ES2495615B1 - Preparación de caspofungina de bajo contenido de impurezas, método para preparar la misma, y uso de la misma - Google Patents

Preparación de caspofungina de bajo contenido de impurezas, método para preparar la misma, y uso de la misma Download PDF

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Publication number
ES2495615B1
ES2495615B1 ES201490033A ES201490033A ES2495615B1 ES 2495615 B1 ES2495615 B1 ES 2495615B1 ES 201490033 A ES201490033 A ES 201490033A ES 201490033 A ES201490033 A ES 201490033A ES 2495615 B1 ES2495615 B1 ES 2495615B1
Authority
ES
Spain
Prior art keywords
caspofungin
preparing
preparation
low impurity
pharmaceutical composition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
ES201490033A
Other languages
English (en)
Other versions
ES2495615R1 (es
ES2495615A2 (es
Inventor
Yunhai Hong
Ying Xue
Lixin Sha
Xiaoming Ji
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.)
Shanghai Techwell Biopharmaceutical Co Ltd
Original Assignee
Shanghai Techwell Biopharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shanghai Techwell Biopharmaceutical Co Ltd filed Critical Shanghai Techwell Biopharmaceutical Co Ltd
Publication of ES2495615A2 publication Critical patent/ES2495615A2/es
Publication of ES2495615R1 publication Critical patent/ES2495615R1/es
Application granted granted Critical
Publication of ES2495615B1 publication Critical patent/ES2495615B1/es
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/50—Cyclic peptides containing at least one abnormal peptide link
    • C07K7/54—Cyclic peptides containing at least one abnormal peptide link with at least one abnormal peptide link in the ring
    • C07K7/56—Cyclic peptides containing at least one abnormal peptide link with at least one abnormal peptide link in the ring the cyclisation not occurring through 2,4-diamino-butanoic acid

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Preparación de caspofungina de bajo contenido de impurezas, método para preparar la misma, y uso de la misma.#Se describe una composición farmacéutica de caspofungina de bajo contenido de impurezas, también se describe un método para preparar la composición farmacéutica de caspofungina de bajo contenido de impurezas. La composición farmacéutica de caspofungina proporcionada en la presente invención está dotada de gran estabilidad.

Description

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Claims (1)

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ES201490033A 2011-09-26 2012-09-25 Preparación de caspofungina de bajo contenido de impurezas, método para preparar la misma, y uso de la misma Expired - Fee Related ES2495615B1 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
CN2011102887533 2011-09-26
CN201110288753 2011-09-26
CN2011104336802 2011-12-21
CN201110433680.2A CN102488886B (zh) 2011-09-26 2011-12-21 一种低杂质含量的卡泊芬净制剂及其制备方法和用途
PCT/CN2012/081956 WO2013044789A1 (zh) 2011-09-26 2012-09-25 一种低杂质含量的卡泊芬净制剂及其制备方法和用途

Publications (3)

Publication Number Publication Date
ES2495615A2 ES2495615A2 (es) 2014-09-17
ES2495615R1 ES2495615R1 (es) 2014-11-12
ES2495615B1 true ES2495615B1 (es) 2015-08-19

Family

ID=46180778

Family Applications (1)

Application Number Title Priority Date Filing Date
ES201490033A Expired - Fee Related ES2495615B1 (es) 2011-09-26 2012-09-25 Preparación de caspofungina de bajo contenido de impurezas, método para preparar la misma, y uso de la misma

Country Status (7)

Country Link
US (1) US9149435B2 (es)
KR (1) KR101720396B1 (es)
CN (2) CN103315969B (es)
DE (1) DE112012003995T5 (es)
ES (1) ES2495615B1 (es)
IN (1) IN2014KN00892A (es)
WO (1) WO2013044789A1 (es)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102488889B (zh) 2011-09-26 2014-01-22 上海天伟生物制药有限公司 一种低杂质含量的卡泊芬净制剂及其制备方法和用途
CN103315969B (zh) 2011-09-26 2016-05-18 上海天伟生物制药有限公司 一种低杂质含量的卡泊芬净制剂及其制备方法和用途
CN103212058A (zh) * 2012-01-18 2013-07-24 江苏恒瑞医药股份有限公司 含有抗真菌药物和乳酸盐缓冲剂的组合物
CN103539841A (zh) * 2012-07-12 2014-01-29 重庆乾泰生物医药有限公司 一种环己肽类化合物及其盐的分离纯化方法
KR20140123782A (ko) * 2013-04-15 2014-10-23 에스케이케미칼주식회사 카스포펀진 및 완충제를 포함하는 안정성이 개선된 약학적 조성물
CN106860856B (zh) * 2015-12-14 2019-05-31 山东新时代药业有限公司 一种含有阿尼芬净的冻干粉及制备方法
CN108760937B (zh) * 2018-07-27 2020-12-29 杭州华东医药集团新药研究院有限公司 醋酸卡泊芬净中残留乙二胺的测定及其应用
CN109394707A (zh) * 2018-12-26 2019-03-01 四川制药制剂有限公司 一种注射用醋酸卡泊芬净的制造方法
CN109568275B (zh) * 2019-01-10 2021-08-27 杭州华东医药集团新药研究院有限公司 一种含醋酸卡泊芬净的冻干组合物及其制备方法

Family Cites Families (17)

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US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US5952300A (en) * 1996-04-19 1999-09-14 Merck & Co., Inc. Antifungal compositions
AR006598A1 (es) * 1996-04-19 1999-09-08 Merck Sharp & Dohme "composiciones anti-fungosas, su uso en la manufactura de medicamentos y un procedimiento para su preparación"
EP1582204B1 (en) * 1999-03-03 2013-09-25 Eli Lilly & Company Echinocandin pharmaceutical formulations containing micelle-forming surfactants
US6586574B1 (en) * 1999-08-17 2003-07-01 Nn A/S Stabilization of freeze-dried cake
US6954253B2 (en) 2000-07-25 2005-10-11 Scientific Solutions, Inc. Optical multiplexer and cross-switch using etched liquid crystal fabry-perot etalons
JP2004521102A (ja) * 2001-01-09 2004-07-15 メルク　エンド　カムパニー　インコーポレーテッド 抗真菌化合物の活性代謝物
CN101516387B (zh) * 2006-07-26 2014-06-04 桑多斯股份公司 卡泊芬净制剂
US7879805B2 (en) * 2007-06-01 2011-02-01 Acologix, Inc. High temperature stable peptide formulation
CA2692053A1 (en) * 2007-06-26 2008-12-31 Merck Sharp & Dohme Corp. Lyophilized anti-fungal composition
WO2009142761A1 (en) * 2008-05-21 2009-11-26 Teva Gyogyszergyar Zartkoruen Mukodo Reszvenytarsasag Caspofungin bo free of caspofungin co
US20090324635A1 (en) * 2008-06-25 2009-12-31 Ferenc Korodi Caspofungin free of caspofungin impurity A
WO2010008493A2 (en) * 2008-06-25 2010-01-21 Teva Gyógyszergyár Zártkörüen Müködö Részvénytársaság Processes for preparing high purity aza cyclohexapeptides
CN102219832B (zh) * 2010-04-15 2013-08-21 上海天伟生物制药有限公司 一种氮杂环六肽或其盐的纯化方法
CN102153616A (zh) * 2010-12-27 2011-08-17 浙江海正药业股份有限公司 一种环己肽类化合物及其盐的分离纯化方法
CN102488889B (zh) 2011-09-26 2014-01-22 上海天伟生物制药有限公司 一种低杂质含量的卡泊芬净制剂及其制备方法和用途
CN103315969B (zh) 2011-09-26 2016-05-18 上海天伟生物制药有限公司 一种低杂质含量的卡泊芬净制剂及其制备方法和用途

Also Published As

Publication number Publication date
IN2014KN00892A (es) 2015-10-09
KR101720396B1 (ko) 2017-03-27
CN102488886A (zh) 2012-06-13
DE112012003995T5 (de) 2014-08-21
CN103315969A (zh) 2013-09-25
ES2495615R1 (es) 2014-11-12
ES2495615A2 (es) 2014-09-17
KR20140069273A (ko) 2014-06-09
US9149435B2 (en) 2015-10-06
WO2013044789A1 (zh) 2013-04-04
CN103315969B (zh) 2016-05-18
CN102488886B (zh) 2014-03-26
US20140228280A1 (en) 2014-08-14

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