HRP20200260T1 - Pripravci, postupci i sustavi za respiratornu isporuku dva ili više aktivnih sredstava - Google Patents
Pripravci, postupci i sustavi za respiratornu isporuku dva ili više aktivnih sredstava Download PDFInfo
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- HRP20200260T1 HRP20200260T1 HRP20200260TT HRP20200260T HRP20200260T1 HR P20200260 T1 HRP20200260 T1 HR P20200260T1 HR P20200260T T HRP20200260T T HR P20200260TT HR P20200260 T HRP20200260 T HR P20200260T HR P20200260 T1 HRP20200260 T1 HR P20200260T1
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- 239000013543 active substance Substances 0.000 title claims 23
- 239000000203 mixture Substances 0.000 title claims 2
- 230000000241 respiratory effect Effects 0.000 title 1
- 239000002245 particle Substances 0.000 claims 31
- 239000000825 pharmaceutical preparation Substances 0.000 claims 21
- 239000000725 suspension Substances 0.000 claims 12
- 229940071648 metered dose inhaler Drugs 0.000 claims 7
- 239000003380 propellant Substances 0.000 claims 7
- 150000002148 esters Chemical class 0.000 claims 5
- 150000003839 salts Chemical class 0.000 claims 5
- 239000012453 solvate Substances 0.000 claims 5
- VOVIALXJUBGFJZ-KWVAZRHASA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 claims 4
- VPNYRYCIDCJBOM-UHFFFAOYSA-M Glycopyrronium bromide Chemical compound [Br-].C1[N+](C)(C)CCC1OC(=O)C(O)(C=1C=CC=CC=1)C1CCCC1 VPNYRYCIDCJBOM-UHFFFAOYSA-M 0.000 claims 4
- 229960004436 budesonide Drugs 0.000 claims 4
- BPZSYCZIITTYBL-UHFFFAOYSA-N formoterol Chemical compound C1=CC(OC)=CC=C1CC(C)NCC(O)C1=CC=C(O)C(NC=O)=C1 BPZSYCZIITTYBL-UHFFFAOYSA-N 0.000 claims 4
- 229960002848 formoterol Drugs 0.000 claims 4
- 229940015042 glycopyrrolate Drugs 0.000 claims 4
- 208000019693 Lung disease Diseases 0.000 claims 3
- 230000004913 activation Effects 0.000 claims 3
- 230000003287 optical effect Effects 0.000 claims 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 3
- 150000003904 phospholipids Chemical class 0.000 claims 3
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims 2
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 claims 2
- 201000003883 Cystic fibrosis Diseases 0.000 claims 2
- 229910001628 calcium chloride Inorganic materials 0.000 claims 2
- 239000001110 calcium chloride Substances 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 229960002714 fluticasone Drugs 0.000 claims 2
- MGNNYOODZCAHBA-GQKYHHCASA-N fluticasone Chemical compound C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@]1(F)[C@@H]2[C@@H]2C[C@@H](C)[C@@](C(=O)SCF)(O)[C@@]2(C)C[C@@H]1O MGNNYOODZCAHBA-GQKYHHCASA-N 0.000 claims 2
- BLUGYPPOFIHFJS-UUFHNPECSA-N (2s)-n-[(2s)-1-[[(3r,4s,5s)-3-methoxy-1-[(2s)-2-[(1r,2r)-1-methoxy-2-methyl-3-oxo-3-[[(1s)-2-phenyl-1-(1,3-thiazol-2-yl)ethyl]amino]propyl]pyrrolidin-1-yl]-5-methyl-1-oxoheptan-4-yl]-methylamino]-3-methyl-1-oxobutan-2-yl]-3-methyl-2-(methylamino)butanamid Chemical compound CN[C@@H](C(C)C)C(=O)N[C@@H](C(C)C)C(=O)N(C)[C@@H]([C@@H](C)CC)[C@H](OC)CC(=O)N1CCC[C@H]1[C@H](OC)[C@@H](C)C(=O)N[C@H](C=1SC=CN=1)CC1=CC=CC=C1 BLUGYPPOFIHFJS-UUFHNPECSA-N 0.000 claims 1
- 208000007934 ACTH-independent macronodular adrenal hyperplasia Diseases 0.000 claims 1
- 206010001052 Acute respiratory distress syndrome Diseases 0.000 claims 1
- 206010006458 Bronchitis chronic Diseases 0.000 claims 1
- 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 claims 1
- 206010013975 Dyspnoeas Diseases 0.000 claims 1
- 206010014561 Emphysema Diseases 0.000 claims 1
- 206010020751 Hypersensitivity Diseases 0.000 claims 1
- 206010061218 Inflammation Diseases 0.000 claims 1
- FQISKWAFAHGMGT-SGJOWKDISA-M Methylprednisolone sodium succinate Chemical compound [Na+].C([C@@]12C)=CC(=O)C=C1[C@@H](C)C[C@@H]1[C@@H]2[C@@H](O)C[C@]2(C)[C@@](O)(C(=O)COC(=O)CCC([O-])=O)CC[C@H]21 FQISKWAFAHGMGT-SGJOWKDISA-M 0.000 claims 1
- 206010035664 Pneumonia Diseases 0.000 claims 1
- 208000013616 Respiratory Distress Syndrome Diseases 0.000 claims 1
- 206010039085 Rhinitis allergic Diseases 0.000 claims 1
- 201000010105 allergic rhinitis Diseases 0.000 claims 1
- 230000007815 allergy Effects 0.000 claims 1
- 208000006673 asthma Diseases 0.000 claims 1
- 229940092705 beclomethasone Drugs 0.000 claims 1
- NBMKJKDGKREAPL-DVTGEIKXSA-N beclomethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(Cl)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O NBMKJKDGKREAPL-DVTGEIKXSA-N 0.000 claims 1
- 201000009267 bronchiectasis Diseases 0.000 claims 1
- 206010006451 bronchitis Diseases 0.000 claims 1
- 208000007451 chronic bronchitis Diseases 0.000 claims 1
- 229960003728 ciclesonide Drugs 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000035475 disorder Diseases 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000000839 emulsion Substances 0.000 claims 1
- -1 flunizolid Chemical compound 0.000 claims 1
- 230000004054 inflammatory process Effects 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- 239000000463 material Substances 0.000 claims 1
- 229960004584 methylprednisolone Drugs 0.000 claims 1
- 229960001664 mometasone Drugs 0.000 claims 1
- QLIIKPVHVRXHRI-CXSFZGCWSA-N mometasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(Cl)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CCl)(O)[C@@]1(C)C[C@@H]2O QLIIKPVHVRXHRI-CXSFZGCWSA-N 0.000 claims 1
- 239000013618 particulate matter Substances 0.000 claims 1
- WTWWXOGTJWMJHI-UHFFFAOYSA-N perflubron Chemical compound FC(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)Br WTWWXOGTJWMJHI-UHFFFAOYSA-N 0.000 claims 1
- 229960001217 perflubron Drugs 0.000 claims 1
- 229960004618 prednisone Drugs 0.000 claims 1
- XOFYZVNMUHMLCC-ZPOLXVRWSA-N prednisone Chemical compound O=C1C=C[C@]2(C)[C@H]3C(=O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 XOFYZVNMUHMLCC-ZPOLXVRWSA-N 0.000 claims 1
- 230000002685 pulmonary effect Effects 0.000 claims 1
- 208000002815 pulmonary hypertension Diseases 0.000 claims 1
- 230000008695 pulmonary vasoconstriction Effects 0.000 claims 1
- 201000009890 sinusitis Diseases 0.000 claims 1
- 238000001694 spray drying Methods 0.000 claims 1
- 229960005294 triamcinolone Drugs 0.000 claims 1
- GFNANZIMVAIWHM-OBYCQNJPSA-N triamcinolone Chemical compound O=C1C=C[C@]2(C)[C@@]3(F)[C@@H](O)C[C@](C)([C@@]([C@H](O)C4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 GFNANZIMVAIWHM-OBYCQNJPSA-N 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
Classifications
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Claims (25)
1. Farmaceutski pripravak koji se može isporučiti iz inhalatora s odmjerenom dozom, koji sadrži:
medij za suspenziju koji sadrži farmaceutski prihvatljiv propelant;
najmanje tri različite vrste čestica aktivnog sredstva, pri čemu svaka od najmanje tri različite vrste čestica aktivnog sredstva sadrži različito aktivno sredstvo, pri čemu
prva vrsta čestica aktivnog sredstva sadrži glikopirolat uključujući sve njegove farmaceutski prihvatljive soli, estere ili solvate,
druga vrsta čestica aktivnog sredstva sadrži formoterol uključujući sve njegove farmaceutski prihvatljive soli, estere ili solvate, i
treća vrsta čestica aktivnog sredstva sadrži beklometazon, budezonid, ciklezonid, flunizolid, flutikazon, metil-prednizolon, mometazon, prednizon i triamcinolon, uključujući sve njihove farmaceutski prihvatljive soli, estere ili solvate
i najmanje 50% volumena čestica materijala aktivnog sredstva ima optički promjer od 4 µm ili manje; i
jednu ili više vrsta čestica suspendiranih čestica koje se mogu udisati;
pri čemu najmanje jedna vrsta suspendiranih čestica koje se mogu udisati sadrži perforirane fosfolipidne mikrostrukture;
pri čemu ukupna masa najmanje jedne vrste suspendiranih čestica premašuje ukupnu masu najmanje jedne vrste čestica aktivnog sredstva, i tri ili više različite vrste čestica aktivnog sredstva zajednički su smještene sa suspendiranim česticama koje se udišu unutar medija za suspenziju tako da nastane ko-suspenzija.
2. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što treća vrsta čestica aktivnog sredstva sadrži aktivno sredstvo odabrano od flutikazona i budezonida.
3. Farmaceutski pripravak prema patentnom zahtjevu 1 naznačen time što suspendirane čestice za udisanje uključuju kalcijev klorid.
4. Farmaceutski pripravak prema patentnom zahtjevu 1 naznačen time što je fosfolipid disteroilfosfatidilkolin (DSPC).
5. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što se perforirane mikrostrukture pripremaju postupkom sušenja raspršivanjem.
6. Farmaceutski pripravak prema patentnom zahtjevu 5, naznačen time što perforirane mikrostrukture sadrže raspršivanjem osušenu emulziju perfluorooktil bromida, DSPC i kalcijevog klorida u vodi.
7. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što su suspendirane čestice uključene u medij za suspenziju u koncentraciji od sve do 30mg/mL.
8. Farmaceutski pripravak prema patentnom zahtjevu 7, naznačen time što su suspendirane čestice uključene u medij za suspenziju u koncentraciji odabranoj od između 1 mg/ml i 15 mg/ml, između 3 mg/ml i 10 mg/ml, između 5 mg/ml i 8 mg/ml, i oko 6 mg/ml.
9. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što svaka najmanje jedna vrsta suspendiranih čestica ima MMAD odabran od između 10 µm i 500 nm, između 5 µm i 750 nm, i između 1 µm i 3 µm.
10. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što svaka najmanje jedna vrsta suspendiranih čestica ima prosječni volumenski optički promjer odabran od između 0.2 µm i 50 µm, između 0.5 µm i 15 µm, između 1.5 µm i 10 µm, i između 2 µm i 5 µm.
11. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što propelant sadrži propelant koji je odabran od HFA propelanta, PFC propelanta i njihovih kombinacija, te pri čemu je propelant uglavnom bez dodatnih sastojaka.
12. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što je omjer ukupne mase najmanje jedne vrste suspendiranih čestica prema ukupnoj masi najmanje jedne vrste čestica aktivnog sredstva odabran od iznad 1 i sve do 1.5, sve do 5, sve do 10, sve do 15, sve do 17, sve do 20, sve do 30, sve do 40, sve do 50, sve do 60, sve do 75, sve do 100, sve do 150, te sve do 200.
13. Farmaceutski pripravak prema patentnom zahtjevu 12, naznačen time što je omjer ukupne mase najmanje jedne vrste suspendiranih čestica prema ukupnoj masi najmanje jedne vrste čestica aktivnog sredstva odabran od između 3:1 i 15:1 i između 2:1 i 8:1.
14. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što sadrži:
medij za suspenziju koji sadrži farmaceutski prihvatljiv HFA propelant;
prvu vrstu čestica aktivnog sredstva koje sadrže glikopirolat, uključujući sve njegove farmaceutski prihvatljive soli, estere ili solvate, suspendirane u suspenzijskom mediju u koncentraciji dovoljnoj da se osigura isporučena doza glikopirolata od sve do 15 µg to 80 µg po aktiviranju inhalatora s odmjerenom dozom;
drugu vrstu čestica aktivnog sredstva koje sadrže formoterol, uključujući sve njegove farmaceutski prihvatljive soli, estere ili solvate suspendirane u suspenzijskom mediju u koncentraciji dovoljnoj da se osigura isporučena doza formoterola od između 2 µg i 10 µg po aktiviranju inhalatora s odmjerenom dozom; i
mnoštvo suspendiranih čestica koje se mogu udahnuti koje sadrže perforirane fosfolipidne mikrostrukture koje imaju srednji volumenski optički promjer od između oko 1.5 µm i oko 10 µm, pri čemu se prva i druga vrsta čestica aktivnog sredstva povezuju s mnoštvom suspendiranih čestica tako da nastane ko-suspenzija.
15. Farmaceutski pripravak prema patentnom zahtjevu 14, naznačen time što je omjer ukupne mase suspendiranih čestica prema ukupnoj masi prve i druge vrste čestica aktivnog sredstva odabran od između 3:1 i 15:1 i između 2:1 i 8:1.
16. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što je prva vrsta čestica aktivnog sredstva suspendirana u mediju za suspenziju u koncentraciji dovoljnoj da se osigura isporučena doza glikopirolata od do 10 µg po aktiviranju inhalatora s odmjerenom dozom.
17. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što je druga vrsta čestica aktivnog sredstva suspendirana u mediju za suspenziju u koncentraciji dovoljnoj da se osigura isporučena doza formoterola od sve do 5 µg po aktiviranju inhalatora s odmjerenom dozom.
18. Farmaceutski pripravak prema patentnom zahtjevu 1, naznačen time što treća vrsta čestica aktivnog sredstva sadrži budezonid, te se suspendira se u mediju za suspenziju u koncentraciji dovoljnoj da se osigura isporučena doza budezonida od 30 do 240 µg po aktiviranju inhalatora s odmjerenom dozom.
19. Farmaceutski pripravak prema bilo kojem prethodnom patentnom zahtjevu naznačen time što je najmanje jedno aktivno sredstvo prisutno u kristalnom ili uglavnom kristalnom obliku.
20. Farmaceutski pripravak prema bilo kojem prethodnom patentnom zahtjevu naznačen time što su sva aktivna sredstva prisutna u kristalnom ili uglavnom kristalnom obliku.
21. Inhalator s odmjerenom dozom naznačen time što sadrži pripravak kako je definirano u bilo kojem od zahtjeva 1 do 20.
22. Farmaceutski pripravak kako je definiran u bilo kojem od zahtjeva 1 do 20 naznačen time što je za uporabu u medicini.
23. Farmaceutski pripravak kako je definirano u bilo kojem od zahtjeva 1 do 20 naznačen time što se koristi u postupku liječenja plućne bolesti ili poremećaja kod pacijenta.
24. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 23, naznačen time što se plućna bolest ili poremećaj bira od najmanje jednog od astme, KOPB, kroničnog bronhitisa, emfizema, bronhiektazije, alergijskog rinitisa, sinusitisa, plućne vazokonstrikcije, upale, alergija, otežanog disanja, sindroma respiratornog distresa, plućne hipertenzije, upale pluća povezane s cističnom fibrozom, i opstrukcije pluća povezane s cističnom fibrozom.
25. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 24 naznačen time što je bolest ili poremećaj KOPB.
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