HRP20140257T4 - Uporaba ciklesonida za liječenje bolesti dišnih puteva - Google Patents

Uporaba ciklesonida za liječenje bolesti dišnih puteva Download PDF

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Publication number
HRP20140257T4
HRP20140257T4 HRP20140257TT HRP20140257T HRP20140257T4 HR P20140257 T4 HRP20140257 T4 HR P20140257T4 HR P20140257T T HRP20140257T T HR P20140257TT HR P20140257 T HRP20140257 T HR P20140257T HR P20140257 T4 HRP20140257 T4 HR P20140257T4
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HR
Croatia
Prior art keywords
use according
ciclesonide
diene
dione
dose
Prior art date
Application number
HRP20140257TT
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English (en)
Inventor
Thomas Bethke
Renate Engelstaetter
Wilhelm Wurst
Original Assignee
Covis Pharma Gmbh
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Application filed by Covis Pharma Gmbh filed Critical Covis Pharma 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 (18)

1. Uporaba ciklesonida, njegove farmaceutski prihvatljive soli ili solvata, naznačena time, da je za proizvodnju lijeka za liječenje ili prevenciju astme kod pacijenta, pri čemu pacijent je dijete, dok se smanjuje ili izbjegava zastoj u rastu koji je popratna pojava povezana s inhaliranim i intranazalno unesenim kortikosteroidima, i pritom je lijek prikladan za davanje putem inhalacije i primjenjuje se u dnevnoj dozi od 20 do 200µg ciklesonida u neprekidnom režimu liječenja.
2. Uporaba prema patentnom zahtjevu 1, naznačena time, da dijete je čovjek u predpubertetu.
3. Uporaba prema patentnom zahtjevu 1, naznačena time, da dijete je čovjek u dobi od 6 do 12 godina.
4. Uporaba prema patentnom zahtjevu 1, naznačena time, da se lijek primjenjuje u dozi od 20, 40, 60, 80, 100, 120, 140, 160, 180 ili 200µg ciklesonida.
5. Uporaba prema patentnom zahtjevu 1, naznačena time, da se lijek primjenjuje u dozi od 40, 80, 160µg ciklesonida.
6. Uporaba prema patentnom zahtjevu 1, naznačena time, da ona nema utjecaja na brzinu rasta pacijenta.
7. Uporaba prema patentnom zahtjevu 1, naznačena time, da lijek sadrži farmaceutski prihvatljiv nosač i/ili jedno ili više pomoćnih sredstava.
8. Uporaba prema patentnom zahtjevu 1, naznačena time, da se ciklesonid bira iz skupine od: [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-ksopropoksi)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.
9. Uporaba prema patentnom zahtjevu 1, 4 ili 5, naznačena time, da doza je dnevna doza koja se primjenjuje jednom dnevno.
10. Uporaba prema patentnom zahtjevu 1, naznačena time, da pripravak je farmaceutska aerosolna formulacija koja sadrži terapijski djelotvornu količinu ciklesonida i hidrofluorokarbonski pokretač, poželjno odabran od 1,1,1,2- tetrafluoroetana, 1,1,1,2,3,3,3-heptafluoropropana i njihove mješavine, te kootapalo u djelotvornoj količini za rastapanje ciklesonida i opcijski surfaktant.
11. Uporaba prema patentnom zahtjevu 10, naznačena time, da kootapalo jest etanol.
12. Uporaba prema patentnom zahtjevu 1, naznačena time, da pripravak je farmaceutska aerosolna formulacija koja sadrži čestice ciklesonida u terapijski djelotvornoj količini i hidrofluorokarbonski pokretač, poželjno odabran od 1,1,1,2- tetrafluoroetana, 1,1,1,2,3,3,3-heptafluoropropana i njihove mješavine, te polarno kootapalo i opcijski surfaktant u količini od 0,01 do 5 % po masi na temelju pokretača.
13. Uporaba prema patentnom zahtjevu 1, naznačena time, da pripravak je suhi prašak i nosač je saharid.
14. Uporaba prema patentnom zahtjevu 1, naznačena time, da nosač je monohidrat laktoze.
15. Uporaba prema patentnom zahtjevu 1, naznačena time, da astma je blaga ili umjerena astma.
16. Uporaba prema patentnom zahtjevu 1, naznačena time, da se ciklesonid u biti sastoji od R epimera.
17. Uporaba prema patentnom zahtjevu 1, naznačena time, da dijete je čovjek u dobi ispod 18 godina.
18. Uporaba prema patentnom zahtjevu 11, naznačena time, da se doza pripravka daje jednom dnevno i sadrži 40, 80 ili 160µg 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 HRP20140257T1 (hr) 2014-04-25
HRP20140257T4 true HRP20140257T4 (hr) 2022-11-25

Family

ID=34312429

Family Applications (1)

Application Number Title Priority Date Filing Date
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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BRPI0312377A8 (pt) 2002-07-02 2015-12-15 Altana Pharma Ag Suspensão aquosa estéril contendo ciclesonida
ATE405275T1 (de) 2002-12-12 2008-09-15 Nycomed Gmbh Kombinationsarzneimittel aus r,r-formoterol und ciclesonide
EP1452179A1 (en) 2003-02-27 2004-09-01 CHIESI FARMACEUTICI S.p.A. Novel medicament combination of a highly potent long-lasting beta2-agonist and a corticosteroid
CA2538419C (en) 2003-09-16 2012-07-03 Altana Pharma Ag Use of ciclesonide for the treatment of respiratory diseases

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CA2538419A1 (en) 2005-03-24
US8371292B2 (en) 2013-02-12
EP1670482A1 (en) 2006-06-21
JP2007505829A (ja) 2007-03-15
US20190290661A1 (en) 2019-09-26
EP1670482B1 (en) 2013-12-25
CA2538419C (en) 2012-07-03
US20220241297A1 (en) 2022-08-04
WO2005025578A1 (en) 2005-03-24
ES2452691T3 (es) 2014-04-02
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JP5618452B2 (ja) 2014-11-05
AU2004271744A1 (en) 2005-03-24
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US20070025923A1 (en) 2007-02-01
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