CA2963085C - 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
CA2963085C
CA2963085C CA2963085A CA2963085A CA2963085C CA 2963085 C CA2963085 C CA 2963085C CA 2963085 A CA2963085 A CA 2963085A CA 2963085 A CA2963085 A CA 2963085A CA 2963085 C CA2963085 C CA 2963085C
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CA
Canada
Prior art keywords
rapamycin
composition
lung
dose
micrograms
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
CA2963085A
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English (en)
French (fr)
Other versions
CA2963085A1 (en
Inventor
Thomas ARMER
Lawrence S. Melvin Jr.
Jonathan M. Rothberg
Henri Lichenstein
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.)
OrphAI Therapeutics Inc
Original Assignee
AI Therapeutics 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 AI Therapeutics Inc filed Critical AI Therapeutics Inc
Publication of CA2963085A1 publication Critical patent/CA2963085A1/en
Application granted granted Critical
Publication of CA2963085C publication Critical patent/CA2963085C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • 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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436—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 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
    • 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
    • A61K31/557—Eicosanoids, e.g. leukotrienes or prostaglandins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • 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
    • A61M—DEVICES 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
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • Y—GENERAL 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
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against 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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (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)
CA2963085A 2014-10-07 2015-10-07 An inhalable rapamycin formulation for the treatment of pulmonary hypertension Active CA2963085C (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
CA2963085A1 CA2963085A1 (en) 2016-04-14
CA2963085C true CA2963085C (en) 2023-02-21

Family

ID=54360545

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2963085A Active CA2963085C (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 (2)
EP (1) EP3209330B1 (2)
JP (1) JP6679584B2 (2)
KR (1) KR20170095807A (2)
CN (1) CN107249576A (2)
AU (1) AU2015330905B2 (2)
BR (1) BR112017006842A2 (2)
CA (1) CA2963085C (2)
IL (1) IL251385B (2)
MX (1) MX389399B (2)
RU (1) RU2732908C2 (2)
WO (1) WO2016057712A1 (2)

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NZ724756A (en) 2014-04-04 2023-07-28 Ai Therapeutics Inc An inhalable rapamycin formulation for treating age-related conditions
RU2732908C2 (ru) 2014-10-07 2020-09-24 ЭйАй ТЕРАПЬЮТИКС, ИНК. Ингаляционная лекарственная форма рапамицина для лечения легочной гипертензии
IL262720B2 (en) 2016-05-05 2024-06-01 Liquidia Tech Inc Dry powder treprostinil for the treatment of pulmonary hypertension
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IL277402B1 (en) 2018-03-20 2026-04-01 Abraxis Bioscience Llc Methods for treating central nervous system disorders using administration of MTOR inhibitor nanoparticles and albumin
TW202015659A (zh) * 2018-05-22 2020-05-01 美商亞伯辛生物科學有限責任公司 用於治療肺高血壓之方法及組合物
KR102936433B1 (ko) * 2019-03-19 2026-03-09 아브락시스 바이오사이언스, 엘엘씨 질환의 치료를 위한 mTOR 억제제 및 알부민을 포함하는 나노입자의 피하 투여
CN114072136B (zh) 2019-04-29 2024-11-29 英斯梅德股份有限公司 曲前列素前药的干粉组合物及其使用方法
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
US11491143B2 (en) 2022-11-08
US20170304276A1 (en) 2017-10-26
CA2963085A1 (en) 2016-04-14
AU2015330905B2 (en) 2021-02-25
CN107249576A (zh) 2017-10-13
US20200306230A1 (en) 2020-10-01
US12611398B2 (en) 2026-04-28
JP2017534604A (ja) 2017-11-24
MX389399B (es) 2025-03-20
IL251385A0 (en) 2017-05-29
IL251385B (en) 2022-05-01
WO2016057712A1 (en) 2016-04-14
AU2015330905A1 (en) 2017-05-18
RU2017115990A3 (2) 2019-05-08
MX2017004440A (es) 2017-11-01
NZ731059A (en) 2023-12-22
RU2017115990A (ru) 2018-11-13
EP3209330B1 (en) 2022-02-23
US20230255944A1 (en) 2023-08-17
RU2732908C2 (ru) 2020-09-24
BR112017006842A2 (pt) 2017-12-12
KR20170095807A (ko) 2017-08-23
EP3209330A1 (en) 2017-08-30
JP6679584B2 (ja) 2020-04-15

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