BR112018008769A2 - formulações farmacêuticas, formulações líquidas aquosa reconstituída e liofilizada, seringa, método de fabricação de uma formulação farmacêutica, método para tratamento de uma doença e uso de uma formulação reconstruída - Google Patents

formulações farmacêuticas, formulações líquidas aquosa reconstituída e liofilizada, seringa, método de fabricação de uma formulação farmacêutica, método para tratamento de uma doença e uso de uma formulação reconstruída

Info

Publication number
BR112018008769A2
BR112018008769A2 BR112018008769A BR112018008769A BR112018008769A2 BR 112018008769 A2 BR112018008769 A2 BR 112018008769A2 BR 112018008769 A BR112018008769 A BR 112018008769A BR 112018008769 A BR112018008769 A BR 112018008769A BR 112018008769 A2 BR112018008769 A2 BR 112018008769A2
Authority
BR
Brazil
Prior art keywords
formulation
pharmaceutical
formulations
reconstituted
reconstructed
Prior art date
Application number
BR112018008769A
Other languages
English (en)
Inventor
Gikanga Benson
petry Christopher
Chih Hung-Wei
Liu Jun
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
Application filed by Genentech Inc filed Critical Genentech Inc
Publication of BR112018008769A2 publication Critical patent/BR112018008769A2/pt

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • 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
    • 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
    • A61K47/06—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
    • A61K47/26—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
    • A61K9/0012—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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • 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
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics
    • 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
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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

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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Ophthalmology & Optometry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Endocrinology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

são divulgadas formulações farmacêuticas compreendendo anticorpos monoclonais anti-fator d e sua produção e uso para o tratamento de doenças oculares associadas ao complemento. as formulações incluem formulações líquidas estáveis pré-liofilizadas, liofilizadas e reconstituídas de anticorpos anti-fator d, incluindo o lampalizumabe.
BR112018008769A 2015-10-30 2016-10-27 formulações farmacêuticas, formulações líquidas aquosa reconstituída e liofilizada, seringa, método de fabricação de uma formulação farmacêutica, método para tratamento de uma doença e uso de uma formulação reconstruída BR112018008769A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562249082P 2015-10-30 2015-10-30
US201562251015P 2015-11-04 2015-11-04
PCT/US2016/059189 WO2017075259A1 (en) 2015-10-30 2016-10-27 Anti-factor d antibody formulations

Publications (1)

Publication Number Publication Date
BR112018008769A2 true BR112018008769A2 (pt) 2018-12-04

Family

ID=57286812

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018008769A BR112018008769A2 (pt) 2015-10-30 2016-10-27 formulações farmacêuticas, formulações líquidas aquosa reconstituída e liofilizada, seringa, método de fabricação de uma formulação farmacêutica, método para tratamento de uma doença e uso de uma formulação reconstruída

Country Status (12)

Country Link
US (1) US20170137535A1 (pt)
EP (1) EP3368565A1 (pt)
JP (1) JP2018531980A (pt)
KR (1) KR20180069906A (pt)
CN (1) CN108602881A (pt)
AU (1) AU2016344133A1 (pt)
BR (1) BR112018008769A2 (pt)
CA (1) CA3003647A1 (pt)
HK (1) HK1257426A1 (pt)
IL (1) IL258958A (pt)
MX (1) MX2018005226A (pt)
WO (1) WO2017075259A1 (pt)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108472382A (zh) 2015-10-30 2018-08-31 豪夫迈·罗氏有限公司 抗-因子d抗体变体缀合物及其用途
EP3927729A4 (en) 2019-02-18 2023-10-11 Eli Lilly and Company THERAPEUTIC ANTIBODY FORMULATION

Family Cites Families (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4179337A (en) 1973-07-20 1979-12-18 Davis Frank F Non-immunogenic polypeptides
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
US5534615A (en) 1994-04-25 1996-07-09 Genentech, Inc. Cardiac hypertrophy factor and uses therefor
US7122636B1 (en) 1997-02-21 2006-10-17 Genentech, Inc. Antibody fragment-polymer conjugates and uses of same
DE69829891T2 (de) 1997-04-07 2005-10-06 Genentech, Inc., South San Francisco Anti-VEGF Antikörper
US6884879B1 (en) 1997-04-07 2005-04-26 Genentech, Inc. Anti-VEGF antibodies
KR100425965B1 (ko) * 1998-02-20 2004-04-06 타녹스 인코퍼레이티드 보체 활성화의 억제물질
US7112327B2 (en) * 1998-02-20 2006-09-26 Tanox, Inc. Inhibition of complement activation
US6376653B1 (en) 1998-09-28 2002-04-23 Smithkline Beecham Plc Tie2 antagonist antibodies
US20050036991A1 (en) 2000-02-10 2005-02-17 Fodor William L Mixtures of caspase inhibitors and complement inhibitors and methods of use thereof
US20050106667A1 (en) 2003-08-01 2005-05-19 Genentech, Inc Binding polypeptides with restricted diversity sequences
WO2005044853A2 (en) 2003-11-01 2005-05-19 Genentech, Inc. Anti-vegf antibodies
ES2579805T3 (es) 2004-09-23 2016-08-16 Genentech, Inc. Anticuerpos y conjugados modificados por ingeniería genética con cisteína
AR059066A1 (es) 2006-01-27 2008-03-12 Amgen Inc Combinaciones del inhibidor de la angiopoyetina -2 (ang2) y el inhibidor del factor de crecimiento endotelial vascular (vegf)
EP2907827B1 (en) * 2006-11-02 2018-09-19 Genentech, Inc. Humanized anti-factor D antibodies and uses thereof
CR20170001A (es) * 2008-04-28 2017-08-10 Genentech Inc Anticuerpos anti factor d humanizados
US20110165648A1 (en) * 2009-11-04 2011-07-07 Menno Van Lookeren Campagne Co-crystal structure of factor D and anti-factor D antibody
KR20120123299A (ko) 2009-12-04 2012-11-08 제넨테크, 인크. 다중특이적 항체, 항체 유사체, 조성물 및 방법
CA2791841C (en) * 2010-03-05 2023-01-03 Rigshospitalet Chimeric inhibitor molecules of complement activation
JP6618682B2 (ja) * 2011-06-22 2019-12-11 アペリス・ファーマシューティカルズ・インコーポレイテッドＡｐｅｌｌｉｓ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ，Ｉｎｃ． 補体阻害剤による慢性障害の治療方法
EA201490778A1 (ru) 2011-10-14 2014-09-30 Дженентек, Инк. АНТИТЕЛА ПРОТИВ HtrA1 И СПОСОБЫ ПРИМЕНЕНИЯ
SG11201601044XA (en) 2013-08-12 2016-03-30 Genentech Inc Compositions and method for treating complement-associated conditions
MA39934A (fr) * 2014-05-01 2017-03-08 Hoffmann La Roche Variants d'anticorps anti-facteur d et leurs utilisations
WO2016109822A1 (en) * 2014-12-31 2016-07-07 Novelmed Therapeutics, Inc. Formulation of aglycosylated therapeutic antibodies
CA3001362C (en) * 2015-10-30 2020-10-13 Genentech, Inc. Anti-htra1 antibodies and methods of use thereof

Also Published As

Publication number Publication date
CA3003647A1 (en) 2017-05-04
CN108602881A (zh) 2018-09-28
HK1257426A1 (zh) 2019-10-18
KR20180069906A (ko) 2018-06-25
AU2016344133A1 (en) 2018-05-17
EP3368565A1 (en) 2018-09-05
WO2017075259A1 (en) 2017-05-04
IL258958A (en) 2018-06-28
US20170137535A1 (en) 2017-05-18
MX2018005226A (es) 2019-04-29
JP2018531980A (ja) 2018-11-01

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Legal Events

Date Code Title Description
B11A Dismissal acc. art.33 of ipl - examination not requested within 36 months of filing
B11Y Definitive dismissal - extension of time limit for request of examination expired [chapter 11.1.1 patent gazette]