BRPI0815975B8 - preparação aquosa, recipiente farmacêutico, processo para preparar uma preparação aquosa, e, uso de uma preparação aquosa - Google Patents

preparação aquosa, recipiente farmacêutico, processo para preparar uma preparação aquosa, e, uso de uma preparação aquosa

Info

Publication number
BRPI0815975B8
BRPI0815975B8 BRPI0815975A BRPI0815975A BRPI0815975B8 BR PI0815975 B8 BRPI0815975 B8 BR PI0815975B8 BR PI0815975 A BRPI0815975 A BR PI0815975A BR PI0815975 A BRPI0815975 A BR PI0815975A BR PI0815975 B8 BRPI0815975 B8 BR PI0815975B8
Authority
BR
Brazil
Prior art keywords
aqueous preparation
composition
preparing
salts
pharmaceutical container
Prior art date
Application number
BRPI0815975A
Other languages
English (en)
Portuguese (pt)
Inventor
Scheckermann Christian
Hinderer Walter
Original Assignee
Biogenerix Ag
Biogenerix Gmbh
Ratiopharm Gmbh
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 Biogenerix Ag, Biogenerix Gmbh, Ratiopharm Gmbh filed Critical Biogenerix Ag
Publication of BRPI0815975A2 publication Critical patent/BRPI0815975A2/pt
Publication of BRPI0815975B1 publication Critical patent/BRPI0815975B1/pt
Publication of BRPI0815975B8 publication Critical patent/BRPI0815975B8/pt

Links

Classifications

    • 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
    • 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
    • A61K47/51Medicinal 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 the non-active ingredient being a modifying agent
    • A61K47/56Medicinal 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 the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59Medicinal 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 the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60Medicinal 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 the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K17/00Carrier-bound or immobilised peptides; Preparation thereof
    • C07K17/02Peptides being immobilised on, or in, an organic carrier
    • C07K17/08Peptides being immobilised on, or in, an organic carrier the carrier being a synthetic polymer

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Neurology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Biomedical Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
BRPI0815975A 2007-08-27 2008-08-27 preparação aquosa, recipiente farmacêutico, processo para preparar uma preparação aquosa, e, uso de uma preparação aquosa BRPI0815975B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP07115047.8 2007-08-27
EP07115047 2007-08-27
PCT/EP2008/061232 WO2009027437A1 (en) 2007-08-27 2008-08-27 Liquid formulation of g-csf conjugate

Publications (3)

Publication Number Publication Date
BRPI0815975A2 BRPI0815975A2 (pt) 2015-02-18
BRPI0815975B1 BRPI0815975B1 (pt) 2019-04-02
BRPI0815975B8 true BRPI0815975B8 (pt) 2021-05-25

Family

ID=39862881

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0815975A BRPI0815975B8 (pt) 2007-08-27 2008-08-27 preparação aquosa, recipiente farmacêutico, processo para preparar uma preparação aquosa, e, uso de uma preparação aquosa

Country Status (24)

Country Link
US (1) US8546328B2 (cg-RX-API-DMAC7.html)
EP (2) EP2197919B1 (cg-RX-API-DMAC7.html)
JP (2) JP5570988B2 (cg-RX-API-DMAC7.html)
KR (1) KR20100052501A (cg-RX-API-DMAC7.html)
CN (2) CN101827864A (cg-RX-API-DMAC7.html)
AU (1) AU2008292186B9 (cg-RX-API-DMAC7.html)
BR (1) BRPI0815975B8 (cg-RX-API-DMAC7.html)
CA (1) CA2696594C (cg-RX-API-DMAC7.html)
CY (1) CY1115908T1 (cg-RX-API-DMAC7.html)
DE (1) DE202008017456U1 (cg-RX-API-DMAC7.html)
DK (1) DK2197919T3 (cg-RX-API-DMAC7.html)
EA (1) EA020069B1 (cg-RX-API-DMAC7.html)
ES (1) ES2476915T3 (cg-RX-API-DMAC7.html)
HR (1) HRP20140590T1 (cg-RX-API-DMAC7.html)
IL (1) IL204190A (cg-RX-API-DMAC7.html)
MX (1) MX2010002448A (cg-RX-API-DMAC7.html)
NZ (1) NZ583276A (cg-RX-API-DMAC7.html)
PL (1) PL2197919T3 (cg-RX-API-DMAC7.html)
PT (1) PT2197919E (cg-RX-API-DMAC7.html)
RS (1) RS53404B (cg-RX-API-DMAC7.html)
SI (1) SI2197919T1 (cg-RX-API-DMAC7.html)
UA (1) UA98001C2 (cg-RX-API-DMAC7.html)
WO (1) WO2009027437A1 (cg-RX-API-DMAC7.html)
ZA (1) ZA201000798B (cg-RX-API-DMAC7.html)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2011207915B2 (en) * 2010-01-19 2013-07-11 Hanmi Science Co., Ltd. Liquid formulations for long-acting G-CSF conjugate
MX2012010661A (es) 2010-03-17 2013-03-25 Biogenerix Gmbh Metodo para obtener factor estimulante de colonias de granulocitos (g-csf) humano recombinante biologicamente activo.
EP2384759A1 (en) 2010-05-06 2011-11-09 Suomen Punainen Risti Veripalvelu Sulphated hyaluronic acid in combination with G-CSF for use in mobilising blood stem cells
TWI751154B (zh) * 2016-04-18 2022-01-01 大陸商江蘇恆瑞醫藥股份有限公司 一種重組人粒細胞集落刺激因子的製備方法
IT201700108526A1 (it) * 2017-09-28 2019-03-28 Alfasigma Spa Composizioni orali per il trattamento del refluso gastroesofageo.
CN112312890A (zh) * 2018-05-04 2021-02-02 伊尔科根医药工业和贸易有限公司 稳定的杂合fc融合g-csf制剂
CN114224853B (zh) * 2022-01-04 2022-09-23 山东新时代药业有限公司 聚乙二醇化重组人粒细胞刺激因子注射用冻干制剂
TW202417034A (zh) * 2022-08-19 2024-05-01 大陸商億一生物醫藥開發(上海)有限公司 包含g—csf之調配物及其用途

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Also Published As

Publication number Publication date
KR20100052501A (ko) 2010-05-19
CN104689333B (zh) 2018-05-29
WO2009027437A1 (en) 2009-03-05
EP2197919B1 (en) 2014-04-09
BRPI0815975B1 (pt) 2019-04-02
MX2010002448A (es) 2010-10-04
JP2010536929A (ja) 2010-12-02
EP2197919A1 (en) 2010-06-23
EA020069B1 (ru) 2014-08-29
AU2008292186B2 (en) 2014-02-27
UA98001C2 (uk) 2012-04-10
EA201070315A1 (ru) 2010-08-30
SI2197919T1 (sl) 2014-09-30
CN104689333A (zh) 2015-06-10
CA2696594A1 (en) 2009-03-05
CA2696594C (en) 2019-03-19
NZ583276A (en) 2012-06-29
CN101827864A (zh) 2010-09-08
PL2197919T3 (pl) 2014-09-30
US20110053844A1 (en) 2011-03-03
ES2476915T3 (es) 2014-07-15
BRPI0815975A2 (pt) 2015-02-18
EP2578235A2 (en) 2013-04-10
ZA201000798B (en) 2010-10-27
CY1115908T1 (el) 2017-01-25
RS53404B (sr) 2014-10-31
PT2197919E (pt) 2014-07-17
EP2578235A3 (en) 2013-08-28
DE202008017456U1 (de) 2009-08-27
DK2197919T3 (da) 2014-07-07
AU2008292186A1 (en) 2009-03-05
IL204190A (en) 2015-01-29
HRP20140590T1 (hr) 2014-08-15
US8546328B2 (en) 2013-10-01
JP2014101362A (ja) 2014-06-05
JP5836351B2 (ja) 2015-12-24
JP5570988B2 (ja) 2014-08-13
AU2008292186B9 (en) 2014-07-03

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Legal Events

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

Ipc: A61K 47/60 (2017.01), A61P 7/06 (2006.01), A61P 25

B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B15K Others concerning applications: alteration of classification

Ipc: C07K 17/08 (2006.01), A61P 7/06 (2006.01), A61P 25

B07A Application suspended after technical examination (opinion) [chapter 7.1 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: 10 (DEZ) ANOS CONTADOS A PARTIR DE 02/04/2019, OBSERVADAS AS CONDICOES LEGAIS. (CO) 10 (DEZ) ANOS CONTADOS A PARTIR DE 02/04/2019, OBSERVADAS AS CONDICOES LEGAIS

B25D Requested change of name of applicant approved

Owner name: BIOGENERIX GMBH (DE)

B25A Requested transfer of rights approved

Owner name: RATIOPHARM GMBH (DE)

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 27/08/2008 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

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B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2640 DE 10-08-2021 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.