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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Publication number
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 (https=
JP2012526140A (ja
Inventor
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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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • 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
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • 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

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Cardiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Emergency Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hospice & Palliative Care (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Dermatology (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 (https=) 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 (https=)
EP (1) EP2427054A4 (https=)
JP (1) JP5649645B2 (https=)
KR (1) KR101544246B1 (https=)
CN (1) CN102421288B (https=)
CA (1) CA2760499C (https=)
WO (1) WO2010129757A1 (https=)

Families Citing this family (34)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101265226B (zh) 2003-05-22 2013-04-24 联合治疗公司 化合物和释放前列环素类似物的方法
ATE462427T1 (de) * 2004-04-12 2010-04-15 United Therapeutics Corp Verwendung von treprostinil zur behandlung von neuropathischen diabetischen fussgeschwüren
CN101495122B (zh) 2006-05-15 2011-10-05 联合治疗公司 使用定量吸入器给予曲前列尼
DE102006026786A1 (de) 2006-06-07 2007-12-13 Joachim Kern Dosierinhalator
KR20160048222A (ko) 2007-12-17 2016-05-03 유나이티드 세러퓨틱스 코오포레이션 레모둘린?의 활성 성분인 트레프로스티닐의 개선된 제조 방법
EP3108888B1 (en) 2010-03-15 2020-02-12 United Therapeutics Corporation Treatment for pulmonary hypertension
WO2011153363A1 (en) 2010-06-03 2011-12-08 United Therapeutics Corporation Treprostinil production
WO2011159693A2 (en) * 2010-06-15 2011-12-22 United Therapeutics Corporation Oral treatment of digital ischemic lesions
EP2681204B1 (en) 2011-03-02 2016-04-27 United Therapeutics Corporation Synthesis of intermediate for treprostinil production
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
US9505737B2 (en) 2013-01-11 2016-11-29 Corsair Pharma, Inc. Treprostinil derivative compounds and methods of using same
EP3712142B1 (en) 2013-01-11 2022-07-06 Corsair Pharma, Inc. Prodrugs of treprostinil
EP2970091A4 (en) 2013-03-14 2017-02-08 United Therapeutics Corporation Solid forms of treprostinil
US20140275616A1 (en) 2013-03-15 2014-09-18 United Therapeutics Corporation Salts of treprostinil
EP2978313B1 (en) 2013-03-25 2018-02-21 United Therapeutics Corporation Process of making prostacyclin compounds with linker thiol and pegylated forms
LT3060041T (lt) 2013-10-25 2021-03-25 Insmed Incorporated Prostaciklino junginiai
CN106573066A (zh) 2014-06-13 2017-04-19 联合治疗学有限公司 曲前列环素制剂
ES2778274T3 (es) 2014-10-20 2020-08-10 United Therapeutics Corp Síntesis de productos intermedios para producir derivados de prostaciclina
JP6866043B2 (ja) 2014-11-18 2021-04-28 インスメッド インコーポレイテッド トレプロスチニルプロドラッグおよびトレプロスチニル誘導体プロドラッグの製造方法
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
JP7220650B2 (ja) 2016-09-26 2023-02-10 ユナイテッド セラピューティクス コーポレイション トレプロスチニルプロドラッグ
US10799653B2 (en) 2017-01-09 2020-10-13 United Therapeutics Corporation Aerosol delivery device and method for manufacturing and operating the same
AU2019344541B2 (en) 2018-09-18 2022-01-06 Eli Lilly And Company Erbumine salt of treprostinil
JP7455144B2 (ja) 2019-04-29 2024-03-25 インスメッド インコーポレイテッド 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
JP2022546314A (ja) 2019-08-23 2022-11-04 ユナイテッド セラピューティクス コーポレイション トレプロスチニルプロドラッグ
AU2021255621A1 (en) 2020-04-17 2022-10-20 United Therapeutics Corporation Treprostinil for use in the treatment of intersitial lung disease
JP7608480B2 (ja) 2020-06-09 2025-01-06 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フマリルジケトピペリジンプロドラッグ
WO2022132655A1 (en) 2020-12-14 2022-06-23 United Therapeutics Corporation Methods of treating disease with treprostinil prodrugs
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)
US20230263807A1 (en) 2022-02-08 2023-08-24 United Therapeutics Corporation Treprostinil iloprost combination therapy
KR20250002687A (ko) 2022-04-29 2025-01-07 자오커 파마슈티컬 (광저우) 컴퍼니., 리미티드 트레프로스티닐 소프트 미스트 흡입제
AU2024208919A1 (en) 2023-01-19 2025-07-17 United Therapeutics Corporation Treprostinil analogs
CN117800845B (zh) * 2023-03-28 2026-04-14 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
US7230031B2 (en) * 2002-01-30 2007-06-12 Kissei Pharmaceutical Co., Ltd. Thyroid hormone receptor ligand, medicinal compositions containing the same and use thereof
CN101265226B (zh) 2003-05-22 2013-04-24 联合治疗公司 化合物和释放前列环素类似物的方法
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
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
CA2549801C (en) 2003-12-16 2012-10-16 United Therapeutics Corporation Use of treprostinil to improve kidney functions
ATE462427T1 (de) 2004-04-12 2010-04-15 United Therapeutics Corp Verwendung von treprostinil zur behandlung von neuropathischen diabetischen fussgeschwüren
AP2007004067A0 (en) * 2005-02-22 2007-08-31 Pfizer Oxyindole derivatives as 5HT4 receptor agonists
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
CN101495122B (zh) 2006-05-15 2011-10-05 联合治疗公司 使用定量吸入器给予曲前列尼
US20100184862A1 (en) 2006-12-21 2010-07-22 Concert Pharmaceuticals Inc. Prostacyclin derivatives
CA2678258A1 (en) 2007-02-09 2008-08-14 United Therapeutics Corporation Treprostinil treatment for interstitial lung disease and asthma
JP5966202B2 (ja) * 2007-02-20 2016-08-10 アラガン ファーマシューティカルズ インターナショナル リミテッド 安定な消化酵素組成物
KR20160048222A (ko) 2007-12-17 2016-05-03 유나이티드 세러퓨틱스 코오포레이션 레모둘린?의 활성 성분인 트레프로스티닐의 개선된 제조 방법

Also Published As

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

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