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BR112013016770A2 - formulação farmacêutica, fármaco biofarmacêutico, seringa ou caneta pré-preenchida, uso de uma formulação farmacêutica - Google Patents

formulação farmacêutica, fármaco biofarmacêutico, seringa ou caneta pré-preenchida, uso de uma formulação farmacêutica

Info

Publication number
BR112013016770A2
BR112013016770A2 BR112013016770A BR112013016770A BR112013016770A2 BR 112013016770 A2 BR112013016770 A2 BR 112013016770A2 BR 112013016770 A BR112013016770 A BR 112013016770A BR 112013016770 A BR112013016770 A BR 112013016770A BR 112013016770 A2 BR112013016770 A2 BR 112013016770A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical formulation
pen
filled syringe
biopharmaceutical drug
biopharmaceutical
Prior art date
Application number
BR112013016770A
Other languages
English (en)
Inventor
Bernt Pragl
Britta Deutel
Drago Kuzman
Martina Danek-Bulius
Sabine Fürtinger
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 BR112013016770A2 publication Critical patent/BR112013016770A2/pt

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
    • A61K39/39533—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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/14—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
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Endocrinology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (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

formulação farmacêutica, fármaco biofarmacêutico, seringa ou caneta pré-preenchida, uso de uma formulação farmacêutica a presente invenção se refere a uma formulação farmacêutica compreendendo um fármaco biofarmacêutico, a referida composição adicionalmente compreendendo pelo menos um ácido mono- ou dicarboxílico com uma estrutura de 2 - 6 átomos de carbono, ou pelo menos um sal do mesmo (fig. 4a).
BR112013016770A 2010-12-28 2011-12-28 formulação farmacêutica, fármaco biofarmacêutico, seringa ou caneta pré-preenchida, uso de uma formulação farmacêutica BR112013016770A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP10197122A EP2471554A1 (en) 2010-12-28 2010-12-28 Pharmaceutical formulation comprising a biopharmaceutical drug
PCT/EP2011/074181 WO2012089778A1 (en) 2010-12-28 2011-12-28 Pharmaceutical formulation comprising a biopharmaceutical drug

Publications (1)

Publication Number Publication Date
BR112013016770A2 true BR112013016770A2 (pt) 2016-10-11

Family

ID=43982272

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112013016770A BR112013016770A2 (pt) 2010-12-28 2011-12-28 formulação farmacêutica, fármaco biofarmacêutico, seringa ou caneta pré-preenchida, uso de uma formulação farmacêutica

Country Status (22)

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

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AU2023413756A1 (en) 2022-12-21 2025-07-10 Formycon Ag Formulations of anti-pd1 antibodies

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Also Published As

Publication number Publication date
MX352245B (es) 2017-10-31
NO2658575T3 (pt) 2018-04-14
HRP20171931T1 (hr) 2018-02-23
JP2014505682A (ja) 2014-03-06
PT2658575T (pt) 2018-02-22
CA2822859C (en) 2016-11-08
ZA201304446B (en) 2014-02-26
MX2013007537A (es) 2014-03-13
AU2011351414B2 (en) 2017-01-19
TW201302223A (zh) 2013-01-16
JP5767340B2 (ja) 2015-08-19
US9480743B2 (en) 2016-11-01
JP2015131832A (ja) 2015-07-23
AR124676A2 (es) 2023-04-26
ZA201308841B (en) 2015-02-25
CN103269718A (zh) 2013-08-28
RU2013133953A (ru) 2015-02-10
SI2658575T1 (en) 2018-02-28
KR20130137653A (ko) 2013-12-17
DK2658575T3 (en) 2018-01-22
RU2587056C2 (ru) 2016-06-10
KR101808367B1 (ko) 2018-01-18
WO2012089778A1 (en) 2012-07-05
EP2658575A1 (en) 2013-11-06
US20130336968A1 (en) 2013-12-19
HUE035707T2 (en) 2018-05-28
CA2822859A1 (en) 2012-07-05
TWI530295B (zh) 2016-04-21
EP2471554A1 (en) 2012-07-04
AR084627A1 (es) 2013-05-29
PL2658575T3 (pl) 2018-04-30
CN103269718B (zh) 2016-02-10
ES2659981T3 (es) 2018-03-20
AU2011351414A1 (en) 2013-07-04
EP2658575B1 (en) 2017-11-15

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06T Formal requirements before examination [chapter 6.20 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09B Patent application refused [chapter 9.2 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]
B12B Appeal against refusal [chapter 12.2 patent gazette]