MX2019008544A - Nueva formulacion estable para anticuerpos anti-fxia. - Google Patents

Nueva formulacion estable para anticuerpos anti-fxia.

Info

Publication number
MX2019008544A
MX2019008544A MX2019008544A MX2019008544A MX2019008544A MX 2019008544 A MX2019008544 A MX 2019008544A MX 2019008544 A MX2019008544 A MX 2019008544A MX 2019008544 A MX2019008544 A MX 2019008544A MX 2019008544 A MX2019008544 A MX 2019008544A
Authority
MX
Mexico
Prior art keywords
stable formulation
novel stable
fxia antibodies
refers
fxia
Prior art date
Application number
MX2019008544A
Other languages
English (en)
Inventor
Olbrich Carsten
Trill Thomas
VEURINK Marieke
Original Assignee
Bayer Pharma 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 Bayer Pharma AG filed Critical Bayer Pharma AG
Publication of MX2019008544A publication Critical patent/MX2019008544A/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/36—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Hematology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Nuevas formulaciones farmacéuticas líquidas que comprenden un anticuerpo humano contra el factor de coagulación FXIa como ingrediente activo. La invención también se refiere a liofilizados de la formulación líquida especificada y también a su uso en la terapia y la profilaxis de trastornos trombóticos o tromboembólicos.
MX2019008544A 2017-01-19 2018-01-16 Nueva formulacion estable para anticuerpos anti-fxia. MX2019008544A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP17152108 2017-01-19
PCT/EP2018/050951 WO2018134184A1 (en) 2017-01-19 2018-01-16 Novel stable formulation for fxia antibodies

Publications (1)

Publication Number Publication Date
MX2019008544A true MX2019008544A (es) 2019-10-07

Family

ID=57914707

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2019008544A MX2019008544A (es) 2017-01-19 2018-01-16 Nueva formulacion estable para anticuerpos anti-fxia.

Country Status (25)

Country Link
US (1) US20190367636A1 (es)
EP (1) EP3570882B1 (es)
JP (1) JP7072577B2 (es)
KR (1) KR20190105588A (es)
CN (1) CN110234353B (es)
AR (1) AR110762A1 (es)
AU (1) AU2018209118A1 (es)
BR (1) BR112019014785A2 (es)
CA (1) CA3050172A1 (es)
CY (1) CY1124922T1 (es)
DK (1) DK3570882T3 (es)
ES (1) ES2904474T3 (es)
HR (1) HRP20220011T1 (es)
HU (1) HUE056858T2 (es)
IL (1) IL267917B2 (es)
LT (1) LT3570882T (es)
MX (1) MX2019008544A (es)
PE (1) PE20191476A1 (es)
PL (1) PL3570882T3 (es)
PT (1) PT3570882T (es)
RS (1) RS62780B1 (es)
SG (1) SG11201906557UA (es)
SI (1) SI3570882T1 (es)
TW (1) TWI753087B (es)
WO (1) WO2018134184A1 (es)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JOP20200312A1 (ar) 2015-06-26 2017-06-16 Novartis Ag الأجسام المضادة للعامل xi وطرق الاستخدام
TW201802121A (zh) 2016-05-25 2018-01-16 諾華公司 抗因子XI/XIa抗體之逆轉結合劑及其用途
BR112019012667A2 (pt) 2016-12-23 2020-02-11 Novartis Ag Anticorpos do fator xi e métodos de uso
CR20210435A (es) 2019-02-18 2021-09-20 Lilly Co Eli Formulación de anticuerpos terapéuticos
KR20220119090A (ko) * 2019-12-20 2022-08-26 안토스 테라퓨틱스, 인크. 인자 XI/XIa 항체에 대한 제약 제제 및 투여 요법
WO2022002233A1 (zh) 2020-07-03 2022-01-06 苏州康宁杰瑞生物科技有限公司 凝血因子xi(fxi)结合蛋白
WO2022122993A1 (en) * 2020-12-11 2022-06-16 Boehringer Ingelheim International Gmbh Formulation for multi-purpose application

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002013860A1 (fr) * 2000-08-11 2002-02-21 Chugai Seiyaku Kabushiki Kaisha Preparations stabilisees contenant un anticorps
US20040191243A1 (en) * 2002-12-13 2004-09-30 Bei Chen System and method for stabilizing antibodies with histidine
CA2736864C (en) * 2008-09-19 2020-10-13 Pfizer Inc. Stable liquid antibody formulation
CN102438652B (zh) * 2008-11-12 2014-08-13 米迪缪尼有限公司 抗体制剂
LT2847228T (lt) * 2012-05-10 2018-11-12 Bayer Pharma Aktiengesellschaft Antikūnai, galintys jungtis prie koaguliacijos faktoriaus xi ir (arba) jo aktyvuotos formos faktoriaus xia, ir jų panaudojimas
WO2015059147A1 (en) * 2013-10-25 2015-04-30 Bayer Pharma Aktiengesellschaft A novel stable formulation

Also Published As

Publication number Publication date
SI3570882T1 (sl) 2022-01-31
EP3570882B1 (en) 2021-11-17
HUE056858T2 (hu) 2022-03-28
CN110234353B (zh) 2023-07-04
CY1124922T1 (el) 2023-01-05
HRP20220011T1 (hr) 2022-04-01
PT3570882T (pt) 2022-01-11
DK3570882T3 (da) 2022-01-10
IL267917B2 (en) 2023-10-01
IL267917B1 (en) 2023-06-01
RU2019125947A3 (es) 2021-05-25
EP3570882A1 (en) 2019-11-27
WO2018134184A1 (en) 2018-07-26
CA3050172A1 (en) 2018-07-26
PL3570882T3 (pl) 2022-02-07
JP2020506175A (ja) 2020-02-27
TWI753087B (zh) 2022-01-21
ES2904474T3 (es) 2022-04-05
CN110234353A (zh) 2019-09-13
IL267917A (en) 2019-09-26
RS62780B1 (sr) 2022-01-31
PE20191476A1 (es) 2019-10-16
US20190367636A1 (en) 2019-12-05
TW201831170A (zh) 2018-09-01
KR20190105588A (ko) 2019-09-17
BR112019014785A2 (pt) 2020-05-12
AU2018209118A1 (en) 2019-07-11
LT3570882T (lt) 2021-12-10
SG11201906557UA (en) 2019-08-27
AR110762A1 (es) 2019-05-02
JP7072577B2 (ja) 2022-05-20
RU2019125947A (ru) 2021-02-19

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