HRP20190747T1 - Uređaj za inhalaciju - Google Patents

Uređaj za inhalaciju Download PDF

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Publication number
HRP20190747T1
HRP20190747T1 HRP20190747TT HRP20190747T HRP20190747T1 HR P20190747 T1 HRP20190747 T1 HR P20190747T1 HR P20190747T T HRP20190747T T HR P20190747TT HR P20190747 T HRP20190747 T HR P20190747T HR P20190747 T1 HRP20190747 T1 HR P20190747T1
Authority
HR
Croatia
Prior art keywords
aqueous solution
use according
colistimethate
sodium
solution
Prior art date
Application number
HRP20190747TT
Other languages
English (en)
Inventor
Nenad BENCIC
Original Assignee
Xellia Pharmaceuticals Aps
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.)
Filing date
Publication date
Application filed by Xellia Pharmaceuticals Aps filed Critical Xellia Pharmaceuticals Aps
Publication of HRP20190747T1 publication Critical patent/HRP20190747T1/hr

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Classifications

    • 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
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • 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
    • A61K9/0078Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/001Particle size control
    • A61M11/003Particle size control by passing the aerosol trough sieves or filters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • 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
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/08Bronchodilators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Dispersion Chemistry (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Otolaryngology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Manipulator (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (22)

1. Uređaj za plućnu primjenu, koji sadrži jedinicu mlaznice jedinicu mlaznice za raspršivanje i patronu koja sadrži vodenu otopinu sastavljenu od 80 do 400 mg A/mL sulfometiliranog polimiksina.
2. Uređaj sukladno patentnom zahtjevu 1, pri čemu je sulfometilizirani polimiksin kolistimetat natrij.
3. Uređaj sukladno patentnom zahtjevu 1 ili 2, pri čemu je koncentracija sulfometiliziranog polimiksina u rasponu od 80 do 200 mg A/mL.
4. Uređaj sukladno patentnom zahtjevu 2 , pri čemu koncentracija kolistimetat natrij u rasponu od 80 do 120 mg A/mL.
5. Uređaj sukladno patentnom zahtjevu 2, pri čemu koncentracija kolistimetat natrija u rasponu od 85 do 113 mg A/mL.
6. Uređaj sukladno patentnom zahtjevu 2-5, pri čemu ta patrona ima nominalnu vrijednost od 0,5-1,5 mL.
7. Vodeni rastvor koji obuhvata od 80 do 400 mg A/mL sulfometilisanog polimiksina za upotrebu u terapijskom ili profilaktičkom liječenju bakterijske infekcije u plućnom sistemu, pri čemu je ta supstanca/ otopina za isporuku u pluća.
8. Otopina za uporabu sukladno patentnom zahtjevu 7, pri čemu je sulfometilizirani polimiksin kolistimetat natrij.
9. Otopina za uporabu sukladno patentnom zahtjevu 7 ili 8, pri čemu je koncentracija sulfometiliziranog polimiksina u rasponu od 90 do 150 mg A/mL.
10. Otopina za uporabu sukladno patentnom zahtjevu 8, pri čemu je koncentracija kolistimetat natrija u rasponu od 90 do 110 mg A/mL.
11. Otopina za uporabu sukladno patentnom zahtjevu 8, pri čemu je koncentracija kolistimetat natrija u rasponu od 90 do 100 mg A/mL.
12. Otopina za uporabu sukladno patentnom zahtjevu 7-11, pri čemu ta patrona ima nominalni volumen od 0,5-1,5 mL.
13. Vodena otopina za uporabu sukladno patentnom zahtjevu 7-12 pri čemu isporuka pacijentu, sadrži: pokretanje inhalatora koji sadrži jedinicu s mlaznicom za raspršivanje i patronu koja sadrži vodenu otopinu i davanje vodene otopine pacijentu u obliku kapiljica koje imaju srednju aerodinamičku masu promjera od 4 do 8 µm.
14. Vodena otopina za uporabu sukladno patentnom zahtjevu 13 pri čemu je srednja aerodinamička masa kapiljica promjera od 5,5 do 7,5 µm.
15. Vodena otopina za uporabu sukladno patentnom zahtjevu 13-14, naznačena time, da jedinica mlaznice za raspršivanje ima otvore promjera od 1,5 do 2,2 mm.
16. Vodena otopina za uporabu sukladno patentnom zahtjevu 7-14, pri čemu je bakterijska infekcija prouzročena gram negativnim bakterijama.
17. Vodena otopina za uporabu sukladno bilo kojem patentnom zahtjevu 7-8 i 12-16, pri čemu vodena otopina sadrži od 80 do 120 mg A/mL kolistimetat natrija.
18. Vodena otopina za uporabu sukladno patentnom zahtjevu 17, pri čemu vodena otopina sadrži od 85 do 113 mg A/mL kolistimetat natrija.
19. Vodena otopina za uporabu sukladno patentnom zahtjevu 16, pri čemu su te gram negativne bakterije Enterobacter aerogenes, Escherichia coli, Klebsiella pneumonaiae, Pseudomonas aeruginosa, ili njihova kombinacija.
20. Vodena otopina za uporabu sukladno patentnom zahtjevu 13, pri čemu pacijent pati od kroničnog poremećaja pluća.
21. Vodena otopina za uporabu sukladno patentnom zahtjevu 20, pri čemu se kronični poremećaj pluća odabire iz skupine bolesti kao što je astma, cistična fibroza (CF), necistična fizbrozna bronhiektazija, kronične opstruktivna bolest pluća, ili njihova kombinacija.
22. Vodena otopina za uporabu sukladno patentnom zahtjevu 11, pri čemu isporuka pacijentu sadrži: aktiviranje inhalatora sadrži jedinicu mlaznice za raspršivanje koja s presjekom otvora od 1,7-2,0 µm i patronu koja sadrži vodenu otopinu; i isporuku vodene otopine pacijentu u obliku kapiljica srednjeg aerodinamičke mase presjeka od 4 do 8 µm s protokom zraka od 15-20 L/min.
HRP20190747TT 2014-10-03 2019-04-23 Uređaj za inhalaciju HRP20190747T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462059748P 2014-10-03 2014-10-03
PCT/EP2015/072736 WO2016050933A1 (en) 2014-10-03 2015-10-01 Inhalation device
EP15774606.6A EP3200762B1 (en) 2014-10-03 2015-10-01 Inhalation device

Publications (1)

Publication Number Publication Date
HRP20190747T1 true HRP20190747T1 (hr) 2019-07-12

Family

ID=54249495

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20190747TT HRP20190747T1 (hr) 2014-10-03 2019-04-23 Uređaj za inhalaciju

Country Status (26)

Country Link
US (1) US11033602B2 (hr)
EP (2) EP3200762B1 (hr)
JP (1) JP6626890B2 (hr)
KR (1) KR102494511B1 (hr)
CN (1) CN106999542B (hr)
AU (1) AU2015326847B2 (hr)
BR (1) BR112017006816A2 (hr)
CA (1) CA2962120C (hr)
CO (1) CO2017004442A2 (hr)
CY (1) CY1121803T1 (hr)
DK (1) DK3200762T3 (hr)
ES (1) ES2721401T3 (hr)
HR (1) HRP20190747T1 (hr)
HU (1) HUE044289T2 (hr)
IL (1) IL251480B (hr)
LT (1) LT3200762T (hr)
MX (1) MX2017004175A (hr)
PH (1) PH12017500538A1 (hr)
PL (1) PL3200762T3 (hr)
PT (1) PT3200762T (hr)
RS (1) RS58792B1 (hr)
RU (1) RU2702335C2 (hr)
SG (1) SG11201702666SA (hr)
SI (1) SI3200762T1 (hr)
TR (1) TR201906108T4 (hr)
WO (1) WO2016050933A1 (hr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL3200827T3 (pl) 2014-10-03 2020-12-14 Xellia Pharmaceuticals Aps Kompozycje
CN112546030A (zh) * 2019-09-26 2021-03-26 盈科瑞(天津)创新医药研究有限公司 一种吸入用多粘菌素e甲磺酸钠溶液及其制备方法
US20230052317A1 (en) * 2021-08-05 2023-02-16 Zambon S.P.A. Treatment of non-cystic fibrosis bronchiectasis

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PL3200827T3 (pl) 2014-10-03 2020-12-14 Xellia Pharmaceuticals Aps Kompozycje

Also Published As

Publication number Publication date
PH12017500538A1 (en) 2017-08-07
JP6626890B2 (ja) 2019-12-25
PT3200762T (pt) 2019-05-28
EP3520777B1 (en) 2020-09-30
EP3200762A1 (en) 2017-08-09
EP3200762B1 (en) 2019-03-27
IL251480A0 (en) 2017-05-29
LT3200762T (lt) 2019-06-10
AU2015326847B2 (en) 2018-11-29
EP3520777A1 (en) 2019-08-07
CN106999542B (zh) 2021-02-02
US20190022171A1 (en) 2019-01-24
AU2015326847A1 (en) 2017-04-13
DK3200762T3 (da) 2019-05-06
RU2702335C2 (ru) 2019-10-08
CA2962120A1 (en) 2016-04-07
RU2017114144A3 (hr) 2019-04-17
KR20170062521A (ko) 2017-06-07
CN106999542A (zh) 2017-08-01
CY1121803T1 (el) 2020-07-31
ES2721401T3 (es) 2019-07-31
TR201906108T4 (tr) 2019-05-21
SI3200762T1 (sl) 2019-08-30
CA2962120C (en) 2023-09-19
PL3200762T3 (pl) 2019-08-30
RS58792B1 (sr) 2019-07-31
CO2017004442A2 (es) 2017-09-29
KR102494511B1 (ko) 2023-01-31
WO2016050933A1 (en) 2016-04-07
US11033602B2 (en) 2021-06-15
JP2017530138A (ja) 2017-10-12
MX2017004175A (es) 2017-08-28
HUE044289T2 (hu) 2019-10-28
IL251480B (en) 2019-09-26
SG11201702666SA (en) 2017-04-27
RU2017114144A (ru) 2018-11-06
BR112017006816A2 (pt) 2018-01-09

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