CL2019001818A1 - Composición farmacéutica acuosa de anticuerpo monoclonal anti-tnf a recombinante. - Google Patents

Composición farmacéutica acuosa de anticuerpo monoclonal anti-tnf a recombinante.

Info

Publication number
CL2019001818A1
CL2019001818A1 CL2019001818A CL2019001818A CL2019001818A1 CL 2019001818 A1 CL2019001818 A1 CL 2019001818A1 CL 2019001818 A CL2019001818 A CL 2019001818A CL 2019001818 A CL2019001818 A CL 2019001818A CL 2019001818 A1 CL2019001818 A1 CL 2019001818A1
Authority
CL
Chile
Prior art keywords
monoclonal antibody
aqueous pharmaceutical
tnfa
tnf
pharmaceutical composition
Prior art date
Application number
CL2019001818A
Other languages
English (en)
Inventor
Dmitry Valentinovich Morozov
Ekaterina Aleksandrovna Lomkova
Aleksandr Olegovich Iakovlev
Viktoriya Olegovna Shitikova
Anastasiya Mikhajlovna Ryakhovskaya
Original Assignee
Biocad Joint Stock Co
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
Priority claimed from RU2016152691A external-priority patent/RU2665966C2/ru
Priority claimed from RU2017146821A external-priority patent/RU2764521C2/ru
Application filed by Biocad Joint Stock Co filed Critical Biocad Joint Stock Co
Publication of CL2019001818A1 publication Critical patent/CL2019001818A1/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
    • 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
    • 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
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/26Carbohydrates, 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
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Rheumatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

LA INVENCIÓN SE RELACIONA CON COMPOSICIONES FARMACÉUTICAS ACUOSAS MEJORADAS DE UN ANTICUERPO MONOCLONAL RECOMBINANTE PARA TNFA Y UN MÉTODO DE PRODUCCIÓN DEL MISMO. LA PRESENTE INVENCIÓN SE RELACIONA ADEMÁS CON EL USO DE COMPOSICIONES FARMACÉUTICAS ACUOSAS MEJORADAS DE UN ANTICUERPO MONOCLONAL RECOMBINANTE PARA TNFA PARA TRATAR ENFERMEDADES MEDIADAS POR TNFA. LA INVENCIÓN PROPUESTA PERMITE LA PREVENCIÓN DE INESTABILIDAD FÍSICO-QUÍMICA EXPRESADA EN LA FORMACIÓN DE CÚMULOS Y FRAGMENTOS DE PROTEÍNAS O EN LA MODIFICACIÓN DE PROTEÍNAS EN UNA SOLUCIÓN; ADEMÁS, PREVIENE LA INESTABILIDAD DURANTE LA CONGELACIÓN/DESCONGELACIÓN, LA AGITACIÓN Y EL MOVIMIENTO.
CL2019001818A 2016-12-30 2019-06-28 Composición farmacéutica acuosa de anticuerpo monoclonal anti-tnf a recombinante. CL2019001818A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RU2016152691A RU2665966C2 (ru) 2016-12-30 2016-12-30 Водная фармацевтическая композиция рекомбинантного моноклонального антитела к ФНОα
RU2017146821A RU2764521C2 (ru) 2017-12-29 2017-12-29 Водная фармацевтическая композиция рекомбинантного моноклонального антитела к ФНОа

Publications (1)

Publication Number Publication Date
CL2019001818A1 true CL2019001818A1 (es) 2019-11-29

Family

ID=62710701

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2019001818A CL2019001818A1 (es) 2016-12-30 2019-06-28 Composición farmacéutica acuosa de anticuerpo monoclonal anti-tnf a recombinante.

Country Status (15)

Country Link
EP (1) EP3563867A4 (es)
JP (1) JP2020506955A (es)
KR (1) KR20190104043A (es)
AU (1) AU2017384942A1 (es)
BR (1) BR112019013673A2 (es)
CL (1) CL2019001818A1 (es)
CR (1) CR20190316A (es)
EC (1) ECSP19048656A (es)
JO (1) JOP20190162A1 (es)
MX (1) MX2019007911A (es)
NI (1) NI201900072A (es)
PE (1) PE20191550A1 (es)
PH (1) PH12019501530A1 (es)
WO (1) WO2018124948A1 (es)
ZA (1) ZA201904305B (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20220152540A (ko) * 2020-03-13 2022-11-16 삼성바이오에피스 주식회사 안정성이 증진된 액상 약제학적 조성물
RU2745814C1 (ru) * 2020-06-05 2021-04-01 Закрытое Акционерное Общество "Биокад" Водная фармацевтическая композиция левилимаба и ее применение
AU2022245592A1 (en) * 2021-03-24 2023-10-19 Jcr Pharmaceuticals Co., Ltd. Stable aqueous pharmaceutical composition or freeze-dried pharmaceutical composition

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DE3631229A1 (de) 1986-09-13 1988-03-24 Basf Ag Monoklonale antikoerper gegen humanen tumornekrosefaktor (tnf) und deren verwendung
SG43205A1 (en) 1988-12-19 1997-10-17 American Cyanamid Co A method for the treatment of endotoxic shock in a mammal
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GB8921123D0 (en) 1989-09-19 1989-11-08 Millar Ann B Treatment of ards
DE4037604A1 (de) 1990-04-25 1991-10-31 Bayer Ag Verwendung von anti-tnf-antikoerpern als arzneimittel bei der behandlung von ischaemien und deren folgen
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Also Published As

Publication number Publication date
JP2020506955A (ja) 2020-03-05
NI201900072A (es) 2019-10-31
MX2019007911A (es) 2019-12-05
JOP20190162A1 (ar) 2019-06-27
EP3563867A1 (en) 2019-11-06
WO2018124948A8 (ru) 2018-09-27
CR20190316A (es) 2019-09-04
BR112019013673A2 (pt) 2020-01-28
EP3563867A4 (en) 2020-12-16
PE20191550A1 (es) 2019-10-24
KR20190104043A (ko) 2019-09-05
ECSP19048656A (es) 2019-07-31
AU2017384942A1 (en) 2019-08-08
ZA201904305B (en) 2022-04-28
PH12019501530A1 (en) 2020-02-24
WO2018124948A1 (ru) 2018-07-05

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