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
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United Therapeutics Corp
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Publication date
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Application filed by United Therapeutics Corp filed Critical United Therapeutics Corp
Publication of CA2760499A1 publication Critical patent/CA2760499A1/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)
  • 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)
  • Cardiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Emergency Medicine (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Hospice & Palliative Care (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 (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 (35)

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Publication number Priority date Publication date Assignee Title
CN102697790A (zh) 2003-05-22 2012-10-03 联合治疗公司 化合物和释放前列环素类似物的方法
DE602005020269D1 (de) * 2004-04-12 2010-05-12 United Therapeutics Corp Verwendung von treprostinil zur behandlung von neuropathischen diabetischen fussgeschwüren
CA2654492C (en) 2006-05-15 2017-06-27 United Therapeutics Corporation Treprostinil administration using a metered dose inhaler
DE102006026786A1 (de) 2006-06-07 2007-12-13 Joachim Kern Dosierinhalator
WO2009078965A1 (en) 2007-12-17 2009-06-25 United Therapeutics Corporation An improved process to prepare treprostinil, the active ingredient in remodulin
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
WO2011159693A2 (en) * 2010-06-15 2011-12-22 United Therapeutics Corporation Oral treatment of digital ischemic lesions
ES2581762T3 (es) 2011-03-02 2016-09-07 United Therapeutics Corporation Síntesis de producto intermedio para la producción de treprostinil
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
EP2970081A4 (en) 2013-03-15 2016-10-12 United Therapeutics Corp SALTS OF TREPROSTINIL
WO2014160638A1 (en) 2013-03-25 2014-10-02 United Therapeutics Corporation Process of making prostacyclin compounds with linker thiol and pegylated forms
US9469600B2 (en) 2013-10-25 2016-10-18 Insmed Incorporated Prostacyclin compounds, compositions and methods of use thereof
ES2908142T3 (es) 2014-06-13 2022-04-27 United Therapeutics Corp Formulaciones de treprostinil
CN107108427A (zh) 2014-10-20 2017-08-29 联合治疗学有限公司 用于制备前列环素衍生物的中间体的合成
US10343979B2 (en) 2014-11-18 2019-07-09 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
WO2018058124A1 (en) 2016-09-26 2018-03-29 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
CN112739679B (zh) 2018-09-18 2024-03-12 伊莱利利公司 曲前列环素的特丁胺盐
CN119632930A (zh) 2019-04-29 2025-03-18 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
CN114616225A (zh) 2019-08-23 2022-06-10 联合治疗公司 曲前列环素前药
IL296567A (en) 2020-04-17 2022-11-01 United Therapeutics Corp Terfostinil for use in the treatment of interstitial lung disease
AU2021289336B2 (en) 2020-06-09 2025-08-28 Mannkind Corporation Fumaryl diketopiperidine prodrugs of treprostinil
KR102849520B1 (ko) 2020-12-14 2025-08-25 유나이티드 쎄러퓨틱스 코포레이션 트레프로스티닐 프로드러그로 질환을 치료하는 방법
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)
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
CN121241041A (zh) 2023-01-19 2025-12-30 联合治疗公司 曲前列尼尔类似物及相关制备和使用方法
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
US20260166056A1 (en) 2024-12-13 2026-06-18 United Therapeutics Corporation Treprostinil formulations and their uses

Family Cites Families (24)

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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
ES2214753T3 (es) * 1997-11-14 2004-09-16 United Therapeutics Corporation Uso de 9-desoxi-2',9-alfa-metano-3-oxa-4,5,6-trinor-3,7-(1',3'-interfenilen)-13,14-dihidro-prostaglandina f1 para tratar la enfermedad vascular periferica.
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
CN102697790A (zh) * 2003-05-22 2012-10-03 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
US7199157B2 (en) * 2003-12-16 2007-04-03 United Therapeutics Corporation Use of treprostinil to improve kidney functions
DE602005020269D1 (de) * 2004-04-12 2010-05-12 United Therapeutics Corp Verwendung von treprostinil zur behandlung von neuropathischen diabetischen fussgeschwüren
AU2006217534B8 (en) * 2005-02-22 2011-12-08 Pfizer Inc. 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
CA2654492C (en) * 2006-05-15 2017-06-27 United Therapeutics Corporation Treprostinil administration using a metered dose inhaler
KR20090101276A (ko) * 2006-12-21 2009-09-24 콘서트 파마슈티컬즈, 인크. 프로스타시클린 유도체
CA2678258A1 (en) * 2007-02-09 2008-08-14 United Therapeutics Corporation Treprostinil treatment for interstitial lung disease and asthma
PT2079445E (pt) * 2007-02-20 2016-02-29 Allergan Pharmaceuticals Internat Ltd Composições de enzimas digestivas estáveis
WO2009078965A1 (en) * 2007-12-17 2009-06-25 United Therapeutics Corporation An improved process to prepare treprostinil, the active ingredient in remodulin

Also Published As

Publication number Publication date
EP2427054A4 (en) 2014-01-15
CA2760499A1 (en) 2010-11-11
US20100282622A1 (en) 2010-11-11
EP2427054A1 (en) 2012-03-14
JP2012526140A (ja) 2012-10-25
JP5649645B2 (ja) 2015-01-07
CN102421288B (zh) 2015-04-22
CN102421288A (zh) 2012-04-18
KR101544246B1 (ko) 2015-08-12
US8349892B2 (en) 2013-01-08
WO2010129757A1 (en) 2010-11-11
KR20120017058A (ko) 2012-02-27

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