AR124676A2 - Formulación farmacéutica que comprende una droga biofarmacéutica - Google Patents

Formulación farmacéutica que comprende una droga biofarmacéutica

Info

Publication number
AR124676A2
AR124676A2 ARP220100101A ARP220100101A AR124676A2 AR 124676 A2 AR124676 A2 AR 124676A2 AR P220100101 A ARP220100101 A AR P220100101A AR P220100101 A ARP220100101 A AR P220100101A AR 124676 A2 AR124676 A2 AR 124676A2
Authority
AR
Argentina
Prior art keywords
biopharmaceutical drug
pharmaceutical formulation
antibodies
antibody
formulation according
Prior art date
Application number
ARP220100101A
Other languages
English (en)
Inventor
Martina Danek-Bulius
Britta Deutel
Sabine Frtinger
Bernt Pragl
Drago Kuzman
Original Assignee
Hexal 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 Hexal Ag filed Critical Hexal Ag
Publication of AR124676A2 publication Critical patent/AR124676A2/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Endocrinology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Neurosurgery (AREA)
  • Transplantation (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

Una formulación farmacéutica que comprende una droga biofarmacéutica, donde dicha composición además comprende por lo menos un ácido mono- o dicarboxílico con un esqueleto principal de 2 - 6 átomos de C, o por lo menos una sal del mismo. Reivindicación 8: La formulación de acuerdo con cualquiera de las reivindicaciones mencionadas anteriormente, caracterizada porque dicha droga biofarmacéutica es una proteína. Reivindicación 10: La formulación de acuerdo con cualquiera de las reivindicaciones mencionadas anteriormente, caracterizada porque dicha proteína es por lo menos un anticuerpo, o un fragmento o un derivado del mismo, que se selecciona entre el grupo que consiste en: anticuerpos derivados de hibridoma, anticuerpos quimerizados, anticuerpos humanizados, y/o anticuerpos humanos. Reivindicación 11: La formulación de acuerdo con la reivindicación 9 ó 10, caracterizada porque dicho anticuerpo, o fragmento o derivado del mismo, es un anticuerpo anti-TNFa.
ARP220100101A 2010-12-28 2022-01-18 Formulación farmacéutica que comprende una droga biofarmacéutica AR124676A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP10197122A EP2471554A1 (en) 2010-12-28 2010-12-28 Pharmaceutical formulation comprising a biopharmaceutical drug

Publications (1)

Publication Number Publication Date
AR124676A2 true AR124676A2 (es) 2023-04-26

Family

ID=43982272

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP110104977A AR084627A1 (es) 2010-12-28 2011-12-28 Formulacion farmaceutica que comprende una droga biofarmaceutica
ARP220100101A AR124676A2 (es) 2010-12-28 2022-01-18 Formulación farmacéutica que comprende una droga biofarmacéutica

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ARP110104977A AR084627A1 (es) 2010-12-28 2011-12-28 Formulacion farmaceutica que comprende una droga biofarmaceutica

Country Status (22)

Country Link
US (1) US9480743B2 (es)
EP (2) EP2471554A1 (es)
JP (2) JP5767340B2 (es)
KR (1) KR101808367B1 (es)
CN (1) CN103269718B (es)
AR (2) AR084627A1 (es)
AU (1) AU2011351414B2 (es)
BR (1) BR112013016770A2 (es)
CA (1) CA2822859C (es)
DK (1) DK2658575T3 (es)
ES (1) ES2659981T3 (es)
HR (1) HRP20171931T1 (es)
HU (1) HUE035707T2 (es)
MX (1) MX352245B (es)
NO (1) NO2658575T3 (es)
PL (1) PL2658575T3 (es)
PT (1) PT2658575T (es)
RU (1) RU2587056C2 (es)
SI (1) SI2658575T1 (es)
TW (1) TWI530295B (es)
WO (1) WO2012089778A1 (es)
ZA (2) ZA201304446B (es)

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WO2025149960A1 (en) * 2024-01-11 2025-07-17 Lupin Limited Pharmaceutical formulation of anti-il-5 antibody

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Also Published As

Publication number Publication date
ES2659981T3 (es) 2018-03-20
ZA201308841B (en) 2015-02-25
ZA201304446B (en) 2014-02-26
PT2658575T (pt) 2018-02-22
MX2013007537A (es) 2014-03-13
DK2658575T3 (en) 2018-01-22
RU2013133953A (ru) 2015-02-10
EP2471554A1 (en) 2012-07-04
JP2015131832A (ja) 2015-07-23
AU2011351414B2 (en) 2017-01-19
HRP20171931T1 (hr) 2018-02-23
MX352245B (es) 2017-10-31
CN103269718A (zh) 2013-08-28
EP2658575A1 (en) 2013-11-06
KR101808367B1 (ko) 2018-01-18
TW201302223A (zh) 2013-01-16
BR112013016770A2 (pt) 2016-10-11
WO2012089778A1 (en) 2012-07-05
CA2822859C (en) 2016-11-08
EP2658575B1 (en) 2017-11-15
TWI530295B (zh) 2016-04-21
US9480743B2 (en) 2016-11-01
SI2658575T1 (en) 2018-02-28
RU2587056C2 (ru) 2016-06-10
JP2014505682A (ja) 2014-03-06
NO2658575T3 (es) 2018-04-14
HUE035707T2 (en) 2018-05-28
US20130336968A1 (en) 2013-12-19
PL2658575T3 (pl) 2018-04-30
JP5767340B2 (ja) 2015-08-19
KR20130137653A (ko) 2013-12-17
CN103269718B (zh) 2016-02-10
AU2011351414A1 (en) 2013-07-04
CA2822859A1 (en) 2012-07-05
AR084627A1 (es) 2013-05-29

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