AR091530A1 - Formulacion farmaceutica liquida de un anticuerpo y acetato - Google Patents

Formulacion farmaceutica liquida de un anticuerpo y acetato

Info

Publication number
AR091530A1
AR091530A1 ARP130102208A AR091530A1 AR 091530 A1 AR091530 A1 AR 091530A1 AR P130102208 A ARP130102208 A AR P130102208A AR 091530 A1 AR091530 A1 AR 091530A1
Authority
AR
Argentina
Prior art keywords
pharmaceutical formulation
antibody
acetate
liquid pharmaceutical
formulation liquid
Prior art date
Application number
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=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR091530(A1) "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 AR091530A1 publication Critical patent/AR091530A1/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
    • 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)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Genetics & Genomics (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

Reivindicación 1: Una formulación farmacéutica líquida caracterizada porque comprende un anticuerpo como ingrediente activo a una concentración de entre 200 y 400 mg/ml y acetato. Reivindicación 3: La formulación farmacéutica líquida de las reivindicaciones 1 ó 2 caracterizada porque comprende glicina a una concentración de entre 100 y 500 mM. Reivindicación 11: La formulación farmacéutica líquida de cualquiera de las reivindicaciones 1 a 10 caracterizada porque el anticuerpo es epratuzumab. Reivindicación 14: Un método para reducir la viscosidad de una formulación farmacéutica líquida que contiene una proteína o un anticuerpo, caracterizado porque comprende: a) proporcionar la formulación farmacéutica líquida, y b) añadir acetato hasta una concentración final de entre 20 y 150 mM, caracterizado porque la viscosidad de la formulación farmacéutica líquida se encuentra reducida en comparación con la misma formulación farmacéutica líquida sin acetato.
ARP130102208 2012-06-21 2013-06-24 Formulacion farmaceutica liquida de un anticuerpo y acetato AR091530A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201261662621P 2012-06-21 2012-06-21

Publications (1)

Publication Number Publication Date
AR091530A1 true AR091530A1 (es) 2015-02-11

Family

ID=48745904

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP130102208 AR091530A1 (es) 2012-06-21 2013-06-24 Formulacion farmaceutica liquida de un anticuerpo y acetato

Country Status (25)

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

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2923844C (en) 2013-09-11 2022-07-26 Arsia Therapeutics, Inc. Liquid protein formulations containing organophosphates
WO2016054259A1 (en) 2014-10-01 2016-04-07 Arsia Therapeutics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
CN109496153B (zh) 2016-05-28 2024-04-23 印度政府生物技术部独立机构拉吉夫甘地生物技术中心 作为肝细胞癌治疗剂的龙葵皂苷b及其衍生物
KR20190078572A (ko) * 2016-10-31 2019-07-04 프레제니우스 카비 도이치란트 게엠베하 액상의 약학 조성물
ES2933808T3 (es) 2017-01-11 2023-02-14 Celltrion Inc Fórmula líquida estable
WO2018211517A1 (en) 2017-05-16 2018-11-22 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
US20230405018A1 (en) * 2020-11-18 2023-12-21 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
US6875432B2 (en) * 2000-10-12 2005-04-05 Genentech, Inc. Reduced-viscosity concentrated protein formulations
GB0113179D0 (en) * 2001-05-31 2001-07-25 Novartis Ag Organic compounds
PL1610820T5 (pl) * 2003-04-04 2014-01-31 Genentech Inc Preparaty zawierające wysokoskoncentrowane przeciwciała i białka
NZ561137A (en) * 2005-03-08 2011-09-30 Pharmacia & Upjohn Co Llc Stable anti-CTLA-4 antibody compositions with chelating agents
JP5419709B2 (ja) * 2007-01-09 2014-02-19 ワイス・エルエルシー 抗il−13抗体製剤およびその使用
PL2170390T3 (pl) * 2007-06-14 2019-05-31 Biogen Ma Inc Preparaty przeciwciała natalizumab
MX2012012743A (es) * 2010-05-03 2012-11-23 Genentech Inc Composiciones y metodos utiles para reducir la viscosidad de formulaciones que contienen proteina.
SG185465A1 (en) * 2010-05-14 2012-12-28 Amgen Inc High concentration antibody formulations
US8754195B2 (en) * 2010-07-02 2014-06-17 Medimmune, Llc Antibody formulations
CA2832560A1 (en) * 2011-04-07 2012-10-18 Glaxosmithkline Llc Formulations with reduced viscosity
CA2831572C (en) * 2011-05-02 2019-11-26 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration

Also Published As

Publication number Publication date
ECSP15002095A (es) 2015-11-30
CO7170174A2 (es) 2015-01-28
BR112014031841A2 (pt) 2017-06-27
MX2014014717A (es) 2015-03-06
NZ702342A (en) 2016-07-29
CL2014003283A1 (es) 2016-04-01
JP6157611B2 (ja) 2017-07-05
ZA201409020B (en) 2016-09-28
AU2013279347A1 (en) 2014-12-18
EA201590061A1 (ru) 2015-05-29
PH12014502596A1 (en) 2015-01-12
US20150150979A1 (en) 2015-06-04
WO2013190047A1 (en) 2013-12-27
MA37777B1 (fr) 2017-07-31
CN104520326A (zh) 2015-04-15
TW201406398A (zh) 2014-02-16
JP2015520206A (ja) 2015-07-16
PE20150190A1 (es) 2015-02-13
EP2864356A1 (en) 2015-04-29
CA2876012A1 (en) 2013-12-27
SG11201407779YA (en) 2015-02-27
IL235921A0 (en) 2015-01-29
MA20150436A1 (fr) 2015-11-30
HK1205146A1 (en) 2015-12-11
TN2014000498A1 (en) 2016-03-30
KR20150032941A (ko) 2015-03-31

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