HRP20120235T1 - Formulacija tekućeg hormona rasta - Google Patents

Formulacija tekućeg hormona rasta Download PDF

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Publication number
HRP20120235T1
HRP20120235T1 HR20120235T HRP20120235T HRP20120235T1 HR P20120235 T1 HRP20120235 T1 HR P20120235T1 HR 20120235 T HR20120235 T HR 20120235T HR P20120235 T HRP20120235 T HR P20120235T HR P20120235 T1 HRP20120235 T1 HR P20120235T1
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HR
Croatia
Prior art keywords
formulation according
metal salt
formulation
growth hormone
alkaline earth
Prior art date
Application number
HR20120235T
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English (en)
Inventor
Arvinte Tudor
Luet Kleiber Karine
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Ares Trading S.A.
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.)
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Publication date
Application filed by Ares Trading S.A. filed Critical Ares Trading S.A.
Publication of HRP20120235T1 publication Critical patent/HRP20120235T1/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
    • A61K9/08Solutions
    • 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
    • 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
    • A61K38/22Hormones
    • A61K38/27Growth hormone [GH], i.e. somatotropin
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/02Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/10Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH

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

Abstract

Tekuća formulacija naznačena time da sadržihormon rasta, ili otpuštajući hormon hormona rasta (GHRH), koji stimulira otpuštanje ili potencira aktivnost endogenog hGH; sol alkalijskog metalasol zemnoalkalijskog metala ili sol pseudo zemnoalkalijskog metala; tecitratni/fosfatni pufer, pri čemu je pH formulacije u rasponu od 5,5 - 5,8. Patent sadrži još 24 patentna zahtjeva.

Claims (25)

1. Tekuća formulacija naznačena time da sadrži a) hormon rasta, ili otpuštajući hormon hormona rasta (GHRH), koji stimulira otpuštanje ili potencira aktivnost endogenog hGH; b) sol alkalijskog metala c) sol zemnoalkalijskog metala ili sol pseudo zemnoalkalijskog metala; te d) citratni/fosfatni pufer, pri čemu je pH formulacije u rasponu od 5,5 – 5,8.
2. Formulacija prema zahtjevu 1, naznačena time da hormon rasta je humani hormon rasta.
3. Formulacija prema bilo kojem od zahtjeva 1-2, naznačena time da je sol alkalijskog metala odabrana iz skupine koja sadrži NaCl, KCl, Na2SO4, Na2CO3.
4. Formulacija prema zahtjevu 3, naznačena time da je sol alkalijskog metala NaCl ili Na2SO4.
5. Formulacija prema bilo kojem od zahtjeva 1-4, naznačena time da je sol zemnoalkalijskog metala odabrana iz skupine koja sadrži CaCl2, MgCl2, MgSO4, NH4CO3.
6. Formulacija prema zahtjevu 5, naznačena time da je sol zemnoalkalijskog metala MgCl2.
7. Formulacija prema bilo kojem od zahtjeva 1-6, naznačena time da je pufersko sredstvo natrij citratni/natrij fosfatni pufer.
8. Formulacija prema zahtjevu 7, naznačena time da je pufer u koncentraciji u rasponu od 1 do 100 mM ili od 5 do 50 mM ili od 10 do 20 mM.
9. Formulacija prema bilo kojem od zahtjeva 1-8, naznačena time da nadalje sadrži surfaktant.
10. Formulacija prema zahtjevu 9, naznačena time da surfaktant je polietilen-polipropilen glikol.
11. Formulacija prema zahtjevu 10, naznačena time da surfaktant je Pluronic F68.
12. Formulacija prema zahtjevu 10 ili 11, naznačena time da sadrži polietilen-polipropilen glikol u koncentraciji u rasponu od 0,5 do 5 mg/ml ili 1 do 2 mg/ml ili 1,5 mg/ml.
13. Formulacija prema bilo kojem od zahtjeva 1-12, naznačena time da nadalje sadrži stabilizator.
14. Formulacija prema zahtjevu 13, naznačena time da stabilizator je sukroza.
15. Formulacija prema zahtjevu 14, naznačena time da sadrži sukrozu u koncentraciji u rasponu od 10 mg/ml do 100 mg/ml ili 20 mg/ml do 80 mg/ml ili oko 60 mg/ml.
16. Formulacija prema bilo kojem od zahtjeva 1-15, naznačena time da nadalje sadrži konzervans.
17. Formulacija prema zahtjevu 16, naznačena time da sadrži konzervans u koncentraciji u rasponu od 1 do 10 mg/ml ili 2 do 5 mg/ml ili 3 mg/ml.
18. Formulacija prema zahtjevu 16 ili 17, naznačena time da je konzervans fenol.
19. Formulacija prema bilo kojem od zahtjeva 1 do 18 naznačena time da navedena formulacija ima pH od 5,8 i sadrži r-hGH, natrij citrat/natrij fosfat, Na2SO4, MgCl2, fenol, Pluronic F68, te proizvoljno vodu za ubrizgavanje.
20. Formulacija prema bilo kojem od zahtjeva 1 do 18 naznačena time da navedena formulacija ima pH od 5,8 i sadrži r-hGH, natrij citrat/natrij fosfat, NaCl, MgCl2, fenol, Pluronic F68, te proizvoljno vodu za ubrizgavanje.
21. Farmaceutski pripravak naznačen time da sadrži formulaciju prema bilo kojem od zahtjeva 1 do 20.
22. Prezentacijski oblik tekuće formulacije prema bilo kojem od zahtjeva 1 do 20 naznačen time da je hermetički zatvoren u sterilnim uvjetima unutar spremnika pogodnog za pohranjivanje prije uporabe.
23. Uporaba formulacije prema bilo kojem od zahtjeva 1 do 20 naznačena time da je za dobivanje lijeka za liječenje nedostatka hormona rasta kod djece, gubitak težine i mršavljenje kod pacijenata sa AIDS-om, za Turnerov sindrom kod djevojčica, kao i za kronično zatajenje bubrega kod djece.
24. Uporaba formulacije prema zahtjevu 23 naznačena time da lijek je za primjenu u jednostrukoj dozi.
25. Uporaba formulacije prema zahtjevu 23 naznačena time da lijek je za primjenu u višestrukim dozama.
HR20120235T 2004-04-07 2012-03-14 Formulacija tekućeg hormona rasta HRP20120235T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP04101444 2004-04-07
PCT/EP2005/051448 WO2005105148A2 (en) 2004-04-07 2005-03-30 Liquid growth hormone formulation

Publications (1)

Publication Number Publication Date
HRP20120235T1 true HRP20120235T1 (hr) 2012-04-30

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Family Applications (1)

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HR20120235T HRP20120235T1 (hr) 2004-04-07 2012-03-14 Formulacija tekućeg hormona rasta

Country Status (24)

Country Link
US (1) US7662393B2 (hr)
EP (1) EP1740213B9 (hr)
JP (1) JP4991522B2 (hr)
KR (1) KR101120879B1 (hr)
CN (1) CN100574801C (hr)
AT (1) ATE547121T1 (hr)
AU (1) AU2005237775B2 (hr)
BR (1) BRPI0508798A (hr)
CA (1) CA2559918A1 (hr)
CY (1) CY1113834T1 (hr)
DK (1) DK1740213T3 (hr)
EA (1) EA010626B1 (hr)
ES (1) ES2383994T3 (hr)
HK (1) HK1098708A1 (hr)
HR (1) HRP20120235T1 (hr)
IL (1) IL178416A (hr)
MX (1) MXPA06011029A (hr)
NO (1) NO337249B1 (hr)
PL (1) PL1740213T3 (hr)
PT (1) PT1740213E (hr)
RS (1) RS52310B (hr)
SI (1) SI1740213T1 (hr)
UA (1) UA89781C2 (hr)
WO (1) WO2005105148A2 (hr)

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AU2011208620B2 (en) 2010-01-22 2015-04-16 Novo Nordisk Health Care Ag Stable growth hormone compounds
AU2011208625C1 (en) 2010-01-22 2022-08-18 Novo Nordisk Health Care Ag Growth hormones with prolonged in-vivo efficacy
EP2417982A1 (en) * 2010-07-30 2012-02-15 Ferring B.V. Stabilization of gonadotropins
EP2736490A1 (en) 2011-07-25 2014-06-04 Sandoz AG Aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein
US8871713B2 (en) * 2013-03-01 2014-10-28 Theratechnologies Inc. Formulations of growth hormone releasing factor (GRF) molecules with improved stability
CN105120887A (zh) 2013-04-05 2015-12-02 诺和诺德保健股份有限公司 生长激素化合物制剂
WO2017159540A1 (ja) * 2016-03-14 2017-09-21 Jcrファーマ株式会社 血清アルブミン-20k成長ホルモン融合タンパク質
AU2018314767B2 (en) * 2017-08-08 2024-03-21 Csl Behring Ag Hemopexin formulations
WO2024026224A1 (en) 2022-07-29 2024-02-01 University Of Rochester Methods for improving muscle mass, strength, or function with a combination of testosterone and growth hormone

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Also Published As

Publication number Publication date
KR20070005628A (ko) 2007-01-10
IL178416A0 (en) 2007-02-11
JP2007532515A (ja) 2007-11-15
WO2005105148A3 (en) 2006-07-20
UA89781C2 (uk) 2010-03-10
NO337249B1 (no) 2016-02-22
US20080038292A1 (en) 2008-02-14
CA2559918A1 (en) 2005-11-10
PL1740213T3 (pl) 2012-08-31
SI1740213T1 (sl) 2012-04-30
EA200601874A1 (ru) 2007-02-27
HK1098708A1 (en) 2007-07-27
ATE547121T1 (de) 2012-03-15
DK1740213T3 (da) 2012-04-10
JP4991522B2 (ja) 2012-08-01
RS52310B (en) 2012-12-31
KR101120879B1 (ko) 2012-02-27
MXPA06011029A (es) 2007-01-25
CN100574801C (zh) 2009-12-30
CN1946427A (zh) 2007-04-11
CY1113834T1 (el) 2016-07-27
WO2005105148A8 (en) 2005-12-08
EP1740213A2 (en) 2007-01-10
EP1740213B9 (en) 2012-06-13
NO20065097L (no) 2007-01-02
PT1740213E (pt) 2012-03-21
IL178416A (en) 2012-12-31
ES2383994T3 (es) 2012-06-28
AU2005237775B2 (en) 2010-03-04
AU2005237775A1 (en) 2005-11-10
EA010626B1 (ru) 2008-10-30
EP1740213B1 (en) 2012-02-29
US7662393B2 (en) 2010-02-16
BRPI0508798A (pt) 2007-09-04
WO2005105148A2 (en) 2005-11-10

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