CN102387784B - 冻干的重组vwf配方 - Google Patents

冻干的重组vwf配方 Download PDF

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Publication number
CN102387784B
CN102387784B CN200980142453.5A CN200980142453A CN102387784B CN 102387784 B CN102387784 B CN 102387784B CN 200980142453 A CN200980142453 A CN 200980142453A CN 102387784 B CN102387784 B CN 102387784B
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concentration
formulation
amino acid
rvwf
vwf
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CN102387784A (zh
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库尔特·施内克尔
埃娃·海德韦格
皮特·图雷切克
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Takeda Pharmaceutical Co Ltd
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Baxter Healthcare SA
Baxter International Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • 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
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Hematology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
CN200980142453.5A 2008-10-21 2009-10-21 冻干的重组vwf配方 Active CN102387784B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10727308P 2008-10-21 2008-10-21
US61/107,273 2008-10-21
PCT/US2009/061470 WO2010048275A2 (en) 2008-10-21 2009-10-21 Lyophilized recombinant vwf formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN201410067147.2A Division CN103919736A (zh) 2008-10-21 2009-10-21 冻干的重组vwf配方

Publications (2)

Publication Number Publication Date
CN102387784A CN102387784A (zh) 2012-03-21
CN102387784B true CN102387784B (zh) 2014-04-02

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Family Applications (2)

Application Number Title Priority Date Filing Date
CN200980142453.5A Active CN102387784B (zh) 2008-10-21 2009-10-21 冻干的重组vwf配方
CN201410067147.2A Pending CN103919736A (zh) 2008-10-21 2009-10-21 冻干的重组vwf配方

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN201410067147.2A Pending CN103919736A (zh) 2008-10-21 2009-10-21 冻干的重组vwf配方

Country Status (21)

Country Link
US (4) US20100099603A1 (https=)
EP (2) EP2349314B1 (https=)
JP (6) JP5781931B2 (https=)
KR (2) KR101772674B1 (https=)
CN (2) CN102387784B (https=)
AR (2) AR074054A1 (https=)
AU (1) AU2009307648C1 (https=)
BR (1) BRPI0919693A2 (https=)
CA (1) CA2740919A1 (https=)
CY (1) CY1113869T1 (https=)
DK (1) DK2349314T3 (https=)
ES (1) ES2409032T3 (https=)
HR (1) HRP20130414T1 (https=)
MX (1) MX2011004247A (https=)
NZ (1) NZ592704A (https=)
PL (1) PL2349314T3 (https=)
PT (1) PT2349314E (https=)
SI (1) SI2349314T1 (https=)
SM (1) SMT201300093B (https=)
TW (3) TWI593421B (https=)
WO (1) WO2010048275A2 (https=)

Families Citing this family (23)

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Publication number Priority date Publication date Assignee Title
EP2349314B1 (en) * 2008-10-21 2013-02-27 Baxter International Inc. Lyophilized recombinant vwf formulations
WO2011150284A2 (en) 2010-05-26 2011-12-01 Baxter International Inc. Removal of serine proteases by treatment with finely divided silicon dioxide
AU2010202125B1 (en) 2010-05-26 2010-09-02 Takeda Pharmaceutical Company Limited A method to produce an immunoglobulin preparation with improved yield
JP5990176B2 (ja) * 2010-10-12 2016-09-07 メルツ ファーマ ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コンパニー コマンディト ゲゼルシャフト アウフ アクティーン タンパク質の安定化に好適な哺乳動物性賦形剤非含有製剤
ES2682249T3 (es) * 2011-06-10 2018-09-19 Baxalta GmbH Tratamiento de una enfermedad de la coagulación mediante la administración de VWF recombinante
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PL3158055T3 (pl) 2014-06-13 2020-03-31 Csl Limited Ulepszone wytwarzanie rekombinowanego czynnika von Willebranda w bioreaktorze
WO2016138413A1 (en) * 2015-02-27 2016-09-01 Board Of Regents, The University Of Texas System Polypeptide therapeutics and uses thereof
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US20190091298A1 (en) 2017-07-07 2019-03-28 Baxalta Incorporated Treatment of patients with severe von willebrand disease undergoing elective surgery by administration of recombinant vwf
CA3069295A1 (en) 2017-07-07 2019-01-10 Baxalta Incorporated Treatment of gastrointestinal bleeding in patients with severe von willebrand disease by administration of recombinant vwf
KR20200038309A (ko) 2017-08-23 2020-04-10 체에스엘 베링 게엠베하 폰 빌레브란트 인자의 바이러스 여과 방법
CA3094644A1 (en) 2018-03-21 2019-09-26 Baxalta Incorporated Separation of vwf and vwf propeptide by chromatographic methods
AU2019339260B2 (en) 2018-09-10 2025-06-26 Rein Therapeutics, Inc. Modified peptide fragments of Cav-1 protein and the use thereof in the treatment of fibrosis
US12128090B2 (en) 2019-02-01 2024-10-29 Takeda Pharmaceutical Company Limited Methods of prophylactic treatment using recombinant VWF (rVWF)
US20220401524A1 (en) 2019-09-11 2022-12-22 Takeda Pharmaceutical Company Limited Methods of treatment related to complexes of von willebrand factor and complement c1q
KR20220150303A (ko) 2020-02-04 2022-11-10 다케다 야쿠힌 고교 가부시키가이샤 재조합 vwf의 투여에 의한 중증 폰 빌레브란트병 환자의 월경과다 치료
CN111789867B (zh) * 2020-08-27 2022-01-11 中国人民解放军军事科学院军事医学研究院 一种适用于提高血浆干粉功能的适配液
JP7371208B2 (ja) * 2022-01-19 2023-10-30 Kmバイオロジクス株式会社 von Willebrand因子含有製剤
CN119173446A (zh) 2022-03-08 2024-12-20 赤盾医疗有限公司 机器人药物制备系统中的流体转移站
CN116251194A (zh) * 2023-01-17 2023-06-13 青岛润达生物科技有限公司 一种转移因子冻干赋形保护剂及方法

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