ES2575565T3 - Procedimiento para la preparación de monohidrato de treprostinilo y su utilización para el almacenamiento y el envío - Google Patents
Procedimiento para la preparación de monohidrato de treprostinilo y su utilización para el almacenamiento y el envío Download PDFInfo
- Publication number
- ES2575565T3 ES2575565T3 ES09743053.2T ES09743053T ES2575565T3 ES 2575565 T3 ES2575565 T3 ES 2575565T3 ES 09743053 T ES09743053 T ES 09743053T ES 2575565 T3 ES2575565 T3 ES 2575565T3
- Authority
- ES
- Spain
- Prior art keywords
- treprostinyl
- monohydrate
- shipping
- procedure
- preparation
- 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
Links
- 238000000034 method Methods 0.000 title abstract 2
- 150000004682 monohydrates Chemical class 0.000 title abstract 2
- 239000007787 solid Substances 0.000 abstract 2
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 239000003960 organic solvent Substances 0.000 abstract 1
- 239000002904 solvent Substances 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C59/00—Compounds having carboxyl groups bound to acyclic carbon atoms and containing any of the groups OH, O—metal, —CHO, keto, ether, groups, groups, or groups
- C07C59/40—Unsaturated compounds
- C07C59/58—Unsaturated compounds containing ether groups, groups, groups, or groups
- C07C59/72—Unsaturated compounds containing ether groups, groups, groups, or groups containing six-membered aromatic rings and other rings
-
- 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
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- 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
-
- 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
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
-
- 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
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C51/00—Preparation of carboxylic acids or their salts, halides or anhydrides
- C07C51/42—Separation; Purification; Stabilisation; Use of additives
- C07C51/487—Separation; Purification; Stabilisation; Use of additives by treatment giving rise to chemical modification
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/07—Optical isomers
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C2603/00—Systems containing at least three condensed rings
- C07C2603/02—Ortho- or ortho- and peri-condensed systems
- C07C2603/04—Ortho- or ortho- and peri-condensed systems containing three rings
- C07C2603/06—Ortho- or ortho- and peri-condensed systems containing three rings containing at least one ring with less than six ring members
- C07C2603/10—Ortho- or ortho- and peri-condensed systems containing three rings containing at least one ring with less than six ring members containing five-membered rings
- C07C2603/12—Ortho- or ortho- and peri-condensed systems containing three rings containing at least one ring with less than six ring members containing five-membered rings only one five-membered ring
- C07C2603/14—Benz[f]indenes; Hydrogenated benz[f]indenes
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Immunology (AREA)
- Pulmonology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Urology & Nephrology (AREA)
- Hospice & Palliative Care (AREA)
- Neurology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (AREA)
- Vascular Medicine (AREA)
- Transplantation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US5150908P | 2008-05-08 | 2008-05-08 | |
| US51509 | 2008-05-08 | ||
| PCT/US2009/002818 WO2009137066A1 (en) | 2008-05-08 | 2009-05-07 | Treprostinil monohydrate |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2575565T3 true ES2575565T3 (es) | 2016-06-29 |
Family
ID=41037724
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES09743053.2T Active ES2575565T3 (es) | 2008-05-08 | 2009-05-07 | Procedimiento para la preparación de monohidrato de treprostinilo y su utilización para el almacenamiento y el envío |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US8350079B2 (enExample) |
| EP (2) | EP2300408B1 (enExample) |
| JP (1) | JP6219016B2 (enExample) |
| KR (1) | KR20110010753A (enExample) |
| CN (1) | CN102015613B (enExample) |
| CA (1) | CA2723540C (enExample) |
| ES (1) | ES2575565T3 (enExample) |
| WO (1) | WO2009137066A1 (enExample) |
Families Citing this family (33)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2526534C (en) | 2003-05-22 | 2011-07-12 | United Therapeutics Corporation | Compounds and methods for delivery of prostacyclin analogs |
| CN103274926B (zh) | 2007-12-17 | 2016-08-10 | 联合治疗公司 | 一种制备Remodulin中的活性成分曲前列素的改良方法 |
| JP5681276B2 (ja) | 2010-03-15 | 2015-03-04 | ユナイテッド セラピューティクス コーポレイション | 肺高血圧症のための治療 |
| WO2011153363A1 (en) | 2010-06-03 | 2011-12-08 | United Therapeutics Corporation | Treprostinil production |
| EP2681204B1 (en) | 2011-03-02 | 2016-04-27 | United Therapeutics Corporation | Synthesis of intermediate for treprostinil production |
| CN103193626B (zh) | 2012-01-10 | 2016-05-11 | 上海天伟生物制药有限公司 | 一种前列腺素类似物的晶型及其制备方法和用途 |
| CN103193627B (zh) * | 2012-01-10 | 2016-04-20 | 上海天伟生物制药有限公司 | 一种前列腺素类似物的晶型及其制备方法和用途 |
| EP2970091A4 (en) * | 2013-03-14 | 2017-02-08 | United Therapeutics Corporation | Solid forms of treprostinil |
| JP2016516693A (ja) | 2013-03-15 | 2016-06-09 | ユナイテッド セラピューティクス コーポレイション | トレプロスチニルの塩 |
| CN105228451B (zh) | 2013-03-25 | 2018-03-30 | 联合治疗公司 | 制备具有硫醇连接子和聚乙二醇化形式的前列环素化合物的方法 |
| CN105407883A (zh) | 2013-04-30 | 2016-03-16 | 联合治疗学有限公司 | 控释药物制剂 |
| HRP20210351T1 (hr) | 2013-10-25 | 2021-04-30 | Insmed Incorporated | Spojevi prostaciklina |
| JP2017517550A (ja) * | 2014-06-13 | 2017-06-29 | ユナイテッド セラピューティクス コーポレイション | トレプロスチニル製剤 |
| WO2016038532A1 (en) * | 2014-09-09 | 2016-03-17 | Mylan Laboratories Limited | Amorphous treprostinil diethanolamine |
| HU231184B1 (hu) * | 2014-10-08 | 2021-07-28 | CHINOIN Gyógyszer és Vegyészeti Termékek Gyára Zrt. | Treprostinil-nátrium-monohidrát és eljárás ennek előállítására |
| CN107108427A (zh) | 2014-10-20 | 2017-08-29 | 联合治疗学有限公司 | 用于制备前列环素衍生物的中间体的合成 |
| US10343979B2 (en) | 2014-11-18 | 2019-07-09 | Insmed Incorporated | Methods of manufacturing treprostinil and treprostinil derivative prodrugs |
| IL310250B2 (en) | 2016-05-05 | 2025-09-01 | Liquidia Tech Inc | Terpostinil in dry powder form for the treatment of pulmonary hypertension |
| CA3038276A1 (en) | 2016-09-26 | 2018-03-29 | United Therapeutics Corporation | Treprostinil prodrugs |
| EP3548010A1 (en) | 2016-12-05 | 2019-10-09 | Corsair Pharma, Inc. | Dermal and transdermal administration of treprostinil and salts thereof |
| ES2976468T3 (es) | 2018-09-18 | 2024-08-01 | Lilly Co Eli | Sal de treprostinil erbumina |
| 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 |
| US12435023B2 (en) * | 2019-05-21 | 2025-10-07 | Shanghai Forefront Pharmceutical Co., Ltd. | Crystal form of Treprostinil sodium salt and preparation method therefor |
| CN114616225A (zh) | 2019-08-23 | 2022-06-10 | 联合治疗公司 | 曲前列环素前药 |
| US11339110B2 (en) | 2019-12-19 | 2022-05-24 | Chirogate International Inc. | Efficient crystallization process for preparing ultrapure Treprostinil and crystal prepared therefrom |
| WO2021211916A1 (en) | 2020-04-17 | 2021-10-21 | United Therapeutics Corporation | Treprostinil for use in the treatment of intersitial lung disease |
| EP4161909A1 (en) | 2020-06-09 | 2023-04-12 | United Therapeutics Corporation | Fumaryl diketopiperidine prodrugs of treprostinil |
| US11447440B2 (en) | 2020-10-29 | 2022-09-20 | Chirogate International Inc. | Treprostinil monohydrate crystals and methods for preparation thereof |
| CN117062605A (zh) | 2020-12-14 | 2023-11-14 | 联合治疗公司 | 使用曲前列环素前药治疗疾病的方法 |
| CN117479946A (zh) | 2021-03-03 | 2024-01-30 | 联合治疗公司 | 含曲前列环素及其前药并还包含(e)-3,6-双[4-(n-羰基-2-丙烯基)酰胺丁基]-2,5-二酮哌嗪(fdkp)的干粉组合物 |
| WO2023154705A1 (en) | 2022-02-08 | 2023-08-17 | United Therapeutics Corporation | Treprostinil iloprost combination therapy |
| EP4516297A1 (en) | 2022-04-29 | 2025-03-05 | Zhaoke Pharmaceutical (Guangzhou) Co., Ltd | Treprostinil soft mist inhalant |
| AU2024208919A1 (en) | 2023-01-19 | 2025-07-17 | United Therapeutics Corporation | Treprostinil analogs |
Family Cites Families (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4306075A (en) * | 1980-03-28 | 1981-12-15 | The Upjohn Company | Composition and process |
| GB8814438D0 (en) | 1988-06-17 | 1988-07-20 | Wellcome Found | Compounds for use in medicine |
| GB9300763D0 (en) * | 1993-01-15 | 1993-03-03 | Leo Pharm Prod Ltd | Chemical compound |
| JP3215338B2 (ja) * | 1995-12-15 | 2001-10-02 | 三菱化学株式会社 | アミノベンゼンスルホン酸誘導体一水和物及びその製造方法 |
| IT1282733B1 (it) * | 1996-05-20 | 1998-03-31 | Flarer S A | Composizioni farmaceutiche contenenti ciclosporina ed un veicolante comprendente almeno un estere dell'acido alfa-glicerofosforico |
| US6441245B1 (en) | 1997-10-24 | 2002-08-27 | United Therapeutics Corporation | Process for stereoselective synthesis of prostacyclin derivatives |
| ATE262336T1 (de) | 1997-11-14 | 2004-04-15 | United Therapeutics Corp | Verwendung von 9-desoxy-2',9-alpha-methano-3-oxa- 4,5,6-trinor-3,7-(1',3'-interphenylen)-13,14- dihydroprostaglandin-f1 zur behandlung von peripheren vaskulären erkrankungen |
| US6017922A (en) * | 1998-05-18 | 2000-01-25 | U.S. Bioscience, Inc. | Thermally stable trimetrexates and processes for producing the same |
| US6521212B1 (en) | 1999-03-18 | 2003-02-18 | United Therapeutics Corporation | Method for treating peripheral vascular disease by administering benzindene prostaglandins by inhalation |
| US6700025B2 (en) * | 2001-01-05 | 2004-03-02 | United Therapeutics Corporation | Process for stereoselective synthesis of prostacyclin derivatives |
| US6803386B2 (en) * | 2002-01-16 | 2004-10-12 | United Therapeutics Corporation | Prostacyclin derivative containing compositions and methods of using the same for the treatment of cancer |
| US6756117B1 (en) | 2002-12-20 | 2004-06-29 | The United States Of America As Represented By The United States Department Of Energy | Photonic polymer-blend structures and method for making |
| CA2526534C (en) * | 2003-05-22 | 2011-07-12 | United Therapeutics Corporation | Compounds and methods for delivery of prostacyclin analogs |
| KR20050024121A (ko) * | 2003-09-04 | 2005-03-10 | 동아제약주식회사 | 7-카르복시메틸옥시-3',4',5-트리메톡시 플라본.일수화물, 이의 제조방법 및 용도 |
| DE602004028155D1 (de) * | 2003-12-16 | 2010-08-26 | United Therapeutics Corp | Verwendung von treprostinil zur behandlung von ischämischen läsionen |
| WO2005058329A1 (en) * | 2003-12-16 | 2005-06-30 | United Therapeutics Corporation | Use of treprostinil to improve kidney functions |
| JP2007532663A (ja) * | 2004-04-12 | 2007-11-15 | ユナイテッド セラピューティクス インコーポレイテッド | ニューロパシー性の糖尿病性足潰瘍を治療するためのトレプロスチニルの使用 |
| US8747897B2 (en) * | 2006-04-27 | 2014-06-10 | Supernus Pharmaceuticals, Inc. | Osmotic drug delivery system |
| US20080200449A1 (en) | 2006-05-15 | 2008-08-21 | United Therapeutics Corporation | Treprostinil administration using a metered dose inhaler |
| US20090036465A1 (en) * | 2006-10-18 | 2009-02-05 | United Therapeutics Corporation | Combination therapy for pulmonary arterial hypertension |
| CA2678258A1 (en) * | 2007-02-09 | 2008-08-14 | United Therapeutics Corporation | Treprostinil treatment for interstitial lung disease and asthma |
| US20080280985A1 (en) | 2007-03-27 | 2008-11-13 | Scott Robert A D | Methods and Compositions Using Certain Phenolic Derivatives for the Treatment of Diabetes |
| CN103274926B (zh) * | 2007-12-17 | 2016-08-10 | 联合治疗公司 | 一种制备Remodulin中的活性成分曲前列素的改良方法 |
-
2009
- 2009-05-07 US US12/437,054 patent/US8350079B2/en active Active
- 2009-05-07 JP JP2011508505A patent/JP6219016B2/ja active Active
- 2009-05-07 EP EP09743053.2A patent/EP2300408B1/en active Active
- 2009-05-07 ES ES09743053.2T patent/ES2575565T3/es active Active
- 2009-05-07 CA CA2723540A patent/CA2723540C/en active Active
- 2009-05-07 WO PCT/US2009/002818 patent/WO2009137066A1/en not_active Ceased
- 2009-05-07 EP EP15190454.7A patent/EP3002274A1/en not_active Withdrawn
- 2009-05-07 KR KR1020107027068A patent/KR20110010753A/ko not_active Ceased
- 2009-05-07 CN CN2009801161262A patent/CN102015613B/zh active Active
Also Published As
| Publication number | Publication date |
|---|---|
| KR20110010753A (ko) | 2011-02-07 |
| WO2009137066A1 (en) | 2009-11-12 |
| CA2723540C (en) | 2016-01-05 |
| US20090281189A1 (en) | 2009-11-12 |
| CA2723540A1 (en) | 2009-11-12 |
| US8350079B2 (en) | 2013-01-08 |
| EP3002274A8 (en) | 2016-07-13 |
| EP2300408A1 (en) | 2011-03-30 |
| CN102015613A (zh) | 2011-04-13 |
| JP6219016B2 (ja) | 2017-10-25 |
| CN102015613B (zh) | 2013-07-31 |
| EP2300408B1 (en) | 2016-04-13 |
| JP2011519927A (ja) | 2011-07-14 |
| EP3002274A1 (en) | 2016-04-06 |
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