BR112017009021A2 - formulação farmacêutica de anticorpo anti-tnfa - Google Patents

formulação farmacêutica de anticorpo anti-tnfa

Info

Publication number
BR112017009021A2
BR112017009021A2 BR112017009021A BR112017009021A BR112017009021A2 BR 112017009021 A2 BR112017009021 A2 BR 112017009021A2 BR 112017009021 A BR112017009021 A BR 112017009021A BR 112017009021 A BR112017009021 A BR 112017009021A BR 112017009021 A2 BR112017009021 A2 BR 112017009021A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical formulation
tnfa antibody
antibody pharmaceutical
pharmaceutical formulations
citrate
Prior art date
Application number
BR112017009021A
Other languages
English (en)
Inventor
Varga János
József Lázár
Marcell Olajos
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 BR112017009021A2 publication Critical patent/BR112017009021A2/pt

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)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (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

trata-se de formulações farmacêuticas líquidas estáveis para armazenamento melhoradas de anticorpo. particularmente, formulações farmacêuticas aquosas líquidas de adalimumab com base em sistemas de tampão alternativos para citrato/fosfato e recipientes farmacêuticos como dispositivos de auto injeção que contêm as mesmas são descritos.
BR112017009021A 2014-10-28 2015-10-28 formulação farmacêutica de anticorpo anti-tnfa BR112017009021A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
HU1400510A HUP1400510A1 (hu) 2014-10-28 2014-10-28 Gyógyászati TNFalfa ellenes antitest készítmény
HUHUP1400510 2014-10-28
PCT/EP2015/074986 WO2016066688A1 (en) 2014-10-28 2015-10-28 Pharmaceutical anti-tnf-alpha antibody formulation

Publications (1)

Publication Number Publication Date
BR112017009021A2 true BR112017009021A2 (pt) 2018-02-06

Family

ID=89991627

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017009021A BR112017009021A2 (pt) 2014-10-28 2015-10-28 formulação farmacêutica de anticorpo anti-tnfa

Country Status (18)

Country Link
US (2) US20170252437A1 (pt)
EP (2) EP3212667B1 (pt)
BR (1) BR112017009021A2 (pt)
CA (1) CA2989930A1 (pt)
CY (1) CY1120937T1 (pt)
DE (4) DE202015009016U1 (pt)
DK (1) DK3212667T3 (pt)
ES (1) ES2703586T3 (pt)
HR (1) HRP20182006T1 (pt)
HU (2) HUP1400510A1 (pt)
LT (1) LT3212667T (pt)
MX (1) MX2017005575A (pt)
PL (1) PL3212667T3 (pt)
PT (1) PT3212667T (pt)
RS (1) RS58172B1 (pt)
SI (1) SI3212667T1 (pt)
TR (1) TR201816518T4 (pt)
WO (1) WO2016066688A1 (pt)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015057910A1 (en) 2013-10-16 2015-04-23 Oncobiologics, 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
MX2018009341A (es) * 2016-02-03 2019-05-15 Oncobiologics Inc Formulaciones tamponadas para una mayor estabilidad de anticuerpos.
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
MA47106A (fr) * 2016-12-21 2019-10-30 Amgen Inc Formulations d'anticorps anti-tnf alpha
US11608357B2 (en) 2018-08-28 2023-03-21 Arecor Limited Stabilized antibody protein solutions
EP3372241A1 (en) * 2017-03-06 2018-09-12 Ares Trading S.A. Liquid pharmaceutical composition
EP3372242A1 (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
WO2018184693A1 (en) * 2017-04-07 2018-10-11 Ares Trading S.A. Liquid pharmaceutical composition
WO2018184692A1 (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
BR112021013497A2 (pt) * 2019-01-11 2021-09-14 Samsung Bioepis Co., Ltd. Composição farmacêutica compreendendo anticorpo, dispositivo compreendendo o mesmo e uso do mesmo
AU2021233503A1 (en) * 2020-03-13 2022-09-22 Samsung Bioepis Co., Ltd. Liquid pharmaceutical composition having improved stability
DE102020129648A1 (de) * 2020-11-10 2022-05-12 Leopold MTX GmbH Pharmazeutische zusammensetzung
WO2023147426A2 (en) * 2022-01-27 2023-08-03 Janssen Biotech, Inc. Enhanced 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
MX336813B (es) 1996-02-09 2016-02-02 Abbvie Biotechnology Ltd Anticuerpos humanos que ligan el tnfa humano.
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
MY164611A (en) * 2012-01-23 2018-01-30 Regeneron Pharma Stabilized formulations containing anti-ang2 antibodies
EA201491644A1 (ru) 2012-03-07 2014-12-30 Кадила Хелзкэр Лимитед Фармацевтические композиции
US20150150982A1 (en) * 2012-06-12 2015-06-04 Boehringer Ingelheim International Gmbh Pharmaceutical formulation for a therapeutic antibody
WO2014039903A2 (en) 2012-09-07 2014-03-13 Coherus Biosciences, Inc. Stable aqueous formulations of adalimumab
EP2727602A1 (en) 2012-10-31 2014-05-07 Takeda GmbH Method for preparation of a high concentration liquid formulation of an antibody
CN105051064A (zh) 2013-01-24 2015-11-11 葛兰素史克知识产权开发有限公司 抗TNF-α抗原结合蛋白
HUP1400510A1 (hu) 2014-10-28 2016-05-30 Richter Gedeon Nyrt Gyógyászati TNFalfa ellenes antitest készítmény

Also Published As

Publication number Publication date
MX2017005575A (es) 2017-09-01
DE18190279T1 (de) 2019-07-11
ES2703586T3 (es) 2019-03-11
HRP20182006T1 (hr) 2019-01-25
DE202015009509U9 (de) 2018-05-30
DE202015009619U1 (de) 2018-08-29
SI3212667T1 (sl) 2018-11-30
LT3212667T (lt) 2018-12-10
US20220016244A1 (en) 2022-01-20
DE202015009016U1 (de) 2016-06-24
PL3212667T3 (pl) 2019-02-28
CY1120937T1 (el) 2019-12-11
HUE040621T2 (hu) 2019-03-28
HUP1400510A1 (hu) 2016-05-30
US20170252437A1 (en) 2017-09-07
WO2016066688A1 (en) 2016-05-06
EP3428189A1 (en) 2019-01-16
PT3212667T (pt) 2018-12-20
EP3212667A1 (en) 2017-09-06
DE202015009509U1 (de) 2018-01-18
TR201816518T4 (tr) 2018-11-21
DK3212667T3 (en) 2018-12-03
CA2989930A1 (en) 2016-05-06
EP3212667B1 (en) 2018-09-19
RS58172B1 (sr) 2019-03-29

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Legal Events

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07G Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]

Free format text: NOTIFICACAO DE DEVOLUCAO DO PEDIDO EM FUNCAO DA REVOGACAO DO ART. 229-C DA LEI NO 9.279, DE 1996, POR FORCA DA LEI NO 14.195, DE 2021

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09B Patent application refused [chapter 9.2 patent gazette]