ES2071292T3 - Soluciones inyectables estables de factor viii. - Google Patents

Soluciones inyectables estables de factor viii.

Info

Publication number
ES2071292T3
ES2071292T3 ES91901746T ES91901746T ES2071292T3 ES 2071292 T3 ES2071292 T3 ES 2071292T3 ES 91901746 T ES91901746 T ES 91901746T ES 91901746 T ES91901746 T ES 91901746T ES 2071292 T3 ES2071292 T3 ES 2071292T3
Authority
ES
Spain
Prior art keywords
viii
stable injectable
factor solutions
disacarids
mol
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
ES91901746T
Other languages
English (en)
Inventor
Horst Schwinn
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.)
Octapharma AG
Original Assignee
Octapharma 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=6398370&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2071292(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Octapharma AG filed Critical Octapharma AG
Application granted granted Critical
Publication of ES2071292T3 publication Critical patent/ES2071292T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • 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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/644—Coagulation factor IXa (3.4.21.22)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21022—Coagulation factor IXa (3.4.21.22)

Landscapes

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

Abstract

SOLUCION ESTABLE INYECTABLE QUE CONTIENE FACTOR VIII O FACTOR IX ADECUADO PARA EL TRATAMIENTO HUMANO, DISACARIDOS NATURALES O SINTETICOS, PREFERENTEMENTE SACAROSA, EN UNA CONCENTRACION DE 0,1 HASTA 0,65 MOL/L, Y UNO O VARIOS AMINOACIDOS EN UNA CONCENTRACION DE 0,1 HASTA 1,0 MOL/L. UN PROCEDIMIENTO PARA LA OBTENCION DE LAS MISMAS Y LA UTILIZACION DE DISACARIDOS NATURALES O SINTETICOS, PREFERENTEMENTE SACAROSA, Y UNO O MAS AMINOACIDOS PARA LA ESTABILIZACION DE LOS FACTORES VIII Y IX.
ES91901746T 1990-01-19 1990-12-19 Soluciones inyectables estables de factor viii. Expired - Lifetime ES2071292T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE4001451A DE4001451A1 (de) 1990-01-19 1990-01-19 Stabile injizierbare loesungen von faktor viii und faktor ix

Publications (1)

Publication Number Publication Date
ES2071292T3 true ES2071292T3 (es) 1995-06-16

Family

ID=6398370

Family Applications (1)

Application Number Title Priority Date Filing Date
ES91901746T Expired - Lifetime ES2071292T3 (es) 1990-01-19 1990-12-19 Soluciones inyectables estables de factor viii.

Country Status (8)

Country Link
US (1) US5328694A (es)
EP (1) EP0511234B1 (es)
JP (1) JPH05504342A (es)
AT (1) ATE120960T1 (es)
DE (2) DE4001451A1 (es)
DK (1) DK0511234T3 (es)
ES (1) ES2071292T3 (es)
WO (1) WO1991010439A1 (es)

Families Citing this family (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4111393A1 (de) * 1991-04-09 1992-10-15 Behringwerke Ag Stabilisierte faktor viii-praeparationen
GB9122609D0 (en) * 1991-10-24 1991-12-04 Brownlee George G Improvements relating to the treatment of haemophilia
EP0627924B1 (en) * 1992-10-02 2000-12-27 Genetics Institute, Inc. Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
SE9301581D0 (sv) * 1993-05-07 1993-05-07 Kabi Pharmacia Ab Protein formulation
US6288030B1 (en) 1993-12-22 2001-09-11 Amgen Inc. Stem cell factor formulations and methods
US6242417B1 (en) 1994-03-08 2001-06-05 Somatogen, Inc. Stabilized compositions containing hemoglobin
IL113010A (en) * 1994-03-31 1999-10-28 Pharmacia & Upjohn Ab Pharmaceutical formulation comprising factor viii with an activity of at least 500iu/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration
US6372716B1 (en) * 1994-04-26 2002-04-16 Genetics Institute, Inc. Formulations for factor IX
SE9501189D0 (sv) * 1995-03-31 1995-03-31 Pharmacia Ab Protein formulation
US5770700A (en) * 1996-01-25 1998-06-23 Genetics Institute, Inc. Liquid factor IX formulations
US5763401A (en) * 1996-07-12 1998-06-09 Bayer Corporation Stabilized albumin-free recombinant factor VIII preparation having a low sugar content
MXPA01008515A (es) 1999-02-22 2003-06-06 Baxter Int Formulaciones novedosas de factor viii libres de albumina.
AU1344102A (en) * 2000-10-12 2002-04-22 Genentech Inc Reduced-viscosity concentrated protein formulations
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
WO2003055512A1 (en) 2001-12-21 2003-07-10 Novo Nordisk Health Care Ag Liquid composition of factor vii polypeptides
RU2366451C2 (ru) 2002-06-21 2009-09-10 Ново Нордиск Хелт Кэр Аг Стабилизированные твердые композиции полипептидов фактора vii
US7897734B2 (en) 2003-03-26 2011-03-01 Novo Nordisk Healthcare Ag Method for the production of proteins
MXPA05010555A (es) * 2003-04-04 2006-03-09 Genentech Inc Formulaciones de proteina y anticuerpo de alta concentracion.
DE602004025100D1 (de) 2003-05-23 2010-03-04 Novo Nordisk Healthcare Ag Stabilisierung von proteinen in lösung
ATE547114T1 (de) 2003-06-25 2012-03-15 Novo Nordisk Healthcare Ag Flüssige zusammensetzungen von factor vii polypeptiden
RU2388460C2 (ru) 2003-08-14 2010-05-10 Ново Нордиск Хелс Кеа Аг Жидкая водная фармацевтическая композиция, содержащая полипептид фактора vii
AU2004274430A1 (en) 2003-09-12 2005-03-31 Antigenics, Inc. Vaccine for treatment and prevention of herpes simplex virus infection
SI2298287T1 (en) 2003-12-19 2018-08-31 Novo Nordisk Health Care Ag Stabilized compositions of factor VII polypeptides
KR100624013B1 (ko) * 2004-06-25 2006-09-19 주식회사 녹십자홀딩스 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제
FI121025B (fi) * 2004-12-07 2010-06-15 Sandvik Mining & Constr Oy Menetelmä putkiporaukseen, porausyksikkö sekä adapterilaite
CA2591852A1 (en) 2004-12-27 2006-07-06 Baxter International Inc. Polymer-von willebrand factor-conjugates
KR20080108147A (ko) * 2006-03-31 2008-12-11 백스터 인터내셔널 인코포레이티드 페질화된 인자 ｖｉｉｉ
US7645860B2 (en) 2006-03-31 2010-01-12 Baxter Healthcare S.A. Factor VIII polymer conjugates
BRPI0917656A2 (pt) 2008-08-21 2017-07-11 Octapharma Ag Fatores viii e ix humanos produzidos de forma recombinante
BRPI0918589B1 (pt) * 2008-09-03 2021-07-13 Octapharma Ag Composições de proteção para fator viii recombinantemente produzido
NZ593190A (en) 2008-11-07 2013-01-25 Baxter Int Factor viii formulations
CA2754528A1 (en) 2009-03-06 2010-09-10 Genetech, Inc. Antibody formulation
NZ729629A (en) 2014-08-04 2021-12-24 Csl Ltd Factor viii formulation
SG10201912485PA (en) 2015-05-13 2020-02-27 Agenus Inc Vaccines for treatment and prevention of cancer
CA3096909A1 (en) 2018-04-26 2019-10-31 Agenus Inc. Heat shock protein-binding peptide compositions and methods of use thereof
KR20220029733A (ko) 2019-07-04 2022-03-08 체에스엘 베링 렝나우 아게 응고 인자 viii의 시험관내 안정성을 증가시키기 위한 절단된 폰 빌레브란트 인자 (vwf)
EP4240757A2 (en) 2020-11-09 2023-09-13 Takeda Pharmaceutical Company Limited Purification of fviii from plasma using silicon oxide adsorption

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4186192A (en) * 1978-12-18 1980-01-29 Cutter Laboratories, Inc. Stabilized immune serum globulin
DE2916711A1 (de) * 1979-04-25 1980-11-06 Behringwerke Ag Blutgerinnungsfaktoren und verfahren zu ihrer herstellung
DE3176491D1 (en) * 1980-03-05 1987-11-26 Miles Lab Pasteurized therapeutically active protein compositions
DE3045153A1 (de) * 1980-11-29 1982-07-08 Behringwerke Ag, 3550 Marburg Verfahren zur herstellung von blutgerinnungsfaktoren und danach hergestellte praeparation der faktoren ix und x
US4495278A (en) * 1981-04-27 1985-01-22 Baxter Travenol Laboratories, Inc. Process for making novel blood clotting enzyme compositions
JPS5874617A (ja) * 1981-10-28 1983-05-06 Green Cross Corp:The 人由来血液凝固第７因子含有水溶液の加熱処理方法
JPS58191881A (ja) * 1982-05-01 1983-11-09 服部　盛義 自動車用ドア−の両開き装置
DE3237512A1 (de) * 1982-10-09 1984-04-12 Behringwerke Ag, 3550 Marburg Verfahren zur pasteurisierung von antihaemophilem kryopraezipitat (ahk) und danach hergestelltes antihaemophiles kryopraezipitat
JPS59112630A (ja) * 1982-12-17 1984-06-29 Matsushita Electric Ind Co Ltd ワイヤボンデイング装置
JPS59134730A (ja) * 1983-01-20 1984-08-02 Green Cross Corp:The 血液凝固第８因子の加熱処理法
DE3336631A1 (de) * 1983-10-08 1985-04-18 Behringwerke Ag, 3550 Marburg Verfahren zur pasteurisierung von plasma oder von konzentraten der blutgerinnungsfaktoren ii, vii, ix und x
DE3432083A1 (de) * 1984-08-31 1986-03-06 Behringwerke Ag, 3550 Marburg Pasteurisierte, isoagglutininfreie faktor viii-praeparation und verfahren zu ihrer herstellung
US4847362A (en) * 1985-02-01 1989-07-11 New York University Method for purifying antihemophilic factor
DE3625090A1 (de) * 1986-07-24 1988-01-28 Behringwerke Ag Mittel zur therapie faktor viii-resistenter haemophilie a und verfahren zu seiner herstellung
CA1329760C (en) * 1987-10-29 1994-05-24 Ted C. K. Lee Plasma and recombinant protein formulations in high ionic strength media
US5110907A (en) * 1989-08-01 1992-05-05 Alpha Therapeutic Corporation Factor viii complex purification using heparin affinity chromatography

Also Published As

Publication number Publication date
US5328694A (en) 1994-07-12
EP0511234B1 (de) 1995-04-12
EP0511234A1 (de) 1992-11-04
WO1991010439A1 (de) 1991-07-25
DK0511234T3 (da) 1995-08-21
DE59008910D1 (de) 1995-05-18
ATE120960T1 (de) 1995-04-15
JPH05504342A (ja) 1993-07-08
DE4001451A1 (de) 1991-08-01

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