RU2012108108A - Концентрированные полипептидные лекарственные формы с пониженной вязкостью - Google Patents

Концентрированные полипептидные лекарственные формы с пониженной вязкостью Download PDF

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Publication number
RU2012108108A
RU2012108108A RU2012108108/15A RU2012108108A RU2012108108A RU 2012108108 A RU2012108108 A RU 2012108108A RU 2012108108/15 A RU2012108108/15 A RU 2012108108/15A RU 2012108108 A RU2012108108 A RU 2012108108A RU 2012108108 A RU2012108108 A RU 2012108108A
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RU
Russia
Prior art keywords
dosage form
form according
polypeptide
dma
dmso
Prior art date
Application number
RU2012108108/15A
Other languages
English (en)
Russian (ru)
Inventor
Тим КАМЕРЦЕЛЛ
Шерри МАРТИН-МО
Джон Ючанг ВАНГ
Original Assignee
Дженентек, Инк.
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 Дженентек, Инк. filed Critical Дженентек, Инк.
Publication of RU2012108108A publication Critical patent/RU2012108108A/ru

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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
    • A61K39/39533Antibodies; 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • 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
    • 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
    • A61K47/20Organic 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
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/249Interferons
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/10Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14Specific host cells or culture conditions, e.g. components, pH or temperature
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Endocrinology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
RU2012108108/15A 2009-08-04 2010-08-03 Концентрированные полипептидные лекарственные формы с пониженной вязкостью RU2012108108A (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US23114009P 2009-08-04 2009-08-04
US61/231,140 2009-08-04
PCT/US2010/044258 WO2011017330A1 (en) 2009-08-04 2010-08-03 Concentrated polypeptide formulations with reduced viscosity

Publications (1)

Publication Number Publication Date
RU2012108108A true RU2012108108A (ru) 2013-09-10

Family

ID=43544629

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2012108108/15A RU2012108108A (ru) 2009-08-04 2010-08-03 Концентрированные полипептидные лекарственные формы с пониженной вязкостью

Country Status (15)

Country Link
US (1) US20130236448A1 (https=)
EP (1) EP2461677A4 (https=)
JP (1) JP2013501058A (https=)
KR (1) KR20120047995A (https=)
CN (1) CN102573459A (https=)
AU (1) AU2010279569A1 (https=)
BR (1) BR112012002596A2 (https=)
CA (1) CA2769221A1 (https=)
IL (1) IL217887A0 (https=)
MX (1) MX2012001560A (https=)
NZ (1) NZ598518A (https=)
RU (1) RU2012108108A (https=)
SG (1) SG178226A1 (https=)
WO (1) WO2011017330A1 (https=)
ZA (1) ZA201200760B (https=)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9345661B2 (en) 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof
AR078161A1 (es) 2009-09-11 2011-10-19 Hoffmann La Roche Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento.
JP6125436B2 (ja) 2011-02-09 2017-05-10 グラクソスミスクライン・リミテッド・ライアビリティ・カンパニーGlaxoSmithKline LLC 凍結乾燥製剤
FR2994390B1 (fr) 2012-08-10 2014-08-15 Adocia Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee
IL312865B2 (en) * 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
CN111402950B (zh) * 2013-11-29 2024-03-19 豪夫迈·罗氏有限公司 抗体选择装置和方法
WO2016019969A1 (en) 2014-08-08 2016-02-11 Ludwig-Maximilians-Universität München Subcutaneously administered bispecific antibodies for use in the treatment of cancer
AU2015325055B2 (en) 2014-10-01 2021-02-25 Eagle Biologics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
DK4364724T3 (da) 2018-05-10 2025-12-22 Regeneron Pharma Formuleringer med høj koncentration af VEGF-receptorfusionsprotein

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR013202A1 (es) * 1997-07-10 2000-12-13 Biotech Australia Pty Ltd Vacunas no acuosas
AU2002213441B2 (en) * 2000-10-12 2006-10-26 Genentech, Inc. Reduced-viscosity concentrated protein formulations
GB0113179D0 (en) * 2001-05-31 2001-07-25 Novartis Ag Organic compounds
CN1671741A (zh) * 2002-06-21 2005-09-21 拜奥根Idec公司 浓缩抗体的缓冲剂制剂及其使用方法
US20050158303A1 (en) * 2003-04-04 2005-07-21 Genentech, Inc. Methods of treating IgE-mediated disorders comprising the administration of high concentration anti-IgE antibody formulations
US8236292B2 (en) * 2004-06-04 2012-08-07 Camurus Ab Liquid depot formulations
GB0412530D0 (en) * 2004-06-04 2004-07-07 Camurus Ab Formulation
EA200601714A1 (ru) * 2004-06-14 2007-06-29 Ю Эс Ви ЛИМИТЕД Способ получения пептидов
US20080200383A1 (en) * 2005-04-08 2008-08-21 Amylin Pharmaceuticals, Inc. Pharmaceutical Formulations Comprising Incretin Peptide and Aprotic Polar Solvent
BRPI0620316A2 (pt) * 2005-12-21 2011-11-08 Wyeth Corp formulações de proteìnas com viscosidades reduzida e seus usos

Also Published As

Publication number Publication date
WO2011017330A1 (en) 2011-02-10
CA2769221A1 (en) 2011-02-10
SG178226A1 (en) 2012-03-29
JP2013501058A (ja) 2013-01-10
BR112012002596A2 (pt) 2015-09-15
MX2012001560A (es) 2012-06-01
CN102573459A (zh) 2012-07-11
AU2010279569A1 (en) 2012-03-01
NZ598518A (en) 2014-12-24
WO2011017330A8 (en) 2011-04-21
ZA201200760B (en) 2013-05-29
EP2461677A4 (en) 2014-01-08
US20130236448A1 (en) 2013-09-12
KR20120047995A (ko) 2012-05-14
IL217887A0 (en) 2012-03-29
EP2461677A1 (en) 2012-06-13

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Effective date: 20150526