GT201200024A - Formulación subcutánea de anticuerpo anti-her2 - Google Patents

Formulación subcutánea de anticuerpo anti-her2

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Publication number
GT201200024A
GT201200024A GT201200024A GT201200024A GT201200024A GT 201200024 A GT201200024 A GT 201200024A GT 201200024 A GT201200024 A GT 201200024A GT 201200024 A GT201200024 A GT 201200024A GT 201200024 A GT201200024 A GT 201200024A
Authority
GT
Guatemala
Prior art keywords
formulations
formulation
her2 antibody
alfa
stabilizing
Prior art date
Application number
GT201200024A
Other languages
English (en)
Inventor
Adler Michael
Grauschopf Ulla
Mahler Hanns-Christian
Stauch Oliver Boris
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.)
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Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43500473&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=GT201200024(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed filed Critical
Publication of GT201200024A publication Critical patent/GT201200024A/es

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    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • 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
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01035—Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase

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

Abstract

LA PRESENTE INVENCIÓN ESTÁ RELACIONADA CON UNA FORMULACIÓN FARMACÉUTICA ALTAMENTE CONCENTRADA Y ESTABLE DE UN ANTICUERPO ANTI-HER2 FARMACÉUTICAMENTE ACTIVO, COMO POR EJEMPLO EL TRASTUZUMAB (HERCEPIN), PERTUZUMAB O T-DM1, O UNA MEZCLA DE TALES MOLÉCULAS DE ANTICUERPO PARA LA INYECCIÓN SUBCUTÁNEA. EN PARTICULAR, LA PRESENTE INVENCIÓN ESTÁ RELACIONADA CON FORMULACIONES QUE COMPRENDEN, ADEMÁS DE UNA CANTIDAD ADECUADA DEL ANTICUERPO ANTI-HER2, UNA CANTIDAD EFECTIVA DE AL MENOS UNA ENZIMA HIALURONIDASA COMO UNA FORMULACIÓN COMBINADA O PARA SU UTILIZACIÓN EN FORMA DE UNA CO-FORMULACIÓN. DICHAS FORMULACIONES COMPRENDEN ADICIONALMENTE AL MENOS UN AGENTE TAMPONANTE, COMO POR EJEMPLO UN TAMPÓN HISTIDINA, UN ESTABILIZANTE O UNA MEZCLA DE DOS O MÁS ESTABILIZANTES (POR EJEMPLO UN SACÁRIDO, COMO POR EJEMPLO LA ALFA, ALFA-TREHALOSA DIHIDRATADA O LA SACAROSA, Y OPCIONALMENTE METIONINA COMO SEGUNDO ESTABILIZANTE), UN TENSIOACTIVO NO IÓNICO Y UNA CANTIDAD EFECTIVA DE AL MENOS UNA ENZIMA HIALURONIDASA. TAMBIÉN SE PROPORCIONAN LOS MÉTODOS PARA PREPARAR TALES FORMULACIONES Y LA UTILIZACIÓN DE LAS MISMAS.
GT201200024A 2009-07-31 2012-01-30 Formulación subcutánea de anticuerpo anti-her2 GT201200024A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP09167025 2009-07-31

Publications (1)

Publication Number Publication Date
GT201200024A true GT201200024A (es) 2013-10-28

Family

ID=43500473

Family Applications (1)

Application Number Title Priority Date Filing Date
GT201200024A GT201200024A (es) 2009-07-31 2012-01-30 Formulación subcutánea de anticuerpo anti-her2

Country Status (41)

Country Link
US (5) US9345661B2 (es)
EP (4) EP4257150A3 (es)
JP (2) JP5462944B2 (es)
KR (2) KR101769652B1 (es)
CN (3) CN105168125A (es)
AR (2) AR077605A1 (es)
AU (1) AU2010277657B2 (es)
BR (1) BR112012002080A2 (es)
CA (1) CA2768458C (es)
CL (2) CL2012000269A1 (es)
CO (1) CO6430421A2 (es)
CR (1) CR20110679A (es)
CY (1) CY1114185T1 (es)
DK (2) DK2687202T3 (es)
DO (1) DOP2015000255A (es)
EA (2) EA027553B1 (es)
EC (2) ECSP12011643A (es)
ES (2) ES2948033T3 (es)
FI (1) FI2687202T3 (es)
GT (1) GT201200024A (es)
HK (2) HK1172236A1 (es)
HR (2) HRP20130697T4 (es)
HU (1) HUE062122T2 (es)
IL (2) IL217382A (es)
IN (1) IN2012CN00961A (es)
LT (1) LT2687202T (es)
MA (1) MA33471B1 (es)
MX (2) MX355450B (es)
MY (2) MY163001A (es)
NZ (2) NZ603900A (es)
PE (2) PE20131324A1 (es)
PL (2) PL2459167T5 (es)
PT (2) PT2687202T (es)
RS (2) RS52913B2 (es)
SG (2) SG193146A1 (es)
SI (2) SI2687202T1 (es)
TN (1) TN2012000023A1 (es)
TW (2) TWI401089B (es)
UA (2) UA102166C2 (es)
WO (1) WO2011012637A2 (es)
ZA (2) ZA201109459B (es)

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RS52913B (en) 2014-02-28
PL2459167T5 (pl) 2023-12-11
UA102166C2 (ru) 2013-06-10
CA2768458C (en) 2013-12-03
IL253941A0 (en) 2017-10-31
JP2013500947A (ja) 2013-01-10
CN113967194A (zh) 2022-01-25
PE20120665A1 (es) 2012-06-01

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