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CN112313202A - 曲前列尼尔钠盐新晶型及制备方法 - Google Patents

曲前列尼尔钠盐新晶型及制备方法 Download PDF

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Publication number
CN112313202A
CN112313202A CN202080003368.7A CN202080003368A CN112313202A CN 112313202 A CN112313202 A CN 112313202A CN 202080003368 A CN202080003368 A CN 202080003368A CN 112313202 A CN112313202 A CN 112313202A
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CN
China
Prior art keywords
sodium salt
treprostinil
pentahydrate
treprostinil sodium
crystal form
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Pending
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CN202080003368.7A
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English (en)
Inventor
李巍
任毅
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Shanghai Forefront Pharmceutical Co ltd
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Jiangsu Zhongqiang Pharmaceutical Co ltd
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Publication of CN112313202A publication Critical patent/CN112313202A/zh
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C59/00—Compounds having carboxyl groups bound to acyclic carbon atoms and containing any of the groups OH, O—metal, —CHO, keto, ether, groups, groups, or groups
    • C07C59/40—Unsaturated compounds
    • C07C59/58—Unsaturated compounds containing ether groups, groups, groups, or groups
    • C07C59/72—Unsaturated compounds containing ether groups, groups, groups, or groups containing six-membered aromatic rings and other rings
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C51/00—Preparation of carboxylic acids or their salts, halides or anhydrides
    • C07C51/42—Separation; Purification; Stabilisation; Use of additives
    • C07C51/43—Separation; Purification; Stabilisation; Use of additives by change of the physical state, e.g. crystallisation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C2603/00—Systems containing at least three condensed rings
    • C07C2603/02—Ortho- or ortho- and peri-condensed systems
    • C07C2603/04—Ortho- or ortho- and peri-condensed systems containing three rings
    • C07C2603/06—Ortho- or ortho- and peri-condensed systems containing three rings containing at least one ring with less than six ring members
    • C07C2603/10—Ortho- or ortho- and peri-condensed systems containing three rings containing at least one ring with less than six ring members containing five-membered rings
    • C07C2603/12—Ortho- or ortho- and peri-condensed systems containing three rings containing at least one ring with less than six ring members containing five-membered rings only one five-membered ring
    • C07C2603/14—Benz[f]indenes; Hydrogenated benz[f]indenes

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Epidemiology (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Hospice & Palliative Care (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Diabetes (AREA)
  • Ophthalmology & Optometry (AREA)
  • Hematology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

Abstract

本发明披露了曲前列尼尔钠盐(结构式见式1)的新晶型及其制备方法，具体地，本发明披露了曲前列尼尔钠盐的五点五水合物及其部分脱水晶型，所述的新晶型具备较好的稳定性和吸湿性，作为曲前列尼尔原料药能满足存储、装运的要求并且质量稳定，以确保后继制剂产品的质量可控。

Description

PCT国内申请，说明书已公开。

Claims (10)

  1. PCT国内申请，权利要求书已公开。
CN202080003368.7A 2019-05-21 2020-05-20 曲前列尼尔钠盐新晶型及制备方法 Pending CN112313202A (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
CN2019104256861 2019-05-21
CN201910425686 2019-05-21
CN2019108999100 2019-09-23
CN201910899910 2019-09-23
PCT/CN2020/091218 WO2020233588A1 (zh) 2019-05-21 2020-05-20 曲前列尼尔钠盐新晶型及制备方法

Publications (1)

Publication Number Publication Date
CN112313202A true CN112313202A (zh) 2021-02-02

Family

ID=73458350

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202080003368.7A Pending CN112313202A (zh) 2019-05-21 2020-05-20 曲前列尼尔钠盐新晶型及制备方法

Country Status (6)

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US (1) US20220242811A1 (zh)
EP (1) EP3981759A4 (zh)
JP (1) JP7365073B2 (zh)
CN (1) CN112313202A (zh)
CA (1) CA3141164C (zh)
WO (1) WO2020233588A1 (zh)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102015613A (zh) * 2008-05-08 2011-04-13 联合治疗公司 曲前列素一水合物
CN105164098A (zh) * 2013-03-14 2015-12-16 联合治疗公司 曲前列环素的固体形式
CN107001221A (zh) * 2014-10-08 2017-08-01 奇诺因药物和化学工厂私人有限公司 用于制备曲前列尼尔的方法
CN109734580A (zh) * 2019-03-05 2019-05-10 江苏众强药业有限公司 曲前列尼尔钠盐新晶型及制备方法

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2726599C (en) * 2010-12-30 2017-07-25 Alphora Research Inc. Process for treprostinil salt preparation
CA2841032C (en) * 2011-07-08 2020-12-15 Grunenthal Gmbh Crystalline (1r,4r)-6'-fluoro-n,n-dimethyl-4-phenyl-4',9'-dihydro-3'h-spiro[cyclohexane-1,1'-pyrano[3,4,b]indol]-4-amine
KR20210142781A (ko) * 2014-10-21 2021-11-25 다케다 야쿠힌 고교 가부시키가이샤 결정 형태의 5-클로로-n4-[2-(디메틸포스포릴)페닐]-n2-｛2-메톡시-4-[4-(4-메틸피페라진-1-일)피페리딘-1-일]피리미딘-2,4-디아민
CN110650963B (zh) * 2017-04-28 2022-09-27 豪夫迈·罗氏有限公司 Gdc-0077的多晶型物和固体形式及其制备方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102015613A (zh) * 2008-05-08 2011-04-13 联合治疗公司 曲前列素一水合物
CN105164098A (zh) * 2013-03-14 2015-12-16 联合治疗公司 曲前列环素的固体形式
CN107001221A (zh) * 2014-10-08 2017-08-01 奇诺因药物和化学工厂私人有限公司 用于制备曲前列尼尔的方法
CN109734580A (zh) * 2019-03-05 2019-05-10 江苏众强药业有限公司 曲前列尼尔钠盐新晶型及制备方法

Also Published As

Publication number Publication date
JP7365073B2 (ja) 2023-10-19
US20220242811A1 (en) 2022-08-04
EP3981759A1 (en) 2022-04-13
CA3141164A1 (en) 2020-11-26
JP2022534087A (ja) 2022-07-27
CA3141164C (en) 2023-09-05
EP3981759A4 (en) 2023-07-19
WO2020233588A1 (zh) 2020-11-26

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