DK2146704T3 - Anvendelse af en sammensætning omfattende formoterol og beclometasondipropionat til behandling af en forværring af asthma - Google Patents
Anvendelse af en sammensætning omfattende formoterol og beclometasondipropionat til behandling af en forværring af asthma Download PDFInfo
- Publication number
- DK2146704T3 DK2146704T3 DK08748930.8T DK08748930T DK2146704T3 DK 2146704 T3 DK2146704 T3 DK 2146704T3 DK 08748930 T DK08748930 T DK 08748930T DK 2146704 T3 DK2146704 T3 DK 2146704T3
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- DK
- Denmark
- Prior art keywords
- formoterol
- use according
- asthma
- combination
- beclomethasone dipropionate
- Prior art date
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- 239000000203 mixture Substances 0.000 title claims description 60
- 229960002848 formoterol Drugs 0.000 title claims description 42
- 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 title claims description 41
- KUVIULQEHSCUHY-XYWKZLDCSA-N Beclometasone 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)COC(=O)CC)(OC(=O)CC)[C@@]1(C)C[C@@H]2O KUVIULQEHSCUHY-XYWKZLDCSA-N 0.000 title claims description 36
- 229950000210 beclometasone dipropionate Drugs 0.000 title claims description 32
- 238000011282 treatment Methods 0.000 title claims description 18
- 208000037874 Asthma exacerbation Diseases 0.000 title description 2
- 208000006673 asthma Diseases 0.000 claims description 35
- 239000004480 active ingredient Substances 0.000 claims description 15
- 239000003380 propellant Substances 0.000 claims description 14
- 150000003839 salts Chemical class 0.000 claims description 14
- 239000003814 drug Substances 0.000 claims description 13
- 238000009115 maintenance therapy Methods 0.000 claims description 12
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 10
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 10
- 230000001154 acute effect Effects 0.000 claims description 10
- LVGUZGTVOIAKKC-UHFFFAOYSA-N 1,1,1,2-tetrafluoroethane Chemical compound FCC(F)(F)F LVGUZGTVOIAKKC-UHFFFAOYSA-N 0.000 claims description 9
- 239000002245 particle Substances 0.000 claims description 9
- 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 description 8
- 239000003085 diluting agent Substances 0.000 claims description 8
- 239000012453 solvate Substances 0.000 claims description 8
- 238000011418 maintenance treatment Methods 0.000 claims description 6
- 239000000654 additive Substances 0.000 claims description 5
- 239000006184 cosolvent Substances 0.000 claims description 5
- 229940112141 dry powder inhaler Drugs 0.000 claims description 5
- YFMFNYKEUDLDTL-UHFFFAOYSA-N 1,1,1,2,3,3,3-heptafluoropropane Chemical compound FC(F)(F)C(F)C(F)(F)F YFMFNYKEUDLDTL-UHFFFAOYSA-N 0.000 claims description 4
- 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 description 4
- 239000002253 acid Substances 0.000 claims description 4
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- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 3
- 230000000996 additive effect Effects 0.000 claims description 3
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 3
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- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 2
- 229920002307 Dextran Polymers 0.000 claims description 2
- 229930195725 Mannitol Natural products 0.000 claims description 2
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- 238000001704 evaporation Methods 0.000 claims description 2
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 claims description 2
- 239000000594 mannitol Substances 0.000 claims description 2
- 235000010355 mannitol Nutrition 0.000 claims description 2
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- 230000000087 stabilizing effect Effects 0.000 claims description 2
- 239000000126 substance Substances 0.000 claims description 2
- 239000004094 surface-active agent Substances 0.000 claims description 2
- 230000004913 activation Effects 0.000 claims 1
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- 238000009472 formulation Methods 0.000 description 20
- 230000005713 exacerbation Effects 0.000 description 9
- 208000023819 chronic asthma Diseases 0.000 description 7
- 229940071648 metered dose inhaler Drugs 0.000 description 7
- 229940068196 placebo Drugs 0.000 description 6
- 239000000902 placebo Substances 0.000 description 6
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 5
- 230000001186 cumulative effect Effects 0.000 description 5
- 201000010099 disease Diseases 0.000 description 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 5
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- 210000002966 serum Anatomy 0.000 description 5
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- 229940021599 formoterol and beclometasone Drugs 0.000 description 4
- 229960000193 formoterol fumarate Drugs 0.000 description 4
- 229940127212 long-acting beta 2 agonist Drugs 0.000 description 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 4
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- 229960001375 lactose Drugs 0.000 description 3
- 238000012423 maintenance Methods 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- XWTYSIMOBUGWOL-UHFFFAOYSA-N (+-)-Terbutaline Chemical compound CC(C)(C)NCC(O)C1=CC(O)=CC(O)=C1 XWTYSIMOBUGWOL-UHFFFAOYSA-N 0.000 description 2
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.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 WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 description 2
- 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 description 2
- 206010061218 Inflammation Diseases 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 description 2
- 206010047924 Wheezing Diseases 0.000 description 2
- 208000024716 acute asthma Diseases 0.000 description 2
- 208000037883 airway inflammation Diseases 0.000 description 2
- NDAUXUAQIAJITI-UHFFFAOYSA-N albuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- 239000004411 aluminium Substances 0.000 description 2
- 230000003110 anti-inflammatory effect Effects 0.000 description 2
- 229940124630 bronchodilator Drugs 0.000 description 2
- 229960004436 budesonide Drugs 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- -1 hydrochloric Chemical class 0.000 description 2
- 230000004054 inflammatory process Effects 0.000 description 2
- 210000004072 lung Anatomy 0.000 description 2
- 235000019359 magnesium stearate Nutrition 0.000 description 2
- 230000002265 prevention Effects 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 229960002052 salbutamol Drugs 0.000 description 2
- 229960000195 terbutaline Drugs 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- UPHOPMSGKZNELG-UHFFFAOYSA-N 2-hydroxynaphthalene-1-carboxylic acid Chemical compound C1=CC=C2C(C(=O)O)=C(O)C=CC2=C1 UPHOPMSGKZNELG-UHFFFAOYSA-N 0.000 description 1
- 125000005274 4-hydroxybenzoic acid group Chemical group 0.000 description 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 description 1
- 208000000884 Airway Obstruction Diseases 0.000 description 1
- 208000009079 Bronchial Spasm Diseases 0.000 description 1
- PJFHZKIDENOSJB-UHFFFAOYSA-N Budesonide/formoterol Chemical compound C1=CC(OC)=CC=C1CC(C)NCC(O)C1=CC=C(O)C(NC=O)=C1.C1CC2=CC(=O)C=CC2(C)C2C1C1CC3OC(CCC)OC3(C(=O)CO)C1(C)CC2O PJFHZKIDENOSJB-UHFFFAOYSA-N 0.000 description 1
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- 206010016654 Fibrosis Diseases 0.000 description 1
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical class OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 1
- 208000027771 Obstructive airways disease Diseases 0.000 description 1
- 208000037656 Respiratory Sounds Diseases 0.000 description 1
- GIIZNNXWQWCKIB-UHFFFAOYSA-N Serevent Chemical compound C1=C(O)C(CO)=CC(C(O)CNCCCCCCOCCCCC=2C=CC=CC=2)=C1 GIIZNNXWQWCKIB-UHFFFAOYSA-N 0.000 description 1
- 230000009471 action Effects 0.000 description 1
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- 239000000924 antiasthmatic agent Substances 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid group Chemical group C(C1=CC=CC=C1)(=O)O WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 description 1
- 102000014974 beta2-adrenergic receptor activity proteins Human genes 0.000 description 1
- 108040006828 beta2-adrenergic receptor activity proteins Proteins 0.000 description 1
- 230000036772 blood pressure Effects 0.000 description 1
- 229940080593 budesonide / formoterol Drugs 0.000 description 1
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- 238000009826 distribution Methods 0.000 description 1
- 229960001022 fenoterol Drugs 0.000 description 1
- 230000004761 fibrosis Effects 0.000 description 1
- 229960000289 fluticasone propionate Drugs 0.000 description 1
- 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 description 1
- 239000012458 free base Substances 0.000 description 1
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- 150000002430 hydrocarbons Chemical class 0.000 description 1
- 208000027866 inflammatory disease Diseases 0.000 description 1
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- 230000001788 irregular Effects 0.000 description 1
- 230000002427 irreversible effect Effects 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 150000007522 mineralic acids Chemical class 0.000 description 1
- 239000003595 mist Substances 0.000 description 1
- 229960002744 mometasone furoate Drugs 0.000 description 1
- WOFMFGQZHJDGCX-ZULDAHANSA-N mometasone furoate Chemical compound O([C@]1([C@@]2(C)C[C@H](O)[C@]3(Cl)[C@@]4(C)C=CC(=O)C=C4CC[C@H]3[C@@H]2C[C@H]1C)C(=O)CCl)C(=O)C1=CC=CO1 WOFMFGQZHJDGCX-ZULDAHANSA-N 0.000 description 1
- 208000024696 nocturnal asthma Diseases 0.000 description 1
- 230000000422 nocturnal effect Effects 0.000 description 1
- 235000021313 oleic acid Nutrition 0.000 description 1
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Classifications
-
- 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
- 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
-
- 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
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61P11/06—Antiasthmatics
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Pulmonology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pain & Pain Management (AREA)
- Otolaryngology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Claims (18)
1. Anvendelse af en sammensætning omfattende en fast kombination af a) formoterol, et farmaceutisk acceptabelt salt eller solvat deraf eller et solvat af et sådant salt; og b) beclometasondipropionat; til fremstilling af et medikament indgivet ved inhalation ved hjælp af en tør-pulverinhalator, formuleret i form af en tørpulversammensætning omfattende et eller flere egnede fortyndingsmidler eller bærere, eller ved hjælp af en trykpåvirket doseringsinhalator, hvor både de aktive bestanddele (a) og (b) er opløst helt i en flydende drivmiddelblanding, til anvendelse til nødbehandling ved akutte episoder af asthmaanfald, ved behov herfor, som et komplement til vedligeholdelsesbehandling af asthma med det samme medikament.
2. Anvendelse ifølge krav 1, hvor molforholdet mellem (a) og (b), kalkuleret som mellem formoterol og beclometasondipropionat, er fra 1:1 til 1:500.
3. Anvendelse ifølge krav 2, hvor molforholdet mellem (a) og (b), kalkuleret som mellem formoterol og beclometasondipropionat, er fra 1:1 til 1:100.
4. Anvendelse ifølge krav 3, hvor molforholdet mellem (a) og (b), kalkuleret som mellem formoterol og beclometasondipropionat, er fra 1:3 til 1:30.
5. Anvendelse ifølge krav 4, hvor molforholdet mellem (a) og (b), kalkuleret som mellem formoterol og beclometasondipropionat, er 1:12,8.
6. Anvendelse ifølge krav 4, hvor molforholdet mellem (a) og (b), kalkuleret som mellem formoterol og beclometasondipropionat, er 1:25,6.
7. Anvendelse ifølge et af kravene 1 til 6, hvor den aktive bestanddel (a) er formoterolfumaratdihydrat.
8. Anvendelse ifølge et af kravene 1 til 6, hvor den aktive bestanddel (a) er R,R-enantiomeren af formoterol eller farmaceutisk acceptabelt salt eller sol- vat deraf eller et solvat af et sådant salt.
9. Anvendelse ifølge et hvilket som helst foregående krav, hvor medikamentet omfatter en daglig dosis formoterol for voksne, herunder vedligeholdelsesterapi, i en mængde på 72 mikrogram.
10. Anvendelse ifølge et hvilket som helst foregående krav, hvor medikamentet omfatter en daglig dosis beclometasondipropionat for voksne, herunder vedligeholdelsesterapi, i en mængde på 1200 mikrogram.
11. Anvendelse ifølge et af kravene 1 til 10, hvor, når medikamentet er formuleret i form af en tørpulversammensætning, det ene eller de flere egnede fortyndingsmidler eller bærere er udvalgt blandt lactose, dextran, mannitol og glucose.
12. Anvendelse ifølge krav 11, hvor både de aktive bestanddele (a) og (b) af kombinationen og fortyndingsmidlet/bæreren foreligger i en mikroniseret form.
13. Anvendelse ifølge krav 12, hvor et groft fortyndingsmiddel/en grov bærer kan tilsættes til sammensætningen for at danne en ordineret blanding.
14. Anvendelse ifølge krav 13, hvor den ordinerede blanding kan indeholde et additiv for at fremme frigivelsen af de aktive bestanddele udvalgt blandt substanser med antiklæbe-, glide- eller smøreegenskaber.
15. Anvendelse ifølge et af kravene 1 til 10, hvor, når medikamentet er formuleret i form af en trykpåvirket doseringsinhalator, den flydende drivmiddelblanding omfatter HFA 134a (1,1,1,2-tetrafluorethan), HFA 227 (1,1,1,2,3,3, 3-heptafluorpropan) eller deres blandinger, i kombination med et eller flere co-opløsningsmidler, overfladeaktivt stof, glidemiddel, antioxidant, stabiliserings- og/eller konserveringsmiddel.
16. Anvendelse ifølge krav 15, hvor det flydende drivmiddel omfatter HFA 134a (1,1,1,2-tetrafluorethan), ethanol som et co-opløsningsmiddel og en vandig mineralsyre som stabiliseringsmiddel.
17. Anvendelse ifølge krav 16, hvor den vandige mineralsyre er 1M-hydro-chlorsyre.
18. Anvendelse ifølge et af kravene 16 til 17, hvilken efter aktivering af den påvirkede doseringsinhalator, efter fordampning af drivmiddelblandingen, har en gennemsnitlig partikelstørrelse af de to aktive bestanddele, der er lig med eller under 1,1 mikrometer.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP07007930A EP1982709A1 (en) | 2007-04-19 | 2007-04-19 | Use of a composition comprising formoterol and beclomethasone dipropionate for the prevention or treatment of an acute condition of asthma |
| PCT/EP2008/003012 WO2008128685A1 (en) | 2007-04-19 | 2008-04-16 | Use of a composition comprising formoterol and beclometasone dipropionate for the prevention and/or treatment of an exacerbation of asthma |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2146704T3 true DK2146704T3 (da) | 2016-05-23 |
Family
ID=38458097
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK08748930.8T DK2146704T3 (da) | 2007-04-19 | 2008-04-16 | Anvendelse af en sammensætning omfattende formoterol og beclometasondipropionat til behandling af en forværring af asthma |
Country Status (29)
| Country | Link |
|---|---|
| US (1) | US20080261932A1 (da) |
| EP (3) | EP1982709A1 (da) |
| JP (2) | JP5492072B2 (da) |
| KR (3) | KR101621676B1 (da) |
| CN (1) | CN101657191B (da) |
| AU (1) | AU2008241045C1 (da) |
| BR (1) | BRPI0809800A2 (da) |
| CA (1) | CA2684539A1 (da) |
| CO (1) | CO6220945A2 (da) |
| CY (1) | CY1117568T1 (da) |
| DK (1) | DK2146704T3 (da) |
| EA (1) | EA018589B1 (da) |
| ES (2) | ES2568497T3 (da) |
| GE (1) | GEP20145999B (da) |
| HR (1) | HRP20160588T1 (da) |
| HU (1) | HUE029263T2 (da) |
| IL (1) | IL201632A (da) |
| MA (1) | MA31315B1 (da) |
| ME (1) | ME00945B (da) |
| MX (1) | MX2009010851A (da) |
| MY (1) | MY169579A (da) |
| NZ (1) | NZ580526A (da) |
| PL (2) | PL3034073T3 (da) |
| RS (1) | RS54874B1 (da) |
| SI (1) | SI2146704T1 (da) |
| TN (1) | TN2009000390A1 (da) |
| TR (1) | TR201909857T4 (da) |
| UA (1) | UA100237C2 (da) |
| WO (1) | WO2008128685A1 (da) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1982709A1 (en) | 2007-04-19 | 2008-10-22 | CHIESI FARMACEUTICI S.p.A. | Use of a composition comprising formoterol and beclomethasone dipropionate for the prevention or treatment of an acute condition of asthma |
| WO2011038872A1 (en) * | 2009-10-02 | 2011-04-07 | Chiesi Farmaceutici S.P.A. | Pharmaceutical aerosol formulations of formoterol and beclometasone dipropionate |
| CN102247597B (zh) * | 2010-05-19 | 2015-01-07 | 天津金耀集团有限公司 | 一种糖皮质激素与支气管扩张剂的吸入剂 |
| EA026267B1 (ru) * | 2012-01-25 | 2017-03-31 | КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А. | Композиция в форме сухого порошка, содержащая кортикостероид и бета-адренергическое лекарственное средство, для введения ингаляцией |
| US11052202B2 (en) * | 2012-11-07 | 2021-07-06 | Chiesi Farmaceutici S.P.A. | Drug delivery device for the treatment of patients with respiratory diseases |
| MX2019003103A (es) * | 2016-09-19 | 2019-08-01 | Mexichem Fluor Sa De Cv | Composicion farmaceutica. |
| CN107233311B (zh) * | 2017-06-27 | 2020-12-04 | 长风药业股份有限公司 | 一种以阿福特罗和格隆溴铵为活性成分的雾化剂及其制备方法 |
| AU2019282562A1 (en) * | 2018-06-04 | 2021-01-21 | Lupin Inc. | Stable pharmaceutical compositions for pressurized metered dose inhalers |
| JP2025538083A (ja) * | 2022-11-03 | 2025-11-26 | デイナ ファーバー キャンサー インスティチュート，インコーポレイテッド | ホルモテロール又はその薬学的に許容される塩を使用して貧血を治療する方法 |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5795564A (en) * | 1991-04-05 | 1998-08-18 | Sepracor, Inc. | Methods and compositions for treating pulmonary disorders using optically pure (R,R)-formoterol |
| DK0613371T3 (da) | 1991-12-18 | 2002-05-13 | Astrazeneca Ab | Ny kombination af formoterol og budesonid |
| SE9802073D0 (sv) | 1998-06-11 | 1998-06-11 | Astra Ab | New use |
| AU2000250701B2 (en) | 2000-05-22 | 2004-07-01 | Chiesi Farmaceutici S.P.A. | Stable pharmaceutical solution formulations for pressurised metered dose inhalers |
| FI20002177A0 (fi) * | 2000-10-02 | 2000-10-02 | Orion Yhtymae Oyj | Uusi yhdistelmä astman hoitoon |
| FI20002215A0 (fi) * | 2000-10-06 | 2000-10-06 | Orion Yhtymae Oyj | Yhdistelmäpartikkelit |
| FI20002216A0 (fi) * | 2000-10-06 | 2000-10-06 | Orion Yhtymae Oyj | Yhdistelmäpartikkelit astman hoitoon |
| ES2342463T3 (es) | 2002-03-01 | 2010-07-07 | Chiesi Farmaceutici S.P.A. | Formulacion superfina de formoterol. |
| EP1982709A1 (en) | 2007-04-19 | 2008-10-22 | CHIESI FARMACEUTICI S.p.A. | Use of a composition comprising formoterol and beclomethasone dipropionate for the prevention or treatment of an acute condition of asthma |
-
2007
- 2007-04-19 EP EP07007930A patent/EP1982709A1/en not_active Withdrawn
-
2008
- 2008-04-16 PL PL16152451T patent/PL3034073T3/pl unknown
- 2008-04-16 ES ES08748930.8T patent/ES2568497T3/es active Active
- 2008-04-16 GE GEAP200811515A patent/GEP20145999B/en unknown
- 2008-04-16 PL PL08748930.8T patent/PL2146704T3/pl unknown
- 2008-04-16 MX MX2009010851A patent/MX2009010851A/es active IP Right Grant
- 2008-04-16 CA CA002684539A patent/CA2684539A1/en not_active Abandoned
- 2008-04-16 CN CN200880012407.9A patent/CN101657191B/zh active Active
- 2008-04-16 NZ NZ580526A patent/NZ580526A/en unknown
- 2008-04-16 TR TR2019/09857T patent/TR201909857T4/tr unknown
- 2008-04-16 KR KR1020157017841A patent/KR101621676B1/ko active Active
- 2008-04-16 KR KR1020097019229A patent/KR20100014408A/ko not_active Abandoned
- 2008-04-16 EP EP16152451.7A patent/EP3034073B1/en active Active
- 2008-04-16 HR HRP20160588TT patent/HRP20160588T1/hr unknown
- 2008-04-16 HU HUE08748930A patent/HUE029263T2/en unknown
- 2008-04-16 SI SI200831597A patent/SI2146704T1/sl unknown
- 2008-04-16 JP JP2010503394A patent/JP5492072B2/ja active Active
- 2008-04-16 DK DK08748930.8T patent/DK2146704T3/da active
- 2008-04-16 UA UAA200909905A patent/UA100237C2/uk unknown
- 2008-04-16 KR KR1020157005890A patent/KR101668203B1/ko active Active
- 2008-04-16 RS RS20160439A patent/RS54874B1/sr unknown
- 2008-04-16 ME MEP-2009-315A patent/ME00945B/me unknown
- 2008-04-16 ES ES16152451T patent/ES2740103T3/es active Active
- 2008-04-16 EP EP08748930.8A patent/EP2146704B1/en active Active
- 2008-04-16 AU AU2008241045A patent/AU2008241045C1/en active Active
- 2008-04-16 MY MYPI20094314A patent/MY169579A/en unknown
- 2008-04-16 BR BRPI0809800-0A2A patent/BRPI0809800A2/pt not_active Application Discontinuation
- 2008-04-16 WO PCT/EP2008/003012 patent/WO2008128685A1/en not_active Ceased
- 2008-04-16 EA EA200901201A patent/EA018589B1/ru not_active IP Right Cessation
- 2008-04-21 US US12/106,493 patent/US20080261932A1/en not_active Abandoned
-
2009
- 2009-09-24 TN TNP2009000390A patent/TN2009000390A1/fr unknown
- 2009-10-13 CO CO09113200A patent/CO6220945A2/es not_active Application Discontinuation
- 2009-10-15 MA MA32284A patent/MA31315B1/fr unknown
- 2009-10-19 IL IL201632A patent/IL201632A/en active IP Right Grant
-
2013
- 2013-10-18 JP JP2013217531A patent/JP2014005312A/ja not_active Withdrawn
-
2016
- 2016-04-14 CY CY20161100313T patent/CY1117568T1/el unknown
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