MX2019007911A - Composicion farmaceutica acuosa de anticuerpo monoclonal anti-tnfa recombinante. - Google Patents

Composicion farmaceutica acuosa de anticuerpo monoclonal anti-tnfa recombinante.

Info

Publication number
MX2019007911A
MX2019007911A MX2019007911A MX2019007911A MX2019007911A MX 2019007911 A MX2019007911 A MX 2019007911A MX 2019007911 A MX2019007911 A MX 2019007911A MX 2019007911 A MX2019007911 A MX 2019007911A MX 2019007911 A MX2019007911 A MX 2019007911A
Authority
MX
Mexico
Prior art keywords
tnfa
monoclonal antibody
aqueous pharmaceutical
recombinant monoclonal
pharmaceutical composition
Prior art date
Application number
MX2019007911A
Other languages
English (en)
Inventor
Aleksandrovna Lomkova Ekaterina
Mikhajlovna RYAKHOVSKAYA Anastasiya
Valentinovich MOROZOV Dmitry
Olegovich Iakovlev Aleksandr
Olegovna SHITIKOVA Viktoriya
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
Application filed by Biocad Joint Stock Co filed Critical Biocad Joint Stock Co
Priority claimed from RU2017146821A external-priority patent/RU2764521C2/ru
Publication of MX2019007911A publication Critical patent/MX2019007911A/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
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K47/08—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
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/26—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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • 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

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.
MX2019007911A 2016-12-30 2017-12-29 Composicion farmaceutica acuosa de anticuerpo monoclonal anti-tnfa recombinante. MX2019007911A (es)

Applications Claiming Priority (3)

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
PCT/RU2017/050133 WO2018124948A1 (ru) 2016-12-30 2017-12-29 ВОДНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ РЕКОМБИНАНТНОГО МОНОКЛОНАЛЬНОГО АНТИТЕЛА К ФНОα

Publications (1)

Publication Number Publication Date
MX2019007911A true MX2019007911A (es) 2019-12-05

Family

ID=62710701

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2019007911A MX2019007911A (es) 2016-12-30 2017-12-29 Composicion farmaceutica acuosa de anticuerpo monoclonal anti-tnfa 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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Also Published As

Publication number Publication date
JP2020506955A (ja) 2020-03-05
NI201900072A (es) 2019-10-31
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
CL2019001818A1 (es) 2019-11-29
WO2018124948A1 (ru) 2018-07-05

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