BR112012022223A8 - Formulação de proteína concentrada, uso e método de preparação da mesma - Google Patents

Formulação de proteína concentrada, uso e método de preparação da mesma

Info

Publication number
BR112012022223A8
BR112012022223A8 BR112012022223A BR112012022223A BR112012022223A8 BR 112012022223 A8 BR112012022223 A8 BR 112012022223A8 BR 112012022223 A BR112012022223 A BR 112012022223A BR 112012022223 A BR112012022223 A BR 112012022223A BR 112012022223 A8 BR112012022223 A8 BR 112012022223A8
Authority
BR
Brazil
Prior art keywords
preparation
formulations
concentrated protein
protein formulation
protein drug
Prior art date
Application number
BR112012022223A
Other languages
English (en)
Other versions
BR112012022223A2 (pt
BR112012022223B1 (pt
Inventor
T Chen Tracy
Original Assignee
Progenics Pharm Inc
Cytodyn 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 Progenics Pharm Inc, Cytodyn Inc filed Critical Progenics Pharm Inc
Publication of BR112012022223A2 publication Critical patent/BR112012022223A2/pt
Publication of BR112012022223A8 publication Critical patent/BR112012022223A8/pt
Publication of BR112012022223B1 publication Critical patent/BR112012022223B1/pt

Links

Classifications

    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • 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
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • A61P31/18Antivirals for RNA viruses for HIV
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Abstract

FORMULAÇÕES DE PROTEÍNA CONCENTRADA E SEU MÉTODO DE PREPARAÇÃO. A presente invenção refere-se a viscosidade, hipotônica formulações contendo um ou mais proteínas, por exemplo, anticorpos, a altas concentrações, usos das formulações e artigos de manufatura. Em particular, as formulações são úteis e benéficas para a administração ou distribuição subcutânea de uma alta concentração de um fármaco de proteína, tal como um anticorpo, a um indivíduo que está sofrendo com uma doença ou condição que e tratável por um fármaco de proteína.
BR112012022223-6A 2010-03-01 2011-03-01 Formulação de proteína concentrada, uso e método de preparação da mesma BR112012022223B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US33919110P 2010-03-01 2010-03-01
US61/339,191 2010-03-01
PCT/US2011/026647 WO2011109365A2 (en) 2010-03-01 2011-03-01 Concentrated protein formulations and uses thereof

Publications (3)

Publication Number Publication Date
BR112012022223A2 BR112012022223A2 (pt) 2016-07-05
BR112012022223A8 true BR112012022223A8 (pt) 2017-12-05
BR112012022223B1 BR112012022223B1 (pt) 2022-08-09

Family

ID=44542798

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112012022223-6A BR112012022223B1 (pt) 2010-03-01 2011-03-01 Formulação de proteína concentrada, uso e método de preparação da mesma

Country Status (16)

Country Link
US (2) US9956165B2 (pt)
EP (1) EP2542221A4 (pt)
JP (2) JP5937523B2 (pt)
KR (1) KR101853981B1 (pt)
CN (2) CN102946861B (pt)
AU (2) AU2011223805B2 (pt)
BR (1) BR112012022223B1 (pt)
CA (1) CA2794929C (pt)
HK (1) HK1223835A1 (pt)
IL (1) IL221748B (pt)
MX (1) MX347504B (pt)
NZ (1) NZ602685A (pt)
RU (1) RU2626512C2 (pt)
SG (1) SG184355A1 (pt)
WO (1) WO2011109365A2 (pt)
ZA (1) ZA201207331B (pt)

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Also Published As

Publication number Publication date
BR112012022223A2 (pt) 2016-07-05
AU2016200495B2 (en) 2017-11-09
JP2013521296A (ja) 2013-06-10
CN105521491A (zh) 2016-04-27
EP2542221A2 (en) 2013-01-09
RU2012141655A (ru) 2014-04-10
KR101853981B1 (ko) 2018-05-02
US11571383B2 (en) 2023-02-07
KR20130010898A (ko) 2013-01-29
US20180263898A1 (en) 2018-09-20
JP6229007B2 (ja) 2017-11-08
ZA201207331B (en) 2014-07-30
CA2794929C (en) 2018-06-05
CN102946861B (zh) 2016-01-20
WO2011109365A3 (en) 2012-01-05
AU2016200495A1 (en) 2016-02-18
HK1223835A1 (zh) 2017-08-11
CN102946861A (zh) 2013-02-27
SG184355A1 (en) 2012-11-29
BR112012022223B1 (pt) 2022-08-09
CN105521491B (zh) 2020-03-24
WO2011109365A2 (en) 2011-09-09
JP2016193911A (ja) 2016-11-17
IL221748B (en) 2019-09-26
CA2794929A1 (en) 2011-09-09
US20130216525A1 (en) 2013-08-22
AU2011223805A1 (en) 2012-10-25
NZ602685A (en) 2014-10-31
US9956165B2 (en) 2018-05-01
MX347504B (es) 2017-04-28
AU2011223805B2 (en) 2015-10-29
EP2542221A4 (en) 2013-10-23
RU2626512C2 (ru) 2017-07-28
MX2012010114A (es) 2013-01-29
JP5937523B2 (ja) 2016-06-22

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Legal Events

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B25A Requested transfer of rights approved

Owner name: CYTODYN INC. (US)

B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B15K Others concerning applications: alteration of classification

Ipc: A61K 9/00 (2006.01), A61K 39/395 (2006.01), A61K 4

B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 01/03/2011, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO.