MX2017005575A - Formulacion farmaceutica de anticuerpos anti-tnf alfa. - Google Patents

Formulacion farmaceutica de anticuerpos anti-tnf alfa.

Info

Publication number
MX2017005575A
MX2017005575A MX2017005575A MX2017005575A MX2017005575A MX 2017005575 A MX2017005575 A MX 2017005575A MX 2017005575 A MX2017005575 A MX 2017005575A MX 2017005575 A MX2017005575 A MX 2017005575A MX 2017005575 A MX2017005575 A MX 2017005575A
Authority
MX
Mexico
Prior art keywords
tnf
antibody formulation
alpha antibody
pharmaceutical
pharmaceutical anti
Prior art date
Application number
MX2017005575A
Other languages
English (en)
Inventor
LÁZÁR József
Olajos Marcell
János Varga
Original Assignee
Richter Gedeon Nyrt
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 Richter Gedeon Nyrt filed Critical Richter Gedeon Nyrt
Publication of MX2017005575A publication Critical patent/MX2017005575A/es

Links

Classifications

    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K47/08—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
    • A61K47/26—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
    • 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
    • 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
    • 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
    • C07K2317/20—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
    • 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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

Se proporcionan formulaciones farmacéuticas de anticuerpos estables líquidas al almacenamiento. En particular, se describen las formulaciones farmacéuticas liquidas acuosas de Adalimumab basadas en sistemas tampón alternativos a citrato/fosfato y contenedores farmacéuticos como dispositivos autoinyectables que contienen las mismas.
MX2017005575A 2014-10-28 2015-10-28 Formulacion farmaceutica de anticuerpos anti-tnf alfa. MX2017005575A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
HU1400510A HUP1400510A1 (hu) 2014-10-28 2014-10-28 Gyógyászati TNFalfa ellenes antitest készítmény
PCT/EP2015/074986 WO2016066688A1 (en) 2014-10-28 2015-10-28 Pharmaceutical anti-tnf-alpha antibody formulation

Publications (1)

Publication Number Publication Date
MX2017005575A true MX2017005575A (es) 2017-09-01

Family

ID=89991627

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2017005575A MX2017005575A (es) 2014-10-28 2015-10-28 Formulacion farmaceutica de anticuerpos anti-tnf alfa.

Country Status (18)

Country Link
US (2) US20170252437A1 (es)
EP (2) EP3428189A1 (es)
BR (1) BR112017009021A2 (es)
CA (1) CA2989930A1 (es)
CY (1) CY1120937T1 (es)
DE (4) DE202015009509U1 (es)
DK (1) DK3212667T3 (es)
ES (1) ES2703586T3 (es)
HR (1) HRP20182006T1 (es)
HU (2) HUP1400510A1 (es)
LT (1) LT3212667T (es)
MX (1) MX2017005575A (es)
PL (1) PL3212667T3 (es)
PT (1) PT3212667T (es)
RS (1) RS58172B1 (es)
SI (1) SI3212667T1 (es)
TR (1) TR201816518T4 (es)
WO (1) WO2016066688A1 (es)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10376582B2 (en) 2013-10-16 2019-08-13 Outlook Therapeutics, Inc. Buffer formulations for enhanced antibody stability
HUP1400510A1 (hu) 2014-10-28 2016-05-30 Richter Gedeon Nyrt Gyógyászati TNFalfa ellenes antitest készítmény
EP3247718B1 (en) 2015-01-21 2021-09-01 Outlook Therapeutics, Inc. Modulation of charge variants in a monoclonal antibody composition
CN109563161A (zh) 2016-02-03 2019-04-02 安口生物公司 用于提高抗体稳定性的缓冲制剂
BR112018076377A2 (pt) 2016-06-30 2019-03-26 Celltrion Inc. formulação farmacêutica líquida estável
HUP1600456A2 (en) 2016-07-19 2018-01-29 Richter Gedeon Nyrt Novel cell-based tnf-alpha binding assay
WO2018119142A1 (en) * 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
US11608357B2 (en) 2018-08-28 2023-03-21 Arecor Limited Stabilized antibody protein solutions
EP3372242A1 (en) * 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
EP3372241A1 (en) 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
BR112019019162A2 (pt) * 2017-03-16 2020-04-14 Lg Chemical Ltd formulação líquida de um anticorpo anti-tnf-a e método para preparar a formulação líquida
WO2018184692A1 (en) * 2017-04-07 2018-10-11 Ares Trading S.A. Liquid pharmaceutical composition
WO2018184693A1 (en) * 2017-04-07 2018-10-11 Ares Trading S.A. Liquid pharmaceutical composition
EA201900360A1 (ru) * 2017-12-29 2019-12-30 Закрытое Акционерное Общество "Биокад" ВОДНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ РЕКОМБИНАНТНОГО МОНОКЛОНАЛЬНОГО АНТИТЕЛА К ФНОα
JP7465260B2 (ja) * 2018-09-20 2024-04-10 テバ・ファーマシューティカルズ・インターナショナル・ゲーエムベーハー 充填済シリンジおよび自動注射器
EP3909607A4 (en) * 2019-01-11 2022-10-26 Samsung Bioepis Co., Ltd. PHARMACEUTICAL COMPOSITION WITH ANTIBODIES, DEVICE CONTAINING THIS AND USE THEREOF
WO2021182874A1 (ko) * 2020-03-13 2021-09-16 삼성바이오에피스 주식회사 안정성이 증진된 액상 약제학적 조성물
DE102020129648A1 (de) * 2020-11-10 2022-05-12 Leopold MTX GmbH Pharmazeutische zusammensetzung
IL314523A (en) * 2022-01-27 2024-09-01 Janssen Biotech Inc Improved protein compositions

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5945098A (en) 1990-02-01 1999-08-31 Baxter International Inc. Stable intravenously-administrable immune globulin preparation
US6090382A (en) 1996-02-09 2000-07-18 Basf Aktiengesellschaft Human antibodies that bind human TNFα
PL188192B1 (pl) 1996-02-09 2004-12-31 Abbott Lab Bermuda Ltd Izolowane ludzkie przeciwciało albo jego część wiążąca antygen, rekombinowane ludzkie przeciwciało albo jego część wiążąca antygen, kompozycje farmaceutyczne, izolowane kwasy nukleinowe, rekombinowany wektor ekspresyjny, komórka gospodarza, sposób syntetyzowania przeciwciała ludzkiego, które wiąże ludzki TNFalfa, sposób hamowania aktywności ludzkiego TNFalfa in vitro, przeciwciało albo jego częśćwiążąca antygen, zastosowanie przeciwciała albo jego części wiążącej antygen
FI20021199A (fi) 2002-06-19 2003-12-20 Kemira Growhow Oy Menetelmä tuotantoa rajoittavien paikkakohtaisten kasvutekijöiden analysoimiseksi
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
EP3216462A3 (en) * 2010-02-26 2017-12-20 Novo Nordisk A/S Stable antibody containing compositions
EP2471554A1 (en) 2010-12-28 2012-07-04 Hexal AG Pharmaceutical formulation comprising a biopharmaceutical drug
GB201112429D0 (en) * 2011-07-19 2011-08-31 Glaxo Group Ltd Antigen-binding proteins with increased FcRn binding
SG11201403792TA (en) * 2012-01-23 2014-10-30 Regeneron Pharma Stabilized formulations containing anti-ang2 antibodies
NZ629261A (en) 2012-03-07 2017-08-25 Cadila Healthcare Ltd Pharmaceutical formulations of tnf-alpha antibodies
WO2013186230A1 (en) * 2012-06-12 2013-12-19 Boehringer Ingelheim International Gmbh Pharmaceutical formulation for a therapeutic antibody
PT2892550T (pt) 2012-09-07 2020-03-27 Coherus Biosciences Inc Formulações aquosas estáveis de adalimumab
EP2727602A1 (en) 2012-10-31 2014-05-07 Takeda GmbH Method for preparation of a high concentration liquid formulation of an antibody
US20150368333A1 (en) 2013-01-24 2015-12-24 Glaxosmithkline Intellectual Property Development Limited Tnf-alpha antigen-binding proteins
HUP1400510A1 (hu) 2014-10-28 2016-05-30 Richter Gedeon Nyrt Gyógyászati TNFalfa ellenes antitest készítmény

Also Published As

Publication number Publication date
DE202015009509U9 (de) 2018-05-30
BR112017009021A2 (pt) 2018-02-06
PT3212667T (pt) 2018-12-20
US20220016244A1 (en) 2022-01-20
SI3212667T1 (sl) 2018-11-30
EP3212667B1 (en) 2018-09-19
TR201816518T4 (tr) 2018-11-21
WO2016066688A1 (en) 2016-05-06
RS58172B1 (sr) 2019-03-29
CA2989930A1 (en) 2016-05-06
US20170252437A1 (en) 2017-09-07
DK3212667T3 (en) 2018-12-03
PL3212667T3 (pl) 2019-02-28
EP3428189A1 (en) 2019-01-16
EP3212667A1 (en) 2017-09-06
HRP20182006T1 (hr) 2019-01-25
CY1120937T1 (el) 2019-12-11
HUE040621T2 (hu) 2019-03-28
DE202015009619U1 (de) 2018-08-29
DE18190279T1 (de) 2019-07-11
DE202015009509U1 (de) 2018-01-18
LT3212667T (lt) 2018-12-10
DE202015009016U1 (de) 2016-06-24
ES2703586T3 (es) 2019-03-11
HUP1400510A1 (hu) 2016-05-30

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