HRP20161098T1 - Pripravci za respiratorni unos aktivnih sredstava, te prateći postupci i sustavi - Google Patents
Pripravci za respiratorni unos aktivnih sredstava, te prateći postupci i sustavi Download PDFInfo
- Publication number
- HRP20161098T1 HRP20161098T1 HRP20161098TT HRP20161098T HRP20161098T1 HR P20161098 T1 HRP20161098 T1 HR P20161098T1 HR P20161098T T HRP20161098T T HR P20161098TT HR P20161098 T HRP20161098 T HR P20161098T HR P20161098 T1 HRP20161098 T1 HR P20161098T1
- Authority
- HR
- Croatia
- Prior art keywords
- suspension
- particles
- accordance
- dose inhaler
- active agent
- Prior art date
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- 239000013543 active substance Substances 0.000 title claims 20
- 239000000203 mixture Substances 0.000 title claims 8
- 230000000241 respiratory effect Effects 0.000 title 1
- 239000000725 suspension Substances 0.000 claims 30
- 239000002245 particle Substances 0.000 claims 23
- 229940071648 metered dose inhaler Drugs 0.000 claims 13
- HBAQYPYDRFILMT-UHFFFAOYSA-N 8-[3-(1-cyclopropylpyrazol-4-yl)-1H-pyrazolo[4,3-d]pyrimidin-5-yl]-3-methyl-3,8-diazabicyclo[3.2.1]octan-2-one Chemical class C1(CC1)N1N=CC(=C1)C1=NNC2=C1N=C(N=C2)N1C2C(N(CC1CC2)C)=O HBAQYPYDRFILMT-UHFFFAOYSA-N 0.000 claims 8
- 150000003839 salts Chemical class 0.000 claims 8
- 239000010419 fine particle Substances 0.000 claims 7
- 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 5
- 150000002148 esters Chemical class 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
- 229940021598 formoterol and budesonide Drugs 0.000 claims 4
- 229940015042 glycopyrrolate Drugs 0.000 claims 4
- 239000012453 solvate Substances 0.000 claims 4
- 238000009472 formulation Methods 0.000 claims 3
- 206010020751 Hypersensitivity Diseases 0.000 claims 2
- 230000001133 acceleration Effects 0.000 claims 2
- 208000026935 allergic disease Diseases 0.000 claims 2
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- OBRNDARFFFHCGE-PERKLWIXSA-N (S,S)-formoterol fumarate Chemical compound OC(=O)\C=C\C(O)=O.C1=CC(OC)=CC=C1C[C@H](C)NC[C@@H](O)C1=CC=C(O)C(NC=O)=C1.C1=CC(OC)=CC=C1C[C@H](C)NC[C@@H](O)C1=CC=C(O)C(NC=O)=C1 OBRNDARFFFHCGE-PERKLWIXSA-N 0.000 claims 1
- SJJCQDRGABAVBB-UHFFFAOYSA-N 1-hydroxy-2-naphthoic acid Chemical compound C1=CC=CC2=C(O)C(C(=O)O)=CC=C21 SJJCQDRGABAVBB-UHFFFAOYSA-N 0.000 claims 1
- DCYGAPKNVCQNOE-UHFFFAOYSA-N 2,2,2-triphenylacetic acid Chemical compound C=1C=CC=CC=1C(C=1C=CC=CC=1)(C(=O)O)C1=CC=CC=C1 DCYGAPKNVCQNOE-UHFFFAOYSA-N 0.000 claims 1
- PYHXGXCGESYPCW-UHFFFAOYSA-M 2,2-diphenylacetate Chemical compound C=1C=CC=CC=1C(C(=O)[O-])C1=CC=CC=C1 PYHXGXCGESYPCW-UHFFFAOYSA-M 0.000 claims 1
- ALKYHXVLJMQRLQ-UHFFFAOYSA-N 3-Hydroxy-2-naphthoate Chemical class C1=CC=C2C=C(O)C(C(=O)O)=CC2=C1 ALKYHXVLJMQRLQ-UHFFFAOYSA-N 0.000 claims 1
- ALKYHXVLJMQRLQ-UHFFFAOYSA-M 3-carboxynaphthalen-2-olate Chemical compound C1=CC=C2C=C(C([O-])=O)C(O)=CC2=C1 ALKYHXVLJMQRLQ-UHFFFAOYSA-M 0.000 claims 1
- XRHGYUZYPHTUJZ-UHFFFAOYSA-M 4-chlorobenzoate Chemical compound [O-]C(=O)C1=CC=C(Cl)C=C1 XRHGYUZYPHTUJZ-UHFFFAOYSA-M 0.000 claims 1
- FJKROLUGYXJWQN-UHFFFAOYSA-M 4-hydroxybenzoate Chemical compound OC1=CC=C(C([O-])=O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-M 0.000 claims 1
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 1
- 206010001052 Acute respiratory distress syndrome Diseases 0.000 claims 1
- CPELXLSAUQHCOX-UHFFFAOYSA-M Bromide Chemical compound [Br-] CPELXLSAUQHCOX-UHFFFAOYSA-M 0.000 claims 1
- COVZYZSDYWQREU-UHFFFAOYSA-N Busulfan Chemical compound CS(=O)(=O)OCCCCOS(C)(=O)=O COVZYZSDYWQREU-UHFFFAOYSA-N 0.000 claims 1
- FERIUCNNQQJTOY-UHFFFAOYSA-M Butyrate Chemical compound CCCC([O-])=O FERIUCNNQQJTOY-UHFFFAOYSA-M 0.000 claims 1
- FERIUCNNQQJTOY-UHFFFAOYSA-N Butyric acid Natural products CCCC(O)=O FERIUCNNQQJTOY-UHFFFAOYSA-N 0.000 claims 1
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 1
- 201000003883 Cystic fibrosis Diseases 0.000 claims 1
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims 1
- 206010013975 Dyspnoeas Diseases 0.000 claims 1
- KRHYYFGTRYWZRS-UHFFFAOYSA-M Fluoride anion Chemical compound [F-] KRHYYFGTRYWZRS-UHFFFAOYSA-M 0.000 claims 1
- BDAGIHXWWSANSR-UHFFFAOYSA-M Formate Chemical compound [O-]C=O BDAGIHXWWSANSR-UHFFFAOYSA-M 0.000 claims 1
- 206010061218 Inflammation Diseases 0.000 claims 1
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 claims 1
- 208000019693 Lung disease Diseases 0.000 claims 1
- AFVFQIVMOAPDHO-UHFFFAOYSA-N Methanesulfonic acid Chemical compound CS(O)(=O)=O AFVFQIVMOAPDHO-UHFFFAOYSA-N 0.000 claims 1
- 229910002651 NO3 Inorganic materials 0.000 claims 1
- NHNBFGGVMKEFGY-UHFFFAOYSA-N Nitrate Chemical compound [O-][N+]([O-])=O NHNBFGGVMKEFGY-UHFFFAOYSA-N 0.000 claims 1
- 206010061876 Obstruction Diseases 0.000 claims 1
- 208000011623 Obstructive Lung disease Diseases 0.000 claims 1
- 229910019142 PO4 Inorganic materials 0.000 claims 1
- 206010035664 Pneumonia Diseases 0.000 claims 1
- XBDQKXXYIPTUBI-UHFFFAOYSA-M Propionate Chemical compound CCC([O-])=O XBDQKXXYIPTUBI-UHFFFAOYSA-M 0.000 claims 1
- 208000013616 Respiratory Distress Syndrome Diseases 0.000 claims 1
- 206010039085 Rhinitis allergic Diseases 0.000 claims 1
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 claims 1
- DTQVDTLACAAQTR-UHFFFAOYSA-M Trifluoroacetate Chemical compound [O-]C(=O)C(F)(F)F DTQVDTLACAAQTR-UHFFFAOYSA-M 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
- 229940077388 benzenesulfonate Drugs 0.000 claims 1
- SRSXLGNVWSONIS-UHFFFAOYSA-M benzenesulfonate Chemical compound [O-]S(=O)(=O)C1=CC=CC=C1 SRSXLGNVWSONIS-UHFFFAOYSA-M 0.000 claims 1
- 229910001628 calcium chloride Inorganic materials 0.000 claims 1
- 239000001110 calcium chloride Substances 0.000 claims 1
- 238000005119 centrifugation Methods 0.000 claims 1
- 229940001468 citrate Drugs 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000035475 disorder Diseases 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 230000005713 exacerbation Effects 0.000 claims 1
- 229960000193 formoterol fumarate Drugs 0.000 claims 1
- XMBWDFGMSWQBCA-UHFFFAOYSA-N hydrogen iodide Chemical compound I XMBWDFGMSWQBCA-UHFFFAOYSA-N 0.000 claims 1
- 230000009610 hypersensitivity Effects 0.000 claims 1
- 208000027866 inflammatory disease Diseases 0.000 claims 1
- 230000002757 inflammatory effect Effects 0.000 claims 1
- 230000004054 inflammatory process Effects 0.000 claims 1
- 229940001447 lactate Drugs 0.000 claims 1
- 229940049920 malate Drugs 0.000 claims 1
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 claims 1
- BJEPYKJPYRNKOW-UHFFFAOYSA-N malic acid Chemical compound OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims 1
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid group Chemical group C(CCCCCCC\C=C/CCCCCCCC)(=O)O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 claims 1
- 230000003287 optical effect Effects 0.000 claims 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 1
- 239000010452 phosphate Substances 0.000 claims 1
- 230000003389 potentiating effect Effects 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 239000003380 propellant Substances 0.000 claims 1
- 208000002815 pulmonary hypertension Diseases 0.000 claims 1
- 230000008695 pulmonary vasoconstriction Effects 0.000 claims 1
- 230000029058 respiratory gaseous exchange Effects 0.000 claims 1
- YGSDEFSMJLZEOE-UHFFFAOYSA-M salicylate Chemical compound OC1=CC=CC=C1C([O-])=O YGSDEFSMJLZEOE-UHFFFAOYSA-M 0.000 claims 1
- 201000009890 sinusitis Diseases 0.000 claims 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 claims 1
- 229940095064 tartrate Drugs 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims 1
Classifications
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Claims (25)
1. Ko-suspenzija koju se može unijeti iz inhalatora za odmjerene doze, naznačena time što stabilna ko-suspenzija sadrži:
medij za suspenzije koji sadrži farmaceutski prihvatljiv HFA kao pogonski plin;
čestice više aktivnih sredstava koje sadrže kombinaciju aktivnih sredstava koja se bira između (a) kombinacije formoterola i budesonida ili soli, estera, solvata, enantiomera i smjesa odgovarajućih enantiomera, te (b) kombinacije glikopirolata, formoterola i budesonida, ili soli, estera, solvata, enantiomera i smjesa odgovarajućih enantiomera; i više suspendirajućih čestica pogodnih za respiraciju, gdje se više suspendirajućih čestica pogodnih za respiraciju ko-lociraju sa česticama više aktivnih sredstava unatoč razlikama u uzgonu između čestica aktivnog sredstva i suspendirajućih čestice u mediju za suspenzije
gdje suspendirajuće čestice pogodne za respiraciju perforirane mikrostrukture koje sadrže DSPC (1,2-disteroil-sn-glicero-3-fosfokolin) i kalcijev klorid.
2. Ko-suspenzija u skladu s patentnim zahtjevom 1, naznačena time što suspendirajuće čestice imaju volumni srednji optički promjer između 0,5 µm i 15 µm.
3. Ko-suspenzija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što su suspendirajuće čestice uključene u medij za suspenzije u koncentraciji koja se bira između do 30 mg/ml i do 25 mg/ml.
4. Ko-suspenzija u skladu s patentnim zahtjevom 3, naznačena time što su suspendirajuće čestice uključene u medij za suspenzije u koncentraciji koja se bira između od 1 mg/ml do 15 mg/ml, 3 mg/ml do 10 mg/ml, te 1,5 mg/ml do 10 mg/ml.
5. Ko-suspenzija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što je ukupna masa suspendirajućih čestica veća od ukupne mase čestica aktivnog sredstva, gdje se omjer ukupne mase suspendirajućih čestica i ukupne mase čestica aktivnog sredstva bira između preko 1, po mogućnosti vrijednosti koju se bira između do 1,5, do 5, do 10, do 15, do 17, do 20, do 30, do 40, do 50, do 60, do 75, do 100, do 150, te do 200.
6. Ko-suspenzija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što je ukupna masa suspendirajućih čestica veća od ukupne mase čestica aktivnog sredstva, gdje je najmanje jedno od aktivnih sredstava uključenih u čestice aktivnog sredstva je visoko potentno aktivno sredstvo, gdje se omjer ukupne mase suspendirajućih čestica i ukupne mase čestica aktivnog sredstva bira između 10 i 150, između 15 i 125, te između 25 i 75.
7. Ko-suspenzija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što suspendirajuće čestice ostaju ko-locirane s česticama aktivnog sredstva čak i kada ih se podvrgava uzgonskim silama uvećanim centrifugiranjem uz ubrzanje koje se bira između ubrzanja od najmanje 1 g, najmanje 10 g, najmanje 50 g, te najmanje 100 g.
8. Ko-suspenzija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što se farmaceutski prihvatljiva sol glikopirolata bira između fluorida, klorida, bromida, jodida, nitrata, sulfata, fosfata, formijata, acetata, trifluoracetata, propionata, butirat, laktata, citrata, tartarata, malata, maleata, sukcinata, benzoata, p-klorbenzoata, difenilacetata ili trifenilacetata, o-hidroksibenzoata, p-hidroksibenzoat, 1-hidroksinaftalen-2-karboksilata, 3-hidroksinaftalen-2-karboksilata, metansulfonata i benzensulfonata.
9. Ko-suspenzija u skladu s patentnim zahtjevom 8, naznačena time što je farmaceutski prihvatljiva sol glikopirolata 3-[(ciklopentilhidroksifenilacetil)oksi]-1,1-dimetilpirolidinijev bromid.
10. Ko-suspenzija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što se farmaceutski prihvatljiva sol formoterola bira između soli klorovodične, bromovodične, sumporne, fosforne, fumarne, maleinske, octene, mliječne, limunske, vinske, askorbinske, jantarne, glutarne, glukonske, trikarbalilne, oleinske, benzojeve, p-metoksibenzojeve, salicilne, o- i p-hidroksibenzojeve, p-klorbenzojeve, metansulfonske, p-toluensulfonske i 3-hidroksi-2-naftalenkarboksilne kiseline.
11. Ko-suspenzija u skladu s patentnim zahtjevom 10, naznačena time što je farmaceutski prihvatljiva sol formoterola formoterol-fumarat.
12. Ko-suspenzija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što je najmanje jedno aktivno sredstvo prisutno u kristalnom ili uglavnom kristalnom obliku.
13. Ko-suspenzija u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što su sva aktivna sredstva prisutna u kristalnom ili uglavnom kristalnom obliku.
14. Inhalator za odmjerene doze, naznačen time što sadrži spremnik s izlaznim ventilom koji uključuje aktuator za izdavanje odmjereni volumen, gdje navedeni spremnik sadrži ko-suspenziju u skladu s bilo kojim od patentnih zahtjeva 1 do 13, gdje inhalator za odmjerene doze pokazuje ujednačenost unesenih doza ("DDU") za sususpenzijsku formulaciju koja se bira između DDU od ± 30%, ili iznad, a DDU od ± 25%, ili iznad, te DDU od ± 20%, ili iznad, tijekom pražnjenja spremnika.
15. Inhalator za odmjerene doze u skladu s patentnim zahtjevom 14, naznačen time što inhalator za odmjerene doze izdaje ko-suspenziju u početnoj frakciji finih čestica, gdje se početnu frakciju finih čestica izdanu iz inhalatora za odmjerene doze uglavnom održava, tako da se, tijekom pražnjenja spremnika, frakciju finih čestica unesena iz inhalatora za odmjerene doze održava unutar 80% od početne frakcije finih čestica, unutar 90% od početne frakcije finih čestica ili unutar 95% od početne frakcije finih čestica.
16. Inhalator za odmjerene doze u skladu s bilo kojim od patentnih zahtjeva 14 ili 15, naznačen time što je ko-suspenzijska formulacija koja sadrži spremnik inhalatora za odmjerene doze stabilna za skladištenje unutar najmanje šest mjeseci.
17. Inhalator za odmjerene doze u skladu s patentnim zahtjevom 14, naznačen time što inhalator za odmjerene doze pokazuje ujednačenost unesenih doza ("DDU") za ko-suspenzijsku formulaciju koja se bira između DDU od ± 30%, ili iznad, a DDU od ± 25%, ili iznad, te DDU od ± 20%, ili iznad, tijekom pražnjenja spremnika, nakon što se navedeni spremnik podvrgava temperaturama koje variraju između –5 °C i 40 °C svakih 6 sati u periodu od šest tjedana.
18. Inhalator za odmjerene doze u skladu s patentnim zahtjevom 15, naznačen time što se frakcija finih čestica uglavnom održava tijekom pražnjenja spremnika, nakon što se navedeni spremnik podvrgava temperaturama koje variraju između –5 °C i 40 °C svakih 6 sati u periodu od šest tjedana.
19. Ko-suspenzija u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačena time što je namijenjena upotrebi u medicini.
20. Ko-suspenzija u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačena time što je namijenjena upotrebi u liječenje pacijenta koji boluje od upalne ili opstruktivne plućne bolesti ili stanja.
21. Ko-suspenzija namijenjena upotrebi u skladu s patentnim zahtjevom 20, naznačena time što se plućna bolest ili poremećaj bira između najmanje jednog od astme, COPD, pogoršanja preosjetljivosti dišnih puteva kao posljedice terapije drugim lijekom, alergijskog rinitisa, sinusitisa, plućne vazokonstrikcije, upale, alergija, otežanog disanja, respiratornog distresnog sindroma, plućne hipertenzije, te upale pluća i opstrukcije povezane s cističnom fibrozom.
22. Ko-suspenzija namijenjena upotrebi u skladu s patentnim zahtjevom 21, naznačena time što je bolest ili poremećaj COPD.
23. Ko-suspenzija u skladu s bilo kojim od jedan od patentnih zahtjeva 1 do 13, te namijenjena upotrebi u skladu s bilo kojim od patentnih zahtjeva 19 do 22, naznačena time što čestice više aktivnih sredstava sadrže kombinaciju aktivnih sredstava koju se bira između kombinacije formoterola i budesonida, ili soli, estera, solvata, enantiomera i smjesa odgovarajućih enantiomera.
24. Ko-suspenzija u skladu s bilo kojim od jedan od patentnih zahtjeva 1 do 13, te namijenjena upotrebi u skladu s bilo kojim od patentnih zahtjeva 19 do 22, naznačena time što čestice više aktivnih sredstava sadrže kombinaciju aktivnih sredstava koja se bira između kombinacije glikopirolata, formoterola i budesonida, ili soli, estera, solvata, enantiomera i smjesa odgovarajućih enantiomera.
25. Ko-suspenzija u skladu s bilo kojim od jedan od patentnih zahtjeva 1 do 13, te namijenjena upotrebi u skladu s patentnim zahtjevima 23 i 24, naznačena time što je formoterol kao aktivno sredstvo uključen u pripravak u koncentraciji dovoljnoj za osiguravanje unesene doze formoterola koja se bira između do 30 µg, do 10 µg, do 5 µg, do 2,5 µg, do 2 µg, ili do 1,5 µg po aktuaciji inhalatora za odmjerene doze.
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