HRP20210379T1 - Poboljšane formulacije - Google Patents
Poboljšane formulacije Download PDFInfo
- Publication number
- HRP20210379T1 HRP20210379T1 HRP20210379TT HRP20210379T HRP20210379T1 HR P20210379 T1 HRP20210379 T1 HR P20210379T1 HR P20210379T T HRP20210379T T HR P20210379TT HR P20210379 T HRP20210379 T HR P20210379T HR P20210379 T1 HRP20210379 T1 HR P20210379T1
- Authority
- HR
- Croatia
- Prior art keywords
- fluticasone propionate
- formoterol fumarate
- micrograms
- hfa
- suspension formulation
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 27
- 238000009472 formulation Methods 0.000 title claims 25
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 32
- 229960000289 fluticasone propionate Drugs 0.000 claims 29
- WMWTYOKRWGGJOA-CENSZEJFSA-N fluticasone propionate 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)(OC(=O)CC)[C@@]2(C)C[C@@H]1O WMWTYOKRWGGJOA-CENSZEJFSA-N 0.000 claims 29
- 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 24
- 229960000193 formoterol fumarate Drugs 0.000 claims 24
- 239000000725 suspension Substances 0.000 claims 21
- 239000000443 aerosol Substances 0.000 claims 20
- VLARUOGDXDTHEH-UHFFFAOYSA-L disodium cromoglycate Chemical group [Na+].[Na+].O1C(C([O-])=O)=CC(=O)C2=C1C=CC=C2OCC(O)COC1=CC=CC2=C1C(=O)C=C(C([O-])=O)O2 VLARUOGDXDTHEH-UHFFFAOYSA-L 0.000 claims 18
- 229960000265 cromoglicic acid Drugs 0.000 claims 15
- YFMFNYKEUDLDTL-UHFFFAOYSA-N 1,1,1,2,3,3,3-heptafluoropropane Chemical group FC(F)(F)C(F)C(F)(F)F YFMFNYKEUDLDTL-UHFFFAOYSA-N 0.000 claims 14
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 6
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 6
- 239000003906 humectant Substances 0.000 claims 6
- 239000002245 particle Substances 0.000 claims 6
- RATSWNOMCHFQGJ-TUYNVFRMSA-N (e)-but-2-enedioic acid;n-[2-hydroxy-5-[(1s)-1-hydroxy-2-[[(2s)-1-(4-methoxyphenyl)propan-2-yl]amino]ethyl]phenyl]formamide;dihydrate Chemical compound O.O.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 RATSWNOMCHFQGJ-TUYNVFRMSA-N 0.000 claims 5
- 229960003610 formoterol fumarate dihydrate Drugs 0.000 claims 5
- 229940071648 metered dose inhaler Drugs 0.000 claims 5
- 239000003380 propellant Substances 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 3
- 239000002253 acid Substances 0.000 claims 2
- NDAUXUAQIAJITI-UHFFFAOYSA-N albuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 claims 2
- CDQSJQSWAWPGKG-UHFFFAOYSA-N butane-1,1-diol Chemical compound CCCC(O)O CDQSJQSWAWPGKG-UHFFFAOYSA-N 0.000 claims 2
- 229960004398 nedocromil Drugs 0.000 claims 2
- RQTOOFIXOKYGAN-UHFFFAOYSA-N nedocromil Chemical compound CCN1C(C(O)=O)=CC(=O)C2=C1C(CCC)=C1OC(C(O)=O)=CC(=O)C1=C2 RQTOOFIXOKYGAN-UHFFFAOYSA-N 0.000 claims 2
- 229960002052 salbutamol Drugs 0.000 claims 2
- 229940127211 short-acting beta 2 agonist Drugs 0.000 claims 2
- XWTYSIMOBUGWOL-UHFFFAOYSA-N (+-)-Terbutaline Chemical compound CC(C)(C)NCC(O)C1=CC(O)=CC(O)=C1 XWTYSIMOBUGWOL-UHFFFAOYSA-N 0.000 claims 1
- NDAUXUAQIAJITI-LBPRGKRZSA-N (R)-salbutamol Chemical compound CC(C)(C)NC[C@H](O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-LBPRGKRZSA-N 0.000 claims 1
- LSLYOANBFKQKPT-DIFFPNOSSA-N 5-[(1r)-1-hydroxy-2-[[(2r)-1-(4-hydroxyphenyl)propan-2-yl]amino]ethyl]benzene-1,3-diol Chemical compound C([C@@H](C)NC[C@H](O)C=1C=C(O)C=C(O)C=1)C1=CC=C(O)C=C1 LSLYOANBFKQKPT-DIFFPNOSSA-N 0.000 claims 1
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 claims 1
- VQDBNKDJNJQRDG-UHFFFAOYSA-N Pirbuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=N1 VQDBNKDJNJQRDG-UHFFFAOYSA-N 0.000 claims 1
- 206010039085 Rhinitis allergic Diseases 0.000 claims 1
- 201000010105 allergic rhinitis Diseases 0.000 claims 1
- 208000006673 asthma Diseases 0.000 claims 1
- 230000008021 deposition Effects 0.000 claims 1
- 229960001022 fenoterol Drugs 0.000 claims 1
- 239000010419 fine particle Substances 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 229950008204 levosalbutamol Drugs 0.000 claims 1
- 229960005414 pirbuterol Drugs 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 229960002720 reproterol Drugs 0.000 claims 1
- WVLAAKXASPCBGT-UHFFFAOYSA-N reproterol Chemical compound C1=2C(=O)N(C)C(=O)N(C)C=2N=CN1CCCNCC(O)C1=CC(O)=CC(O)=C1 WVLAAKXASPCBGT-UHFFFAOYSA-N 0.000 claims 1
- 229960000195 terbutaline Drugs 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
- A61K9/0012—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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
-
- 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
-
- 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
- A61K31/573—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 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/08—Bronchodilators
-
- 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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Pulmonology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Otolaryngology (AREA)
- Pain & Pain Management (AREA)
- Transplantation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Claims (18)
1. Uporaba ovlaživača u aerosolnoj suspenzijskoj formulaciji koja sadrži čestice formoterolfumarat dihidrata i flutikazon propionata, suspendirane u HFA pogonskom gorivu, koje se nalaze u doznom inhalatoru s odmjernom dozom koji obuhvaća posudu i mjerni ventil, naznačena time, da je za smanjivanje taloženja čestica na površinama posude i mjernog ventila, pri čemu se ovlaživač odabire iz skupine koja se sastoji od etanola, propilen glikola, glicerola, butandiola i njihovih mješavina, gdje je ovlaživač poželjno etanol.
2. Uporaba prema patentnom zahtjevu 1, naznačena time, da se ovlaživač koristi u količini manjoj od 2% mase na temelju ukupne mase aerosolne suspenzijske formulacije, poželjno od 1,99 do 0,01% mase na temelju ukupne mase aerosolne suspenzijske formulacije, poželjnije od 1,5 do 1,0% mase na temelju ukupne mase aerosolne suspenzijske formulacije.
3. Uporaba prema patentnom zahtjevu 1, naznačena time, da HFA pogonsko gorivo jest HFA 227.
4. Uporaba prema patentnom zahtjevu 1, naznačena time, da se formoterol fumarat dihidrat koristi u količini od 0,003 do 0,04% mase.
5. Uporaba prema patentnom zahtjevu 1, naznačena time, da se flutikazon propionat koristi u količini od 0,01 do 0,6% mase.
6. Uporaba prema patentnom zahtjevu 1, naznačena time, da aerosolna suspenzijska formulacija sadrži sol odabranu iz skupine koja se sastoji od nedokromila i kromoglicinske kiseline, poželjno gdje je sol natrijev kromoglikat (DSCG), poželjno gdje se natrijev kromoglikat koristi u količini od 0,01 do 0,1% mase na temelju ukupne mase formulacije.
7. Uporaba prema patentnom zahtjevu 1, naznačena time, da kada se aerosolna suspenzijska formulacija ispušta iz inhalatora s odmjernom dozom, ona dostavlja dozu oba i formoterol fumarat dihidrata i flutikazon propionata, koja ima varijancu ne veću od +/- 15% od prosječne ispuštene ciljane doze (i ne više od jedne vrijednosti izvan +/- 25% od ciljane vrijednosti i niti jedne izvan +/- 30% od ciljane vrijednosti), kada se formulacija pohranjuje na 25 stupnjeva Celzijusa i 60% relativne vlažnosti, prvenstveno na 40 stupnjeva Celzijusa i 75% relativne vlažnosti u vremenskom periodu od najviše jednog mjeseca, još poželjnije do najviše tri mjeseca, te osobito poželjno do najviše šest mjeseci.
8. Uporaba prema patentnom zahtjevu 1, naznačena time, da kada je aerosolna suspenzijska formulacija pohranjena u inhalatoru s odmjernom dozom u vremenu od najmanje dva tjedna i na temperaturi od 17 do 25 stupnjeva Celzijusa te uz relativnu vlažnost od 29 do 63%, ima prosječnu frakciju finih čestica od 30 do 60 % od označene doze kao u in vitro zastupljenosti aerodinamičke raspodjele veličine čestica.
9. Uporaba prema patentnom zahtjevu 1, naznačena time, da aerosolna suspenzijska formulacija koja se nalazi u inhalatoru s odmjernom dozom, sadrži:
(i) 0,035% flutikazon propionata, 0,007% formoterol fumarata, 0,034% natrijevog kromoglikata, 1,4% etanola i HFA 227 q.s. ad 100, gdje se svi postoci temelje na ukupnoj masi pripravka, i gdje nominalna doza iznosi 50 mikrograma za flutikazon propionat i 10 mikrograma za formoterol fumarat, dva puta dnevno (BID);
(ii) 0,071% flutikazon propionata, 0,007% formoterol fumarata, 0,034% natrijevog kromoglikata, 1,4% etanola i HFA 227 q.s. ad 100, gdje se svi postoci temelje na ukupnoj masi pripravka, i gdje nominalna doza iznosi 100 mikrograma za flutikazon propionat, i 10 mikrograma za formoterol fumarat, dva puta dnevno (BID);
(iii) 0,178% flutikazon propionata, 0,007% formoterol fumarata, 0,034% natrijevog kromoglikata, 1,4% etanola i HFA 227 q.s. ad 100, gdje se svi postoci temelje na ukupnoj masi pripravka, i gdje nominalna doza iznosi 250 mikrograma za flutikazon propionat, i 10 mikrograma za formoterol fumarat, dva puta dnevno (BID);
(iv) 0,357% flutikazon propionata, 0,007% formoterol fumarata, 0,034% natrijevog kromoglikata, 1,4% etanola i HFA 227 q.s. ad 100, gdje se svi postoci temelje na ukupnoj masi pripravka, i gdje nominalna doza iznosi 500 mikrograma za flutikazon propionat, i 10 mikrograma za formoterol fumarat, dva puta dnevno (BID);
(v) 0,357% flutikazon propionata, 0,014% formoterol fumarata, 0,068% natrijevog kromoglikata, 1,4% etanola i HFA 227 q.s. ad 100, gdje se svi postoci temelje na ukupnoj masi pripravka, i gdje nominalna doza iznosi 500 mikrograma za flutikazon propionat, i 20 mikrograma za formoterol fumarat, dva puta dnevno; ili
0,357% flutikazon propionata, 0,014% formoterol fumarata, 0,034% natrijevog kromoglikata, 1,4% etanola i HFA 227 q.s. ad 100, gdje se svi postoci temelje na ukupnoj masi pripravka, i gdje nominalna doza iznosi 500 mikrograma za flutikazon propionat, i
20 mikrograma za formoterol fumarat, dva puta dnevno.
10. Aerosolna suspenzijska formulacija, naznačena time, da sadrži čestice formoterol fumarat dihidrata i flutikazon propionata, suspendirane u HFApogonskom gorivu i ovlaživač, gdje se ovlaživač odabire iz skupine koja se sastoji od etanola, propilen glikola, glicerola, butandiola i njihovih mješavina, s time, da se ovlaživač koristi u količini manjoj od 2% po masi na temelju ukupne mase formulacije, i pritom čestice posjeduju raspodjelu veličina čestica pri čemu se D10 (10% od distribucijskog volumena) nalazi u rasponu od 0,2 do 2 mikrometra, D50 se nalazi su rasponu od 1 do 4 mikrometra i D90 se nalazi u rasponu od 2 do 6 mikrometara, kada se mjeri pomoću laserske difrakcije ili u suspenziji ili kao dispergirani suhi prah.
11. Aerosolna suspenzijska formulacija prema patentnom zahtjevu 10, naznačena time, da se ovlaživač koristi u količini od 1,99 do 0,01% mase na temelju ukupne mase aerosolne suspenzijske formulacije, poželjno u količini od 1,5 do 1,0% mase na temelju ukupne mase aerosolne suspenzijske formulacije.
12. Aerosolna suspenzijska formulacija prema patentnom zahtjevu 10, naznačena time, da HFA pogonsko gorivo jest HFA 227.
13. Aerosolna suspenzijska formulacija prema patentnom zahtjevu 10, naznačena time, da se formoterol fumarat dihidrat unosi u količini od 0,003 do 0,04% mase.
14. Aerosolna suspenzijska formulacija prema patentnom zahtjevu 10, naznačena time, da se flutikazon propionat unosi u količini od 0,01 do 0,6% mase.
15. Aerosolna suspenzijska formulacija prema patentnom zahtjevu 10, naznačena time, da aerosolna suspenzijska formulacija dodatno sadrži sol odabranu iz skupine koja se sastoji od nedokromila i kromoglicilne kiseline, gdje se poželjno radi o soli natrijevog kromoglikata (DSCG), još poželjnije gdje se natrijev kromoglikat koristi u količini od 0,01 do 0,1% mase na temelju ukupne mase formulacije.
16. Aerosolna suspenzijska formulacija prema patentnom zahtjevu 10, koja se nalazi u inhalatoru s odmjernom dozom, naznačena time, da sadrži:
(i) 0,035% flutikazon propionata, 0,007% formoterol fumarata, 0,034% natrijevog kromoglikata, 1,4% etanola i HFA 227 q.s. ad 100, gdje se svi postoci temelje na ukupnoj masi pripravka, i gdje nominalna doza iznosi 50 mikrograma za flutikazon propionat i 10 mikrograma za formoterol fumarat, dva puta dnevno (BID);
(ii) 0,071% flutikazon propionata, 0,007% formoterol fumarata, 0,034% natrijevog kromoglikata, 1,4% etanola i HFA 227 q.s. ad 100, gdje se svi postoci temelje na ukupnoj masi pripravka, i gdje nominalna doza iznosi 100 mikrograma za flutikazon propionat i 10 mikrograma za formoterol fumarat, dva puta dnevno (BID);
(iii) 0,178% flutikazon propionata, 0,007% formoterol fumarata, 0,034% natrijevog kromoglikata, 1,4% etanola i HFA 227 q.s. ad 100, gdje se svi postoci temelje na ukupnoj masi pripravka, i gdje nominalna doza iznosi 250 mikrograma za flutikazon propionat i 10 mikrograma za formoterol fumarat, dva puta dnevno (BID);
(iv) 0,357% flutikazon propionata, 0,007% formoterol fumarata, 0,034% natrijevog kromoglikata, 1,4% etanola i HFA 227 q.s. ad 100, gdje se svi postoci temelje na ukupnoj masi pripravka, i gdje nominalna doza iznosi 500 mikrograma za flutikazon propionat i 10 ikrograma za formoterol fumarat, dva puta dnevno (BID);
(v) 0,357% flutikazon propionata, 0,014% formoterol fumarata, 0,068% natrijevog kromoglikata, 1,4% etanola i HFA 227 q.s. ad 100, gdje se svi postoci temelje na ukupnoj masi pripravka, i gdje nominalna doza iznosi 500 mikrograma za flutikazon propionat i 20 mikrograma za formoterol fumarat, dva puta dnevno; ili
(vi0,357% flutikazon propionata, 0,014% formoterol fumarata, 0,034% natrijevog kromoglikata, 1,4% etanola i HFA 227 q.s. ad 100, gdje se svi postoci temelje na ukupnoj masi pripravka, i gdje nominalna doza iznosi 500 mikrograma za flutikazon propionat i 20 mikrograma za formoterol fumarat, dva puta dnevno.
17. Aerosolna suspenzijska formulacija prema patentnom zahtjevu 10, naznačena time, da je za uporabu u liječenju astme, alergijskog rinitisa ili kronične opstrukcijske plućne bolesti (KOPB).
18. Aerosolna suspenzijska formulacija prema patentnom zahtjevu 17, naznačena time, da je za uporabu istovremeno, uzastopno ili odvojeno s beta-2-agonistom kratkog djelovanja, pri čemu je beta-2-agonist kratkog djelovanja odabran iz skupine koja se sastoji od albuterola, salbutamola, terbutalina, fenoterola, levalbuterola, reproterola i pirbuterola.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB0918150.4A GB0918150D0 (en) | 2009-10-16 | 2009-10-16 | Improved formulations |
EP10768760.0A EP2488157B1 (en) | 2009-10-16 | 2010-10-15 | Improved formulations |
PCT/EP2010/065569 WO2011045429A1 (en) | 2009-10-16 | 2010-10-15 | Improved formulations |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20210379T1 true HRP20210379T1 (hr) | 2021-04-16 |
Family
ID=41462451
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20210379TT HRP20210379T1 (hr) | 2009-10-16 | 2021-03-04 | Poboljšane formulacije |
Country Status (24)
Country | Link |
---|---|
US (2) | US20120263766A1 (hr) |
EP (2) | EP2488157B1 (hr) |
JP (2) | JP5818801B2 (hr) |
CN (1) | CN102573791B (hr) |
AU (1) | AU2010305695B2 (hr) |
BR (1) | BR112012008969B1 (hr) |
CA (1) | CA2776845C (hr) |
CL (1) | CL2012000948A1 (hr) |
CY (1) | CY1123918T1 (hr) |
DK (1) | DK2488157T3 (hr) |
ES (1) | ES2859629T3 (hr) |
GB (1) | GB0918150D0 (hr) |
HR (1) | HRP20210379T1 (hr) |
HU (1) | HUE054030T2 (hr) |
IL (2) | IL219162A0 (hr) |
LT (1) | LT2488157T (hr) |
MX (1) | MX2012004338A (hr) |
NZ (1) | NZ599900A (hr) |
PL (1) | PL2488157T3 (hr) |
PT (1) | PT2488157T (hr) |
RS (1) | RS61430B1 (hr) |
SI (1) | SI2488157T1 (hr) |
WO (1) | WO2011045429A1 (hr) |
ZA (1) | ZA201202595B (hr) |
Families Citing this family (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
RO121172B1 (ro) * | 2001-03-30 | 2007-01-30 | Jago Research Ag | Compoziţie farmaceutică de aerosol şi utilizarea acesteia |
GB0323684D0 (en) | 2003-10-09 | 2003-11-12 | Jagotec Ag | Improvements in or relating to organic compounds |
GB0918150D0 (en) * | 2009-10-16 | 2009-12-02 | Jagotec Ag | Improved formulations |
GB0918149D0 (en) * | 2009-10-16 | 2009-12-02 | Jagotec Ag | Improved medicinal aerosol formulation |
WO2013127738A1 (de) * | 2012-02-28 | 2013-09-06 | Boehringer Ingelheim International Gmbh | Neue treibgashaltige tiotropium-formulierung |
EP2836198A2 (en) | 2012-04-11 | 2015-02-18 | Cipla Limited | Pharmaceutical composition comprising arformoterol and fluticasone furoate |
GB201321712D0 (en) * | 2013-12-09 | 2014-01-22 | Pharmachemie Bv | Dry Powder Inhaler |
CN105963282B (zh) * | 2016-05-04 | 2019-04-19 | 四川普锐特医药科技有限责任公司 | 一种医用定量吸入气雾剂 |
WO2018059390A1 (zh) * | 2016-09-29 | 2018-04-05 | 广东东阳光药业有限公司 | 药物组合物 |
Family Cites Families (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6596260B1 (en) | 1993-08-27 | 2003-07-22 | Novartis Corporation | Aerosol container and a method for storage and administration of a predetermined amount of a pharmaceutically active aerosol |
JPH11509433A (ja) | 1995-04-14 | 1999-08-24 | グラクソ、ウェルカム、インコーポレーテッド | アルブテロール用計量投与用吸入器 |
RO119116B1 (ro) | 1995-04-14 | 2004-04-30 | Glaxo Wellcome Inc. | Inhalator pentru dozarea salmeterolului |
JPH101442A (ja) * | 1996-06-12 | 1998-01-06 | Taisho Pharmaceut Co Ltd | 鼻炎用点鼻薬 |
EP0969816B1 (en) * | 1997-03-20 | 2004-12-15 | Schering Corporation | Preparation of powder agglomerates |
GB9903759D0 (en) * | 1999-02-18 | 1999-04-14 | Novartis Ag | Organic compounds |
DZ3358A1 (fr) * | 2000-05-22 | 2001-11-29 | Chiesi Farma Spa | Formulations en solution pharmaceutiques pour inhalateurs-doseurs sous pression |
US20060257324A1 (en) * | 2000-05-22 | 2006-11-16 | Chiesi Farmaceutici S.P.A. | Pharmaceutical solution formulations for pressurised metered dose inhalers |
WO2002024552A2 (en) | 2000-09-18 | 2002-03-28 | Glaxo Group Limited | Coated can for a metered dose inhaler |
WO2002030394A2 (en) * | 2000-10-09 | 2002-04-18 | 3M Innovative Properties Company | Medicinal aerosol formulations |
RO121172B1 (ro) * | 2001-03-30 | 2007-01-30 | Jago Research Ag | Compoziţie farmaceutică de aerosol şi utilizarea acesteia |
US6667344B2 (en) * | 2001-04-17 | 2003-12-23 | Dey, L.P. | Bronchodilating compositions and methods |
GB0201400D0 (en) * | 2002-01-22 | 2002-03-13 | Glaxo Group Ltd | Novel apparatus and process |
JP2005539046A (ja) * | 2002-08-29 | 2005-12-22 | シプラ・リミテッド | 特異的な抗コリン作用薬、β−2アゴニスト、および副腎皮質ステロイドを含む、治療薬および組成物 |
GB0323684D0 (en) * | 2003-10-09 | 2003-11-12 | Jagotec Ag | Improvements in or relating to organic compounds |
GB0327727D0 (en) * | 2003-11-28 | 2003-12-31 | Quadrant Drug Delivery Ltd | Viral microparticles |
GB0410399D0 (en) * | 2004-05-10 | 2004-06-16 | Arakis Ltd | The treatment of respiratory disease |
GB0918150D0 (en) * | 2009-10-16 | 2009-12-02 | Jagotec Ag | Improved formulations |
-
2009
- 2009-10-16 GB GBGB0918150.4A patent/GB0918150D0/en not_active Ceased
-
2010
- 2010-10-15 CA CA2776845A patent/CA2776845C/en active Active
- 2010-10-15 MX MX2012004338A patent/MX2012004338A/es active IP Right Grant
- 2010-10-15 WO PCT/EP2010/065569 patent/WO2011045429A1/en active Application Filing
- 2010-10-15 AU AU2010305695A patent/AU2010305695B2/en active Active
- 2010-10-15 EP EP10768760.0A patent/EP2488157B1/en active Active
- 2010-10-15 PT PT107687600T patent/PT2488157T/pt unknown
- 2010-10-15 RS RS20210159A patent/RS61430B1/sr unknown
- 2010-10-15 EP EP20213235.3A patent/EP3811928A1/en not_active Withdrawn
- 2010-10-15 US US13/502,097 patent/US20120263766A1/en not_active Abandoned
- 2010-10-15 PL PL10768760T patent/PL2488157T3/pl unknown
- 2010-10-15 NZ NZ599900A patent/NZ599900A/en unknown
- 2010-10-15 BR BR112012008969-2A patent/BR112012008969B1/pt active IP Right Grant
- 2010-10-15 HU HUE10768760A patent/HUE054030T2/hu unknown
- 2010-10-15 JP JP2012533648A patent/JP5818801B2/ja active Active
- 2010-10-15 DK DK10768760.0T patent/DK2488157T3/da active
- 2010-10-15 SI SI201032050T patent/SI2488157T1/sl unknown
- 2010-10-15 CN CN201080046305.6A patent/CN102573791B/zh active Active
- 2010-10-15 LT LTEP10768760.0T patent/LT2488157T/lt unknown
- 2010-10-15 ES ES10768760T patent/ES2859629T3/es active Active
-
2012
- 2012-04-11 ZA ZA2012/02595A patent/ZA201202595B/en unknown
- 2012-04-13 CL CL2012000948A patent/CL2012000948A1/es unknown
- 2012-04-15 IL IL219162A patent/IL219162A0/en unknown
-
2015
- 2015-09-29 JP JP2015191177A patent/JP2016040286A/ja active Pending
-
2017
- 2017-03-21 US US15/464,879 patent/US20180296468A2/en not_active Abandoned
-
2019
- 2019-09-15 IL IL26936919A patent/IL269369A/en unknown
-
2021
- 2021-03-04 HR HRP20210379TT patent/HRP20210379T1/hr unknown
- 2021-03-05 CY CY20211100190T patent/CY1123918T1/el unknown
Also Published As
Similar Documents
Publication | Publication Date | Title |
---|---|---|
HRP20210379T1 (hr) | Poboljšane formulacije | |
JP2013507429A5 (hr) | ||
HRP20200260T1 (hr) | Pripravci, postupci i sustavi za respiratornu isporuku dva ili više aktivnih sredstava | |
HRP20221432T1 (hr) | Formulacija suhog praška koja sadrži antikolinergik, kortikosteroid i beta-adrenergik za davanje inhalacijom | |
JP2014528470A5 (hr) | ||
JP2012528200A5 (hr) | ||
HRP20130835T1 (hr) | Farmaceutske formulacije otopine za davanje kao stlaäśeni inhalat u inhalatoru | |
JP2012503668A5 (hr) | ||
JP2007520508A5 (hr) | ||
WO2012107765A3 (en) | Particle formulation | |
HRP20220929T3 (hr) | Sastav za inhalaciju koji sadrži aklidinij za liječenje astme | |
Shemirani et al. | In vitro investigation of the effect of ambient humidity on regional delivered dose with solution and suspension MDIs | |
DK2793886T3 (en) | Inhalable medicament comprising tiotropium | |
Chrystyn | Is total particle dose more important than particle distribution? | |
JP2014530231A5 (hr) | ||
JP2020527377A5 (hr) | ||
WO2005063777A8 (en) | Benzylphosphate and substituted benzylphosphate prodrugs for the treatment of pulmonary inflammation | |
RS53821B1 (en) | INHALATION PHARMACEUTICAL COMPOSITION | |
EA201401354A1 (ru) | Новая дозированная форма и препарат, содержащий абедитерол | |
HRP20140818T1 (hr) | Farmaceutske aerosolne formulacije formoterola i beklometazon-dipropionata | |
Pornputtapitak et al. | Nanocluster budesonide formulations enhance drug delivery through endotracheal tubes | |
GB201118188D0 (en) | Manufacture of medicinal aerosol canisters | |
EP2821061A1 (en) | Novel inhalation formulations | |
Bagherisadeghi et al. | Real-life budesonide and formoterol dose emission from the medium and high strength fixed dosed combinations in a Spiromax® dry powder inhaler using inhalation profiles from patients with chronic obstructive pulmonary disease | |
MY187442A (en) | A pharmaceutical composition containing budesonide and formoterol |