BR112014031841A2 - formulação farmacêutica - Google Patents

formulação farmacêutica

Info

Publication number
BR112014031841A2
BR112014031841A2 BR112014031841A BR112014031841A BR112014031841A2 BR 112014031841 A2 BR112014031841 A2 BR 112014031841A2 BR 112014031841 A BR112014031841 A BR 112014031841A BR 112014031841 A BR112014031841 A BR 112014031841A BR 112014031841 A2 BR112014031841 A2 BR 112014031841A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical formulation
antibody
high concentration
viscosity
abstract
Prior art date
Application number
BR112014031841A
Other languages
English (en)
Inventor
Jeffrey Yates Andrew
Gregory Clipstone James
Original Assignee
Ucb Pharma Sa
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=48745904&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112014031841(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ucb Pharma Sa filed Critical Ucb Pharma Sa
Publication of BR112014031841A2 publication Critical patent/BR112014031841A2/pt

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
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/16Organic 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
    • 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
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • 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
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Inorganic Chemistry (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

1/1 resumo “formulação farmacêutica” a invenção atual refere-se a um método e meios para a redução da viscosidade de uma formulação farmacêutica compreendendo um anticorpo ou outra proteína terapêutica em uma concentração elevada. a invenção atual apresenta uma formulação farmacêutica líquida, compreendendo um anticorpo em uma concentração elevada com viscosidade reduzida que não impede o processamento ou a injeção da formulação farmacêutica.
BR112014031841A 2012-06-21 2013-06-20 formulação farmacêutica BR112014031841A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261662621P 2012-06-21 2012-06-21
PCT/EP2013/062898 WO2013190047A1 (en) 2012-06-21 2013-06-20 Pharmaceutical formulation

Publications (1)

Publication Number Publication Date
BR112014031841A2 true BR112014031841A2 (pt) 2017-06-27

Family

ID=48745904

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112014031841A BR112014031841A2 (pt) 2012-06-21 2013-06-20 formulação farmacêutica

Country Status (25)

Country Link
US (1) US20150150979A1 (pt)
EP (1) EP2864356A1 (pt)
JP (1) JP6157611B2 (pt)
KR (1) KR20150032941A (pt)
CN (1) CN104520326A (pt)
AR (1) AR091530A1 (pt)
AU (1) AU2013279347A1 (pt)
BR (1) BR112014031841A2 (pt)
CA (1) CA2876012A1 (pt)
CL (1) CL2014003283A1 (pt)
CO (1) CO7170174A2 (pt)
EA (1) EA201590061A1 (pt)
EC (1) ECSP15002095A (pt)
HK (1) HK1205146A1 (pt)
IL (1) IL235921A0 (pt)
MA (1) MA37777B1 (pt)
MX (1) MX2014014717A (pt)
NZ (1) NZ702342A (pt)
PE (1) PE20150190A1 (pt)
PH (1) PH12014502596A1 (pt)
SG (1) SG11201407779YA (pt)
TN (1) TN2014000498A1 (pt)
TW (1) TW201406398A (pt)
WO (1) WO2013190047A1 (pt)
ZA (1) ZA201409020B (pt)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015038811A2 (en) 2013-09-11 2015-03-19 Arsia Therapeutics, Inc. Liquid protein formulations containing ionic liquids
JP6716577B2 (ja) 2014-10-01 2020-07-01 イーグル・バイオロジクス・インコーポレイテッドEagle Biologics, Inc. 粘度低下物質を含有する、多糖および核酸の調合薬
KR102293156B1 (ko) 2016-05-28 2021-08-24 라지브 간디 센트레 포 바이오테크놀로지, 언 오토노모우스 인스티튜트 언더 더 디파트먼트 오브 바이오-테크놀로지, 거버먼트 오브 인디아 간세포 암종에 대한 치료제로서의 우트트로시드(Uttroside) B 및 이의 유도체
JP2019536761A (ja) * 2016-10-31 2019-12-19 フレゼニウス カービ ドイチュラント ゲーエムベーハー 液体医薬組成物
US10980881B2 (en) 2017-01-11 2021-04-20 Celltrion Inc. Stable liquid formula having an anti-TNFalpha antibody, acetate buffer and glycine
EP3624846A1 (en) 2017-05-16 2020-03-25 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
GB201719447D0 (en) * 2017-11-23 2018-01-10 Ucb Biopharma Sprl Pharmaceutical composition
EP4247386A1 (en) * 2020-11-18 2023-09-27 Bexson Biomedical, Inc. Flumazenil formulations for subcutaneous injection and methods of treatment using gaba receptor modulators

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT1324776E (pt) * 2000-10-12 2009-12-23 Genentech Inc Formulações de proteína concentradas de viscosidade reduzida
GB0113179D0 (en) * 2001-05-31 2001-07-25 Novartis Ag Organic compounds
US8658773B2 (en) * 2011-05-02 2014-02-25 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
ZA200507757B (en) * 2003-04-04 2007-01-31 Genentech Inc High concentration antibody and protein formulations
CA2600608A1 (en) * 2005-03-08 2006-09-14 Pharmacia & Upjohn Company Llc Composition comprising human igg2 antibody and chelating agent
AU2008204901A1 (en) * 2007-01-09 2008-07-17 Wyeth Anti-IL-13 antibody formulations and uses thereof
AU2008266051B2 (en) * 2007-06-14 2014-07-31 Biogen Ma Inc. Antibody formulations
MX2012012743A (es) * 2010-05-03 2012-11-23 Genentech Inc Composiciones y metodos utiles para reducir la viscosidad de formulaciones que contienen proteina.
KR101861867B1 (ko) * 2010-05-14 2018-05-29 암젠 인크 고농도의 항체 제제
WO2012003470A2 (en) * 2010-07-02 2012-01-05 Medimmune, Llc Antibody formulations
EP2694708A4 (en) * 2011-04-07 2014-10-01 Glaxosmithkline Llc FORMULATIONS WITH REDUCED VISCOSITY

Also Published As

Publication number Publication date
TN2014000498A1 (en) 2016-03-30
MA20150436A1 (fr) 2015-11-30
JP2015520206A (ja) 2015-07-16
SG11201407779YA (en) 2015-02-27
AU2013279347A1 (en) 2014-12-18
CO7170174A2 (es) 2015-01-28
WO2013190047A1 (en) 2013-12-27
PE20150190A1 (es) 2015-02-13
JP6157611B2 (ja) 2017-07-05
NZ702342A (en) 2016-07-29
MA37777B1 (fr) 2017-07-31
ECSP15002095A (es) 2015-11-30
PH12014502596A1 (en) 2015-01-12
EP2864356A1 (en) 2015-04-29
IL235921A0 (en) 2015-01-29
EA201590061A1 (ru) 2015-05-29
CL2014003283A1 (es) 2016-04-01
CA2876012A1 (en) 2013-12-27
US20150150979A1 (en) 2015-06-04
ZA201409020B (en) 2016-09-28
HK1205146A1 (en) 2015-12-11
KR20150032941A (ko) 2015-03-31
TW201406398A (zh) 2014-02-16
AR091530A1 (es) 2015-02-11
CN104520326A (zh) 2015-04-15
MX2014014717A (es) 2015-03-06

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06I Publication of requirement cancelled [chapter 6.9 patent gazette]

Free format text: ANULADA A PUBLICACAO CODIGO 6.6.1 NA RPI NO 2462 DE 13/03/2018 POR TER SIDO INDEVIDA.

B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 6A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2519 DE 16-04-2019 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.