HRP20140257T1 - Uporaba ciklesonida za lijeäśenje bolesti dišnih puteva - Google Patents

Uporaba ciklesonida za lijeäśenje bolesti dišnih puteva Download PDF

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Publication number
HRP20140257T1
HRP20140257T1 HRP20140257TT HRP20140257T HRP20140257T1 HR P20140257 T1 HRP20140257 T1 HR P20140257T1 HR P20140257T T HRP20140257T T HR P20140257TT HR P20140257 T HRP20140257 T HR P20140257T HR P20140257 T1 HRP20140257 T1 HR P20140257T1
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HR
Croatia
Prior art keywords
use according
ciclesonide
drug
respiratory tract
dose
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HRP20140257TT
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English (en)
Inventor
Thomas Bethke
Renate Engelstaetter
Wilhelm Wurst
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Takeda Gmbh
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Application filed by Takeda Gmbh filed Critical Takeda Gmbh
Publication of HRP20140257T1 publication Critical patent/HRP20140257T1/hr
Publication of HRP20140257T4 publication Critical patent/HRP20140257T4/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • 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
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • 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
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/02Nasal agents, e.g. decongestants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Epidemiology (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Immunology (AREA)
  • Communicable Diseases (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)

Claims (30)

1. Uporaba ciklesonida, njegove farmaceutski prihvatljive soli, njegovih solvata ili njegovih fiziološki učinkovitih derivata, naznačena time, da je za proizvodnju lijeka za liječenje ili prevenciju bolesti dišnih puteva kod pacijenta, dok pacijent je dijete, pri čemu se smanjuje ili izbjegava pojačanje zagušenja koje je popratna pojava povezana s inhaliranim i intranazalno unesenim kortikosteroidima, te pri čemu se lijek primjenjuje u dozi od 20 do 200 μg ciklesonida.
2. Uporaba prema zahtjevu 1, naznačena time, da dijete je čovjek u predpubertetu.
3. Uporaba prema zahtjevu 1, naznačena time, da dijete je čovjek u dobi od 6 do 12 godina.
4. Uporaba prema zahtjevu 1, naznačena time, da se lijek primjenjuje u dozi od 20, 40, 60, 80, 100, 120, 140, 160, 180 ili 200 μg ciklesonida.
5. Uporaba prema zahtjevu 1, naznačena time, da se lijek primjenjuje u dozi od 40, 80, 160 μg ciklesonida.
6. Uporaba prema zahtjevu 1, naznačena time, da doza lijeka je dnevna doza u stalnom režimu liječenja.
7. Uporaba prema zahtjevu 6, naznačena time, da razdoblje liječenja je dulje od jednog dana.
8. Uporaba prema zahtjevu 7, naznačena time, da razdoblje liječenja je dulje od jednog tjedna.
9. Uporaba prema zahtjevu 1, naznačena time, da ona nema utjecaja na brzinu rasta pacijenta.
10. Uporaba prema zahtjevu 1, naznačena time, da lijek sadrži farmaceutski prihvatljiv nosač i/ili jedno ili više pomoćnih sredstava.
11. Uporaba prema zahtjevu 1, naznačena time, da je ciklesonid odabran iz sljedeće skupine: [11β,16α-(R)]-16,17-[(cikloheksilmetilen)bis(oksi)]-11-hidroksi-21-(2-metil-1-oksopropoksi)pregna-1,4-dien-3,20-dion, [11β,16α-(S)]-16,17-[(cikloheksilmetilen)bis(oksi)]-11-hidroksi-21-(2-metil-1-oksopropoksi)pregna-1,4-dien-3,20-dion, [11β,16α-(R,S)]-16,17-[(cikloheksilmetilen)bis(oksi)]-11-hidroksi-21-(2-metil-1-oksopropoksi)pregna-1,4-dien-3,20-dion, 16α,17-(22R)-cikloheksilmetilendioksi-11β,21-dihidroksipregna-1,4-dien-3,20-dion, 16α,17-(22S)-cikloheksilmetilendioksi-11β,21-dihidroksipregna-1,4-dien-3,20-dion, i 16α,17-(22R,S)-cikloheksilmetilendioksi-11β,21-dihidroksipregna-1,4-dien-3,20-dion.
12. Uporaba prema zahtjevu 1, 4 ili 5, naznačena time, da doza lijeka je dnevna doza koja se primjenjuje jednom dnevno.
13. Uporaba prema zahtjevu 1, naznačena time, da je lijek prikladan za primjenu putem inhalacije.
14. Uporaba prema zahtjevu 13, naznačena time, da sastav lijeka je farmaceutska aerosolna formulacija koja sadrži djelotvornu količinu ciklesonida i hidrofluorokarbonski stlačeni plin (propelant), poželjno odabran od 1,1,1,2-tetrafluoroetana, 1,1,1,2,3,3,3-heptafluoropropana i njihovih mješavina, te kootapalo u djelotvornoj količini za rastapanje ciklesonida i opcijski tenzida.
15. Uporaba prema zahtjevu 14, naznačena time, da kootapalo je etanol.
16. Uporaba prema zahtjevu 13, naznačena time, da sastav lijeka je farmaceutska aerosolna formulacija koja sadrži čestice ciklesonida u terapeutski djelotvornoj količini i hidrofluorokarbonski stlačeni plin (propelant), poželjno odabran od 1,1,1,2-tetrafluoroetana, 1,1,1,2,3,3,3-heptafluoropropana i njihovih mješavina, te polarno kootapalo i opcijski tenzid u količini od 0,01 do 5 masenih % prema masi propelanta.
17. Uporaba prema zahtjevu 13, naznačena time, da sastav lijeka je suhi prašak i nosač je saharid.
18. Uporaba prema zahtjevu 13, naznačena time, da nosač je monohidrat laktoze.
19. Uporaba prema zahtjevu 1, naznačena time, da je bolest dišnih puteva odabrana iz skupine koju čine astma, noćna astma, astma inducirana napornom vježbom, kronična opstrukcijska plućna bolest (COPD), kronični i hripavi bronhitis, emfizem, upala respiratornog trakta i bolest gornjeg respiratornog trakta, rinitis, alergijski i sezonski rinitis.
20. Uporaba prema zahtjevu 1, naznačena time, da bolest dišnih puteva je slaba ili prosječna astma.
21. Uporaba prema zahtjevu 1, naznačena time, da se ciklesonid uglavnom sastoji od R-epimera.
22. Uporaba prema zahtjevu 1, naznačena time, da lijek je intranazalni sprej ili su to kapi za nos.
23. Uporaba prema zahtjevu 22, naznačena time, da lijek je vodena formulacija za primjenu na sluznicu.
24. Uporaba prema zahtjevu 22, naznačena time, da lijek je formuliran s ne-vodenim nosačima.
25. Uporaba prema zahtjevu 1, naznačena time, da bolest dišnih puteva je rinitis.
26. Uporaba prema zahtjevu 1, naznačena time, da bolest dišnih puteva je alergijski rinitis.
27. Uporaba prema zahtjevu 1, naznačena time, da bolest dišnih puteva je sezonski alergijski rinitis.
28. Uporaba prema zahtjevu 1, naznačena time, da dijete je čovjek u dobi ispod 18 godina.
29. Uporaba prema zahtjevu 1, 4 ili 5, naznačena time, da se primjenjuje količina ciklesonida kao dnevna doza.
30. Uporaba prema zahtjevu 15, naznačena time, da bolest dišnih puteva je astma, pri kojoj se doza sastava primjenjuje jednom dnevno, a sadrži 40, 80 ili 160 µg ciklesonida.
HRP20140257TT 2003-09-16 2014-03-18 Uporaba ciklesonida za liječenje bolesti dišnih puteva HRP20140257T4 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US50298403P 2003-09-16 2003-09-16
EP04766791.0A EP1670482B2 (en) 2003-09-16 2004-09-15 Use of ciclesonide for the treatment of respiratory diseases
PCT/EP2004/052172 WO2005025578A1 (en) 2003-09-16 2004-09-15 Use of ciclesonide for the treatment of respiratory diseases

Publications (2)

Publication Number Publication Date
HRP20140257T1 true HRP20140257T1 (hr) 2014-04-25
HRP20140257T4 HRP20140257T4 (hr) 2022-11-25

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HRP20140257TT HRP20140257T4 (hr) 2003-09-16 2014-03-18 Uporaba ciklesonida za liječenje bolesti dišnih puteva

Country Status (11)

Country Link
US (4) US8371292B2 (hr)
EP (1) EP1670482B2 (hr)
JP (2) JP5618452B2 (hr)
AU (1) AU2004271744B2 (hr)
CA (1) CA2538419C (hr)
DK (1) DK1670482T4 (hr)
ES (1) ES2452691T5 (hr)
HR (1) HRP20140257T4 (hr)
PL (1) PL1670482T5 (hr)
PT (1) PT1670482E (hr)
WO (1) WO2005025578A1 (hr)

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US20190290661A1 (en) 2019-09-26
US20070025923A1 (en) 2007-02-01
DK1670482T3 (en) 2014-03-17
CA2538419A1 (en) 2005-03-24
US8371292B2 (en) 2013-02-12
CA2538419C (en) 2012-07-03
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JP2012197306A (ja) 2012-10-18
PL1670482T5 (pl) 2022-10-03
JP2007505829A (ja) 2007-03-15
US20130143849A1 (en) 2013-06-06
ES2452691T3 (es) 2014-04-02
WO2005025578A1 (en) 2005-03-24
AU2004271744B2 (en) 2010-07-29
JP5618452B2 (ja) 2014-11-05
DK1670482T4 (da) 2022-08-22
US20220241297A1 (en) 2022-08-04
PL1670482T3 (pl) 2014-05-30
AU2004271744A1 (en) 2005-03-24
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HRP20140257T4 (hr) 2022-11-25
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