MX2019010479A - Formulacion de anticuerpo anti her2. - Google Patents

Formulacion de anticuerpo anti her2.

Info

Publication number
MX2019010479A
MX2019010479A MX2019010479A MX2019010479A MX2019010479A MX 2019010479 A MX2019010479 A MX 2019010479A MX 2019010479 A MX2019010479 A MX 2019010479A MX 2019010479 A MX2019010479 A MX 2019010479A MX 2019010479 A MX2019010479 A MX 2019010479A
Authority
MX
Mexico
Prior art keywords
her2 antibody
antibody formulation
anti her2
lyoprotectant
antibody
Prior art date
Application number
MX2019010479A
Other languages
English (en)
Inventor
André Albanese Jonathan
Pier- Lorenzo GIOVANNINI Roberto
Niall O´MAHONY Kevin
Original Assignee
Glenmark Pharmaceuticals 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
Application filed by Glenmark Pharmaceuticals Sa filed Critical Glenmark Pharmaceuticals Sa
Publication of MX2019010479A publication Critical patent/MX2019010479A/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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/16—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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Oncology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Inorganic Chemistry (AREA)
  • Reproductive Health (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Se describe una formulacion farmaceutica que comprende una cantidad terapeuticamente efectiva de un anticuerpo, un regulador de pH de acetato, un lioprotector, un agente de abultamiento y un agente tensoactivo.
MX2019010479A 2012-12-21 2015-06-22 Formulacion de anticuerpo anti her2. MX2019010479A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201261745293P 2012-12-21 2012-12-21

Publications (1)

Publication Number Publication Date
MX2019010479A true MX2019010479A (es) 2019-10-15

Family

ID=49779926

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2015008194A MX367748B (es) 2012-12-21 2013-12-18 Formulación de anticuerpo anti her2.
MX2019010479A MX2019010479A (es) 2012-12-21 2015-06-22 Formulacion de anticuerpo anti her2.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
MX2015008194A MX367748B (es) 2012-12-21 2013-12-18 Formulación de anticuerpo anti her2.

Country Status (16)

Country Link
US (2) US20150343058A1 (es)
EP (1) EP2934582B1 (es)
JP (2) JP6400595B2 (es)
AU (1) AU2013360812B2 (es)
BR (1) BR112015014853A2 (es)
CA (1) CA2895869C (es)
DK (1) DK2934582T3 (es)
EA (1) EA201391729A1 (es)
ES (1) ES2773103T3 (es)
HK (1) HK1215796A1 (es)
IL (1) IL239509A0 (es)
MX (2) MX367748B (es)
PL (1) PL2934582T3 (es)
SG (1) SG11201504897YA (es)
WO (1) WO2014096051A1 (es)
ZA (1) ZA201504564B (es)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101776879B1 (ko) * 2015-01-19 2017-09-08 주식회사 녹십자 항-egfr 항체를 포함하는 약학 제제
GB2542391A (en) * 2015-09-17 2017-03-22 Annexin Pharmaceuticals Ab Process of manufacture
EP3828206A4 (en) * 2018-07-25 2022-04-20 Daiichi Sankyo Company, Limited METHOD OF PREPARING AN ANTIBODY DRUG CONJUGATE
CN113474360A (zh) 2019-02-18 2021-10-01 伊莱利利公司 治疗性抗体制剂
BR112021026492A2 (pt) 2019-06-28 2022-02-08 Genentech Inc Formulações líquidas, formulação liofilizada, artigos de fabricação e método para preparar uma formulação líquida
EP3999537A1 (en) * 2019-07-19 2022-05-25 Ichnos Sciences SA Lyophilized antibody formulation
US11958910B2 (en) 2020-02-28 2024-04-16 Regeneron Pharmaceuticals, Inc. Bispecific antigen binding molecules that bind HER2, and methods of use thereof
CN114762727A (zh) * 2021-01-15 2022-07-19 海正生物制药有限公司 一种稳定的帕妥珠单抗的药物组合物
WO2023140807A1 (en) * 2022-01-19 2023-07-27 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Pharmaceutical compositions of trastuzumab

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH03504605A (ja) * 1988-05-27 1991-10-09 セントカー・インコーポレーテツド 抗体産生物の凍結乾燥した配合物
SI2275119T1 (sl) * 1995-07-27 2013-12-31 Genentech, Inc. Stabilna izotonična liofilizirana proteinska formulacija
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
ES2190087T3 (es) * 1997-06-13 2003-07-16 Genentech Inc Formulacion estabilizada de un anticuerpo.
US7452539B2 (en) * 2001-12-19 2008-11-18 Genentech, Inc. Stabilizing polypeptides which have been exposed to urea
US20060182740A1 (en) * 2002-06-21 2006-08-17 Biogen Idec, Inc. Buffered formulations for concentrating antibodies and methods of use thereof
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
KR101457223B1 (ko) * 2005-06-07 2014-11-04 에스바테크 - 어 노바티스 컴파니 엘엘씨 ＴＮＦα를 억제하는 안정적이고 가용성인 항체
BRPI0611901A2 (pt) * 2005-06-14 2012-08-28 Amgen, Inc composição, liofilizado, kit, e, processo para preparar uma composição
US9345661B2 (en) * 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof

Also Published As

Publication number Publication date
US20150343058A1 (en) 2015-12-03
SG11201504897YA (en) 2015-07-30
MX2015008194A (es) 2016-02-05
JP2018199720A (ja) 2018-12-20
IL239509A0 (en) 2015-08-31
EA201391729A1 (ru) 2014-09-30
HK1215796A1 (zh) 2016-09-15
WO2014096051A1 (en) 2014-06-26
EP2934582A1 (en) 2015-10-28
EP2934582B1 (en) 2019-11-27
CA2895869A1 (en) 2014-06-26
WO2014096051A9 (en) 2014-10-02
JP2016508973A (ja) 2016-03-24
BR112015014853A2 (pt) 2017-08-22
AU2013360812A1 (en) 2015-07-09
DK2934582T3 (da) 2020-02-24
PL2934582T3 (pl) 2020-08-10
JP6400595B2 (ja) 2018-10-03
ZA201504564B (en) 2016-11-30
CA2895869C (en) 2020-09-22
MX367748B (es) 2019-09-04
ES2773103T3 (es) 2020-07-09
AU2013360812B2 (en) 2018-11-08
US20200061190A1 (en) 2020-02-27

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