A1 (en) * 2007-02-11 2010-04-01 Map Pharmaceuticals, Inc. Method of therapeutic administration of dhe to enable rapid relief of migraine while minimizing side effect profile
US20160263101A1 (en) * 2012-12-21 2016-09-15 Map Pharmaceuticals, Inc. 8'-hydroxy-dihydroergotamine compounds and compositions

Also Published As

Publication number Publication date
IL305506A (en) 2023-10-01
EP4301334A1 (en) 2024-01-10
WO2022187222A1 (en) 2022-09-09
AU2025256073A1 (en) 2025-11-13
JP2024510564A (ja) 2024-03-08
CA3210442A1 (en) 2022-09-09
US20240033218A1 (en) 2024-02-01
AU2022228443A1 (en) 2023-09-21
KR20230152083A (ko) 2023-11-02
MX2023010120A (es) 2023-10-30
WO2022187222A8 (en) 2023-11-02
CN117222401A (zh) 2023-12-12
BR112023017538A2 (pt) 2023-11-07

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Legal Events

Date Code Title Description
DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS: AMEND THE INVENTION TITLE TO READ DIHYDROERGOTAMINE DRY POWDER FORMULATIONS AND METHODS OF USE

FGA Letters patent sealed or granted (standard patent)