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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Application filed by United Therapeutics Corp filed Critical United Therapeutics Corp
Publication of CA2760499A1 publication Critical patent/CA2760499A1/en
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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)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Cardiology (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 (OSRAM)
EP (1) EP2427054A4 (OSRAM)
JP (1) JP5649645B2 (OSRAM)
KR (1) KR101544246B1 (OSRAM)
CN (1) CN102421288B (OSRAM)
CA (1) CA2760499C (OSRAM)
WO (1) WO2010129757A1 (OSRAM)

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ES2670872T3 (es) * 2003-05-22 2018-06-01 United Therapeutics Corporation Polimorfo de una sal de dietanolamina de treprostinil
CA2562614C (en) * 2004-04-12 2013-09-17 United Therapeutics, Inc. Use of treprostinil to treat neuropathic diabetic foot ulcers
JP5797376B2 (ja) 2006-05-15 2015-10-21 ユナイテッド セラピューティクス コーポレーション 定量吸入器を用いたトレプロスチニル投与
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
JP5681276B2 (ja) 2010-03-15 2015-03-04 ユナイテッド セラピューティクス コーポレイション 肺高血圧症のための治療
US8481782B2 (en) 2010-06-03 2013-07-09 United Therapeutics Corporation Treprostinil production
WO2011159693A2 (en) * 2010-06-15 2011-12-22 United Therapeutics Corporation Oral treatment of digital ischemic lesions
KR101454571B1 (ko) 2011-03-02 2014-10-23 유나이티드 세러퓨틱스 코오포레이션 트레프로스티닐 생산을 위한 중간체 합성
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
ES2927844T3 (es) 2013-01-11 2022-11-11 Corsair Pharma Inc Profármacos de treprostinil
CA3125504C (en) 2013-03-14 2023-10-24 United Therapeutics Corporation Solid forms of treprostinil
KR20150128903A (ko) 2013-03-15 2015-11-18 유나이티드 세러퓨틱스 코오포레이션 트레프로스티닐의 염
WO2014160638A1 (en) 2013-03-25 2014-10-02 United Therapeutics Corporation Process of making prostacyclin compounds with linker thiol and pegylated forms
SI3060041T1 (sl) 2013-10-25 2021-04-30 Insmed Incorporated Spojine prostaciklina
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
EP3904326A1 (en) 2014-11-18 2021-11-03 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
CA3038276A1 (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
EP3853200B1 (en) 2018-09-18 2024-01-24 Eli Lilly and Company Erbumine salt of treprostinil
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
WO2021041320A1 (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
KR20250133451A (ko) 2020-12-14 2025-09-05 유나이티드 쎄러퓨틱스 코포레이션 트레프로스티닐 프로드러그로 질환을 치료하는 방법
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

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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
ES2670872T3 (es) * 2003-05-22 2018-06-01 United Therapeutics Corporation Polimorfo de una sal de dietanolamina de treprostinil
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
US8765813B2 (en) 2003-12-16 2014-07-01 United Therapeutics Corporation Use of treprostinil to treat and prevent ischemic lesions
JP4906514B2 (ja) 2003-12-16 2012-03-28 ユナイテッド セラピューティクス コーポレイション 腎臓機能改善のためのトレプロスチニルの用途
CA2562614C (en) 2004-04-12 2013-09-17 United Therapeutics, Inc. Use of treprostinil to treat neuropathic diabetic foot ulcers
NZ556627A (en) 2005-02-22 2010-09-30 Pfizer Oxyindole derivatives as 5HT4 receptor agonists
US20060222792A1 (en) * 2006-04-21 2006-10-05 Chemagis Ltd. Temozolomide storage system
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JP5797376B2 (ja) 2006-05-15 2015-10-21 ユナイテッド セラピューティクス コーポレーション 定量吸入器を用いたトレプロスチニル投与
WO2008079383A1 (en) 2006-12-21 2008-07-03 Concert Pharmaceuticals Inc. Prostacyclin derivatives
US20080280986A1 (en) 2007-02-09 2008-11-13 United Therapeutics Corporation Treprostinil treatment for interstitial lung disease and asthma
AU2008218595B2 (en) * 2007-02-20 2012-05-24 Allergan Therapeutics LLC Stable digestive enzyme compositions
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
CN102421288B (zh) 2015-04-22
EP2427054A1 (en) 2012-03-14
EP2427054A4 (en) 2014-01-15
US20100282622A1 (en) 2010-11-11
CN102421288A (zh) 2012-04-18
KR101544246B1 (ko) 2015-08-12
WO2010129757A1 (en) 2010-11-11
US8349892B2 (en) 2013-01-08
CA2760499A1 (en) 2010-11-11
JP5649645B2 (ja) 2015-01-07
JP2012526140A (ja) 2012-10-25
KR20120017058A (ko) 2012-02-27

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