HRP20201005T1 - Formulacija koja sadrži glikopirolat, postupak i uređaj - Google Patents
Formulacija koja sadrži glikopirolat, postupak i uređaj Download PDFInfo
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- HRP20201005T1 HRP20201005T1 HRP20201005TT HRP20201005T HRP20201005T1 HR P20201005 T1 HRP20201005 T1 HR P20201005T1 HR P20201005T T HRP20201005T T HR P20201005TT HR P20201005 T HRP20201005 T HR P20201005T HR P20201005 T1 HRP20201005 T1 HR P20201005T1
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- 238000000034 method Methods 0.000 title claims 18
- 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 title claims 7
- 229940015042 glycopyrrolate Drugs 0.000 title claims 7
- 238000009472 formulation Methods 0.000 title claims 6
- 239000000203 mixture Substances 0.000 title claims 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 14
- 239000011246 composite particle Substances 0.000 claims 12
- 230000003750 conditioning effect Effects 0.000 claims 8
- 235000019359 magnesium stearate Nutrition 0.000 claims 7
- 239000000843 powder Substances 0.000 claims 6
- 238000000227 grinding Methods 0.000 claims 5
- 238000010902 jet-milling Methods 0.000 claims 5
- 239000000048 adrenergic agonist Substances 0.000 claims 3
- 102000014974 beta2-adrenergic receptor activity proteins Human genes 0.000 claims 3
- 108040006828 beta2-adrenergic receptor activity proteins Proteins 0.000 claims 3
- 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
- IREJFXIHXRZFER-PCBAQXHCSA-N indacaterol maleate Chemical compound OC(=O)\C=C/C(O)=O.N1C(=O)C=CC2=C1C(O)=CC=C2[C@@H](O)CNC1CC(C=C(C(=C2)CC)CC)=C2C1 IREJFXIHXRZFER-PCBAQXHCSA-N 0.000 claims 2
- 238000003801 milling Methods 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
- 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
- IHOXNOQMRZISPV-YJYMSZOUSA-N 5-[(1r)-1-hydroxy-2-[[(2r)-1-(4-methoxyphenyl)propan-2-yl]azaniumyl]ethyl]-2-oxo-1h-quinolin-8-olate Chemical compound C1=CC(OC)=CC=C1C[C@@H](C)NC[C@H](O)C1=CC=C(O)C2=C1C=CC(=O)N2 IHOXNOQMRZISPV-YJYMSZOUSA-N 0.000 claims 1
- 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 claims 1
- 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 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 claims 1
- NDAUXUAQIAJITI-UHFFFAOYSA-N albuterol Chemical group CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 claims 1
- 229960004977 anhydrous lactose Drugs 0.000 claims 1
- 229950010713 carmoterol Drugs 0.000 claims 1
- 229960001022 fenoterol Drugs 0.000 claims 1
- 229960002848 formoterol Drugs 0.000 claims 1
- 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 1
- 229960004078 indacaterol Drugs 0.000 claims 1
- QZZUEBNBZAPZLX-QFIPXVFZSA-N indacaterol Chemical compound N1C(=O)C=CC2=C1C(O)=CC=C2[C@@H](O)CNC1CC(C=C(C(=C2)CC)CC)=C2C1 QZZUEBNBZAPZLX-QFIPXVFZSA-N 0.000 claims 1
- 229960004735 indacaterol maleate Drugs 0.000 claims 1
- 229960001375 lactose Drugs 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- LMOINURANNBYCM-UHFFFAOYSA-N metaproterenol Chemical compound CC(C)NCC(O)C1=CC(O)=CC(O)=C1 LMOINURANNBYCM-UHFFFAOYSA-N 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
- 229960002744 mometasone furoate Drugs 0.000 claims 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 claims 1
- 229960002657 orciprenaline Drugs 0.000 claims 1
- 229960002288 procaterol Drugs 0.000 claims 1
- FKNXQNWAXFXVNW-BLLLJJGKSA-N procaterol Chemical compound N1C(=O)C=CC2=C1C(O)=CC=C2[C@@H](O)[C@@H](NC(C)C)CC FKNXQNWAXFXVNW-BLLLJJGKSA-N 0.000 claims 1
- 229960002052 salbutamol Drugs 0.000 claims 1
- 229960004017 salmeterol Drugs 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 238000001179 sorption measurement Methods 0.000 claims 1
- 229960000195 terbutaline Drugs 0.000 claims 1
Classifications
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- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
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- 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
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4704—2-Quinolinones, e.g. carbostyril
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- 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
- A61K9/1682—Processes
- A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
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- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5015—Organic compounds, e.g. fats, sugars
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- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/51—Nanocapsules; Nanoparticles
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- A61P11/04—Drugs for disorders of the respiratory system for throat disorders
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- A61P11/06—Antiasthmatics
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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Claims (15)
1. Postupak priprave suhe praškaste formulacije, te postupak uključuje ko-mlazno mljevenje nemikroniziranog glikopirolata i magnezijevog stearata s plinom za mljevenje koji ima vlažnost ispod 20% relativne vlažnosti radi dobivanja mikroniziranih kompozitnih čestica, pri čemu se mikronizirane kompozitne čestice zatim podvrgavaju koraku kondicioniranja koji uključuje izlaganje mikroniziranih kompozitnih čestica vlazi u rasponu od 10%-95% relativne vlažnosti pri temperaturama između 5°C do 88°C tijekom najmanje 60 minuta.
2. Postupak prema patentnom zahtjevu 1, naznačen time što kondicioniranje započinje u roku od 30 minuta nakon završetka mljevenja, unutar 25 minuta, unutar 20 minuta, unutar 15 minuta, poželjno unutar 10 minuta, poželjnije unutar 5 minuta, najpoželjnije odmah nakon završetka ko-mlaznog mljevenja glikopirolata i magnezijevog stearata.
3. Postupak prema patentnim zahtjevima 1 do 2, naznačen time što se magnezijev stearat ko-mlazno melje u količini od 1 do 25 % (m/m), poželjnije od 2 do 20 % (m/m), poželjnije 3 do 15 % (m/m), poželjnije 4 do 10 % (m/m) ali najpoželjnije od 5 do 7,5 % (m/m) magnezijevog stearata po masi ko-mlazno mljevene kombinacije glikopirolata i magnezijevog stearata.
4. Postupak prema patentnim zahtjevima 1 do 3, naznačen time što postupak nadalje uključuje podvrgavanje mikroniziranih kompozitnih čestica atmosferi za prozračivanje koja ima relativnu vlažnost u rasponu od 10%-95% RH, poželjno 30-90% RH, 45-90% RH ili 50-88% RH ili poželjnije 60-87%, poželjno pri čemu je atmosfera zrak.
5. Postupak prema patentnom zahtjevu 4, naznačen time što atmosfera za prozračivanje prolazi preko i kroz praškasti sloj koji sadrži mikronizirane kompozitne čestice brzinom manjom od 100 cm3/s, manjom od 10 cm3/s, manjom od 5 cm3/s, manjom od 2 cm3/s, manjom od 1 cm3/s, poželjno manjom od 0,8 cm3/s, poželjno manjom od 0,6 cm3/s, poželjno manjom od 0,4 cm3/s, poželjno manjom od 0,2 cm3/s, poželjno manjom od 0,1 cm3/s, poželjnije oko 0,001 cm3/s.
6. Postupak prema patentnim zahtjevima 1 do 5, naznačen time što korak kondicioniranja uključuje miješanje praška, po izboru pri čemu je miješanje isprekidano miješanje praška.
7. Postupak prema patentnom zahtjevu 6, naznačen time što se miješanje praška odvija u roku od 30 minuta nakon završetka mljevenja, unutar 25 minuta, unutar 20 minuta, unutar 15 minuta, poželjno unutar 10 minuta, poželjnije unutar 5 minuta, najpoželjnije odmah nakon završetka mljevenja glikopirolata i magnezijevog stearata.
8. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što formulacija nadalje sadrži agonist beta-2 adrenoceptora, poželjno pri čemu je agonist beta-2 adrenoceptora salbutamol, metaproterenol, terbutalin, salmeterol, fenoterol, prokaterol, poželjno, formoterol, karmoterol i njihove farmaceutski prihvatljive soli, poželjnije pri čemu je agonist beta-2 adrenoceptora (R)-5-[2-(5,6-dietil-indan-2-ilamino)-1-hidroksi-etil]-8-hidroksi-1H-kinolin-2-on maleat.
9. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što formulacija nadalje sadrži indakaterol i mometazon, poželjno indakaterol maleat i mometazon furoat.
10. Postupak dobivanja formulacije suhog praha, te postupak uključuje ko-mlazno mljevenje nemikroniziranog glikopirolata i magnezijevog stearata s plinom za mljevenje koji ima vlažnost ispod 20% relativne vlažnosti radi dobivanja mikroniziranih kompozitnih čestica, pri čemu se mikronizirane kompozitne čestice podvrgavaju koraku kondicioniranja koji uključuje izlaganje mikroniziranih kompozitnih čestica vlazi vlažnosti u rasponu od 10%-95% RH pri temperaturama između 5°C do 88°C tijekom najmanje 10 minuta.
11. Postupak prema patentnim zahtjevima 1 do 10, naznačen time što su mikronizirane kompozitne čestice pomiješane s nosačem, poželjno laktozom, poželjnije bezvodnom laktozom, poželjnije alfa-laktozom monohidratom, po izboru nakon koraka kondicioniranja.
12. Postupak prema patentnom zahtjevu 11, naznačen time što su mikronizirane kompozitne čestice prisutne u količini manjoj od 5%, manjoj od 4%, manjoj od 3%, poželjno manjoj od 2%, poželjno manjoj od 1%, poželjno manjoj od 0,75%, poželjno manjoj od 0,5 masenih % formulacije.
13. Postupak prema patentnim zahtjevima 1 do 12, naznačen time što se korak kondicioniranja provodi distribucijom mikroniziranih kompozitnih čestica na površini, po izboru pri čemu se korak kondicioniranja odvija na pladnju.
14. Postupak prema patentnim zahtjevima 1 do 13, naznačen time što korak kondicioniranja uključuje izlaganje vlazi mikroniziranih kompozitnih čestica dovoljno vremena da se amorfni glikopirolat ponovno kristalizira nakon ko-mlaznog mljevenja, kao što je određeno dinamičkom sorpcijom pare.
15. Postupak prema patentnim zahtjevima 1 do 14, naznačen time što plin za mljevenje ima vlažnost poželjno ispod 15% relativne vlažnosti, poželjno ispod 10% relativne vlažnosti, poželjno ispod 5% relativne vlažnosti, poželjnije ispod 2,5% relativne vlažnosti.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14184164 | 2014-09-09 | ||
| EP15762595.5A EP3191081B1 (en) | 2014-09-09 | 2015-09-09 | Formulation comprising glycopyrrolate, method and apparatus |
| PCT/EP2015/070660 WO2016038116A1 (en) | 2014-09-09 | 2015-09-09 | Formulation comprising glycopyrrolate, method and apparatus |
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| EP3595631A1 (en) * | 2017-03-15 | 2020-01-22 | Vectura Limited | Method and formulation |
| CN112137957B (zh) * | 2019-06-26 | 2022-07-29 | 长风药业股份有限公司 | 一种药用吸入气雾剂及其制备方法 |
| WO2021143785A1 (zh) * | 2020-01-15 | 2021-07-22 | 四川海思科制药有限公司 | 一种含茚达特罗的吸入气雾剂药物组合物及其制备方法 |
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