HRP20221529T1 - Sastavi za inhalaciju za upotrebu u liječenju plućnih bolesti - Google Patents
Sastavi za inhalaciju za upotrebu u liječenju plućnih bolesti Download PDFInfo
- Publication number
- HRP20221529T1 HRP20221529T1 HRP20221529TT HRP20221529T HRP20221529T1 HR P20221529 T1 HRP20221529 T1 HR P20221529T1 HR P20221529T T HRP20221529T T HR P20221529TT HR P20221529 T HRP20221529 T HR P20221529T HR P20221529 T1 HRP20221529 T1 HR P20221529T1
- Authority
- HR
- Croatia
- Prior art keywords
- pharmaceutical composition
- use according
- filter
- liquid
- aerosol
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 9
- 208000019693 Lung disease Diseases 0.000 title claims 6
- 239000008194 pharmaceutical composition Substances 0.000 claims 32
- 239000007788 liquid Substances 0.000 claims 17
- 239000000443 aerosol Substances 0.000 claims 13
- 229930105110 Cyclosporin A Natural products 0.000 claims 10
- PMATZTZNYRCHOR-CGLBZJNRSA-N Cyclosporin A Chemical compound CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O PMATZTZNYRCHOR-CGLBZJNRSA-N 0.000 claims 10
- 108010036949 Cyclosporine Proteins 0.000 claims 10
- 229960001265 ciclosporin Drugs 0.000 claims 9
- 239000012528 membrane Substances 0.000 claims 8
- 206010029888 Obliterative bronchiolitis Diseases 0.000 claims 6
- 201000003848 bronchiolitis obliterans Diseases 0.000 claims 6
- 208000023367 bronchiolitis obliterans with obstructive pulmonary disease Diseases 0.000 claims 6
- 239000000126 substance Substances 0.000 claims 5
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 4
- 229930006000 Sucrose Natural products 0.000 claims 4
- 239000012530 fluid Substances 0.000 claims 4
- 239000000463 material Substances 0.000 claims 4
- 150000003904 phospholipids Chemical class 0.000 claims 4
- 239000005720 sucrose Substances 0.000 claims 4
- 239000004480 active ingredient Substances 0.000 claims 3
- 210000004072 lung Anatomy 0.000 claims 3
- 239000002736 nonionic surfactant Substances 0.000 claims 3
- 230000002265 prevention Effects 0.000 claims 3
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 2
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 claims 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound 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 GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 2
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 2
- 230000004308 accommodation Effects 0.000 claims 2
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 2
- 239000007864 aqueous solution Substances 0.000 claims 2
- 208000006673 asthma Diseases 0.000 claims 2
- 230000001684 chronic effect Effects 0.000 claims 2
- 150000002016 disaccharides Chemical class 0.000 claims 2
- 201000010099 disease Diseases 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 230000001506 immunosuppresive effect Effects 0.000 claims 2
- 239000008101 lactose Substances 0.000 claims 2
- 239000000787 lecithin Substances 0.000 claims 2
- 235000010445 lecithin Nutrition 0.000 claims 2
- 229940067606 lecithin Drugs 0.000 claims 2
- 239000006199 nebulizer Substances 0.000 claims 2
- 229920000136 polysorbate Polymers 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- PZNPLUBHRSSFHT-RRHRGVEJSA-N 1-hexadecanoyl-2-octadecanoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCCCC(=O)O[C@@H](COP([O-])(=O)OCC[N+](C)(C)C)COC(=O)CCCCCCCCCCCCCCC PZNPLUBHRSSFHT-RRHRGVEJSA-N 0.000 claims 1
- 206010035664 Pneumonia Diseases 0.000 claims 1
- 230000001154 acute effect Effects 0.000 claims 1
- 206010006451 bronchitis Diseases 0.000 claims 1
- 238000006243 chemical reaction Methods 0.000 claims 1
- 230000002708 enhancing effect Effects 0.000 claims 1
- 230000003176 fibrotic effect Effects 0.000 claims 1
- 229940042880 natural phospholipid Drugs 0.000 claims 1
- 210000000056 organ Anatomy 0.000 claims 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- 229920000053 polysorbate 80 Polymers 0.000 claims 1
- 229940068968 polysorbate 80 Drugs 0.000 claims 1
- 229940068965 polysorbates Drugs 0.000 claims 1
- 238000004626 scanning electron microscopy Methods 0.000 claims 1
- 239000008347 soybean phospholipid Substances 0.000 claims 1
- 238000005507 spraying Methods 0.000 claims 1
- 238000002054 transplantation Methods 0.000 claims 1
Classifications
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/127—Liposomes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
- A61K38/13—Cyclosporins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/0078—Sprays 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0005—Details of inhalators; Constructional features thereof with means for agitating the medicament
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0018—Details of inhalators; Constructional features thereof with exhalation check valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0021—Mouthpieces therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M15/00—Inhalators
- A61M15/0085—Inhalators using ultrasonics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M15/00—Inhalators
- A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
-
- 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
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Pulmonology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Dispersion Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Hematology (AREA)
- Heart & Thoracic Surgery (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Otolaryngology (AREA)
- Gastroenterology & Hepatology (AREA)
- Transplantation (AREA)
- Molecular Biology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (25)
1. Farmaceutski sastav koji sadrži ciklosporin A u liposomski solubiliziranom obliku (L-CsA) za upotrebu u prevenciji ili liječenju plućne bolesti ili stanja kod subjekta,
pri čemu se farmaceutski sastav daje subjektu inhalacijom u obliku aerosola, pri čemu se aerosol stvara raspršivanjem farmaceutskog sastava upotrebom raspršivača (100), pri čemu raspršivač sadrži:
a) generator aerosola (101) koji sadrži:
- spremnik tekućine (103) za čuvanje farmaceutskog sastava ili sučelje konfigurirano za povezivanje spremnika tekućine, i
- vibrirajuću membranu (110) koja ima mnoštvo otvora, a otvori su prilagođeni za proizvodnju aerosola koji sadrži kapljice sa srednjim aerodinamičkim promjerom mase (MMAD) do oko 4,0 μm mjereno s 0,9 % (w/v) vodenom otopinom natrijeva klorida;
b) komoru (105) za privremeno smještanje aerosola kojeg stvara generator aerosola (101), komora ima unutarnji lumen s volumenom u rasponu od oko 50 do oko 150 ml; i
c) nastavak za usta (40) za isporuku aerosola subjektu pomoću raspršivača (100), nastavak za usta ima filter za izdisaj (30);
pri čemu nastavak za usta (40) sadrži:
tijelo (46) koje određuje putanju tekućine (47) od ulaznog otvora (41) koji se može spojiti na raspršivač (100) do otvora za inhalaciju (42) koji se prima u usta korisnika; i
filter za izdisanje (30) koji ima bazu filtera (31) u tekućem protoku s putanjom tekućine (47), vrh filtera (33) koji je odvojivo povezan s bazom filtera (31) i materijal filtera (32) postavljen između baze filtera (31) i vrha filtera (33), pri čemu vrh filtera (33) ima otvor za izdisaj (36) koji surađuje s jednosmjernim ventilom (39) koji omogućuje ispuštanje tekućine iz putanje tekućine (47) kroz materijal filtera (32) prema vanjskoj strani nastavka za usta (40) kod izdisaja pacijenta kroz otvor za udisanje;
pri čemu su tijelo (46) i baza filtera (31) integrirana jednodijelna jedinica.
2. Farmaceutski sastav za upotrebu prema patentnom zahtjevu 1, pri čemu je plućna bolest ili stanje odabrano iz skupine koja se sastoji od astme, refraktorne astme, kroničnog opstruktivnog bronhitisa, parenhimskih, fibrotičnih i intersticijskih bolesti i upala pluća, bronhiolitisa obliteransa (BOS) i akutne i kronične reakcije odbacivanja presađenog organa nakon transplantacije pluća i bolesti koje iz toga proizlaze.
3. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, pri čemu je plućna bolest ili stanje bronhiolitis obliterans (BOS) stupnja I. ili višeg, specifično BOS stupnja I. ili II., posebno BOS stupnja I.
4. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, koji sadrži ciklosporin A u koncentraciji u rasponu od oko 1 mg/ml do oko 10 mg/ml.
5. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, pri čemu tekući vodeni sastav sadrži ciklosporin A u liposomski solubiliziranom obliku (L-CsA) u koncentraciji u rasponu od oko 3 mg/ml do oko 5 mg/ml.
6. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, pri čemu je sastav tekući sastav koji sadrži vodeni tekući nosač.
7. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, pri čemu je vodeni tekući sastav koji sadrži ciklosporin A u liposomski solubiliziranom obliku dobiven rekonstitucijom liofilizata koji sadrži ciklosporin A i struktura koje tvore liposome.
8. Farmaceutski sastav za upotrebu prema patentnom zahtjevu 7, pri čemu strukture koje tvore liposome sadrže dvoslojnu membranu sastavljenu od tvari koje tvore membranu odabrane iz skupine fosfolipida.
9. Farmaceutski sastav za upotrebu prema patentnom zahtjevu 8, pri čemu je tvar koja tvori membranu, odabrana iz skupine fosfolipida, mješavina prirodnih fosfolipida.
10. Farmaceutski sastav za uporabu prema patentnom zahtjevu 8 ili 9, pri čemu je tvar koja tvori membranu, odabrana iz skupine fosfolipida, lecitin odabran iz skupine koja se sastoji od sojinog lecitina, Lipoid S75, Lipoid S100, Phospholipon® G90, 100 ili usporedivi lecitin.
11. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, pri čemu sastav dalje sadrži najmanje jednu tvar za povećanje topljivosti odabranu iz skupine ne-ionskih površinski aktivnih tvari.
12. Farmaceutski sastav za upotrebu prema patentnom zahtjevu 11, pri čemu je najmanje jedna ne-ionska površinski aktivna tvar odabrana iz skupine polisorbata.
13. Farmaceutski sastav za upotrebu prema patentnom zahtjevu 11 ili 12, pri čemu je tvar za povećanje topljivosti odabran iz skupine ne-ionskih površinski aktivnih tvari polisorbat 80.
14. Farmaceutski sastav za upotrebu prema patentnom zahtjevu 12 ili 13, pri čemu je maseni udio fosfolipida prema polisorbatu odabran u rasponu od oko 15:1 do oko 9:1, poželjno između oko 14:1 do oko 12:1, na primjer, oko 13:1.
15. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, pri čemu sastav sadrži najmanje jedan disaharid odabran iz skupine koju čine saharoza, laktoza i trehaloza, poželjno saharoza.
16. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, pri čemu sastav sadrži najmanje jedan disaharid odabran iz skupine koju čine saharoza, laktoza i trehaloza, poželjno saharoza, u rasponu od oko 5 do oko 15 mas.-%, poželjno u rasponu od oko 7,5 do oko 12,5 mas.-% temeljeno na ukupnoj masi farmaceutskog sastava.
17. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, pri čemu vibrirajuća membrana (110) ima od oko 100 do oko 400 otvora po mm2.
18. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, pri čemu mnoštvo otvora vibrirajuće membrane (110) ima konusni oblik koji se sužava prema strani otpuštanja aerosola vibrirajuće membrane.
19. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, pri čemu otvori vibrirajuće membrane imaju izlazni promjer u rasponu od oko 1,5 μm do oko 3,0 μm kako je izmjereno skenirajućom elektronskom mikroskopijom (SEM).
20. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, pri čemu se ciklosporin A isporučuje u pluća (ili plućno krilo) subjekta u količini (isporučena doza, DD) od najmanje 70%, točnije u količini u rasponu od oko 70% do oko 80% količine koja se daje subjektu.
21. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, pri čemu se inhalabilni imunosupresivni makrociklički aktivni sastojak daje subjektu ukupnom izlaznom brzinom (TOR) od najmanje 200 mg/min, točnije pri ukupnoj izlaznoj brzini u rasponu od oko 200 do oko 250 mg/min.
22. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, pri čemu je količina ciklosporina A koju subjekt izdahne do 10%, točnije od oko 4% do oko 8% ukupne količine aktivnog sastojka koji se daje subjektu.
23. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, pri čemu je 1 ml farmaceutskog sastava koji sadrži ciklosporin A raspršen (nebuliziran) unutar perioda od oko 5 min.
24. Komplet koji sadrži
- farmaceutski sastav koji sadrži ciklosporin A u liposomski solubiliziranom obliku za upotrebu u prevenciji ili liječenju plućne bolesti ili stanja kod subjekta; i
- raspršivač (100), pri čemu raspršivač sadrži:
a) generator aerosola (101) koji sadrži:
- spremnik tekućine (103) za čuvanje farmaceutskog sastava ili sučelje konfigurirano za povezivanje spremnika tekućine, i
- vibrirajuću membranu (110) koja ima mnoštvo otvora, otvori su prilagođeni za proizvodnju aerosola koji sadrži kapljice koje imaju srednji maseni aerodinamički promjer (MMAD) do oko 4,0 μm, mjereno s 0,9 % (w/v) vodenom otopinom natrijevog klorida;
b) komoru (105) za privremeno smještanje aerosola kojeg stvara generator aerosola (101), pri čemu komora ima unutarnji lumen s volumenom u rasponu od oko 50 do oko 150 ml;
c) nastavak za usta (40) za isporuku aerosola subjektu pomoću raspršivača (100), nastavak za usta s filtrom za izdisaj (30)
pri čemu nastavak za usta (40) sadrži:
tijelo (46) koje određuje putanju tekućine (47) od ulaznog otvora (41) koji se može spojiti na raspršivač (100) do otvora za inhalaciju (42) koji se prima u usta korisnika; i
filter za izdisanje (30) koji ima bazu filtera (31) u tekućem protoku s putanjom tekućine (47), vrh filtera (33) koji je odvojivo povezan s bazom filtera (31) i materijal filtera (32) postavljen između baze filtera (31) i vrha filtera (33), pri čemu vrh filtera (33) ima otvor za izdisaj (36) koji surađuje s jednosmjernim ventilom (39) koji omogućuje ispuštanje tekućine iz putanje tekućine (47) kroz materijal filtera (32) prema vanjskoj strani nastavka za usta (40) pri izdisaju pacijenta kroz otvor za udisanje;
pri čemu su tijelo (46) i baza filtera (31) integrirana jednodijelna jedinica.
25. Komplet prema patentnom zahtjevu 24, pri čemu je farmaceutski sastav koji sadrži ciklosporin A u liposomski solubiliziranom obliku za upotrebu u prevenciji ili liječenju plućne bolesti ili stanja kod subjekta u obliku liofilizata koji sadrži inhalabilni imunosupresivni makrociklički aktivni sastojak i sterilni tekući vodeni tekući nosač za rekonstituciju liofilzata za dobivanje tekućeg farmaceutskog sastava.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP18210255 | 2018-12-04 | ||
| EP19813329.0A EP3890767B1 (en) | 2018-12-04 | 2019-12-03 | Inhalable compositions for use in the treatment of pulmonary diseases |
| PCT/EP2019/083470 WO2020115032A1 (en) | 2018-12-04 | 2019-12-03 | Inhalable compositions for use in the treatment of pulmonary diseases |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20221529T1 true HRP20221529T1 (hr) | 2023-02-17 |
Family
ID=64606777
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20221529TT HRP20221529T1 (hr) | 2018-12-04 | 2019-12-03 | Sastavi za inhalaciju za upotrebu u liječenju plućnih bolesti |
Country Status (22)
| Country | Link |
|---|---|
| US (3) | US11419819B2 (hr) |
| EP (1) | EP3890767B1 (hr) |
| JP (1) | JP7285930B2 (hr) |
| KR (1) | KR102475644B1 (hr) |
| CN (3) | CN113164553B (hr) |
| AU (1) | AU2019392626B2 (hr) |
| BR (1) | BR112021010756A2 (hr) |
| CA (1) | CA3121362C (hr) |
| CO (1) | CO2021007141A2 (hr) |
| EA (2) | EA202092892A1 (hr) |
| ES (1) | ES2932966T3 (hr) |
| FI (1) | FI3890767T3 (hr) |
| HR (1) | HRP20221529T1 (hr) |
| HU (1) | HUE060322T2 (hr) |
| IL (1) | IL283469B (hr) |
| LT (1) | LT3890767T (hr) |
| MX (1) | MX2021006585A (hr) |
| PL (1) | PL3890767T3 (hr) |
| PT (1) | PT3890767T (hr) |
| RS (1) | RS63847B1 (hr) |
| SI (1) | SI3890767T1 (hr) |
| WO (1) | WO2020115032A1 (hr) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3069711A1 (en) * | 2015-03-16 | 2016-09-21 | PARI Pharma GmbH | Cyclosporine formulations for use in the prevention or treatment of pulmonary chronic graft rejection |
| EP4249022A1 (en) * | 2022-03-21 | 2023-09-27 | PARI Pharma GmbH | Drug-device combination |
| CN115006656A (zh) * | 2022-05-18 | 2022-09-06 | 苏州易合医药有限公司 | 一种可连续提供肺部活性剂粉雾剂的给药装置 |
Family Cites Families (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4857319A (en) | 1985-01-11 | 1989-08-15 | The Regents Of The University Of California | Method for preserving liposomes |
| US5049388A (en) * | 1986-11-06 | 1991-09-17 | Research Development Foundation | Small particle aerosol liposome and liposome-drug combinations for medical use |
| US5958378A (en) | 1996-07-03 | 1999-09-28 | Research Development Foundation | High dose liposomal aerosol formulations containing cyclosporin A or budesonide |
| TW497974B (en) | 1996-07-03 | 2002-08-11 | Res Dev Foundation | High dose liposomal aerosol formulations |
| IT1289938B1 (it) | 1997-02-20 | 1998-10-19 | Angelini Ricerche Spa | Preparazione farmaceutica comprendente liposomi liofilizzati in cui e' incapsulato un principio attivo altamente insolubile in acqua e |
| WO2000027455A1 (en) * | 1998-11-06 | 2000-05-18 | Salter Labs | Nebulizer mouthpiece and accessories |
| US6962151B1 (en) | 1999-11-05 | 2005-11-08 | Pari GmbH Spezialisten für effektive Inhalation | Inhalation nebulizer |
| US7971588B2 (en) | 2000-05-05 | 2011-07-05 | Novartis Ag | Methods and systems for operating an aerosol generator |
| DE10102846B4 (de) | 2001-01-23 | 2012-04-12 | Pari Pharma Gmbh | Aerosolgenerator |
| DE10347994A1 (de) * | 2003-10-15 | 2005-06-16 | Pari GmbH Spezialisten für effektive Inhalation | Wässrige Aerosol-Zubereitung |
| US7452524B2 (en) * | 2004-01-27 | 2008-11-18 | Gilead Sciences, Inc. | Method for improvement of tolerance for therapeutically effective agents delivered by inhalation |
| US20060110441A1 (en) * | 2004-10-28 | 2006-05-25 | Harry Wong | Lyophilized liposome formulations and method |
| DE102005038619A1 (de) | 2005-08-16 | 2007-02-22 | Pari GmbH Spezialisten für effektive Inhalation | Inhalationstherapievorrichtung mit einer Ampulle für die Bevorratung eines zu vernebelnden Medikaments |
| DE102006051512A1 (de) * | 2005-12-06 | 2007-06-14 | Pari GmbH Spezialisten für effektive Inhalation | Pharmazeutische Medikamentenzusammensetzungen mit Cyclosporin |
| WO2007067784A2 (en) | 2005-12-08 | 2007-06-14 | Wyeth | Liposomal compositions |
| EP1927373B1 (en) | 2006-11-30 | 2012-08-22 | PARI Pharma GmbH | Inhalation nebulizer |
| ES2452935T3 (es) * | 2008-04-04 | 2014-04-03 | Nektar Therapeutics | Dispositivo de aerosolización |
| EP2608829A4 (en) | 2010-08-23 | 2015-11-18 | Darren Rubin | SYSTEMS AND METHODS FOR AEROSOL SUPPLY WITH AIRFLOW REGULATION |
| US9719184B2 (en) * | 2010-12-28 | 2017-08-01 | Stamford Devices Ltd. | Photodefined aperture plate and method for producing the same |
| HRP20220158T1 (hr) * | 2012-05-21 | 2022-04-15 | Insmed Incorporated | Sustavi za liječenje plućnih infekcija |
| US9677919B2 (en) * | 2014-11-26 | 2017-06-13 | Rosemount Inc. | Gauge display system |
| EP3069711A1 (en) | 2015-03-16 | 2016-09-21 | PARI Pharma GmbH | Cyclosporine formulations for use in the prevention or treatment of pulmonary chronic graft rejection |
| US9566399B1 (en) * | 2015-04-14 | 2017-02-14 | Clempharma LLC | Deep lung alveolar aerosol targeted drug delivery |
-
2019
- 2019-06-25 EA EA202092892A patent/EA202092892A1/ru unknown
- 2019-12-03 HR HRP20221529TT patent/HRP20221529T1/hr unknown
- 2019-12-03 CN CN201980080782.5A patent/CN113164553B/zh active Active
- 2019-12-03 JP JP2021531031A patent/JP7285930B2/ja active Active
- 2019-12-03 US US17/298,603 patent/US11419819B2/en active Active
- 2019-12-03 LT LTEPPCT/EP2019/083470T patent/LT3890767T/lt unknown
- 2019-12-03 IL IL283469A patent/IL283469B/en unknown
- 2019-12-03 SI SI201930419T patent/SI3890767T1/sl unknown
- 2019-12-03 ES ES19813329T patent/ES2932966T3/es active Active
- 2019-12-03 RS RS20221172A patent/RS63847B1/sr unknown
- 2019-12-03 EP EP19813329.0A patent/EP3890767B1/en active Active
- 2019-12-03 BR BR112021010756-8A patent/BR112021010756A2/pt not_active Application Discontinuation
- 2019-12-03 KR KR1020217020795A patent/KR102475644B1/ko active IP Right Grant
- 2019-12-03 CA CA3121362A patent/CA3121362C/en active Active
- 2019-12-03 CN CN202310328774.6A patent/CN116726146A/zh active Pending
- 2019-12-03 PL PL19813329.0T patent/PL3890767T3/pl unknown
- 2019-12-03 PT PT198133290T patent/PT3890767T/pt unknown
- 2019-12-03 HU HUE19813329A patent/HUE060322T2/hu unknown
- 2019-12-03 FI FIEP19813329.0T patent/FI3890767T3/fi active
- 2019-12-03 CN CN202310312402.4A patent/CN116688093A/zh active Pending
- 2019-12-03 MX MX2021006585A patent/MX2021006585A/es unknown
- 2019-12-03 EA EA202191307A patent/EA202191307A1/ru unknown
- 2019-12-03 AU AU2019392626A patent/AU2019392626B2/en active Active
- 2019-12-03 WO PCT/EP2019/083470 patent/WO2020115032A1/en active Search and Examination
-
2021
- 2021-05-31 CO CONC2021/0007141A patent/CO2021007141A2/es unknown
-
2022
- 2022-07-15 US US17/865,426 patent/US11890376B2/en active Active
-
2023
- 2023-12-21 US US18/391,712 patent/US20240122852A1/en active Pending
Also Published As
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| HRP20221529T1 (hr) | Sastavi za inhalaciju za upotrebu u liječenju plućnih bolesti | |
| CN103619323B (zh) | 作为气溶胶团的伊洛前列素的给药 | |
| US20210244662A1 (en) | Inhalable compositions comprising macrocyclic immunosuppressants | |
| JP6228220B2 (ja) | エアロゾル化イロプロストの投与 | |
| JPWO2020115032A5 (hr) | ||
| US20220118198A1 (en) | Mouthpiece and nebulizer having a mouthpiece | |
| JPWO2020002351A5 (hr) | ||
| EA044593B1 (ru) | Ингаляционные композиции, содержащие макроциклические иммуносупрессанты | |
| EA042761B1 (ru) | Способ лечения заболеваний легких и набор |