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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)
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

    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 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
    • A61K47/59—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 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
    • A61K47/60—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 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
    • 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
    • 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
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • 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
    • A61P7/06—Antianaemics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K17/00—Carrier-bound or immobilised peptides; Preparation thereof
    • C07K17/02—Peptides being immobilised on, or in, an organic carrier
    • C07K17/08—Peptides 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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (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)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

preparação aquosa, recipiente farmacêutico, processo para preparar uma preparação aquosa, e, uso de uma preparação aquosa. a presente invenção refere-se a uma composição farmacêutica líquida compreendendo um polipeptídeo do fator estimulador de colônias de granulócitos conjugado com um polímero, a composição tendo um valor de ph na faixa de 4,5 a 5,5. a composição ainda compreende um tensoativo e, opcionalmente, um ou mais outros excipientes farmaceuticamente aceitáveis. além disso, a composição da invenção é livre de ácido tartárico ou seus sais e de ácido succínico e seus sais como agentes de tamponamento, e não contêm aminoácidos como estabilizadores. a composição tem uma boa estabilidade em armazenagem e é especialmente útil para a profilaxia e tratamento de distúrbios e indicações médicas em que as preparações do fator estimulador de colônias de granulócitos são consideradas como remédios úteis.
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 (pt)
EP (2) EP2578235A3 (pt)
JP (2) JP5570988B2 (pt)
KR (1) KR20100052501A (pt)
CN (2) CN101827864A (pt)
AU (1) AU2008292186B9 (pt)
BR (1) BRPI0815975B8 (pt)
CA (1) CA2696594C (pt)
CY (1) CY1115908T1 (pt)
DE (1) DE202008017456U1 (pt)
DK (1) DK2197919T3 (pt)
EA (1) EA020069B1 (pt)
ES (1) ES2476915T3 (pt)
HR (1) HRP20140590T1 (pt)
IL (1) IL204190A (pt)
MX (1) MX2010002448A (pt)
NZ (1) NZ583276A (pt)
PL (1) PL2197919T3 (pt)
PT (1) PT2197919E (pt)
RS (1) RS53404B (pt)
SI (1) SI2197919T1 (pt)
UA (1) UA98001C2 (pt)
WO (1) WO2009027437A1 (pt)
ZA (1) ZA201000798B (pt)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9867777B2 (en) * 2010-01-19 2018-01-16 Hanmi Science Co., Ltd. Liquid formulations for long-acting G-CSF conjugate
KR101853146B1 (ko) 2010-03-17 2018-04-27 라티오팜 게엠베하 생물학적으로 활성인 재조합 인간 ｇ­ｃｓｆ의 수득 방법
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.
KR102589578B1 (ko) * 2018-05-04 2023-10-17 일코겐 일라익 사나이 비 티카렛 에이.에스. 안정한 하이브리드 fc 융합 g-csf 제형
KR102375269B1 (ko) * 2021-01-27 2022-03-17 한미약품 주식회사 단백질 액상 제제 및 이의 제조방법
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
CN119698274A (zh) * 2022-08-19 2025-03-25 亿一生物医药开发(上海)有限公司 包含g-csf的制剂及其用途

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Also Published As

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

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