HRP20141217T1 - G-csf tekuä†a formulacija - Google Patents

G-csf tekuä†a formulacija Download PDF

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Publication number
HRP20141217T1
HRP20141217T1 HRP20141217AT HRP20141217T HRP20141217T1 HR P20141217 T1 HRP20141217 T1 HR P20141217T1 HR P20141217A T HRP20141217A T HR P20141217AT HR P20141217 T HRP20141217 T HR P20141217T HR P20141217 T1 HRP20141217 T1 HR P20141217T1
Authority
HR
Croatia
Prior art keywords
csf
concentration
pharmaceutical preparation
preparation according
container
Prior art date
Application number
HRP20141217AT
Other languages
English (en)
Inventor
Walter Hinderer
Heinz Lubenau
Original Assignee
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
Priority claimed from DE102007040932A external-priority patent/DE102007040932A1/de
Application filed by Ratiopharm Gmbh filed Critical Ratiopharm Gmbh
Publication of HRP20141217T1 publication Critical patent/HRP20141217T1/hr

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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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/193Colony stimulating factors [CSF]
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • 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
    • 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
    • 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
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Virology (AREA)
  • Inorganic Chemistry (AREA)
  • Oncology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • AIDS & HIV (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Communicable Diseases (AREA)
  • Diabetes (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (18)

1. Farmaceutski pripravak za uporabu u liječenju raka, teške kronične neutropenije (SCN), infekcije HIV-om, oštećenja središnjeg živčanog sustava ili u liječenju štetnih nuspojava kod citoksične kemoterapije koja sadrži G-CSF tekuću formulaciju, te se uglavnom sastoji od G-CSF-a i šećernog alkohola, polisorbata 80 u koncentraciji od 0.05-0.06 mg/ml, acetata u koncentraciji od 5-20 mM, kao pufera pri pH od 4.15-4.3, a po potrebi i od aminokiselina i/ili glicerola i/ili ugljikohidrata i/ili konzervansa, naznačen time, da se acetat dodaje u obliku njegove octene kiseline i da se pH podešava s NaOH.
2. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time, da G- CSF nije glikoziliran.
3. Farmaceutski pripravak u skladu s patentnim zahtjevom 1 ili 2, naznačen time, da je G-CSF prisutan u koncentraciji od 0.6 mg / ml.
4. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time, da je šećerni alkohol sorbitol.
5. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time, da je šećerni alkohol prisutan u koncentraciji od 5% (w/v).
6. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačen time, da je acetat prisutan u koncentraciji od 10 mM.
7. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time, da je u biti bez aminokiselina i/ili dodatnog proteina.
8. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time, da je u obliku injekcijske ili infuzijske otopine.
9. Farmaceutski pripravak u skladu s patentnim zahtjevom 1 u obliku injekcijske ili infuzijske otopine, naznačen time, da je G-CSF ljudski, neglikolizirani metionil G-CSF, prisutan u koncentraciji od 0.6 mg/ml, šećerni alkohol je sorbitol koji je prisutan u koncentraciji od 5% (w/v), površinski aktivna tvar (surfaktant) je polisorbat 80, a acetat je prisutan kao pufer u koncentraciji od 10 mM.
10. Spremnik za primjenu tekućih farmaceutskih pripravaka, naznačen time, da sadrži tekuću formulaciju farmaceutskog pripravka u skladu s bilo kojim od patentnih zahtjeva 1 do 9.
11. Spremnik u skladu s patentnim zahtjevom 10, naznačen time, da je najmanje jedna površina navedenog spremnika, koja je u kontaktu s tekućom formulacijom prevučena s materijalom koji se sastoji od silikona ili politetrafluoretilena ili etilentetrafluoretilen (ETFE) kopolimera.
12. Spremnik u skladu s patentnim zahtjevom 10 ili 11, naznačen time, da je spremnik sa štrcaljkom, ampulom, karpulom ili spremnikom za infuziju.
13. Štrcaljka ili ampula u skladu s patentnim zahtjevom 12, naznačena tme, da sadrži tekući pripravak koji se odnosi na koncentraciju G-CSF-a, pri koncentraciji od 0.3 mg u 0.5 ml ili 0.48 mg u 0,8 ml.
14. Oprema za parenteralnu primjenu G-CSF-a, naznačena time, da sadrži spremnik u skladu s bilo kojim od patentnih zahtjeva 10 do 13, kao i upute za skladištenje i/ili korištenje.
15. Oprema u skladu s patentnim zahtjevom 14, naznačena time, da je primjena G-CSF omogućena u doziranju od 5-30 μg/kg tjelesne težine.
16. Oprema u skladu s patentnim zahtjevom 14 ili 15, naznačena time, da sadrži 5 štrcaljki ili ampula u navedenom kompletu.
17. Oprema u skladu s bilo kojim od patentnih zahtjeva 14 do 16, naznačena time, da sadrži sigurnosne odjeljke za štrcaljke ili injekcije i/ili za infuzijske igle.
18. Oprema u skladu s bilo kojim od patentnih zahtjeva 14 do 17, naznačena time, da je namijenjena za pohranjivanje na 5°C.
HRP20141217AT 2007-08-27 2014-12-16 G-csf tekuä†a formulacija HRP20141217T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE102007040932A DE102007040932A1 (de) 2007-08-27 2007-08-27 Flüssigformulierung von G-CSF
EP07016763 2007-08-27
PCT/EP2008/007012 WO2009027076A1 (de) 2007-08-27 2008-08-27 Flüssigformulierung von g-csf
EP08785714.0A EP2076243B9 (de) 2007-08-27 2008-08-27 Flüssigformulierung von g-csf

Publications (1)

Publication Number Publication Date
HRP20141217T1 true HRP20141217T1 (hr) 2015-02-27

Family

ID=39745039

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20141217AT HRP20141217T1 (hr) 2007-08-27 2014-12-16 G-csf tekuä†a formulacija

Country Status (20)

Country Link
US (3) US8562967B2 (hr)
EP (2) EP2076243B9 (hr)
JP (2) JP2010536906A (hr)
KR (1) KR20100044261A (hr)
CN (1) CN101795670A (hr)
AU (1) AU2008291309B2 (hr)
BR (1) BRPI0815280A2 (hr)
CA (1) CA2697376C (hr)
CY (1) CY1115815T1 (hr)
DK (1) DK2076243T3 (hr)
ES (1) ES2524454T3 (hr)
HR (1) HRP20141217T1 (hr)
IL (1) IL204118A (hr)
MX (1) MX2010002348A (hr)
NZ (1) NZ583999A (hr)
PL (1) PL2076243T3 (hr)
PT (1) PT2076243E (hr)
SI (1) SI2076243T1 (hr)
UA (1) UA100245C2 (hr)
WO (1) WO2009027076A1 (hr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2399572A1 (en) * 2010-06-22 2011-12-28 Sandoz AG Long-term storage of non-glycosylated recombinant human G-CSF
AU2015231278B2 (en) * 2014-03-20 2020-01-23 Alkermes Pharma Ireland Limited Aripiprazole formulations having increased injection speeds
US11896037B2 (en) 2016-08-03 2024-02-13 Temple University-Of The Commonwealth System Of Higher Education Microencapsulation of active agents
ES2882181T3 (es) * 2016-10-31 2021-12-01 Fresenius Kabi Deutschland Gmbh Composición farmacéutica líquida

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4810643A (en) 1985-08-23 1989-03-07 Kirin- Amgen Inc. Production of pluripotent granulocyte colony-stimulating factor
US5104651A (en) 1988-12-16 1992-04-14 Amgen Inc. Stabilized hydrophobic protein formulations of g-csf
NZ236819A (en) 1990-02-03 1993-07-27 Max Planck Gesellschaft Enzymatic cleavage of fusion proteins; fusion proteins; recombinant dna and pharmaceutical compositions
DE4014750A1 (de) 1990-05-08 1991-11-14 Boehringer Mannheim Gmbh Muteine des granulozyten-stimulierenden faktors (g-csf)
CA2082951C (en) * 1991-03-15 1999-12-21 Robert M. Platz Pulmonary administration of granulocyte colony stimulating factor
DE4126983A1 (de) 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke
DE4242863A1 (de) 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF
DE4242919A1 (de) * 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Verfahren zur Herstellung von lagerstabilen wässrigen pharmazeutischen Zubereitungen von G-CSF
EP1060746A4 (en) 1998-03-06 2002-06-19 Chugai Pharmaceutical Co Ltd PROTEIN-FREE PREPARATIONS
ES2216447T3 (es) 1998-08-17 2004-10-16 Pfizer Products Inc. Composiciones proteicas estabilizadas.
DK1129720T3 (da) 2000-02-29 2004-09-27 Pfizer Prod Inc Stabiliseret granulocyt-kolonistimulerende faktor
AU2002345829A1 (en) 2002-06-24 2004-01-06 Dr. Reddy's Laboratories Ltd. Process for preparing g-csf
DE10348550A1 (de) * 2003-10-20 2005-06-16 Hexal Biotech Forschungsgmbh Stabile wässrige G-CSF-haltige Zusammensetzungen
WO2005042024A1 (en) 2003-11-04 2005-05-12 Lek Pharmaceuticals D.D. Stable pharmaceutical composition comprising granulocyte-colony stimulating factor
DE102006009437A1 (de) 2006-03-01 2007-09-13 Bioceuticals Arzneimittel Ag G-CSF-Flüssigformulierung

Also Published As

Publication number Publication date
ES2524454T3 (es) 2014-12-09
US8946161B2 (en) 2015-02-03
JP2015038111A (ja) 2015-02-26
US9468685B2 (en) 2016-10-18
EP2471510A1 (de) 2012-07-04
WO2009027076A1 (de) 2009-03-05
PT2076243E (pt) 2014-12-05
NZ583999A (en) 2011-10-28
EP2076243B9 (de) 2015-01-14
CA2697376C (en) 2016-07-19
SI2076243T1 (sl) 2015-01-30
US20150125420A1 (en) 2015-05-07
AU2008291309B2 (en) 2013-10-17
CN101795670A (zh) 2010-08-04
EP2076243B1 (de) 2014-10-01
US20100216698A1 (en) 2010-08-26
JP2010536906A (ja) 2010-12-02
EP2076243A1 (de) 2009-07-08
CY1115815T1 (el) 2017-01-25
IL204118A (en) 2014-11-30
US8562967B2 (en) 2013-10-22
AU2008291309A1 (en) 2009-03-05
KR20100044261A (ko) 2010-04-29
CA2697376A1 (en) 2009-03-05
US20140030214A1 (en) 2014-01-30
PL2076243T3 (pl) 2015-04-30
BRPI0815280A2 (pt) 2018-11-27
DK2076243T3 (da) 2015-01-05
MX2010002348A (es) 2010-07-30
UA100245C2 (uk) 2012-12-10

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