MX379126B - Formulación de factor viii. - Google Patents

Formulación de factor viii.

Info

Publication number
MX379126B
MX379126B MX2017000862A MX2017000862A MX379126B MX 379126 B MX379126 B MX 379126B MX 2017000862 A MX2017000862 A MX 2017000862A MX 2017000862 A MX2017000862 A MX 2017000862A MX 379126 B MX379126 B MX 379126B
Authority
MX
Mexico
Prior art keywords
factor viii
viii formulation
formulation
relates
factor
Prior art date
Application number
MX2017000862A
Other languages
English (en)
Other versions
MX2017000862A (es
Inventor
Christina Bodenbender
Hubert Metzner
Uwe Liebing
Original Assignee
Csl 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 Csl Ltd filed Critical Csl Ltd
Publication of MX2017000862A publication Critical patent/MX2017000862A/es
Publication of MX379126B publication Critical patent/MX379126B/es

Links

Classifications

    • 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
    • A61K38/37Factors VIII
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/16Organic 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
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic 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
    • A61K47/22Heterocyclic 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
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745Blood coagulation or fibrinolysis factors
    • C07K14/755Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)

Landscapes

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

Abstract

La invención se refiere a composiciones de Factor VIII y su uso.
MX2017000862A 2014-08-04 2015-07-24 Formulación de factor viii. MX379126B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP14179732 2014-08-04
PCT/EP2015/066999 WO2016020210A1 (en) 2014-08-04 2015-07-24 Csl behring gmbh

Publications (2)

Publication Number Publication Date
MX2017000862A MX2017000862A (es) 2017-05-01
MX379126B true MX379126B (es) 2025-03-10

Family

ID=51298563

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2017000862A MX379126B (es) 2014-08-04 2015-07-24 Formulación de factor viii.

Country Status (16)

Country Link
US (1) US10238718B2 (es)
EP (1) EP3177317B1 (es)
JP (1) JP6516829B2 (es)
KR (1) KR102192494B1 (es)
CN (1) CN106687126B (es)
AU (1) AU2015299224B2 (es)
BR (1) BR112017002090B1 (es)
DK (1) DK3177317T3 (es)
ES (1) ES2788870T3 (es)
IL (1) IL250343B (es)
MX (1) MX379126B (es)
NZ (1) NZ729629A (es)
PL (1) PL3177317T3 (es)
RU (1) RU2689338C2 (es)
SG (2) SG10201900598TA (es)
WO (1) WO2016020210A1 (es)

Families Citing this family (7)

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Publication number Priority date Publication date Assignee Title
CN106279437B (zh) * 2016-08-19 2017-10-31 安源医药科技(上海)有限公司 高糖基化人凝血因子viii融合蛋白及其制备方法与用途
JP7113429B2 (ja) 2016-11-29 2022-08-05 Spiber株式会社 タンパク質組成物、その製造方法及び熱安定性向上方法
WO2018132874A1 (en) * 2017-01-19 2018-07-26 Csl Limited Method of preventing an immune response with alpha- 1 anti-trypsin
CN111655230A (zh) 2017-11-07 2020-09-11 拉尼医疗有限公司 使用可吞服药物递送装置递送到肠道组织中的凝血因子制剂
CN113105562B (zh) * 2018-09-26 2023-12-01 安源医药科技(上海)有限公司 突变型单链人凝血因子viii在制备融合蛋白中的应用
CN112138149A (zh) * 2019-06-28 2020-12-29 北京基科晟斯医药科技有限公司 重组凝血因子viii制剂
US20220380439A1 (en) 2020-11-09 2022-12-01 Takeda Pharmaceutical Company Limited Purification of fviii from plasma using silicon oxide adsorption

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US4877608A (en) 1987-11-09 1989-10-31 Rorer Pharmaceutical Corporation Pharmaceutical plasma protein formulations in low ionic strength media
DE69029765T2 (de) 1989-07-24 1997-05-15 Bayer Ag Stabilisierung von hochgereinigten Proteinen
DE4001451A1 (de) 1990-01-19 1991-08-01 Octapharma Ag Stabile injizierbare loesungen von faktor viii und faktor ix
DE4111393A1 (de) 1991-04-09 1992-10-15 Behringwerke Ag Stabilisierte faktor viii-praeparationen
DE69333928T2 (de) 1992-04-30 2006-08-17 Probitas Pharma Inc., Los Angeles Verbesserte solubilisierung und stabilisierung des faktor viii-komplexes
CZ290342B6 (cs) * 1992-10-02 2002-07-17 Genetics Institute Inc. Kompozice stabilní při skladování, obsahující koagulační faktor VIII a neiontovou povrchově aktivní látku a způsob její výroby
GB9501040D0 (en) 1995-01-19 1995-03-08 Quadrant Holdings Cambridge Dried composition
SE9501189D0 (sv) 1995-03-31 1995-03-31 Pharmacia Ab Protein formulation
US5763401A (en) 1996-07-12 1998-06-09 Bayer Corporation Stabilized albumin-free recombinant factor VIII preparation having a low sugar content
PT2193809E (pt) * 1999-02-22 2015-08-24 Baxter Int Formulações de fator viii livres de albumina
EP2305312B1 (en) 2001-10-10 2015-03-04 ratiopharm GmbH Remodelling and glycoconjugation of follicle-stimulating hormone (FSH)
GB0207092D0 (en) 2002-03-26 2002-05-08 Sod Conseils Rech Applic Stable pharmaceutical composition containing factor VIII
US7041635B2 (en) 2003-01-28 2006-05-09 In2Gen Co., Ltd. Factor VIII polypeptide
ES2676644T3 (es) 2003-12-19 2018-07-23 Novo Nordisk Health Care Ag Composiciones estabilizadas de polipéptidos de factor VII
KR100624013B1 (ko) * 2004-06-25 2006-09-19 주식회사 녹십자홀딩스 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제
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Also Published As

Publication number Publication date
JP2017528440A (ja) 2017-09-28
KR102192494B1 (ko) 2020-12-18
RU2689338C2 (ru) 2019-05-27
EP3177317B1 (en) 2020-03-18
NZ729629A (en) 2021-12-24
WO2016020210A1 (en) 2016-02-11
US10238718B2 (en) 2019-03-26
BR112017002090A2 (pt) 2018-01-30
IL250343B (en) 2020-10-29
MX2017000862A (es) 2017-05-01
DK3177317T3 (en) 2020-06-15
RU2017106159A (ru) 2018-09-06
RU2017106159A3 (es) 2018-11-28
PL3177317T3 (pl) 2020-07-27
EP3177317A1 (en) 2017-06-14
SG10201900598TA (en) 2019-02-27
US20170252412A1 (en) 2017-09-07
AU2015299224B2 (en) 2019-06-20
JP6516829B2 (ja) 2019-05-22
BR112017002090B1 (pt) 2021-06-01
CN106687126A (zh) 2017-05-17
CN106687126B (zh) 2020-07-28
ES2788870T3 (es) 2020-10-23
WO2016020210A8 (en) 2016-04-28
AU2015299224A1 (en) 2017-03-23
KR20170040327A (ko) 2017-04-12
CA2956412A1 (en) 2016-02-11
SG11201700550YA (en) 2017-02-27
IL250343A0 (en) 2017-03-30

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