PE20210779A1 - NUEVA FORMULACIOìN ESTABLE DE ALTA CONCENTRACIOìN PARA ANTICUERPOS ANTI-FXIa - Google Patents

NUEVA FORMULACIOìN ESTABLE DE ALTA CONCENTRACIOìN PARA ANTICUERPOS ANTI-FXIa

Info

Publication number
PE20210779A1
PE20210779A1 PE2020002228A PE2020002228A PE20210779A1 PE 20210779 A1 PE20210779 A1 PE 20210779A1 PE 2020002228 A PE2020002228 A PE 2020002228A PE 2020002228 A PE2020002228 A PE 2020002228A PE 20210779 A1 PE20210779 A1 PE 20210779A1
Authority
PE
Peru
Prior art keywords
high concentration
formulation
stable high
formulations
fxia
Prior art date
Application number
PE2020002228A
Other languages
English (en)
Inventor
Niklas Gombert
Marieke Veurink
Alexander Klak
Stefan Christian Schneid
Stefan Heke
Matthias Plitzko
Original Assignee
Bayer 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 Ag filed Critical Bayer Ag
Publication of PE20210779A1 publication Critical patent/PE20210779A1/es

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Classifications

    • 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
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • 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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
    • F26B5/065—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing the product to be freeze-dried being sprayed, dispersed or pulverised
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hematology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • General Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Genetics & Genomics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Drying Of Solid Materials (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Glanulating (AREA)

Abstract

Esta referido a formulaciones farmaceuticas liquidas de alta concentracion particularmente adecuadas para la administracion subcutanea, que comprenden anticuerpos humanos contra el factor de coagulacion FXIa como ingrediente activo, las cuales son estables como formulaciones liquidas durante un periodo largo. Esta formulacion comprende el anticuerpo anti-FXIa 076D-M007-H04-CDRL3-N110D a una concentracion de 100 mg/ml o mas, histidina entre 10 y 20 mM, glicina entre 25 y 75 mM y arginina entre 50 y 75 mM, en donde la formulacion tiene un pH de entre 4,7 y 5,3. La invencion tambien se refiere a liofilizados de la formulacion liquida especificada con menor tiempo de reconstitucion y tambien con el uso de estas formulaciones en la terapia y profilaxis de trastornos tromboticos o tromboembolicos.
PE2020002228A 2018-07-05 2019-07-05 NUEVA FORMULACIOìN ESTABLE DE ALTA CONCENTRACIOìN PARA ANTICUERPOS ANTI-FXIa PE20210779A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP2018068250 2018-07-05
PCT/EP2019/068106 WO2020008035A1 (en) 2018-07-05 2019-07-05 NOVEL STABLE HIGH-CONCENTRATION FORMULATION FOR ANTI-FXIa ANTIBODIES

Publications (1)

Publication Number Publication Date
PE20210779A1 true PE20210779A1 (es) 2021-04-21

Family

ID=67139764

Family Applications (2)

Application Number Title Priority Date Filing Date
PE2020002228A PE20210779A1 (es) 2018-07-05 2019-07-05 NUEVA FORMULACIOìN ESTABLE DE ALTA CONCENTRACIOìN PARA ANTICUERPOS ANTI-FXIa
PE2020002238A PE20210462A1 (es) 2018-07-05 2019-07-05 METODO PARA LA PRODUCCION DE GRANULOS LIOFILIZADOS QUE COMPRENDEN UN ANTICUERPO ANTI-FACTOR XIa (FXIa) DE LA COAGULACION

Family Applications After (1)

Application Number Title Priority Date Filing Date
PE2020002238A PE20210462A1 (es) 2018-07-05 2019-07-05 METODO PARA LA PRODUCCION DE GRANULOS LIOFILIZADOS QUE COMPRENDEN UN ANTICUERPO ANTI-FACTOR XIa (FXIa) DE LA COAGULACION

Country Status (15)

Country Link
US (2) US20210292434A1 (es)
EP (2) EP3817727A1 (es)
JP (2) JP2021529801A (es)
KR (2) KR20210029221A (es)
CN (2) CN112367975A (es)
AR (1) AR115713A1 (es)
AU (2) AU2019298656A1 (es)
BR (2) BR112020026789A2 (es)
CA (2) CA3105261A1 (es)
IL (2) IL279865A (es)
MX (2) MX2021000037A (es)
PE (2) PE20210779A1 (es)
SG (2) SG11202100046UA (es)
TW (1) TW202034898A (es)
WO (2) WO2020008035A1 (es)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112020026789A2 (pt) * 2018-07-05 2021-03-30 Bayer Aktiengesellschaft Formulação de alta concentração estável para anticorpos anti-fxia
WO2022122993A1 (en) * 2020-12-11 2022-06-16 Boehringer Ingelheim International Gmbh Formulation for multi-purpose application

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE219517T1 (de) 1995-08-18 2002-07-15 Morphosys Ag Protein-/(poly)peptidbibliotheken
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
DK1794524T3 (da) * 2004-07-23 2012-04-16 Bayer Technology Services Gmbh Fremgangsmåde til frysning, tørring, lagring, analysering og fyldning (SFD-SAF-fremgangsmåde) (fremgangsmåde til frysetørring af piller til parenterale biologiske lægemidler)
ES2750254T3 (es) 2007-09-27 2020-03-25 Amgen Inc Formulaciones farmacéuticas
EP2578974A1 (en) * 2011-10-05 2013-04-10 Sanofi Pasteur Sa Process line for the production of freeze-dried particles
EP2578975A1 (en) 2011-10-05 2013-04-10 Sanofi Pasteur Sa Rotary drum freeze-dryer
JP6348900B2 (ja) * 2012-05-10 2018-06-27 バイエル ファーマ アクチエンゲゼルシャフト 凝固因子ｘｉおよび／またはその活性化形態である因子ｘｉａに結合しうる抗体ならびにその用途
US9592297B2 (en) * 2012-08-31 2017-03-14 Bayer Healthcare Llc Antibody and protein formulations
BR112015008186A2 (pt) 2012-10-25 2017-09-19 Medimmune Llc formulação de um anticorpo estável e de baixa viscosidade
SG11201703152RA (en) 2014-10-23 2017-05-30 Amgen Inc Reducing viscosity of pharmaceutical formulations
EP3167877A1 (en) * 2015-11-12 2017-05-17 Bayer Pharma Aktiengesellschaft Method for the production of freeze-dried pellets comprising factor viii
WO2017180594A1 (en) * 2016-04-13 2017-10-19 Medimmune, Llc Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
EP3254671B1 (en) * 2016-06-10 2019-11-13 Octapharma AG High concentration immunoglobulin composition for pharmaceutical application
JP7139332B2 (ja) * 2016-12-23 2022-09-20 ノバルティス アーゲー 第ｘｉ因子抗体および使用方法
BR112020026789A2 (pt) * 2018-07-05 2021-03-30 Bayer Aktiengesellschaft Formulação de alta concentração estável para anticorpos anti-fxia

Also Published As

Publication number Publication date
KR20210028673A (ko) 2021-03-12
SG11202100046UA (en) 2021-02-25
CN112543627A (zh) 2021-03-23
BR112020026492A2 (pt) 2021-04-06
IL279868A (en) 2021-03-01
MX2021000037A (es) 2021-03-25
MX2021000028A (es) 2021-03-09
PE20210462A1 (es) 2021-03-08
CA3105256A1 (en) 2020-01-09
TW202034898A (zh) 2020-10-01
CN112367975A (zh) 2021-02-12
CA3105261A1 (en) 2020-01-09
SG11202100028PA (en) 2021-01-28
WO2020008022A1 (en) 2020-01-09
US20210290534A1 (en) 2021-09-23
EP3817727A1 (en) 2021-05-12
AU2019298656A1 (en) 2021-01-28
BR112020026789A2 (pt) 2021-03-30
US20210292434A1 (en) 2021-09-23
JP2021529800A (ja) 2021-11-04
JP2021529801A (ja) 2021-11-04
WO2020008035A1 (en) 2020-01-09
KR20210029221A (ko) 2021-03-15
AR115713A1 (es) 2021-02-17
IL279865A (en) 2021-03-01
AU2019297498A1 (en) 2021-01-21
EP3817723A1 (en) 2021-05-12

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