CA2760499C - Solid formulations of prostacyclin analogs - Google Patents

Solid formulations of prostacyclin analogs Download PDF

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Publication number
CA2760499C
CA2760499C CA2760499A CA2760499A CA2760499C CA 2760499 C CA2760499 C CA 2760499C CA 2760499 A CA2760499 A CA 2760499A CA 2760499 A CA2760499 A CA 2760499A CA 2760499 C CA2760499 C CA 2760499C
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Prior art keywords
packaging
desiccant
months
storage method
formulation
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CA2760499A
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English (en)
French (fr)
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CA2760499A1 (en
Inventor
Kenneth Robert Phares
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
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United Therapeutics Corp
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43050464&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2760499(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by United Therapeutics Corp filed Critical United Therapeutics Corp
Publication of CA2760499A1 publication Critical patent/CA2760499A1/en
Application granted granted Critical
Publication of CA2760499C publication Critical patent/CA2760499C/en
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Classifications

    • 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

Landscapes

  • 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)
CA2760499A 2009-05-07 2010-05-06 Solid formulations of prostacyclin analogs Active CA2760499C (en)

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 (2)

Publication Number Publication Date
CA2760499A1 CA2760499A1 (en) 2010-11-11
CA2760499C true CA2760499C (en) 2015-11-03

Family

ID=43050464

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2760499A Active CA2760499C (en) 2009-05-07 2010-05-06 Solid formulations of prostacyclin analogs

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)

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ES2622471T5 (es) 2003-05-22 2020-07-23 United Therapeutics Corp Compuestos y procedimientos para la administración de análogos de prostaciclina
WO2005099680A2 (en) * 2004-04-12 2005-10-27 United Therapeutics, Inc. Use of treprostinil to treat neuropathic diabetic foot ulcers
EP2026816B1 (en) 2006-05-15 2018-10-24 United Therapeutics Corporation Treprostinil administration using a metered dose inhaler
DE102006026786A1 (de) 2006-06-07 2007-12-13 Joachim Kern Dosierinhalator
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
ES2611187T3 (es) 2010-03-15 2017-05-05 United Therapeutics Corporation Tratamiento para hipertensión pulmonar
JP6046034B2 (ja) 2010-06-03 2016-12-14 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製造
US20120004307A1 (en) * 2010-06-15 2012-01-05 United Therapeutics Corporation Oral treatment of digital ischemic lesions
US20130345471A1 (en) 2011-03-02 2013-12-26 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
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
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
CN109608326A (zh) 2013-03-15 2019-04-12 联合治疗公司 曲前列环素的盐
JP6263604B2 (ja) 2013-03-25 2018-01-17 ユナイテッド セラピューティクス コーポレイション チオールリンカーを持つ、ペグ化型のプロスタサイクリン化合物の製造方法
ES2860975T3 (es) 2013-10-25 2021-10-05 Insmed Inc Compuestos de prostaciclina
ES2908142T3 (es) 2014-06-13 2022-04-27 United Therapeutics Corp Formulaciones de treprostinil
US9593061B2 (en) 2014-10-20 2017-03-14 United Therapeutics Corporation Synthesis of intermediates for producing prostacyclin derivatives
AU2015349969B2 (en) 2014-11-18 2020-02-06 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
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
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
EP4017588A1 (en) 2019-08-23 2022-06-29 United Therapeutics Corporation Treprostinil prodrugs
JP2023523557A (ja) 2020-04-17 2023-06-06 ユナイテッド セラピューティクス コーポレイション 間質性肺疾患の治療における使用のためのトレプロスチニル
IL298591A (en) 2020-06-09 2023-01-01 United Therapeutics Corp Pomeryl dictopiperidine prodrugs of treprostinil
KR20250133451A (ko) 2020-12-14 2025-09-05 유나이티드 쎄러퓨틱스 코포레이션 트레프로스티닐 프로드러그로 질환을 치료하는 방법
JP2024510930A (ja) 2021-03-03 2024-03-12 ユナイテッド セラピューティクス コーポレイション トレプロスチニル及びそのプロドラッグの乾燥粉末組成物、及び、さらに(e)-3,6-ビス[4-(n-カルボニル-2-プロペニル)アミドブチル]-2,5-ジケトピペラジン(fdkp)を含む乾燥粉末組成物
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
EP4652151A1 (en) 2023-01-19 2025-11-26 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

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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
KR100638684B1 (ko) * 1997-11-14 2006-10-27 유나이티드 세러퓨틱스 코오포레이션 말초 혈관 질환의 치료를 위한 9-데옥시-2',9-알파-메타노-3-옥사-4,5,6-트리노르-3,7-(1',3'-인터페닐렌)-13,14-디하이드로-프로스타글란딘 에프1의 용도
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
EP1471049A4 (en) * 2002-01-30 2006-08-16 Kissei Pharmaceutical NEW THYROIDIAN HORMONE RECEPTOR LIGAND, MEDICINAL PREPARATIONS CONTAINING THE SAME AND USE THEREOF
ES2622471T5 (es) * 2003-05-22 2020-07-23 United Therapeutics Corp Compuestos y procedimientos para la administración de análogos de prostaciclina
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
ATE441418T1 (de) * 2003-12-16 2009-09-15 United Therapeutics Corp Verwendung von treprostinil zur verbesserung der nierenfunktion
DE602004028155D1 (de) * 2003-12-16 2010-08-26 United Therapeutics Corp Verwendung von treprostinil zur behandlung von ischämischen läsionen
WO2005099680A2 (en) * 2004-04-12 2005-10-27 United Therapeutics, Inc. Use of treprostinil to treat neuropathic diabetic foot ulcers
KR100908547B1 (ko) * 2005-02-22 2009-07-20 화이자 인코포레이티드 5ht4 수용체 작용제로서의 옥시인돌 유도체
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EP2026816B1 (en) * 2006-05-15 2018-10-24 United Therapeutics Corporation Treprostinil administration using a metered dose inhaler
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KR20090101276A (ko) * 2006-12-21 2009-09-24 콘서트 파마슈티컬즈, 인크. 프로스타시클린 유도체
JP2010518122A (ja) * 2007-02-09 2010-05-27 ユナイテッド セラピューティクス コーポレーション 間質性肺疾患および喘息のためのトレプロスチニル処置
US8246950B2 (en) * 2007-02-20 2012-08-21 Aptalis Pharma Limited Stable digestive enzyme compositions
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
CN102421288A (zh) 2012-04-18
US8349892B2 (en) 2013-01-08
JP2012526140A (ja) 2012-10-25
KR20120017058A (ko) 2012-02-27
US20100282622A1 (en) 2010-11-11
JP5649645B2 (ja) 2015-01-07
WO2010129757A1 (en) 2010-11-11
EP2427054A4 (en) 2014-01-15
KR101544246B1 (ko) 2015-08-12
CA2760499A1 (en) 2010-11-11
EP2427054A1 (en) 2012-03-14
CN102421288B (zh) 2015-04-22

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