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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Application number
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
Original Assignee
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

    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Emergency Medicine (AREA)
  • Vascular Medicine (AREA)
  • Hospice & Palliative Care (AREA)
  • Dermatology (AREA)
  • Urology & Nephrology (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 (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)

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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
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
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
CA2777070C (en) 2010-06-03 2019-11-05 United Therapeutics Corporation Treprostinil production
US20120004307A1 (en) * 2010-06-15 2012-01-05 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
WO2014159050A1 (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
WO2014160638A1 (en) 2013-03-25 2014-10-02 United Therapeutics Corporation Process of making prostacyclin compounds with linker thiol and pegylated forms
EP3808731A1 (en) 2013-10-25 2021-04-21 Insmed Incorporated Prostacyclin compounds
US20170095432A1 (en) 2014-06-13 2017-04-06 United Therapeutics Corporation Treprostinil formulations
US9593061B2 (en) 2014-10-20 2017-03-14 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
US9643911B2 (en) 2015-06-17 2017-05-09 Corsair Pharma, Inc. Treprostinil derivatives and compositions and uses thereof
US9394227B1 (en) 2015-06-17 2016-07-19 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
CA3112986C (en) 2018-09-18 2024-06-18 Eli Lilly And Company Erbumine salt of treprostinil
US11458098B2 (en) 2019-04-29 2022-10-04 Insmed Incorporated Dry powder compositions of treprostinil prodrugs and methods of use thereof
CN114616225A (zh) 2019-08-23 2022-06-10 联合治疗公司 曲前列环素前药
US11826327B2 (en) 2020-04-17 2023-11-28 United Therapeutics Corporation Treatment for interstitial lung disease
WO2021252446A1 (en) 2020-06-09 2021-12-16 United Therapeutics Corporation Fumaryl diketopiperidine prodrugs of treprostinil
JP2023553989A (ja) 2020-12-14 2023-12-26 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で疾患を治療する方法
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)
KR20240141319A (ko) 2022-02-08 2024-09-26 유나이티드 쎄러퓨틱스 코포레이션 트레프로스티닐 일로프로스트 조합 치료 요법
EP4516297A1 (en) 2022-04-29 2025-03-05 Zhaoke Pharmaceutical (Guangzhou) Co., Ltd Treprostinil soft mist inhalant
KR20250139830A (ko) 2023-01-19 2025-09-23 유나이티드 쎄러퓨틱스 코포레이션 트레프로스티닐 유사체
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

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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
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
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
WO2003064369A1 (en) * 2002-01-30 2003-08-07 Kissei Pharmaceutical Co., Ltd. Novel 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
CA2549724C (en) * 2003-12-16 2014-02-11 United Therapeutics Corporation Use of treprostinil to treat and prevent ischemic lesions
DE602004022982D1 (de) * 2003-12-16 2009-10-15 United Therapeutics Corp Verwendung von treprostinil zur verbesserung der nierenfunktion
ATE462427T1 (de) * 2004-04-12 2010-04-15 United Therapeutics Corp Verwendung von treprostinil zur behandlung von neuropathischen diabetischen fussgeschwüren
EA012615B1 (ru) * 2005-02-22 2009-10-30 Пфайзер Инк. Производные оксииндола в качестве агонистов 5-htрецептора
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
EP2120961A1 (en) * 2007-02-09 2009-11-25 United Therapeutics Corporation Treprostinil treatment for interstitial lung disease and asthma
CN101686943B (zh) * 2007-02-20 2014-03-26 阿普塔利斯制药有限公司 稳定的消化酶组合物
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
EP2427054A1 (en) 2012-03-14
KR101544246B1 (ko) 2015-08-12
CN102421288A (zh) 2012-04-18
US20100282622A1 (en) 2010-11-11
EP2427054A4 (en) 2014-01-15
WO2010129757A1 (en) 2010-11-11
US8349892B2 (en) 2013-01-08
CN102421288B (zh) 2015-04-22
JP5649645B2 (ja) 2015-01-07
JP2012526140A (ja) 2012-10-25

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Effective date: 20140520