CL2011001132A1 - Metodo para reducir al minimo la inflamacion en el sitio de inyeccion durante la administracion subcutanea de una macromolecula que comprende agregar a una formulacion que contiene la macromolecula de 2% a 30% de ciclodextrina; formulacion que comprende un anticuerpo; y metodo para reducir al minimola precipitacion del anticuerpo. - Google Patents

Metodo para reducir al minimo la inflamacion en el sitio de inyeccion durante la administracion subcutanea de una macromolecula que comprende agregar a una formulacion que contiene la macromolecula de 2% a 30% de ciclodextrina; formulacion que comprende un anticuerpo; y metodo para reducir al minimola precipitacion del anticuerpo.

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Publication number
CL2011001132A1
CL2011001132A1 CL2011001132A CL2011001132A CL2011001132A1 CL 2011001132 A1 CL2011001132 A1 CL 2011001132A1 CL 2011001132 A CL2011001132 A CL 2011001132A CL 2011001132 A CL2011001132 A CL 2011001132A CL 2011001132 A1 CL2011001132 A1 CL 2011001132A1
Authority
CL
Chile
Prior art keywords
macromolecule
antibody
formulation
cyclodextrin
injection site
Prior art date
Application number
CL2011001132A
Other languages
English (en)
Spanish (es)
Inventor
Brian Lobo
Sabrina Lo
Yuchang John Wang
Rita Wong
Original Assignee
Genentech Inc
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=42170392&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CL2011001132(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Genentech Inc filed Critical Genentech Inc
Publication of CL2011001132A1 publication Critical patent/CL2011001132A1/es

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
    • 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
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/04—Drugs for disorders of the muscular or neuromuscular system for myasthenia gravis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/08—Vasodilators for multiple indications
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Neurology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Mycology (AREA)
  • Analytical Chemistry (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
CL2011001132A 2008-11-17 2011-05-16 Metodo para reducir al minimo la inflamacion en el sitio de inyeccion durante la administracion subcutanea de una macromolecula que comprende agregar a una formulacion que contiene la macromolecula de 2% a 30% de ciclodextrina; formulacion que comprende un anticuerpo; y metodo para reducir al minimola precipitacion del anticuerpo. CL2011001132A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US11544108P 2008-11-17 2008-11-17

Publications (1)

Publication Number Publication Date
CL2011001132A1 true CL2011001132A1 (es) 2012-07-20

Family

ID=42170392

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2011001132A CL2011001132A1 (es) 2008-11-17 2011-05-16 Metodo para reducir al minimo la inflamacion en el sitio de inyeccion durante la administracion subcutanea de una macromolecula que comprende agregar a una formulacion que contiene la macromolecula de 2% a 30% de ciclodextrina; formulacion que comprende un anticuerpo; y metodo para reducir al minimola precipitacion del anticuerpo.

Country Status (17)

Country Link
US (2) US20110305639A1 (enExample)
EP (1) EP2358395A4 (enExample)
JP (2) JP2012509269A (enExample)
KR (1) KR20110086705A (enExample)
CN (1) CN102281903B (enExample)
AR (1) AR074357A1 (enExample)
AU (1) AU2009313754A1 (enExample)
BR (1) BRPI0916072A2 (enExample)
CA (1) CA2742988A1 (enExample)
CL (1) CL2011001132A1 (enExample)
IL (1) IL212533A0 (enExample)
MX (1) MX2011005051A (enExample)
PE (1) PE20120169A1 (enExample)
RU (1) RU2563823C2 (enExample)
TW (1) TW201032826A (enExample)
WO (1) WO2010057107A1 (enExample)
ZA (1) ZA201103006B (enExample)

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ME01775B (me) 2003-11-05 2011-02-28 Glycart Biotechnology Ag Cd20 antitijela sa povećanim afinitetom vezivanja za fc receptor i efektornom funkcijom
TW201438738A (zh) 2008-09-16 2014-10-16 Genentech Inc 治療進展型多發性硬化症之方法
JP5341059B2 (ja) 2010-11-09 2013-11-13 株式会社大塚製薬工場 幹細胞懸濁液
SG11201405475UA (en) * 2012-03-07 2014-10-30 Cadila Healthcare Ltd Pharmaceutical formulations of tnf-alpha antibodies
US8883979B2 (en) 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations
MX385713B (es) 2013-03-13 2025-03-18 Seagen Inc Ciclodextrina y formulaciones de conjugados anticuerpo-fármaco.
US10525137B2 (en) * 2015-12-30 2020-01-07 Genentech, Inc. Formulations with reduced degradation of polysorbate
GB201604124D0 (en) * 2016-03-10 2016-04-27 Ucb Biopharma Sprl Pharmaceutical formulation
KR102039709B1 (ko) 2017-11-03 2019-11-01 삼성전자주식회사 유기 인터포저를 포함하는 반도체 패키지
MX2021009851A (es) 2019-02-18 2021-09-10 Lilly Co Eli Formulacion de anticuerpos terapeuticos.
US20230236199A1 (en) * 2020-04-23 2023-07-27 Eli Lilly And Company Subcutaneous absorption and bioavailability of antibodies
RU2754509C1 (ru) * 2020-12-21 2021-09-02 федеральное государственное бюджетное образовательное учреждение высшего образования "Первый Санкт-Петербургский государственный медицинский университет имени академика И.П. Павлова" Министерства здравоохранения Российской Федерации Способ лечения первичной мембранозной нефропатии с нефротическим синдромом и повышенным уровнем анти-plar2

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US5997856A (en) * 1988-10-05 1999-12-07 Chiron Corporation Method and compositions for solubilization and stabilization of polypeptides, especially proteins
AU6818094A (en) * 1993-04-22 1994-11-08 Depotech Corporation Cyclodextrin liposomes encapsulating pharmacologic compounds and methods for their use
JP2000226336A (ja) * 1998-11-30 2000-08-15 Sankyo Co Ltd 免疫グロブリン製剤
CN100389821C (zh) * 1999-10-04 2008-05-28 希龙公司 稳定化的含多肽的液体药物组合物
MXPA03011793A (es) * 2001-06-29 2004-04-02 Maxygen Holdings Ltd Formulaciones de interferon.
DE10228049A1 (de) * 2002-06-24 2004-01-15 Merck Patent Gmbh Flüssige Zubereitung enthaltend Oligopeptide
US7960512B2 (en) * 2003-01-09 2011-06-14 Macrogenics, Inc. Identification and engineering of antibodies with variant Fc regions and methods of using same
JP4817068B2 (ja) * 2003-01-14 2011-11-16 イエダ・リサーチ・アンド・ディベロップメント・カンパニー・リミテッド 全身性エリテマトーデスの治療のためのペプチドの非経口製剤
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
DK1610820T4 (da) * 2003-04-04 2013-11-04 Genentech Inc Høj-koncentration antistof- og proteinformuleringer
HRP20090325T1 (en) * 2003-04-09 2009-07-31 Genentech Therapy of autoimmune disease in a patient with an inadequate response to a tnf-alpha inhibitor
DE10361599A1 (de) * 2003-12-24 2005-07-28 Boehringer Ingelheim Pharma Gmbh & Co. Kg Flüssigformulierung von Antikörperkonjugaten
US7318918B2 (en) * 2004-05-19 2008-01-15 Maxygen, Inc. Interferon-alpha polypeptides and conjugates
US20060128654A1 (en) * 2004-12-10 2006-06-15 Chunlin Tang Pharmaceutical formulation of cytidine analogs and derivatives
DOP2006000029A (es) * 2005-02-07 2006-08-15 Genentech Inc Antibody variants and uses thereof. (variantes de un anticuerpo y usos de las mismas)
WO2007019232A2 (en) * 2005-08-03 2007-02-15 Immunogen, Inc. Immunoconjugate formulations
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CN101204374A (zh) * 2006-12-18 2008-06-25 宜兴市天石饲料有限公司 一种包被复合型多价高效蛋黄抗体
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Also Published As

Publication number Publication date
WO2010057107A1 (en) 2010-05-20
CN102281903B (zh) 2013-11-13
ZA201103006B (en) 2012-07-25
JP2016020350A (ja) 2016-02-04
BRPI0916072A2 (pt) 2015-11-10
RU2011124550A (ru) 2012-12-27
RU2563823C2 (ru) 2015-09-20
US20140093493A1 (en) 2014-04-03
JP2012509269A (ja) 2012-04-19
IL212533A0 (en) 2011-06-30
CN102281903A (zh) 2011-12-14
KR20110086705A (ko) 2011-07-29
AR074357A1 (es) 2011-01-12
AU2009313754A1 (en) 2010-05-20
CA2742988A1 (en) 2010-05-20
TW201032826A (en) 2010-09-16
EP2358395A4 (en) 2013-11-20
US20110305639A1 (en) 2011-12-15
PE20120169A1 (es) 2012-02-29
EP2358395A1 (en) 2011-08-24
MX2011005051A (es) 2011-06-01

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