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)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Immunology (AREA)
- Pulmonology (AREA)
- Urology & Nephrology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Hospice & Palliative Care (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Neurology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Physical Education & Sports Medicine (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 (34)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102697790A (zh) | 2003-05-22 | 2012-10-03 | 联合治疗公司 | 化合物和释放前列环素类似物的方法 |
| WO2009078965A1 (en) | 2007-12-17 | 2009-06-25 | United Therapeutics Corporation | An improved process to prepare treprostinil, the active ingredient in remodulin |
| KR20160132501A (ko) | 2010-03-15 | 2016-11-18 | 유나이티드 세러퓨틱스 코오포레이션 | 폐고혈압의 치료 |
| CN103261142B (zh) | 2010-06-03 | 2014-12-10 | 联合治疗公司 | 曲前列环素的制备 |
| ES2581762T3 (es) | 2011-03-02 | 2016-09-07 | United Therapeutics Corporation | Síntesis de producto intermedio para la producción de treprostinil |
| 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 |
| 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 |
| WO2014159050A1 (en) * | 2013-03-14 | 2014-10-02 | United Therapeutics Corporation | Solid forms of treprostinil |
| EP2970081A4 (en) | 2013-03-15 | 2016-10-12 | United Therapeutics Corp | SALTS OF TREPROSTINIL |
| WO2014160638A1 (en) | 2013-03-25 | 2014-10-02 | United Therapeutics Corporation | Process of making prostacyclin compounds with linker thiol and pegylated forms |
| CA2911172C (en) | 2013-04-30 | 2021-10-19 | United Therapeutics Corporation | Controlled release pharmaceutical formulations |
| US9469600B2 (en) | 2013-10-25 | 2016-10-18 | Insmed Incorporated | Prostacyclin compounds, compositions and methods of use thereof |
| ES2908142T3 (es) * | 2014-06-13 | 2022-04-27 | United Therapeutics Corp | Formulaciones de treprostinil |
| 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 |
| EP3452170A4 (en) | 2016-05-05 | 2020-04-01 | Liquidia Technologies, Inc. | TREPROSTINIL IN POWDER FORM FOR TREATING PULMONAL HYPERTENSION |
| WO2018058124A1 (en) | 2016-09-26 | 2018-03-29 | United Therapeutics Corporation | Treprostinil prodrugs |
| CN110381930A (zh) | 2016-12-05 | 2019-10-25 | 康赛制药公司 | 曲前列环素及其盐的经皮和透皮施用 |
| CN112739679B (zh) | 2018-09-18 | 2024-03-12 | 伊莱利利公司 | 曲前列环素的特丁胺盐 |
| CN119632930A (zh) | 2019-04-29 | 2025-03-18 | 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 |
| JP7365073B2 (ja) * | 2019-05-21 | 2023-10-19 | ジァンスー フォアフロント ファーマシューティカル カンパニー，リミテッド | トレプロスチニルナトリウムの新規な結晶形および製造方法 |
| 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 |
| IL296567A (en) | 2020-04-17 | 2022-11-01 | United Therapeutics Corp | Terfostinil for use in the treatment of interstitial lung disease |
| AU2021289336B2 (en) | 2020-06-09 | 2025-08-28 | Mannkind 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 |
| KR102849520B1 (ko) | 2020-12-14 | 2025-08-25 | 유나이티드 쎄러퓨틱스 코포레이션 | 트레프로스티닐 프로드러그로 질환을 치료하는 방법 |
| WO2022187352A1 (en) | 2021-03-03 | 2022-09-09 | 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) |
| WO2023154705A1 (en) | 2022-02-08 | 2023-08-17 | United Therapeutics Corporation | Treprostinil iloprost combination therapy |
| EP4516297A4 (en) | 2022-04-29 | 2026-02-25 | Zhaoke pharmaceutical guangzhou co ltd | Treprostinil Gentle Inhalation Mist |
| CN121241041A (zh) | 2023-01-19 | 2025-12-30 | 联合治疗公司 | 曲前列尼尔类似物及相关制备和使用方法 |
| US20260166056A1 (en) | 2024-12-13 | 2026-06-18 | United Therapeutics Corporation | Treprostinil formulations and their uses |
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 |
| USRE39706E1 (en) * | 1993-01-15 | 2007-06-26 | Leo Pharma A/S | Crystalline form of a vitamin D analogue |
| 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 |
| ES2214753T3 (es) * | 1997-11-14 | 2004-09-16 | United Therapeutics Corporation | Uso de 9-desoxi-2',9-alfa-metano-3-oxa-4,5,6-trinor-3,7-(1',3'-interfenilen)-13,14-dihidro-prostaglandina f1 para tratar la enfermedad vascular periferica. |
| 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 |
| CN102697790A (zh) * | 2003-05-22 | 2012-10-03 | 联合治疗公司 | 化合物和释放前列环素类似物的方法 |
| KR20050024121A (ko) * | 2003-09-04 | 2005-03-10 | 동아제약주식회사 | 7-카르복시메틸옥시-3',4',5-트리메톡시 플라본.일수화물, 이의 제조방법 및 용도 |
| US7199157B2 (en) | 2003-12-16 | 2007-04-03 | United Therapeutics Corporation | Use of treprostinil to improve kidney functions |
| CN1917866B (zh) | 2003-12-16 | 2010-12-15 | 联合治疗公司 | 曲前列环素或它的衍生物，或其药学上可接受的盐在制备治疗和预防缺血性损害的药物中的用途 |
| DE602005020269D1 (de) * | 2004-04-12 | 2010-05-12 | United Therapeutics Corp | Verwendung von treprostinil zur behandlung von neuropathischen diabetischen fussgeschwüren |
| US8747897B2 (en) * | 2006-04-27 | 2014-06-10 | Supernus Pharmaceuticals, Inc. | Osmotic drug delivery system |
| CA2654492C (en) * | 2006-05-15 | 2017-06-27 | 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 |
| WO2009078965A1 (en) * | 2007-12-17 | 2009-06-25 | United Therapeutics Corporation | An improved process to prepare treprostinil, the active ingredient in remodulin |
-
2009
- 2009-05-07 JP JP2011508505A patent/JP6219016B2/ja active Active
- 2009-05-07 CN CN2009801161262A patent/CN102015613B/zh active Active
- 2009-05-07 CA CA2723540A patent/CA2723540C/en active Active
- 2009-05-07 ES ES09743053.2T patent/ES2575565T3/es active Active
- 2009-05-07 WO PCT/US2009/002818 patent/WO2009137066A1/en not_active Ceased
- 2009-05-07 EP EP09743053.2A patent/EP2300408B1/en active Active
- 2009-05-07 US US12/437,054 patent/US8350079B2/en active Active
- 2009-05-07 EP EP15190454.7A patent/EP3002274A1/en not_active Withdrawn
- 2009-05-07 KR KR1020107027068A patent/KR20110010753A/ko not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| EP3002274A8 (en) | 2016-07-13 |
| KR20110010753A (ko) | 2011-02-07 |
| EP3002274A1 (en) | 2016-04-06 |
| JP2011519927A (ja) | 2011-07-14 |
| CA2723540C (en) | 2016-01-05 |
| EP2300408A1 (en) | 2011-03-30 |
| US8350079B2 (en) | 2013-01-08 |
| US20090281189A1 (en) | 2009-11-12 |
| WO2009137066A1 (en) | 2009-11-12 |
| CN102015613B (zh) | 2013-07-31 |
| CN102015613A (zh) | 2011-04-13 |
| EP2300408B1 (en) | 2016-04-13 |
| CA2723540A1 (en) | 2009-11-12 |
| JP6219016B2 (ja) | 2017-10-25 |
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