HRP20040882B1 - Stabilni farmaceutski pripravak koji sadrži faktor viii - Google Patents

Stabilni farmaceutski pripravak koji sadrži faktor viii

Info

Publication number
HRP20040882B1
HRP20040882B1 HRP20040882AA HRP20040882A HRP20040882B1 HR P20040882 B1 HRP20040882 B1 HR P20040882B1 HR P20040882A A HRP20040882A A HR P20040882AA HR P20040882 A HRP20040882 A HR P20040882A HR P20040882 B1 HRP20040882 B1 HR P20040882B1
Authority
HR
Croatia
Prior art keywords
pharmaceutical composition
factor viii
composition containing
stable pharmaceutical
containing factor
Prior art date
Application number
HRP20040882AA
Other languages
English (en)
Inventor
Mary White
Paul Webb
Original Assignee
Ipsen Pharma S.A.S.
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 Ipsen Pharma S.A.S. filed Critical Ipsen Pharma S.A.S.
Publication of HRP20040882A2 publication Critical patent/HRP20040882A2/hr
Publication of HRP20040882B1 publication Critical patent/HRP20040882B1/hr

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
    • A61K9/14—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
    • A61K38/16—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
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • 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
    • 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
    • A61K47/02—Inorganic compounds

Landscapes

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

Abstract

Izum se odnosi na stabilni farmaceutski pripravak koji sadrži faktor VIII. takav pripravak ne sadrži aminokiseline a sastoji se od: (a) faktora VIII; (b) surfaktanta; (c) kalcij-klorida; (d) saharoze; (e) natrij-klorida; (f) trinatrij-citrata; i (g) pufera bez aminokiselina; i ima pH od 6 do 8 prije liofilizacije i nakon rekonstitucije u vodi za injekcije. Izum se također odnosi na tekući farmaceutski pripravak koji se dobije nakon razrjeđivanja spomenutog stabilnog čvrstog farmaceutskog pripravka sa sterilnom vodom koja prema potrebi može sadržavati natrij-klorid.
HRP20040882AA 2002-03-26 2004-09-24 Stabilni farmaceutski pripravak koji sadrži faktor viii HRP20040882B1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0207092.8A GB0207092D0 (en) 2002-03-26 2002-03-26 Stable pharmaceutical composition containing factor VIII
PCT/GB2003/001297 WO2003080108A1 (en) 2002-03-26 2003-03-26 Stable pharmaceutical composition containing factor viii

Publications (2)

Publication Number Publication Date
HRP20040882A2 HRP20040882A2 (en) 2004-12-31
HRP20040882B1 true HRP20040882B1 (hr) 2013-02-28

Family

ID=9933726

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20040882AA HRP20040882B1 (hr) 2002-03-26 2004-09-24 Stabilni farmaceutski pripravak koji sadrži faktor viii

Country Status (27)

Country Link
US (1) US7790680B2 (hr)
EP (2) EP1490095B1 (hr)
JP (4) JP2005530714A (hr)
KR (1) KR20040093482A (hr)
CN (2) CN1642570B (hr)
AR (1) AR039123A1 (hr)
AT (1) ATE477814T1 (hr)
AU (1) AU2003217030B2 (hr)
BR (1) BR0308442A (hr)
CA (1) CA2480226C (hr)
DE (1) DE60333825D1 (hr)
DK (1) DK1490095T3 (hr)
ES (1) ES2350337T3 (hr)
GB (1) GB0207092D0 (hr)
HK (2) HK1080713A1 (hr)
HR (1) HRP20040882B1 (hr)
IL (2) IL163849A0 (hr)
IS (1) IS7458A (hr)
MX (1) MXPA04009275A (hr)
MY (1) MY149831A (hr)
NO (1) NO328450B1 (hr)
NZ (1) NZ535032A (hr)
PL (1) PL208009B1 (hr)
PT (1) PT1490095E (hr)
RU (1) RU2314825C2 (hr)
TW (1) TWI285106B (hr)
WO (1) WO2003080108A1 (hr)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7560107B2 (en) 1996-06-26 2009-07-14 Emory University Modified factor VIII
NZ539811A (en) * 2002-10-29 2008-08-29 Alza Corp Solid-state polypeptide particles that facilitate the loading of an implant delivery system with a concentration of stabilised, therapeutic polypeptide sufficiently high to enable delivery of therapeutic doses of the polypeptide over an extended period of time
US7485291B2 (en) 2003-06-03 2009-02-03 Cell Genesys, Inc. Compositions and methods for generating multiple polypeptides from a single vector using a virus derived peptide cleavage site, and uses thereof
CA2526120A1 (en) 2003-06-03 2005-02-24 Cell Genesys, Inc. Compositions and methods for enhanced expression of recombinant polypeptides from a single vector using a peptide cleavage site
AU2004288854B2 (en) * 2003-11-10 2009-10-01 Arriva-Pharmaceuticals, Inc. Dry recombinant human alpha 1-antitrypsin formulation
ES2449044T3 (es) * 2004-05-03 2014-03-18 Emory University Procedimiento de administración de fVIII sin dominio B porcino
KR101710471B1 (ko) * 2008-04-21 2017-02-27 노보 노르디스크 헬스 케어 악티엔게젤샤프트 건조한 트랜스글루타미나제 조성물
EP2113564A1 (en) 2008-05-01 2009-11-04 Arecor Limited Protein formulation
KR101921698B1 (ko) 2008-08-21 2018-11-26 옥타파마 아게 재조합에 의해 제조된 인간 인자 ⅷ 및 ⅸ
PT2337580E (pt) * 2008-09-03 2012-05-28 Octapharma Ag Composições estabilizadas para o factor viii produzido de forma recombinante
CA2742328C (en) 2008-11-07 2019-02-26 Baxter International Inc. Factor viii formulations
GB0915480D0 (en) * 2009-09-04 2009-10-07 Arecor Ltd Stable formulation of factor viii
MY165089A (en) 2010-11-05 2018-02-28 Baxalta Inc A new variant of antihemophilic factor viii having increased specific activity
CN105209487A (zh) * 2013-03-15 2015-12-30 拜耳医药保健有限公司 重组因子viii制剂
EA201890671A1 (ru) 2013-03-15 2019-01-31 Биовератив Терапьютикс Инк. Препараты полипептида фактора viii
MX2017000862A (es) 2014-08-04 2017-05-01 Csl Ltd Formulacion de factor viii.
JP6781508B2 (ja) * 2014-11-18 2020-11-04 塩野義製薬株式会社 安定化されたペプチド組成物
WO2021001522A1 (en) 2019-07-04 2021-01-07 CSL Behring Lengnau AG A truncated von willebrand factor (vwf) for increasing the in vitro stability of coagulation factor viii
US20220380439A1 (en) 2020-11-09 2022-12-01 Takeda Pharmaceutical Company Limited Purification of fviii from plasma using silicon oxide adsorption

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000048635A1 (en) * 1999-02-22 2000-08-24 Baxter International Inc. Novel albumin-free factor viii formulations
WO2001003726A1 (en) * 1999-07-13 2001-01-18 Biovitrum Ab Stable factor viii compositions

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6281327A (ja) * 1985-10-04 1987-04-14 Green Cross Corp:The 人トロンビン製剤の加熱処理方法
JPS6485927A (en) * 1987-09-29 1989-03-30 Green Cross Corp Hepatitis b vaccine
US5605884A (en) 1987-10-29 1997-02-25 Rhone-Poulenc Rorer Pharmaceuticals Inc. Factor VIII formulations in high ionic strength media
WO1989009784A1 (en) * 1988-04-08 1989-10-19 Commonwealth Serum Laboratories Commission Production of heat-stable factor viii concentrate
SE465222C5 (sv) 1989-12-15 1998-02-10 Pharmacia & Upjohn Ab Ett rekombinant, humant faktor VIII-derivat och förfarande för dess framställning
IE64738B1 (en) * 1990-03-20 1995-09-06 Akzo Nv Stabilized gonadotropin containing preparations
DE4111393A1 (de) * 1991-04-09 1992-10-15 Behringwerke Ag Stabilisierte faktor viii-praeparationen
CA2124690C (en) 1992-10-02 2007-09-11 Thomas Osterberg 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
SE504074C2 (sv) 1993-07-05 1996-11-04 Pharmacia Ab Proteinberedning för subkutan, intramuskulär eller intradermal administrering
ZA955642B (en) * 1994-07-07 1997-05-06 Ortho Pharma Corp Lyophilized imaging agent formulation
JPH0899999A (ja) 1994-09-30 1996-04-16 Chemo Sero Therapeut Res Inst α１プロテアーゼインヒビターの製造方法
US6458563B1 (en) 1996-06-26 2002-10-01 Emory University Modified factor VIII
US5763401A (en) 1996-07-12 1998-06-09 Bayer Corporation Stabilized albumin-free recombinant factor VIII preparation having a low sugar content
AU6558400A (en) * 1999-08-17 2001-03-13 Novo Nordisk A/S Stabilisation of freeze-dried cake
US6586574B1 (en) * 1999-08-17 2003-07-01 Nn A/S Stabilization of freeze-dried cake
US7576182B1 (en) * 1999-08-31 2009-08-18 Genentech, Inc. Compositions and methods for the treatment of immune related diseases

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000048635A1 (en) * 1999-02-22 2000-08-24 Baxter International Inc. Novel albumin-free factor viii formulations
WO2001003726A1 (en) * 1999-07-13 2001-01-18 Biovitrum Ab Stable factor viii compositions

Also Published As

Publication number Publication date
GB0207092D0 (en) 2002-05-08
IL163849A (en) 2010-12-30
ATE477814T1 (de) 2010-09-15
HRP20040882A2 (en) 2004-12-31
CN103006540B (zh) 2015-09-16
JP5770775B2 (ja) 2015-08-26
JP2015143245A (ja) 2015-08-06
DK1490095T3 (da) 2010-11-08
NO328450B1 (no) 2010-02-22
IS7458A (is) 2004-09-17
KR20040093482A (ko) 2004-11-05
JP2013147508A (ja) 2013-08-01
CN1642570B (zh) 2013-01-09
PL208009B1 (pl) 2011-03-31
NO20044305L (no) 2004-10-11
US20050256038A1 (en) 2005-11-17
RU2004131556A (ru) 2005-08-20
IL163849A0 (en) 2005-12-18
EP2292216A3 (en) 2011-05-11
TWI285106B (en) 2007-08-11
CN103006540A (zh) 2013-04-03
AU2003217030A1 (en) 2003-10-08
TW200304827A (en) 2003-10-16
RU2314825C2 (ru) 2008-01-20
EP1490095A1 (en) 2004-12-29
BR0308442A (pt) 2005-01-18
CA2480226A1 (en) 2003-10-02
NZ535032A (en) 2006-03-31
AU2003217030B2 (en) 2008-12-04
JP2011079862A (ja) 2011-04-21
PT1490095E (pt) 2010-10-21
CN1642570A (zh) 2005-07-20
PL372414A1 (en) 2005-07-25
HK1183446A1 (en) 2013-12-27
CA2480226C (en) 2012-09-18
MXPA04009275A (es) 2005-01-25
AR039123A1 (es) 2005-02-09
EP2292216A2 (en) 2011-03-09
DE60333825D1 (de) 2010-09-30
WO2003080108A1 (en) 2003-10-02
HK1080713A1 (en) 2006-05-04
JP2005530714A (ja) 2005-10-13
US7790680B2 (en) 2010-09-07
MY149831A (en) 2013-10-31
EP1490095B1 (en) 2010-08-18
ES2350337T3 (es) 2011-01-21

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Legal Events

Date Code Title Description
A1OB Publication of a patent application
ARAI Request for the grant of a patent on the basis of the submitted results of a substantive examination of a patent application
PNAN Change of the applicant name, address/residence

Owner name: IPSEN PHARMA S.A.S., FR

B1PR Patent granted
PNAN Change of the applicant name, address/residence

Owner name: BAXALTA GMBH, CH

PPPP Transfer of rights

Owner name: BAXALTA GMBH, CH

Owner name: BAXTER INTERNATIONAL INC.BAXTER HEALTHCARE SA, USC

Owner name: BAXALTA INCORPORATED, US

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