AU2015330905B2 - An inhalable rapamycin formulation for the treatment of pulmonary hypertension - Google Patents

An inhalable rapamycin formulation for the treatment of pulmonary hypertension Download PDF

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Publication number
AU2015330905B2
AU2015330905B2 AU2015330905A AU2015330905A AU2015330905B2 AU 2015330905 B2 AU2015330905 B2 AU 2015330905B2 AU 2015330905 A AU2015330905 A AU 2015330905A AU 2015330905 A AU2015330905 A AU 2015330905A AU 2015330905 B2 AU2015330905 B2 AU 2015330905B2
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AU
Australia
Prior art keywords
rapamycin
lung
sirolimus
dose
formulation
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AU2015330905A
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English (en)
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AU2015330905A1 (en
Inventor
Thomas ARMER
Henri Lichenstein
Lawrence S. Melvin Jr.
Jonathan M. Rothberg
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OrphAI Therapeutics Inc
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AI Therapeutics Inc
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Publication date
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Publication of AU2015330905A1 publication Critical patent/AU2015330905A1/en
Assigned to AI Therapeutics, Inc. reassignment AI Therapeutics, Inc. Amend patent request/document other than specification (104) Assignors: LAM THERAPEUTICS, INC.
Application granted granted Critical
Publication of AU2015330905B2 publication Critical patent/AU2015330905B2/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/4353Heterocyclic 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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436Heterocyclic 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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/557Eicosanoids, e.g. leukotrienes or prostaglandins
    • 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
    • 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
    • A61K9/0075Sprays 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
    • 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
    • A61K9/12Aerosols; Foams
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dispersion Chemistry (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2015330905A 2014-10-07 2015-10-07 An inhalable rapamycin formulation for the treatment of pulmonary hypertension Active AU2015330905B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201462060988P 2014-10-07 2014-10-07
US62/060,988 2014-10-07
US201562144145P 2015-04-07 2015-04-07
US62/144,145 2015-04-07
PCT/US2015/054550 WO2016057712A1 (en) 2014-10-07 2015-10-07 An inhalable rapamycin formulation for the treatment of pulmonary hypertension

Publications (2)

Publication Number Publication Date
AU2015330905A1 AU2015330905A1 (en) 2017-05-18
AU2015330905B2 true AU2015330905B2 (en) 2021-02-25

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
AU2015330905A Active AU2015330905B2 (en) 2014-10-07 2015-10-07 An inhalable rapamycin formulation for the treatment of pulmonary hypertension

Country Status (12)

Country Link
US (3) US20170304276A1 (cg-RX-API-DMAC7.html)
EP (1) EP3209330B1 (cg-RX-API-DMAC7.html)
JP (1) JP6679584B2 (cg-RX-API-DMAC7.html)
KR (1) KR20170095807A (cg-RX-API-DMAC7.html)
CN (1) CN107249576A (cg-RX-API-DMAC7.html)
AU (1) AU2015330905B2 (cg-RX-API-DMAC7.html)
BR (1) BR112017006842A2 (cg-RX-API-DMAC7.html)
CA (1) CA2963085C (cg-RX-API-DMAC7.html)
IL (1) IL251385B (cg-RX-API-DMAC7.html)
MX (1) MX389399B (cg-RX-API-DMAC7.html)
RU (1) RU2732908C2 (cg-RX-API-DMAC7.html)
WO (1) WO2016057712A1 (cg-RX-API-DMAC7.html)

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WO2016057712A1 (en) 2014-10-07 2016-04-14 Lam Therapeutics, Inc. An inhalable rapamycin formulation for the treatment of pulmonary hypertension
IL310250B2 (en) 2016-05-05 2025-09-01 Liquidia Tech Inc Terpostinil in dry powder form for the treatment of pulmonary hypertension
ES2907692T3 (es) * 2017-12-29 2022-04-26 Celon Pharma Sa Composición de ketamina de polvo seco para su administración por vía pulmonar en la depresión resistente al tratamiento
SG11202009145PA (en) 2018-03-20 2020-10-29 Abraxis Bioscience Llc Methods of treating central nervous system disorders via administration of nanoparticles of an mtor inhibitor and an albumin
JP7561628B2 (ja) * 2018-05-22 2024-10-04 アブラクシス バイオサイエンス, エルエルシー 肺高血圧症を処置するための方法および組成物
US20220054404A1 (en) * 2019-03-19 2022-02-24 Abraxis Bioscience, Llc Subcutaneous administration of nanoparticles comprising an mtor inhibitor and albumin for treatment of diseases
JP7455144B2 (ja) 2019-04-29 2024-03-25 インスメッド インコーポレイテッド トレプロスチニルプロドラッグの乾燥粉末組成物およびその使用方法
CN113444730A (zh) * 2021-03-17 2021-09-28 昆明市延安医院 一种原发性肝细胞klotho基因转导干细胞筛选构建方法
WO2025220834A1 (ko) * 2024-04-16 2025-10-23 한미약품 주식회사 흡입제 조성물

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Also Published As

Publication number Publication date
EP3209330B1 (en) 2022-02-23
KR20170095807A (ko) 2017-08-23
US20170304276A1 (en) 2017-10-26
IL251385B (en) 2022-05-01
US20200306230A1 (en) 2020-10-01
BR112017006842A2 (pt) 2017-12-12
CA2963085C (en) 2023-02-21
RU2732908C2 (ru) 2020-09-24
US11491143B2 (en) 2022-11-08
MX389399B (es) 2025-03-20
EP3209330A1 (en) 2017-08-30
RU2017115990A3 (cg-RX-API-DMAC7.html) 2019-05-08
JP6679584B2 (ja) 2020-04-15
JP2017534604A (ja) 2017-11-24
CN107249576A (zh) 2017-10-13
CA2963085A1 (en) 2016-04-14
US20230255944A1 (en) 2023-08-17
AU2015330905A1 (en) 2017-05-18
RU2017115990A (ru) 2018-11-13
IL251385A0 (en) 2017-05-29
WO2016057712A1 (en) 2016-04-14
NZ731059A (en) 2023-12-22
MX2017004440A (es) 2017-11-01

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