ES2519240B1 - 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
ES2519240B1
ES2519240B1 ES201490034A ES201490034A ES2519240B1 ES 2519240 B1 ES2519240 B1 ES 2519240B1 ES 201490034 A ES201490034 A ES 201490034A ES 201490034 A ES201490034 A ES 201490034A ES 2519240 B1 ES2519240 B1 ES 2519240B1
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
ES201490034A
Other languages
English (en)
Spanish (es)
Other versions
ES2519240R1 (es
ES2519240A2 (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 ES2519240A2 publication Critical patent/ES2519240A2/es
Publication of ES2519240R1 publication Critical patent/ES2519240R1/es
Application granted granted Critical
Publication of ES2519240B1 publication Critical patent/ES2519240B1/es
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08Peptides having 5 to 11 amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10Antimycotics
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K7/00Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/50Cyclic peptides containing at least one abnormal peptide link
    • C07K7/54Cyclic peptides containing at least one abnormal peptide link with at least one abnormal peptide link in the ring
    • C07K7/56Cyclic 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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Inorganic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Communicable Diseases (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Oncology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
ES201490034A 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 ES2519240B1 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
CN201110288782 2011-09-26
CN201110288782X 2011-09-26
CN201110434022 2011-12-21
CN201110434022.5A CN102488889B (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/CN2012/081951 WO2013044788A1 (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
ES2519240A2 ES2519240A2 (es) 2014-11-06
ES2519240R1 ES2519240R1 (es) 2014-11-12
ES2519240B1 true ES2519240B1 (es) 2015-08-19

Family

ID=46180781

Family Applications (1)

Application Number Title Priority Date Filing Date
ES201490034A Expired - Fee Related ES2519240B1 (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) US9149502B2 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
KR (1) KR101660603B1 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
CN (2) CN103386117B (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
DE (1) DE112012003996T5 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
ES (1) ES2519240B1 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
IN (1) IN2014KN00893A (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
WO (1) WO2013044788A1 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102488886B (zh) 2011-09-26 2014-03-26 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
CN103386117B (zh) * 2011-09-26 2015-09-30 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
CN103845725A (zh) * 2012-11-30 2014-06-11 上海医药工业研究院 一种更稳定的卡泊芬净组合物
SG11201702175YA (en) * 2014-09-24 2017-04-27 Aileron Therapeutics Inc Peptidomimetic macrocycles and formulations thereof
CN114236018B (zh) * 2022-02-24 2022-08-19 深圳市海滨制药有限公司 一种醋酸卡泊芬净及其异构体的检测方法
EP4364566A1 (en) * 2022-11-04 2024-05-08 B. Braun Melsungen AG Anti-fungal composition

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
PE63998A1 (es) * 1996-04-19 1998-10-30 Merck & Co Inc Composiciones anti-fungosas
ATE294571T1 (de) * 1999-03-03 2005-05-15 Lilly Co Eli Echinocandin pharmazeutische zusammensetzungen
US6586574B1 (en) * 1999-08-17 2003-07-01 Nn A/S Stabilization of freeze-dried cake
CN101516387B (zh) * 2006-07-26 2014-06-04 桑多斯股份公司 卡泊芬净制剂
WO2008150479A2 (en) * 2007-06-01 2008-12-11 Acologix, Inc. High temperature stable peptide formulation
JP5537425B2 (ja) * 2007-06-26 2014-07-02 メルク・シャープ・アンド・ドーム・コーポレーション 凍結乾燥抗真菌組成物
US20090291996A1 (en) * 2008-05-21 2009-11-26 Ferenc Korodi Caspofungin free of caspofungin Co
EP2183271A1 (en) * 2008-06-25 2010-05-12 TEVA Gyógyszergyár Zártkörüen Müködö Részvénytársaság 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
CN102488886B (zh) 2011-09-26 2014-03-26 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
CN103386117B (zh) 2011-09-26 2015-09-30 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
CN103386117B (zh) 2015-09-30
DE112012003996T5 (de) 2014-08-14
CN102488889B (zh) 2014-01-22
US20140221274A1 (en) 2014-08-07
CN102488889A (zh) 2012-06-13
KR20140069272A (ko) 2014-06-09
US9149502B2 (en) 2015-10-06
CN103386117A (zh) 2013-11-13
WO2013044788A1 (zh) 2013-04-04
KR101660603B1 (ko) 2016-09-27
ES2519240R1 (es) 2014-11-12
IN2014KN00893A (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html) 2015-10-09
ES2519240A2 (es) 2014-11-06

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