[go: up one dir, main page]

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 PDF

Info

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
Application number
ES09743053.2T
Other languages
English (en)
Inventor
David A. Walsh
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.)
United Therapeutics Corp
Original Assignee
United Therapeutics Corp
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 United Therapeutics Corp filed Critical United Therapeutics Corp
Application granted granted Critical
Publication of ES2575565T3 publication Critical patent/ES2575565T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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)

Abstract

Procedimiento para preparar monohidrato de treprostinilo, comprendiendo dicho procedimiento a. recristalizar treprostinilo anhidro o trepr ostinilo húmedo a partir de una combinación de disolvente orgánico/agua para proporcionar un sólido; y b. secar al aire el sólido a una temperatura desde 15ºC a 35ºC hasta que no se evapore ningún disolvente adicional.

Description

imagen1
imagen2
imagen3
imagen4
imagen5
imagen6
imagen7

Claims (1)

  1. imagen1
ES09743053.2T 2008-05-08 2009-05-07 Procedimiento para la preparación de monohidrato de treprostinilo y su utilización para el almacenamiento y el envío Active ES2575565T3 (es)

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 (es)
EP (2) EP2300408B1 (es)
JP (1) JP6219016B2 (es)
KR (1) KR20110010753A (es)
CN (1) CN102015613B (es)
CA (1) CA2723540C (es)
ES (1) ES2575565T3 (es)
WO (1) WO2009137066A1 (es)

Families Citing this family (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2959852A1 (en) 2003-05-22 2005-01-27 United Therapeutics Corporation Compounds and methods for delivery of prostacyclin analogs
CN101903324B (zh) 2007-12-17 2013-07-03 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
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
US8461393B2 (en) 2011-03-02 2013-06-11 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
JP2016517410A (ja) 2013-03-14 2016-06-16 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固体形態
US20140275616A1 (en) 2013-03-15 2014-09-18 United Therapeutics Corporation Salts of treprostinil
KR102238501B1 (ko) 2013-03-25 2021-04-08 유나이티드 세러퓨틱스 코오포레이션 링커 티올 및 peg화된 형태를 갖는 프로스타시클린 화합물의 제조 방법
CA2911172C (en) 2013-04-30 2021-10-19 United Therapeutics Corporation Controlled release pharmaceutical formulations
EA031604B1 (ru) 2013-10-25 2019-01-31 Инсмед Инкорпорейтед Трепростинильные соединения, композиции и способы их использования
EP3164155B1 (en) 2014-06-13 2022-02-09 United Therapeutics Corporation Treprostinil formulations
WO2016038532A1 (en) * 2014-09-09 2016-03-17 Mylan Laboratories Limited Amorphous treprostinil diethanolamine
HU231186B1 (hu) * 2014-10-08 2021-06-28 CHINOIN Gyógyszer és Vegyészeti Termékek Gyára Zrt. Új eljárás treprostinil és sói előállítására
JP6224872B1 (ja) 2014-10-20 2017-11-01 ユナイテッド セラピューティクス コーポレイション プロスタサイクリン誘導体を生成するための中間体の合成
EP3221291B1 (en) 2014-11-18 2021-03-31 Insmed Incorporated Methods of manufacturing treprostinil and treprostinil derivative prodrugs
IL262720B2 (en) 2016-05-05 2024-06-01 Liquidia Tech Inc Dry powder treprostinil for the treatment of pulmonary hypertension
KR102541885B1 (ko) 2016-09-26 2023-06-12 유나이티드 쎄러퓨틱스 코포레이션 트레프로스티닐 프로드럭
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
AU2019344541B2 (en) 2018-09-18 2022-01-06 Eli Lilly And Company Erbumine salt of treprostinil
KR20220002600A (ko) 2019-04-29 2022-01-06 인스메드 인코포레이티드 트레프로스티닐 전구약물의 건조 분말 조성물 및 이의 사용 방법
CN112313202A (zh) * 2019-05-21 2021-02-02 江苏众强药业有限公司 曲前列尼尔钠盐新晶型及制备方法
CA3149358A1 (en) 2019-08-23 2021-03-04 United Therapeutics Corporation Treprostinil prodrugs
US11339110B2 (en) 2019-12-19 2022-05-24 Chirogate International Inc. Efficient crystallization process for preparing ultrapure Treprostinil and crystal prepared therefrom
CN115916212A (zh) 2020-04-17 2023-04-04 联合治疗公司 曲前列尼尔用于治疗间质性肺病
WO2021252446A1 (en) 2020-06-09 2021-12-16 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
IL303668A (en) 2020-12-14 2023-08-01 United Therapeutics Corp Stable treprostinil prodrugs and their uses for the treatment of diseases
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)
JP2025506019A (ja) 2022-02-08 2025-03-05 ユナイテッド セラピューティクス コーポレイション トレプロスチニルイロプロスト併用療法
JP2025515512A (ja) 2022-04-29 2025-05-15 兆科薬業（広州）有限公司 トレプロスチニルソフトミスト吸入剤
IL322116A (en) 2023-01-19 2025-09-01 United Therapeutics Corp Analogues of treprostinil

Family Cites Families (23)

* Cited by examiner, † Cited by third party
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
US5763426A (en) * 1993-01-15 1998-06-09 Leo Pharmaceutical Products Ltd. 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
CN1142781C (zh) * 1997-11-14 2004-03-24 联合治疗公司 9－脱氧－2′,9－α－亚甲基－3－氧杂－4,5,6－三去甲－3,7－(1′,3′－间亚苯基)－13,14－二氢－前列腺素F1在治疗外周血管疾病中的用途
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
CA2959852A1 (en) * 2003-05-22 2005-01-27 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
ES2331187T3 (es) 2003-12-16 2009-12-23 United Therapeutics Corporation Utilizacion de treprostinil para mejorar las funciones renales.
CN101647792B (zh) 2003-12-16 2012-11-28 联合治疗公司 曲前列环素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
KR101390579B1 (ko) * 2006-05-15 2014-05-19 유나이티드 세러퓨틱스 코오포레이션 정량 흡입기를 사용한 트레프로스티닐 투여
WO2008049000A2 (en) 2006-10-18 2008-04-24 United Therapeutics Corporation Combination therapy for pulmonary arterial hypertension
EP2120961A1 (en) 2007-02-09 2009-11-25 United Therapeutics Corporation Treprostinil treatment for interstitial lung disease and asthma
WO2008118946A1 (en) 2007-03-27 2008-10-02 Atherogenics, Inc. Methods and compositions using certain phenolic derivatives for the treatment of diabetes
CN101903324B (zh) * 2007-12-17 2013-07-03 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

Also Published As

Publication number Publication date
EP3002274A8 (en) 2016-07-13
JP2011519927A (ja) 2011-07-14
CN102015613B (zh) 2013-07-31
US8350079B2 (en) 2013-01-08
EP2300408A1 (en) 2011-03-30
CA2723540C (en) 2016-01-05
JP6219016B2 (ja) 2017-10-25
CN102015613A (zh) 2011-04-13
WO2009137066A1 (en) 2009-11-12
CA2723540A1 (en) 2009-11-12
US20090281189A1 (en) 2009-11-12
EP3002274A1 (en) 2016-04-06
KR20110010753A (ko) 2011-02-07
EP2300408B1 (en) 2016-04-13

Similar Documents

Publication Publication Date Title
ES2575565T3 (es) Procedimiento para la preparación de monohidrato de treprostinilo y su utilización para el almacenamiento y el envío
ES2532948T3 (es) Composición tópica para el tratamiento de queratosis actínica
ES2573525T3 (es) Grúa de torre giratoria
ES2563323T3 (es) Procedimiento para la preparación de un sólido cristalino a partir de derivados de ácido glicin-N,N-diacético
ES2528026T3 (es) Sales de oxalato de ivabridina cristalino y polimorfos de los mismos
ES2496092T3 (es) El uso de amisulprida para tratar náuseas y vómitos posoperatorios
ES2533617T3 (es) Leche en polvo que contiene lactasa
ES2525918T3 (es) Proceso para la fabricación de Nicorandil
GT200700011A (es) Torre de enfriamiento
CO6321254A2 (es) Pirimidin -5-carboxamidas sustituidas 281
ES2390396T7 (es) Procedimiento de preparación de compuestos p-hidroximandélicos eventualmente sustituidos y derivados
CL2012000033A1 (es) Compuestos n-(3-(4as,7as)-2-amino-4a,5,7,7a-tetrahidro-4h-furo[3,4-d][1,3] tiazin-7a-il)-4- fluorofenilo) -5-fluoropiconilamida, inhibidor de bace; composicion farmaceutica que los comprende, uso del compuesto para el tratamiento de la enfermedad de alzheimer.
CL2008003041A1 (es) Compuestos derivados de acido boronico, inhibidores de proteasoma; composicion farmaceutica que comprende a dicho compuesto; y uso del compuesto para el tratamiento del cancer.
CL2008000110A1 (es) Uso de compuestos derivados de piranona sustituidos para el tratamiento del sindrome metabolico; y compuestos derivados de piranona sustituidos.
ES2642325T3 (es) Sonda de temperatura de núcleo
ES2577294T3 (es) Procedimiento para la síntesis de clopidogrel y nuevas formas de sales farmacéuticamente aceptables del mismo
ES2494140T3 (es) Suspensión de compuesto de boro
ES2508117T3 (es) Uso del butanoato de 4-[etil(dimetil)amonio)] en el tratamiento de la enfermedad cardiovascular
AR070180A1 (es) Sistema interconectado para enfriar el suministro de aire a un edificio
CL2007002637A1 (es) Compuestos derivados de acido 2-fenoxinicotinico; procedimiento de preparacion; composicion farmaceutica que comprende a dicho compuesto; y uso del compuesto para el tratamiento de dislipidemias, arteriosclerosis e insuficiencia cardiaca.
AR081017A1 (es) Composicion topica y uso de la misma para la profilaxis y el tratamiento de los defectos relacionados con dermopatias inflamatorias
ES2525833T3 (es) Supresión del crecimiento del cáncer y la metástasis mediante el uso de derivados de ácido nordihidroguayarético con 7-hidroxiestaurosporina
ES2525528T3 (es) Amicolamicina, método para su producción y su utilización
ES2584802T3 (es) Procedimiento de preparación de sílice precipitada que comprende una etapa de desaglomeración en caliente
ES2528962T9 (es) Un procedimiento para secar la colada