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HRP20140926T1 - Terapeutske formulacije faktora rasta keratinocita - Google Patents

Terapeutske formulacije faktora rasta keratinocita Download PDF

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Publication number
HRP20140926T1
HRP20140926T1 HRP20140926TT HRP20140926T HRP20140926T1 HR P20140926 T1 HRP20140926 T1 HR P20140926T1 HR P20140926T T HRP20140926T T HR P20140926TT HR P20140926 T HRP20140926 T HR P20140926T HR P20140926 T1 HRP20140926 T1 HR P20140926T1
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HR
Croatia
Prior art keywords
kgf
vol
composition according
concentration
seq
Prior art date
Application number
HRP20140926TT
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English (en)
Inventor
Michael J. Treuheit
Vasumathi Dharmavaram
Judith Purtell
Suzanne E. Roy
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Swedish Orphan Biovitrum Ab (Publ)
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Publication of HRP20140926T1 publication Critical patent/HRP20140926T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • 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
    • A61K38/18Growth factors; Growth regulators
    • 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
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1825Fibroblast growth factor [FGF]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/14Drugs for dermatological disorders for baldness or alopecia
    • 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
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/475Growth factors; Growth regulators
    • C07K14/50Fibroblast growth factor [FGF]
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Transplantation (AREA)
  • Pulmonology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Claims (17)

1. Liofilizirana kompozicija faktora rasta keratinocita (KGF) koja sadrži: • KGF u koncentraciji između 3 mg/mL i 15 mg/mL; • histidin kao pufer; • punjač manitol u koncentraciji od 2% do 5% tež./vol.; • saharozu u koncentraciji od 1% do 3% tež./vol.; • polisorbat 20 u koncentraciji unutar opsega od 0.004% do 0.1% tež./vol.; i gdje je pH u opsegu od 6.0 do 8.0.
2. Kompozicija prema patentnom zahtjevu 1 naznačena time što je KGF izabran iz grupe koju čine SEQ ID NO: 2, SEQ ID NO: 3.
3. Kompozicija prema patentnom zahtjevu 1 naznačena time što KGF sadrži aminokiselinsku sekvencu od SEQ ID NO: 2.
4. Kompozicija prema patentnom zahtjevu 1 naznačena time što KGF sadrži ΔN23 KGF naveden u SEQ ID NO: 3.
5. Kompozicija prema patentnom zahtjevu 1 naznačena time što manitol je u koncentraciji od 4% tež./vol.
6. Kompozicija prema patentnom zahtjevu 1 naznačena time što saharoza je 2% tež./vol.
7. Kompozicija prema patentnom zahtjevu 1 naznačena time što pH je u opsegu od 6.0 do 7.0.
8. Kompozicija prema patentnom zahtjevu 7 naznačena time što pH je 6.5.
9. Kompozicija prema patentnom zahtjevu 1 naznačena time što koncentracija polisorbata 20 je 0.01% tež./vol.
10. Kompozicija prema patentnom zahtjevu 1 naznačena time što koncentracija KGF je 5 mg/mL.
11. Liofilizirana KGF kompozicija prema patentnom zahtjevu 1 koja sadrži 10 mM histidin, 4% tež./vol. manitol, 2% tež./vol. saharoze i 0.01% (tež./vol.) polisorbata 20, pri čemu je kompozicija na pH od 6.5.
12. Postupak za pripremu liofilizirane KGF kompozicije prema patentnom zahtjevu 1 koji sadrži korake a) pripreme otopine KGF u koncentraciji između 3 mg/mL i 15 mg/mL; histidina kao pufera; manitola u koncentraciji od 2% do 5% tež./vol.; saharoze u koncentraciji od 1% do 3% tež./vol.; polisorbata 20 u koncentraciji unutar opsega od 0.004% do 0.1% tež./vol., pri čemu je pH u opsegu od 6.0 do 8.0; i b) liofilizacije navedene otopine KGF da bi se dobila navedena liofilizirana kompozicija KGF.
13. Postupak prema patentnom zahtjevu 12 naznačen time što je KGF izabran iz grupe koju čine SEQ ID NO: 2, SEQ ID NO: 3.
14. Postupak prema patentnom zahtjevu 12 naznačen time što KGF sadrži aminokiselinsku sekvencu od SEQ ID NO: 2.
15. Postupak prema patentnom zahtjevu 12 naznačen time što KGF sadrži ΔN23 KGF naveden u SEQ ID NO: 3.
16. Upotreba liofilizirane kompozicije KGF prema patentnom zahtjevu 1 za pripremu lijeka za liječenje crijevne toksičnosti; mukozitisa; opekotina ili drugih povreda djelomične i potpune debljine; repopulaciju folikula dlake, znojnih žlijezda i lojnih žlijezda; proliferacije adneksalne strukture; epidermolizis buloze; alopecije inducirane kemoterapijom; muške ćelavosti; čireva na želudcu; čireva na duodenumu; erozivnog gastritisa, ezofagitisa, ili ezofagealnog refluksa; inflamatorne bolesti crijeva; bolesti hijalinske membrane; povreda od udisanja dima; emfizema; ciroze jetre, insuficijencije jetre, akutnog virusnog hepatitisa, drugih toksičnih povreda jetre; ili bolesti transplanta protiv domaćina (GVHD), povećanjem KGF-posredovane stimulacije rasta epitelnih stanica.
17. Liofilizirana kompozicija KGF prema patentnom zahtjevu 1, za uporabu u liječenju crijevne toksičnosti; mukozitisa; opekotina ili drugih povreda djelomične i potpune debljine; repopulacije folikula dlake, znojnih žlijezda i lojnih žlijezda; proliferacije adneksalne strukture; epidermolizis buloze; alopecije inducirane kemoterapijom; muške ćelavosti; čireva na želudcu; čireva na duodenumu; erozivnog gastritisa, ezofagitisa, ili ezofagealnog refluksa; inflamatorne bolesti crijeva; bolesti hijalinske membrane; povreda od udisanja dima; emfizema; ciroze jetre, insuficijencije jetre, akutnog virusnog hepatitisa, drugih toksičnih povreda jetre; ili bolesti transplanta protiv domaćina (GVHD), povećanjem KGF-posredovane stimulacije rasta epitelnih stanica.
HRP20140926TT 2004-12-15 2014-09-26 Terapeutske formulacije faktora rasta keratinocita HRP20140926T1 (hr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US63621004P 2004-12-15 2004-12-15

Publications (1)

Publication Number Publication Date
HRP20140926T1 true HRP20140926T1 (hr) 2014-11-07

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Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20140926TT HRP20140926T1 (hr) 2004-12-15 2014-09-26 Terapeutske formulacije faktora rasta keratinocita

Country Status (27)

Country Link
US (1) US8304387B2 (hr)
EP (1) EP1827483B1 (hr)
JP (1) JP5201992B2 (hr)
KR (1) KR101283736B1 (hr)
CN (1) CN101084008B (hr)
AR (1) AR052339A1 (hr)
AU (1) AU2005317166B2 (hr)
BR (1) BRPI0519070A2 (hr)
CA (1) CA2589889C (hr)
CR (1) CR9246A (hr)
DK (1) DK1827483T3 (hr)
EA (1) EA013369B1 (hr)
ES (1) ES2504441T3 (hr)
HR (1) HRP20140926T1 (hr)
IL (1) IL183435A (hr)
MX (1) MX2007006822A (hr)
MY (1) MY145638A (hr)
NO (1) NO20073629L (hr)
NZ (1) NZ555503A (hr)
PL (1) PL1827483T3 (hr)
PT (1) PT1827483E (hr)
RS (1) RS53548B1 (hr)
SI (1) SI1827483T1 (hr)
TW (1) TWI351966B (hr)
UA (1) UA88497C2 (hr)
WO (1) WO2006065861A2 (hr)
ZA (1) ZA200706095B (hr)

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UA88497C2 (ru) 2004-12-15 2009-10-26 Биовитрум Аб (Пабл) Терапевтические композиции кератиноцитарного фактора роста
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KR100784134B1 (ko) * 2006-10-09 2007-12-12 주식회사 대웅 상피세포성장인자를 함유하는 안정한 구내염 치료용 액상조성물
CN101780269A (zh) * 2009-01-21 2010-07-21 北京三有利科技发展有限公司 细胞生长因子治疗溃疡性疾病和肺纤维化疾病的应用
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CN102675449B (zh) * 2011-03-17 2016-06-08 重庆富进生物医药有限公司 缺失型人角质细胞生长因子-ⅰ二硫键变构体及其用途
CN102379838B (zh) * 2011-11-02 2013-06-12 广州舒泰生物技术有限公司 一种舒缓静颜化妆品的制备方法及应用
EP2773364A1 (en) * 2011-11-02 2014-09-10 The University of Chicago Stable pharmaceutical formulations of growth factor peptides
US20150126433A1 (en) * 2012-04-25 2015-05-07 University Of Cincinnati Growth factors for the treatment of mycobacterial infection
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CN108359634A (zh) * 2018-02-02 2018-08-03 江阴司特易生物技术有限公司 一种饲养细胞蛋白复合物及其应用
CN109402130A (zh) * 2018-11-23 2019-03-01 成都中医药大学附属医院 一种重组人角质细胞生长因子-1及其制备方法和用途
SG11202113022UA (en) * 2019-06-24 2021-12-30 Hangzhou Dac Biotech Co Ltd A formulation of a conjugate of a tubulysin analog to a cell-binding molecule
CN110339345B (zh) * 2019-07-30 2022-11-29 重庆派金生物科技有限公司 一种重组人截短型角质细胞生长因子-1滴眼液及其制备方法和应用
EP4183796A1 (en) 2021-11-19 2023-05-24 Enantis s.r.o. Thermostable fgf10 polypeptide or fragment thereof use thereof
CN119632934A (zh) * 2025-02-19 2025-03-18 杭州熙岭生物科技有限公司 一种kgf-2组合物的冻干粉及其制备方法

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Also Published As

Publication number Publication date
BRPI0519070A2 (pt) 2008-12-23
US8304387B2 (en) 2012-11-06
EP1827483A2 (en) 2007-09-05
PL1827483T3 (pl) 2014-12-31
IL183435A (en) 2010-11-30
SI1827483T1 (sl) 2014-11-28
US20060128622A1 (en) 2006-06-15
TW200635603A (en) 2006-10-16
HK1115298A1 (en) 2008-11-28
JP5201992B2 (ja) 2013-06-05
MY145638A (en) 2012-03-15
CN101084008A (zh) 2007-12-05
TWI351966B (en) 2011-11-11
RS53548B1 (en) 2015-02-27
WO2006065861A2 (en) 2006-06-22
ES2504441T3 (es) 2014-10-08
AR052339A1 (es) 2007-03-14
AU2005317166A1 (en) 2006-06-22
CN101084008B (zh) 2013-04-10
WO2006065861A3 (en) 2006-08-17
EP1827483B1 (en) 2014-07-02
JP2008524229A (ja) 2008-07-10
DK1827483T3 (da) 2014-10-06
CA2589889C (en) 2013-07-30
IL183435A0 (en) 2007-09-20
UA88497C2 (ru) 2009-10-26
KR20070093977A (ko) 2007-09-19
EA013369B1 (ru) 2010-04-30
NZ555503A (en) 2010-01-29
KR101283736B1 (ko) 2013-07-08
EA200701293A1 (ru) 2008-02-28
MX2007006822A (es) 2007-07-24
AU2005317166B2 (en) 2009-09-10
ZA200706095B (en) 2008-09-25
NO20073629L (no) 2007-09-10
PT1827483E (pt) 2014-09-25
CR9246A (es) 2007-10-23
CA2589889A1 (en) 2006-06-22

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