JP7857292B2 - 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 - Google Patents

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

Info

Publication number
JP7857292B2
JP7857292B2 JP2023526131A JP2023526131A JP7857292B2 JP 7857292 B2 JP7857292 B2 JP 7857292B2 JP 2023526131 A JP2023526131 A JP 2023526131A JP 2023526131 A JP2023526131 A JP 2023526131A JP 7857292 B2 JP7857292 B2 JP 7857292B2
Authority
JP
Japan
Prior art keywords
approximately
powder composition
dry powder
formula
compound
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
JP2023526131A
Other languages
English (en)
Japanese (ja)
Other versions
JP2023548307A (ja
JP2023548307A5 (OSRAM
Inventor
ドゥー，ジュー
プラウント，アダム
マリニン，ウラジミール
パリーク，マウリッククマール
アミン，ハーシュ
パルワイ，ナヴィーン
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.)
Insmed Inc
Original Assignee
Insmed 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 Insmed Inc filed Critical Insmed Inc
Publication of JP2023548307A publication Critical patent/JP2023548307A/ja
Publication of JP2023548307A5 publication Critical patent/JP2023548307A5/ja
Application granted granted Critical
Publication of JP7857292B2 publication Critical patent/JP7857292B2/ja
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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/222—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having aromatic groups, e.g. dipivefrine, ibopamine
    • 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
    • A61K31/5575—Eicosanoids, e.g. leukotrienes or prostaglandins having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
    • A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. 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
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pulmonology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Otolaryngology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Biochemistry (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (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)
JP2023526131A 2020-10-28 2021-10-28 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 Active JP7857292B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063106818P 2020-10-28 2020-10-28
US63/106,818 2020-10-28
PCT/US2021/057078 WO2022094100A1 (en) 2020-10-28 2021-10-28 Dry powder compositions of treprostinil prodrugs and methods of use thereof

Publications (3)

Publication Number Publication Date
JP2023548307A JP2023548307A (ja) 2023-11-16
JP2023548307A5 JP2023548307A5 (OSRAM) 2024-11-07
JP7857292B2 true JP7857292B2 (ja) 2026-05-12

Family

ID=81384296

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2023526131A Active JP7857292B2 (ja) 2020-10-28 2021-10-28 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

Country Status (9)

Country Link
US (2) US20240285570A1 (OSRAM)
EP (1) EP4236934A4 (OSRAM)
JP (1) JP7857292B2 (OSRAM)
KR (1) KR20230096998A (OSRAM)
CN (1) CN116437906A (OSRAM)
AU (1) AU2021369679A1 (OSRAM)
CA (1) CA3196252A1 (OSRAM)
MX (1) MX2023004812A (OSRAM)
WO (1) WO2022094100A1 (OSRAM)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SI3060041T1 (sl) 2013-10-25 2021-04-30 Insmed Incorporated Spojine prostaciklina
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
WO2025096521A1 (en) 2023-10-30 2025-05-08 Insmed Incorporated Medicament delivery device, cover, and methods of medicament delivery
WO2025147662A1 (en) * 2024-01-04 2025-07-10 Insmed Incorporated Methods of treatment using dry powder compositions of treprostinil prodrugs
TW202547521A (zh) * 2024-04-29 2025-12-16 國邑藥品科技股份有限公司 全身性硬化症與凍傷的吸入治療方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019519489A (ja) 2016-05-05 2019-07-11 リクイディア・テクノロジーズ・インコーポレーテッド 肺高血圧症を治療するための乾燥粉末トレプロスチニル
JP2020502121A (ja) 2016-12-14 2020-01-23 レスピラ セラピューティクス インコーポレイテッドＲｅｓｐｉｒａ Ｔｈｅｒａｐｅｕｔｉｃｓ，Ｉｎｃ． 肺高血圧症および他の肺障害の処置のための方法および組成物
JP2021527058A (ja) 2018-06-07 2021-10-11 マンカインド コーポレイション 吸入のための組成物および方法

Family Cites Families (39)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1016489B (it) 1974-03-18 1977-05-30 Isf Spa Inalatore
IT1240750B (it) 1990-04-12 1993-12-17 Chiesi Farma Spa Dispositivo per la somministrazione di sostanze medicamentose in polvere
GB9015522D0 (en) 1990-07-13 1990-08-29 Braithwaite Philip W Inhaler
US6582728B1 (en) 1992-07-08 2003-06-24 Inhale Therapeutic Systems, Inc. Spray drying of macromolecules to produce inhaleable dry powders
US5785049A (en) 1994-09-21 1998-07-28 Inhale Therapeutic Systems Method and apparatus for dispersion of dry powder medicaments
CA2152088C (en) 1992-12-18 1999-12-07 Thomas J. Ambrosio Inhaler for powdered medications
GB9306703D0 (en) 1993-03-31 1993-05-26 Fisons Plc Inhalation device
SE9302550D0 (sv) 1993-07-30 1993-07-30 Ernst Hoerlin Powder inhaler
PT101450B (pt) 1994-02-02 1999-11-30 Hovione Produtos Farmaceuticos Novo dispositivo para inalacao
US6051256A (en) 1994-03-07 2000-04-18 Inhale Therapeutic Systems Dispersible macromolecule compositions and methods for their preparation and use
FI95441C (fi) 1994-05-31 1996-02-12 Leiras Oy Inhalointilaitteen lääkeainekammio
FR2725626A1 (fr) 1994-10-18 1996-04-19 Sofab Dispositif pour l'inhalation de produits en poudre
SE9404439D0 (sv) 1994-12-21 1994-12-21 Astra Ab Inhalation device
ES2216418T3 (es) 1995-12-07 2004-10-16 Jago Research Ag Boquilla para un inhalador para la administracion de varias dosis de un polvo seco farmacologico.
US5797392C1 (en) 1996-01-22 2001-01-09 Direct Haler As Inhaler
US6026809A (en) 1996-01-25 2000-02-22 Microdose Technologies, Inc. Inhalation device
AU5806998A (en) 1996-12-31 1998-07-31 Inhale Therapeutic Systems Processes for spray drying solutions of hydrophobic drugs with hydrophilic excipients and compositions prepared by such processes
PT101988B (pt) 1997-04-04 2004-02-27 Hovione Farmaciencia Sa Sistema de orientacao e posicionamento de um objecto
GB9805102D0 (en) 1998-03-10 1998-05-06 Ciba Geigy Ag Device
US6257233B1 (en) 1998-06-04 2001-07-10 Inhale Therapeutic Systems Dry powder dispersing apparatus and methods for their use
CA2336139C (en) 1998-06-24 2008-10-14 Advanced Inhalation Research, Inc. Large porous particles emitted from an inhaler
JP4416325B2 (ja) 1998-08-25 2010-02-17 アルカーメス，インコーポレイテッド 安定な噴霧乾燥タンパク質製剤
IT1309592B1 (it) 1999-03-05 2002-01-24 Chiesi Farma Spa Particelle veicolo modificate da utilizzarsi nella preparazione diformulazioni farmaceutiche sotto forma di polimeri per inalazione e
PL196951B1 (pl) 1999-03-05 2008-02-29 Chiesi Farma Spa Proszek do stosowania w inhalatorze suchego proszku, cząsteczki nośnika i sposób wytwarzania nośnika
ITMI991582A1 (it) 1999-07-16 2001-01-16 Chiesi Farma Spa Polveri costituite da particelle aventi la superficie perfettamente levigata da utilizzare come veicoli per la preparazione di miscele inala
PL201275B1 (pl) 2000-03-10 2009-03-31 Univ North Carolina Inhalator suchego proszku
PE20011227A1 (es) 2000-04-17 2002-01-07 Chiesi Farma Spa Formulaciones farmaceuticas para inhaladores de polvo seco en la forma de aglomerados duros
US6766799B2 (en) 2001-04-16 2004-07-27 Advanced Inhalation Research, Inc. Inhalation device
US6848197B2 (en) 2001-04-18 2005-02-01 Advanced Inhalation Research, Inc. Control of process humidity to produce large, porous particles
US20040102469A1 (en) 2002-09-13 2004-05-27 Boehringer Ingelheim Pharma Gmbh & Co. Kg Method for reducing the mortality rate
GB0222023D0 (en) 2002-09-21 2002-10-30 Aventis Pharma Ltd Inhaler
US7763280B2 (en) 2002-11-28 2010-07-27 Boehringer Ingelheim Pharma Gmbh & Co. Kg Tiotropium containing powder formulation for inhalation
ES2670872T3 (es) * 2003-05-22 2018-06-01 United Therapeutics Corporation Polimorfo de una sal de dietanolamina de treprostinil
ES2289221T3 (es) 2003-10-06 2008-02-01 BANG & OLUFSEN MEDICOM A/S Inhalador.
US20080280986A1 (en) * 2007-02-09 2008-11-13 United Therapeutics Corporation Treprostinil treatment for interstitial lung disease and asthma
WO2008156586A2 (en) 2007-06-12 2008-12-24 Alkermes, Inc. Inhalation device for powdered substances
SI3060041T1 (sl) 2013-10-25 2021-04-30 Insmed Incorporated Spojine prostaciklina
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
WO2021195328A1 (en) * 2020-03-25 2021-09-30 Insmed Incorporated Pharmaceutical formulations of treprostinil prodrugs and methods of use thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019519489A (ja) 2016-05-05 2019-07-11 リクイディア・テクノロジーズ・インコーポレーテッド 肺高血圧症を治療するための乾燥粉末トレプロスチニル
JP2020502121A (ja) 2016-12-14 2020-01-23 レスピラ セラピューティクス インコーポレイテッドＲｅｓｐｉｒａ Ｔｈｅｒａｐｅｕｔｉｃｓ，Ｉｎｃ． 肺高血圧症および他の肺障害の処置のための方法および組成物
JP2021527058A (ja) 2018-06-07 2021-10-11 マンカインド コーポレイション 吸入のための組成物および方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
Journal of Drug Delivery，2018年，Vol.2018，Article ID 5635010

Also Published As

Publication number Publication date
WO2022094100A1 (en) 2022-05-05
JP2023548307A (ja) 2023-11-16
US20240285570A1 (en) 2024-08-29
CA3196252A1 (en) 2022-05-05
KR20230096998A (ko) 2023-06-30
EP4236934A1 (en) 2023-09-06
US20240122889A1 (en) 2024-04-18
AU2021369679A1 (en) 2023-05-18
EP4236934A4 (en) 2024-10-02
MX2023004812A (es) 2023-07-06
CN116437906A (zh) 2023-07-14

Similar Documents

Publication Publication Date Title
JP7732017B2 (ja) 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
US20240122889A1 (en) Dry powder compositions of treprostinil prodrugs and methods of use thereof
AU2023201307A1 (en) Dry powder treprostinil for the treatment of pulmonary hypertension
HK1254627A1 (en) Method and system for the treatment of chronic obstructive pulmonary disease with nebulized anticholinergic administrations
CN1304290A (zh) 雷洛昔芬的肺和鼻传递给药
US20170202787A1 (en) Treatment of chronic obstructive pulmonary disease with nebulized beta 2-agonist or combined nebulized beta 2-agonist and anticholinergic administration
JP2026509493A (ja) 噴霧乾燥トレプロスチニル製剤
WO2025147662A1 (en) Methods of treatment using dry powder compositions of treprostinil prodrugs
JP2025513460A (ja) 粉末吸入による医薬品の送達
CZ20003544A3 (cs) Pulmonární a nasální podávání raloxifenu

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230705

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20241028

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20241028

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20251030

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20260130

A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20260327

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20260424