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ES2037136T3 - Procedimiento para la preparacion de una solucion con elevada actividad volumetrica de una proteina con actividad de activador de plasminogeno de tejidos (t-pa). - Google Patents

Procedimiento para la preparacion de una solucion con elevada actividad volumetrica de una proteina con actividad de activador de plasminogeno de tejidos (t-pa).

Info

Publication number
ES2037136T3
ES2037136T3 ES198888108656T ES88108656T ES2037136T3 ES 2037136 T3 ES2037136 T3 ES 2037136T3 ES 198888108656 T ES198888108656 T ES 198888108656T ES 88108656 T ES88108656 T ES 88108656T ES 2037136 T3 ES2037136 T3 ES 2037136T3
Authority
ES
Spain
Prior art keywords
activity
solution
protein
preparation
plasminogen activator
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 - Lifetime
Application number
ES198888108656T
Other languages
English (en)
Inventor
Eric Paul Dr. Paques
Hans-Arnold Stohr
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.)
Siemens Healthcare Diagnostics GmbH Germany
Original Assignee
Behringwerke AG
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 Behringwerke AG filed Critical Behringwerke AG
Application granted granted Critical
Publication of ES2037136T3 publication Critical patent/ES2037136T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • 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
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/49Urokinase; Tissue plasminogen activator
    • 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
    • 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
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0023Heat
    • 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
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Microbiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Biotechnology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

EN LA FABRICACION DE SOLUCIONES PARENTERALES PARA TERAPIA Y PROFILAXIS DE TROMBOSIS Y EMBOLIAS LA INFUSION PRESENTA GRAN VOLUMEN DEBIDO A LA DIFICULTAD DE DISOLVER BIEN EL T-PA, O BIEN SE SE PREPARA UNA SOLUCION CON PEQUEÑO VOLUMEN Y ALTA CONCENTRACION T-PA, EL PH NECESARIO ES DE 2 A 5 NO FISIOLOGICAMENTE ACEPTABLE. LA PRESENTE INVENCION PROPOTE UN PROCEDIMIENTO PARA OBTENCION DE UNA DISOLUCION QUE SE DETALLA EN EL TEXTO.
ES198888108656T 1987-06-05 1988-05-31 Procedimiento para la preparacion de una solucion con elevada actividad volumetrica de una proteina con actividad de activador de plasminogeno de tejidos (t-pa). Expired - Lifetime ES2037136T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE19873718889 DE3718889A1 (de) 1987-06-05 1987-06-05 Verfahren zur herstellung einer loesung hoher spezifischer volumenaktivitaet von einem protein mit gewebe-plasminogenaktivator (t-pa)-aktivitaet, loesung, enthaltend protein mit t-pa-aktivitaet und verwendung der loesung in der human- und veterinaermedizin

Publications (1)

Publication Number Publication Date
ES2037136T3 true ES2037136T3 (es) 1993-06-16

Family

ID=6329147

Family Applications (1)

Application Number Title Priority Date Filing Date
ES198888108656T Expired - Lifetime ES2037136T3 (es) 1987-06-05 1988-05-31 Procedimiento para la preparacion de una solucion con elevada actividad volumetrica de una proteina con actividad de activador de plasminogeno de tejidos (t-pa).

Country Status (13)

Country Link
US (1) US5068106A (es)
EP (1) EP0297294B1 (es)
JP (1) JP2690944B2 (es)
KR (1) KR970005837B1 (es)
AT (1) ATE73671T1 (es)
AU (1) AU617322B2 (es)
CA (1) CA1338698C (es)
DE (2) DE3718889A1 (es)
DK (1) DK167738B1 (es)
ES (1) ES2037136T3 (es)
FI (1) FI93798C (es)
GR (1) GR3004869T3 (es)
PT (1) PT87658B (es)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3728852C2 (de) * 1987-08-28 2003-06-18 Wilhelm Hoerrmann Arzneimittel zur Tumortherapie
US4980165A (en) * 1989-01-27 1990-12-25 Genetics Institute, Inc. Pharmaceutical formulations of plasminogen activator proteins
US6207151B1 (en) * 1989-09-21 2001-03-27 Mitsui Chemicals Inc. Aqueous solution of t-PA
JP2520975B2 (ja) * 1989-09-21 1996-07-31 三井東圧化学株式会社 組織プラスミノ―ゲンアクチベ―タ―若しくはその誘導体を含有する血栓溶解剤
DE3939346A1 (de) * 1989-11-29 1991-06-06 Behringwerke Ag Arzneimitel zur subkutanen oder intramuskulaeren applikation enthaltend polypeptide
DE3942142A1 (de) * 1989-12-20 1991-06-27 Boehringer Mannheim Gmbh Stabilisierung von glykosyliertem t-pa
US5366730A (en) * 1989-12-20 1994-11-22 Boehringer Mannheim Gmbh Stabilized compositions having human tissue type plasminogen activator enzymatic activity
DE3942144A1 (de) * 1989-12-20 1991-06-27 Boehringer Mannheim Gmbh Stabilisierung von k1k2p pro
DE3942141A1 (de) * 1989-12-20 1991-06-27 Boehringer Mannheim Gmbh K2p pro-stabilisierung
DE3942143A1 (de) * 1989-12-20 1991-06-27 Boehringer Mannheim Gmbh T-pa pro stabilisierung
DE4405426A1 (de) * 1994-02-21 1995-08-24 Boehringer Mannheim Gmbh Pharmazeutisches Präparat enthaltend Plasminogenaktivator (t-PA) oder dessen Derivate
US7544500B2 (en) 1999-11-13 2009-06-09 Talecris Biotherapeutics, Inc. Process for the production of a reversibly inactive acidified plasmin composition
US6355243B1 (en) 1999-11-13 2002-03-12 Bayer Corporation Method of thrombolysis by local delivery of active plasmin
DE10022092A1 (de) * 2000-05-08 2001-11-15 Aventis Behring Gmbh Stabilisiertes Protein-Präparat und Verfahren zu seiner Herstellung
GB2386469B (en) * 2001-11-14 2006-05-17 Varian Semiconductor Equipment Scan methods and apparatus for ion implantation
WO2009006301A2 (en) * 2007-06-29 2009-01-08 Battelle Memorial Institute Protein stabilization
WO2009149199A2 (en) * 2008-06-04 2009-12-10 Talecris Biotherapeutics, Inc. Composition, method and kit for preparing plasmin
JP5789521B2 (ja) 2009-03-03 2015-10-07 グリフオルス・セラピユーテイクス・インコーポレーテツドGrifols Therapeutics,Inc. プラスミノーゲンを製造するための組成物、方法およびキット;ならびにそれから製造されるプラスミン
CA3036965A1 (en) 2016-09-16 2018-03-22 Leukocare Ag A method for stabilization of a biopharmaceutical drug product during processing

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4258030A (en) * 1979-03-07 1981-03-24 Zeria-Shinyaku Kogyo Kabushiki Kaisha Urokinase preparation for oral administration
US4440679A (en) * 1980-03-05 1984-04-03 Cutter Laboratories, Inc. Pasteurized therapeutically active protein compositions
JPS60181028A (ja) * 1984-02-29 1985-09-14 Asahi Chem Ind Co Ltd 組織プラスミノ−ゲン・アクチベ−タ−の溶解補助法
EP0156169B1 (en) * 1984-02-29 1991-12-18 Asahi Kasei Kogyo Kabushiki Kaisha An aqueous solution of a tissue plasminogen activator dissolved therein at an increased concentration and a method
ATE83153T1 (de) * 1985-09-10 1992-12-15 Eisai Co Ltd Einen gewebe-plasminogen-aktivator enthaltende zusammensetzung.
JPH0669960B2 (ja) * 1985-11-22 1994-09-07 エーザイ株式会社 水溶性を増加したtPA含有医薬組成物
US4646292A (en) * 1985-10-01 1987-02-24 Aetna Telecommunications Laboratories Link controller
JPH0672105B2 (ja) * 1985-10-02 1994-09-14 持田製薬株式会社 血栓溶解剤及びその製法

Also Published As

Publication number Publication date
JPS63317083A (ja) 1988-12-26
FI93798C (fi) 1995-06-12
KR970005837B1 (ko) 1997-04-21
FI882605A0 (fi) 1988-06-02
PT87658A (pt) 1988-07-01
EP0297294A1 (de) 1989-01-04
AU617322B2 (en) 1991-11-28
ATE73671T1 (de) 1992-04-15
GR3004869T3 (es) 1993-04-28
FI93798B (fi) 1995-02-28
DE3869230D1 (de) 1992-04-23
DE3718889A1 (de) 1988-12-22
US5068106A (en) 1991-11-26
DK304288A (da) 1988-12-06
EP0297294B1 (de) 1992-03-18
PT87658B (pt) 1993-03-31
DK304288D0 (da) 1988-06-03
AU1732288A (en) 1988-12-08
FI882605A (fi) 1988-12-06
KR890000103A (ko) 1989-03-11
DK167738B1 (da) 1993-12-13
JP2690944B2 (ja) 1997-12-17
CA1338698C (en) 1996-11-12

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