HRP20140257T4 - Uporaba ciklesonida za liječenje bolesti dišnih puteva - Google Patents
Uporaba ciklesonida za liječenje bolesti dišnih puteva Download PDFInfo
- 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
- Authority
- HR
- Croatia
- Prior art keywords
- use according
- ciclesonide
- diene
- dione
- dose
- Prior art date
Links
- LUKZNWIVRBCLON-GXOBDPJESA-N Ciclesonide Chemical compound C1([C@H]2O[C@@]3([C@H](O2)C[C@@H]2[C@@]3(C[C@H](O)[C@@H]3[C@@]4(C)C=CC(=O)C=C4CC[C@H]32)C)C(=O)COC(=O)C(C)C)CCCCC1 LUKZNWIVRBCLON-GXOBDPJESA-N 0.000 title claims 11
- 229960003728 ciclesonide Drugs 0.000 title claims 11
- 238000011282 treatment Methods 0.000 title claims 2
- 208000023504 respiratory system disease Diseases 0.000 title 1
- 239000003814 drug Substances 0.000 claims 5
- 229940079593 drug Drugs 0.000 claims 4
- 239000000203 mixture Substances 0.000 claims 4
- 208000006673 asthma Diseases 0.000 claims 3
- 239000006184 cosolvent Substances 0.000 claims 3
- -1 cyclohexylmethylene Chemical group 0.000 claims 3
- 239000003999 initiator Substances 0.000 claims 3
- YFMFNYKEUDLDTL-UHFFFAOYSA-N 1,1,1,2,3,3,3-heptafluoropropane Chemical compound FC(F)(F)C(F)C(F)(F)F YFMFNYKEUDLDTL-UHFFFAOYSA-N 0.000 claims 2
- LVGUZGTVOIAKKC-UHFFFAOYSA-N 1,1,1,2-tetrafluoroethane Chemical compound FCC(F)(F)F LVGUZGTVOIAKKC-UHFFFAOYSA-N 0.000 claims 2
- QIEPWCSVQYUPIY-LEKSSAKUSA-N Delta(1)-progesterone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H](C(=O)C)[C@@]1(C)CC2 QIEPWCSVQYUPIY-LEKSSAKUSA-N 0.000 claims 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical group CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 2
- 238000009472 formulation Methods 0.000 claims 2
- 239000008249 pharmaceutical aerosol Substances 0.000 claims 2
- 239000004094 surface-active agent Substances 0.000 claims 2
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical group O.O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 claims 1
- 206010053759 Growth retardation Diseases 0.000 claims 1
- 239000012752 auxiliary agent Substances 0.000 claims 1
- 125000000837 carbohydrate group Chemical group 0.000 claims 1
- 239000003246 corticosteroid Substances 0.000 claims 1
- 229960001334 corticosteroids Drugs 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 231100000001 growth retardation Toxicity 0.000 claims 1
- 229960001021 lactose monohydrate Drugs 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000012453 solvate Substances 0.000 claims 1
- 238000011269 treatment regimen Methods 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0075—Sprays 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/008—Sprays 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]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
Landscapes
- 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.
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) |
Families Citing this family (15)
Publication number | Priority date | Publication date | Assignee | Title |
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ATE405275T1 (de) * | 2002-12-12 | 2008-09-15 | Nycomed Gmbh | Kombinationsarzneimittel aus r,r-formoterol und ciclesonide |
CA2538419C (en) * | 2003-09-16 | 2012-07-03 | Altana Pharma Ag | Use of ciclesonide for the treatment of respiratory diseases |
PE20050941A1 (es) | 2003-12-16 | 2005-11-08 | Nycomed Gmbh | Suspensiones acuosas de ciclesonida para nebulizacion |
EP1720577A2 (en) * | 2004-02-27 | 2006-11-15 | Altana Pharma AG | Ciclesonide and glycopyrronium combination |
WO2005102354A1 (en) * | 2004-04-20 | 2005-11-03 | Altana Pharma Ag | Use of ciclesonide for the treatment of respiratory diseases in a smoking patient |
WO2007092574A2 (en) * | 2006-02-08 | 2007-08-16 | Sicor, Inc. | Crystalline forms of ciclesonide |
KR20100072295A (ko) * | 2007-10-25 | 2010-06-30 | 머크 프로스트 캐나다 리미티드 | 병용 요법 |
ES2471145T3 (es) * | 2009-03-09 | 2014-06-25 | Mikasa Seiyaku Co,. Ltd. | Compuesto esteroide |
AU2012296880A1 (en) | 2011-08-18 | 2014-03-27 | Astrazeneca Ab | Pharmaceutical aerosol product for administration by oral or nasal inhalation |
NZ706573A (en) | 2012-12-21 | 2019-11-29 | Boehringer Ingelheim Vetmedica Gmbh | Ciclesonide for the treatment of airway disease in horses |
LT2934544T (lt) | 2012-12-21 | 2019-02-25 | Boehringer Ingelheim Vetmedica Gmbh | Farmacinė kompozicija, apimanti ciklezonidą |
KR102618119B1 (ko) | 2014-06-18 | 2023-12-27 | 베링거잉겔하임베트메디카게엠베하 | 말의 기도 질환의 치료를 위한 무스카린 길항제 및 이의 병용물 |
CN109219463B (zh) * | 2016-03-24 | 2021-05-11 | 阿诺尔德·琼·兹杜卡医疗服务有限公司 | 用于将颗粒输送到上呼吸道中的装置和方法 |
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-
2004
- 2004-09-15 CA CA2538419A patent/CA2538419C/en not_active Expired - Fee Related
- 2004-09-15 US US10/571,311 patent/US8371292B2/en active Active
- 2004-09-15 AU AU2004271744A patent/AU2004271744B2/en active Active
- 2004-09-15 EP EP04766791.0A patent/EP1670482B2/en active Active
- 2004-09-15 WO PCT/EP2004/052172 patent/WO2005025578A1/en active Application Filing
- 2004-09-15 JP JP2006525842A patent/JP5618452B2/ja active Active
- 2004-09-15 PT PT47667910T patent/PT1670482E/pt unknown
- 2004-09-15 ES ES04766791T patent/ES2452691T5/es active Active
- 2004-09-15 DK DK04766791.0T patent/DK1670482T4/da active
- 2004-09-15 PL PL04766791.0T patent/PL1670482T5/pl unknown
-
2012
- 2012-06-18 JP JP2012137341A patent/JP2012197306A/ja active Pending
-
2013
- 2013-01-18 US US13/744,962 patent/US20130143849A1/en not_active Abandoned
-
2014
- 2014-03-18 HR HRP20140257TT patent/HRP20140257T4/hr unknown
-
2019
- 2019-06-13 US US16/440,557 patent/US20190290661A1/en not_active Abandoned
-
2021
- 2021-09-10 US US17/447,302 patent/US20220241297A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
AU2004271744B2 (en) | 2010-07-29 |
DK1670482T4 (da) | 2022-08-22 |
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 |
PT1670482E (pt) | 2014-03-12 |
JP5618452B2 (ja) | 2014-11-05 |
AU2004271744A1 (en) | 2005-03-24 |
PL1670482T3 (pl) | 2014-05-30 |
PL1670482T5 (pl) | 2022-10-03 |
US20070025923A1 (en) | 2007-02-01 |
HRP20140257T1 (hr) | 2014-04-25 |
ES2452691T5 (es) | 2022-09-14 |
JP2012197306A (ja) | 2012-10-18 |
DK1670482T3 (en) | 2014-03-17 |
US20130143849A1 (en) | 2013-06-06 |
EP1670482B2 (en) | 2022-06-29 |
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