JP5649645B2 - プロスタサイクリンアナログの固形製剤 - Google Patents

プロスタサイクリンアナログの固形製剤 Download PDF

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JP5649645B2
JP5649645B2 JP2012509968A JP2012509968A JP5649645B2 JP 5649645 B2 JP5649645 B2 JP 5649645B2 JP 2012509968 A JP2012509968 A JP 2012509968A JP 2012509968 A JP2012509968 A JP 2012509968A JP 5649645 B2 JP5649645 B2 JP 5649645B2
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JP2012526140A5 (enExample
JP2012526140A (ja
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ファレス,ケネス,ロバート
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ユナイテッド セラピューティクス コーポレイション
ユナイテッド セラピューティクス コーポレイション
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/557Eicosanoids, e.g. leukotrienes or prostaglandins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/04Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Emergency Medicine (AREA)
  • Hospice & Palliative Care (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2012509968A 2009-05-07 2010-05-06 プロスタサイクリンアナログの固形製剤 Active JP5649645B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US17626809P 2009-05-07 2009-05-07
US61/176,268 2009-05-07
PCT/US2010/033852 WO2010129757A1 (en) 2009-05-07 2010-05-06 Solid formulations of prostacyclin analogs

Publications (3)

Publication Number Publication Date
JP2012526140A JP2012526140A (ja) 2012-10-25
JP2012526140A5 JP2012526140A5 (enExample) 2014-05-01
JP5649645B2 true JP5649645B2 (ja) 2015-01-07

Family

ID=43050464

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2012509968A Active JP5649645B2 (ja) 2009-05-07 2010-05-06 プロスタサイクリンアナログの固形製剤

Country Status (7)

Country Link
US (1) US8349892B2 (enExample)
EP (1) EP2427054A4 (enExample)
JP (1) JP5649645B2 (enExample)
KR (1) KR101544246B1 (enExample)
CN (1) CN102421288B (enExample)
CA (1) CA2760499C (enExample)
WO (1) WO2010129757A1 (enExample)

Families Citing this family (34)

* 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
WO2005099680A2 (en) * 2004-04-12 2005-10-27 United Therapeutics, Inc. Use of treprostinil to treat neuropathic diabetic foot ulcers
KR101390579B1 (ko) 2006-05-15 2014-05-19 유나이티드 세러퓨틱스 코오포레이션 정량 흡입기를 사용한 트레프로스티닐 투여
DE102006026786A1 (de) 2006-06-07 2007-12-13 Joachim Kern Dosierinhalator
EP2252570B1 (en) 2007-12-17 2017-04-05 United Therapeutics Corporation An improved process to prepare treprostinil, the active ingredient in remodulin ®
CN102883722B (zh) 2010-03-15 2014-11-05 联合治疗公司 用于肺动脉高血压的治疗
EP2576492B1 (en) 2010-06-03 2017-09-20 United Therapeutics Corporation Treprostinil production
US20120004307A1 (en) * 2010-06-15 2012-01-05 United Therapeutics Corporation Oral treatment of digital ischemic lesions
JP5580491B2 (ja) 2011-03-02 2014-08-27 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造のための中間体の合成
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
EP3712142B1 (en) 2013-01-11 2022-07-06 Corsair Pharma, Inc. Prodrugs of treprostinil
US9505737B2 (en) 2013-01-11 2016-11-29 Corsair Pharma, Inc. Treprostinil derivative compounds and methods of using same
CA3212313A1 (en) 2013-03-14 2014-10-02 United Therapeutics Corporation Solid forms of treprostinil
CN109608326A (zh) 2013-03-15 2019-04-12 联合治疗公司 曲前列环素的盐
CA2908244C (en) 2013-03-25 2021-04-20 United Therapeutics Corporation Process of making prostacyclin compounds with linker thiol and pegylated forms
BR112016009207B1 (pt) 2013-10-25 2022-11-22 Insmed Incorporated Compostos de prostaciclina
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
EP3209415B1 (en) 2014-10-20 2020-02-19 United Therapeutics Corporation Synthesis of intermediates for producing prostacyclin derivatives
CA2967385C (en) 2014-11-18 2023-05-16 Insmed Incorporated Methods of manufacturing treprostinil and treprostinil derivative prodrugs
US9394227B1 (en) 2015-06-17 2016-07-19 Corsair Pharma, Inc. Treprostinil derivatives and compositions and uses thereof
US9643911B2 (en) 2015-06-17 2017-05-09 Corsair Pharma, Inc. Treprostinil derivatives and compositions and uses thereof
EP3515430A1 (en) 2016-09-26 2019-07-31 United Therapeutics Corporation Treprostinil prodrugs
US10799653B2 (en) 2017-01-09 2020-10-13 United Therapeutics Corporation Aerosol delivery device and method for manufacturing and operating the same
ES2976468T3 (es) 2018-09-18 2024-08-01 Lilly Co Eli Sal de treprostinil erbumina
KR20220002600A (ko) 2019-04-29 2022-01-06 인스메드 인코포레이티드 트레프로스티닐 전구약물의 건조 분말 조성물 및 이의 사용 방법
CA3149358A1 (en) 2019-08-23 2021-03-04 United Therapeutics Corporation Treprostinil prodrugs
IL296567A (en) 2020-04-17 2022-11-01 United Therapeutics Corp Terfostinil for use in the treatment of interstitial lung disease
US11793780B2 (en) 2020-06-09 2023-10-24 United Therapeutics Corporation Prodrugs of treprosiinil
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
CA3209987A1 (en) 2021-03-03 2022-09-09 Hitesh Batra 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)
US20230263807A1 (en) 2022-02-08 2023-08-24 United Therapeutics Corporation Treprostinil iloprost combination therapy
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
WO2024155752A1 (en) 2023-01-19 2024-07-25 United Therapeutics Corporation Treprostinil analogs
CN117800845A (zh) * 2023-03-28 2024-04-02 广州楷石医药有限公司 一种羟基取代曲前列尼尔衍生物、合成方法及其应用

Family Cites Families (24)

* 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
GB9011588D0 (en) 1990-05-24 1990-07-11 Wellcome Found Prostaglandin analogues for use in medicine
US6441245B1 (en) 1997-10-24 2002-08-27 United Therapeutics Corporation Process for stereoselective synthesis of prostacyclin derivatives
EP1045695B1 (en) 1997-11-14 2004-03-24 United Therapeutics Corporation Use of 9-deoxy-2', 9-alpha-methano-3- oxa-4,5,6- trinor-3, 7-(1',3'-interphenylene) -13,14-dihydro- prostaglandin f 1? to treat peripheral vascular disease
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
CA2473162A1 (en) * 2002-01-30 2003-08-07 Kissei Pharmaceutical Co., Ltd. Novel thyroid hormone receptor ligand, medicinal compositions containing the same and use thereof
CA2959852A1 (en) * 2003-05-22 2005-01-27 United Therapeutics Corporation Compounds and methods for delivery of prostacyclin analogs
US20040265238A1 (en) 2003-06-27 2004-12-30 Imtiaz Chaudry Inhalable formulations for treating pulmonary hypertension and methods of using same
US20050101608A1 (en) 2003-09-24 2005-05-12 Santel Donald J. Iloprost in combination therapies for the treatment of pulmonary arterial hypertension
DE602004022982D1 (de) 2003-12-16 2009-10-15 United Therapeutics Corp Verwendung von treprostinil zur verbesserung der nierenfunktion
US8765813B2 (en) 2003-12-16 2014-07-01 United Therapeutics Corporation Use of treprostinil to treat and prevent ischemic lesions
WO2005099680A2 (en) 2004-04-12 2005-10-27 United Therapeutics, Inc. Use of treprostinil to treat neuropathic diabetic foot ulcers
ATE513827T1 (de) * 2005-02-22 2011-07-15 Pfizer Oxyindol-derivate als 5ht4-rezeptor-agonisten
US20060222792A1 (en) 2006-04-21 2006-10-05 Chemagis Ltd. Temozolomide storage system
US8747897B2 (en) 2006-04-27 2014-06-10 Supernus Pharmaceuticals, Inc. Osmotic drug delivery system
US20090281129A1 (en) 2006-05-15 2009-11-12 Senex Biotechnology, Inc. Cdki pathway inhibitors and uses thereof
KR101390579B1 (ko) 2006-05-15 2014-05-19 유나이티드 세러퓨틱스 코오포레이션 정량 흡입기를 사용한 트레프로스티닐 투여
US20100184862A1 (en) 2006-12-21 2010-07-22 Concert Pharmaceuticals Inc. Prostacyclin derivatives
CN102648916A (zh) 2007-02-09 2012-08-29 联合治疗公司 用于间质性肺病和哮喘的曲前列尼治疗
TR201808840T4 (tr) * 2007-02-20 2018-07-23 Allergan Pharmaceuticals Int Ltd Stabil sindirim enzimi bileşimleri.
EP2252570B1 (en) 2007-12-17 2017-04-05 United Therapeutics Corporation An improved process to prepare treprostinil, the active ingredient in remodulin ®

Also Published As

Publication number Publication date
JP2012526140A (ja) 2012-10-25
EP2427054A4 (en) 2014-01-15
US20100282622A1 (en) 2010-11-11
CA2760499A1 (en) 2010-11-11
EP2427054A1 (en) 2012-03-14
WO2010129757A1 (en) 2010-11-11
KR20120017058A (ko) 2012-02-27
CN102421288B (zh) 2015-04-22
CA2760499C (en) 2015-11-03
KR101544246B1 (ko) 2015-08-12
CN102421288A (zh) 2012-04-18
US8349892B2 (en) 2013-01-08

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