JP7455144B2 - 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 Download PDFInfo
- Publication number
- JP7455144B2 JP7455144B2 JP2021564297A JP2021564297A JP7455144B2 JP 7455144 B2 JP7455144 B2 JP 7455144B2 JP 2021564297 A JP2021564297 A JP 2021564297A JP 2021564297 A JP2021564297 A JP 2021564297A JP 7455144 B2 JP7455144 B2 JP 7455144B2
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- Japan
- Prior art keywords
- dry powder
- powder composition
- palmityl
- treprostinil
- 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.)
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- 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
- A61K9/146—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 macromolecular 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
- A61K9/0012—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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- 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
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
-
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/557—Eicosanoids, e.g. leukotrienes or prostaglandins
- A61K31/5578—Eicosanoids, e.g. leukotrienes or prostaglandins having a pentalene ring system, e.g. carbacyclin, iloprost
-
- 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
- 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
- A61K9/1617—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
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Pulmonology (AREA)
- Otolaryngology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Emergency Medicine (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2024037977A JP7732017B2 (ja) | 2019-04-29 | 2024-03-12 | 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 |
| JP2025137209A JP2025164854A (ja) | 2019-04-29 | 2025-08-20 | 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 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201962840186P | 2019-04-29 | 2019-04-29 | |
| US62/840,186 | 2019-04-29 | ||
| PCT/US2020/030282 WO2020223237A1 (en) | 2019-04-29 | 2020-04-28 | Dry powder compositions of treprostinil prodrugs and methods of use thereof |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2024037977A Division JP7732017B2 (ja) | 2019-04-29 | 2024-03-12 | 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 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2022530637A JP2022530637A (ja) | 2022-06-30 |
| JP2022530637A5 JP2022530637A5 (OSRAM) | 2023-03-28 |
| JP7455144B2 true JP7455144B2 (ja) | 2024-03-25 |
Family
ID=72917621
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2021564297A Active JP7455144B2 (ja) | 2019-04-29 | 2020-04-28 | 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 |
| JP2024037977A Active JP7732017B2 (ja) | 2019-04-29 | 2024-03-12 | 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 |
| JP2025137209A Pending JP2025164854A (ja) | 2019-04-29 | 2025-08-20 | 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 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2024037977A Active JP7732017B2 (ja) | 2019-04-29 | 2024-03-12 | 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 |
| JP2025137209A Pending JP2025164854A (ja) | 2019-04-29 | 2025-08-20 | 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 (10)
| Country | Link |
|---|---|
| US (4) | US11458098B2 (OSRAM) |
| EP (1) | EP3962472A4 (OSRAM) |
| JP (3) | JP7455144B2 (OSRAM) |
| KR (1) | KR20220002600A (OSRAM) |
| CN (2) | CN114072136B (OSRAM) |
| AU (2) | AU2020265576B2 (OSRAM) |
| BR (1) | BR112021021775A2 (OSRAM) |
| CA (1) | CA3138530A1 (OSRAM) |
| MX (2) | MX2021013329A (OSRAM) |
| WO (1) | WO2020223237A1 (OSRAM) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SI3060041T1 (sl) | 2013-10-25 | 2021-04-30 | Insmed Incorporated | Spojine prostaciklina |
| EP3904326A1 (en) | 2014-11-18 | 2021-11-03 | Insmed Incorporated | Methods of manufacturing treprostinil and treprostinil derivative prodrugs |
| 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 |
| EP4236934A4 (en) * | 2020-10-28 | 2024-10-02 | Insmed Incorporated | Dry powder compositions of treprostinil prodrugs and methods of use thereof |
| AU2022229367A1 (en) * | 2021-03-03 | 2023-09-14 | United Therapeutics Corporation | A dry powder composition of trestinil and its prodrug thereof and further comprising comprising (e)-3,6-bis[4-(n-carbonyl-2-propenyl)amidobutyl]-2,5-diketopiperazine (fdkp) |
| WO2023150747A1 (en) | 2022-02-07 | 2023-08-10 | Insmed Incorporated | Dry powder compositions of bedaquiline and salts and methods of use thereof |
| KR20250169548A (ko) * | 2023-03-17 | 2025-12-03 | 인스메드 인코포레이티드 | 분무 건조 트레프로스티닐 제형 |
| 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 |
| WO2025199537A1 (en) * | 2024-03-22 | 2025-09-25 | Wbx Pharma, Inc. | Inhaled hedgehog inhibitors |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2016540734A (ja) | 2013-10-25 | 2016-12-28 | インスメッド, インコーポレイテッド | プロスタサイクリン化合物、組成物およびその使用方法 |
| WO2017192993A1 (en) | 2016-05-05 | 2017-11-09 | Liquidia Technologies, Inc. | Dry powder treprostinil for the treatment of pulmonary hypertension |
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| US20220409537A1 (en) | 2022-12-29 |
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