HRP20191882T1 - Smanjivanje veličine čestice antimuskarinskog spoja - Google Patents
Smanjivanje veličine čestice antimuskarinskog spoja Download PDFInfo
- Publication number
- HRP20191882T1 HRP20191882T1 HRP20191882TT HRP20191882T HRP20191882T1 HR P20191882 T1 HRP20191882 T1 HR P20191882T1 HR P20191882T T HRP20191882T T HR P20191882TT HR P20191882 T HRP20191882 T HR P20191882T HR P20191882 T1 HRP20191882 T1 HR P20191882T1
- Authority
- HR
- Croatia
- Prior art keywords
- particles
- glycopyrronium
- solvent
- salt
- micronized
- Prior art date
Links
- 230000001022 anti-muscarinic effect Effects 0.000 title 1
- 150000001875 compounds Chemical class 0.000 title 1
- 238000010951 particle size reduction Methods 0.000 title 1
- 238000000034 method Methods 0.000 claims 12
- 239000002245 particle Substances 0.000 claims 8
- ANGKOCUUWGHLCE-HKUYNNGSSA-N [(3s)-1,1-dimethylpyrrolidin-1-ium-3-yl] (2r)-2-cyclopentyl-2-hydroxy-2-phenylacetate Chemical compound C1[N+](C)(C)CC[C@@H]1OC(=O)[C@](O)(C=1C=CC=CC=1)C1CCCC1 ANGKOCUUWGHLCE-HKUYNNGSSA-N 0.000 claims 5
- 239000012296 anti-solvent Substances 0.000 claims 4
- 229960002462 glycopyrronium bromide Drugs 0.000 claims 4
- RIQRGMUSBYGDBL-UHFFFAOYSA-N 1,1,1,2,2,3,4,5,5,5-decafluoropentane Chemical compound FC(F)(F)C(F)C(F)C(F)(F)C(F)(F)F RIQRGMUSBYGDBL-UHFFFAOYSA-N 0.000 claims 2
- 229940079593 drug Drugs 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- 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 1
- CPELXLSAUQHCOX-UHFFFAOYSA-M Bromide Chemical compound [Br-] CPELXLSAUQHCOX-UHFFFAOYSA-M 0.000 claims 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims 1
- KRHYYFGTRYWZRS-UHFFFAOYSA-M Fluoride anion Chemical compound [F-] KRHYYFGTRYWZRS-UHFFFAOYSA-M 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
- 229910019142 PO4 Inorganic materials 0.000 claims 1
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 claims 1
- 150000003842 bromide salts Chemical class 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- XMBWDFGMSWQBCA-UHFFFAOYSA-N hydrogen iodide Chemical compound I XMBWDFGMSWQBCA-UHFFFAOYSA-N 0.000 claims 1
- 229910017053 inorganic salt Inorganic materials 0.000 claims 1
- 238000003801 milling Methods 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- BPHQIXJDBIHMLT-UHFFFAOYSA-N perfluorodecane Chemical compound FC(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)F BPHQIXJDBIHMLT-UHFFFAOYSA-N 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
- 238000002360 preparation method Methods 0.000 claims 1
- 238000005406 washing Methods 0.000 claims 1
- 238000001238 wet grinding Methods 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
-
- 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
- A61K9/1682—Processes
- A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
-
- 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
- A61K31/40—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
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Pulmonology (AREA)
- Otolaryngology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (11)
1. Postupak priprave mikroniziranih kristaliničnih čestica glikopironijeve farmaceutski prihvatljive soli, gdje postupak obuhvaća korake:
(a) dodavanje u komoru za mikronizaciju aparata za mokro mljevenje koji sadrži medij za mljevenje, s anti-otapalom koje se ne miješa s vodom odabrano iz skupine koju čine perfluorodekan, dekafluoropentan i 2H,3H-dekafluoropentan;
(b) suspendiranje čestica glikopironijeve soli u rečenom anti-otapalu;
(c) mikroniziranje rečenih suspendiranih čestica pri tlaku između 50 i 200 kPA te pri temperaturi između 0 i 40 °C;
(d) sušenje dobivenih mikroniziranih čestica da bi se uklonilo anti-otapalo; pri čemu najmanje 90% rečenih čestica lijeka ima volumni promjer manji od 10 mikrona kako je određeno Malvernovim aparatom.
2. Postupak prema patentnom zahtjevu 1, naznačeno time da je tlak između 80 i 120 kPA.
3. Postupak prema patentnom zahtjevu 1 ili 2, naznačeno time da čestice glikopironija ponovo prolaze kroz komoru za mikronizaciju kroz 2 do 10 ciklusa obrade.
4. Postupak prema patentnim zahtjevima 1 do 3, naznačeno time da je temperatura između 10 i 30°C.
5. Postupak prema patentnim zahtjevima 1 do 4, naznačeno time da se korak mikronizacije (c) provodi u vremenu između 15 i 90 minuta.
6. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, koji dalje sadrži korak skupljanja dobivenih mikroniziranih čestica.
7. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačeno time da farmaceutski prihvatljiva sol jest organska ili anorganska.
8. Postupak prema patentnom zahtjevu 7, naznačeno time da je anorganska sol odabrana iz skupine koju čine fluorid, klorid, bromid, jodid, fosfat, nitrat i sulfat.
9. Postupak prema patentnom zahtjevu 7, naznačeno time da je glikopironij u obliku soli bromida.
10. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačeno time da je glikopironij u obliku racemične smjese enantiomera (3S,2’R), (3R,2’S).
11. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, koji dalje sadrži korak pranja u kojem se koristi drugo anti-otapalo za pranje mikroniziranih čestica lijeka.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13165483 | 2013-04-26 | ||
| PCT/EP2014/058295 WO2014173987A1 (en) | 2013-04-26 | 2014-04-24 | Particle size reduction of an antimuscarinic compound |
| EP14724332.3A EP2988728B1 (en) | 2013-04-26 | 2014-04-24 | Particle size reduction of an antimuscarinic compound |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20191882T1 true HRP20191882T1 (hr) | 2019-12-27 |
Family
ID=48190260
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20230337TT HRP20230337T1 (hr) | 2013-04-26 | 2014-04-24 | Smanjivanje veličine čestica antimuskarinskih spojeva |
| HRP20191882TT HRP20191882T1 (hr) | 2013-04-26 | 2019-10-17 | Smanjivanje veličine čestice antimuskarinskog spoja |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20230337TT HRP20230337T1 (hr) | 2013-04-26 | 2014-04-24 | Smanjivanje veličine čestica antimuskarinskih spojeva |
Country Status (28)
| Country | Link |
|---|---|
| US (2) | US9393202B2 (hr) |
| EP (2) | EP3574895B1 (hr) |
| JP (1) | JP6449246B2 (hr) |
| KR (1) | KR102198354B1 (hr) |
| CN (1) | CN105120841B (hr) |
| AR (1) | AR096087A1 (hr) |
| AU (1) | AU2014259443B2 (hr) |
| BR (1) | BR112015024626B1 (hr) |
| CA (1) | CA2910314C (hr) |
| DK (2) | DK2988728T3 (hr) |
| ES (2) | ES2943109T3 (hr) |
| FI (1) | FI3574895T3 (hr) |
| HK (1) | HK1216302A1 (hr) |
| HR (2) | HRP20230337T1 (hr) |
| HU (2) | HUE062002T2 (hr) |
| IL (1) | IL242209A (hr) |
| MX (1) | MX365295B (hr) |
| MY (1) | MY169127A (hr) |
| PH (1) | PH12015502449A1 (hr) |
| PL (2) | PL2988728T3 (hr) |
| PT (2) | PT2988728T (hr) |
| RU (1) | RU2667636C2 (hr) |
| SG (1) | SG11201508760VA (hr) |
| SI (2) | SI3574895T1 (hr) |
| TW (1) | TWI630926B (hr) |
| UA (1) | UA120418C2 (hr) |
| WO (1) | WO2014173987A1 (hr) |
| ZA (1) | ZA201507916B (hr) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9393202B2 (en) * | 2013-04-26 | 2016-07-19 | Chiesi Farmaceutici S.P.A | Particle size reduction of an antimuscarinic compound |
| WO2015004243A1 (en) | 2013-07-11 | 2015-01-15 | Chiesi Farmaceutici S.P.A. | Dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic for administration by inhalation |
| CN107106515A (zh) | 2014-10-16 | 2017-08-29 | 梯瓦优质制药产品研发股份有限公司 | 可吸入的配制剂 |
| JP6500522B2 (ja) * | 2015-03-16 | 2019-04-17 | セイコーエプソン株式会社 | 回路装置、物理量検出装置、電子機器及び移動体 |
| PT3377109T (pt) | 2015-11-16 | 2020-05-13 | Chiesi Farm Spa | Processo para preparar uma formulação de pó seco que compreende um anticolinérgico, um corticoide e um betaadrenérgico |
| PT3620176T (pt) | 2015-11-16 | 2021-09-28 | Chiesi Farm Spa | Processo para preparar uma formulação de pó seco que compreende um anticolinérgico, um corticosteroide e um beta-adrenérgico |
| US9925168B2 (en) * | 2016-01-22 | 2018-03-27 | Chiesi Farmaceutici S.P.A. | Preparation of micronized particles of an antimuscarinic compound by hydrodynamic cavitation |
| JP6323846B2 (ja) * | 2016-04-07 | 2018-05-16 | 塩野義製薬株式会社 | オピオイドを含有する乱用防止製剤 |
| PT109445B (pt) * | 2016-06-08 | 2018-11-06 | Hovione Farm Sa | Co-cristais farmacêuticos cristalinos de brometo de glicopirrónio com lactose |
| EP3490533B1 (en) * | 2016-07-29 | 2020-05-27 | Inke, S.A. | Particle size stabilization process |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5399363A (en) * | 1991-01-25 | 1995-03-21 | Eastman Kodak Company | Surface modified anticancer nanoparticles |
| CA2118517C (en) * | 1992-06-10 | 2003-10-14 | Gary G. Liversidge | Surface modified nsaid nanoparticles |
| GB0008660D0 (en) | 2000-04-07 | 2000-05-31 | Arakis Ltd | The treatment of respiratory diseases |
| KR20050085035A (ko) * | 2002-11-18 | 2005-08-29 | 이 아이 듀폰 디 네모아 앤드 캄파니 | 비구형 분쇄 매체를 사용하는 매체 밀링 |
| GB0321607D0 (en) | 2003-09-15 | 2003-10-15 | Vectura Ltd | Manufacture of pharmaceutical compositions |
| GB0409703D0 (en) * | 2004-04-30 | 2004-06-02 | Vectura Ltd | Pharmaceutical compositions |
| GB0516549D0 (en) | 2005-08-12 | 2005-09-21 | Sulaiman Brian | Milling system |
| GB0613161D0 (en) * | 2006-06-30 | 2006-08-09 | Novartis Ag | Organic Compounds |
| EP2229148B1 (en) * | 2007-12-13 | 2014-03-05 | Novartis AG | Process for preparing a particulate and crystalline drug substance |
| KR20100099281A (ko) * | 2007-12-13 | 2010-09-10 | 노파르티스 아게 | 유기 화합물 |
| DE102008000482A1 (de) | 2008-03-03 | 2009-09-10 | Zf Friedrichshafen Ag | Ölgekühltes Reibschaltelement |
| EP2321023B1 (en) * | 2008-07-18 | 2016-06-15 | Prosonix Limited | Process for improving crystallinity of fluticasone particles |
| EP2435024B1 (en) * | 2009-05-29 | 2016-07-06 | Pearl Therapeutics, Inc. | Compositions for respiratory delivery of active agents and associated methods and systems |
| JP2014504260A (ja) * | 2010-10-15 | 2014-02-20 | グラクソ グループ リミテッド | 集合ナノ粒子状薬物製剤、その製造及び使用 |
| US9393202B2 (en) * | 2013-04-26 | 2016-07-19 | Chiesi Farmaceutici S.P.A | Particle size reduction of an antimuscarinic compound |
-
2014
- 2014-04-22 US US14/258,147 patent/US9393202B2/en active Active
- 2014-04-24 KR KR1020157026634A patent/KR102198354B1/ko active IP Right Grant
- 2014-04-24 WO PCT/EP2014/058295 patent/WO2014173987A1/en active Application Filing
- 2014-04-24 TW TW103114823A patent/TWI630926B/zh active
- 2014-04-24 AU AU2014259443A patent/AU2014259443B2/en active Active
- 2014-04-24 MY MYPI2015002624A patent/MY169127A/en unknown
- 2014-04-24 PL PL14724332T patent/PL2988728T3/pl unknown
- 2014-04-24 ES ES19182996T patent/ES2943109T3/es active Active
- 2014-04-24 HU HUE19182996A patent/HUE062002T2/hu unknown
- 2014-04-24 FI FIEP19182996.9T patent/FI3574895T3/fi active
- 2014-04-24 ES ES14724332T patent/ES2754255T3/es active Active
- 2014-04-24 RU RU2015145521A patent/RU2667636C2/ru active
- 2014-04-24 PT PT147243323T patent/PT2988728T/pt unknown
- 2014-04-24 PL PL19182996.9T patent/PL3574895T3/pl unknown
- 2014-04-24 EP EP19182996.9A patent/EP3574895B1/en active Active
- 2014-04-24 SG SG11201508760VA patent/SG11201508760VA/en unknown
- 2014-04-24 SI SI201432023T patent/SI3574895T1/sl unknown
- 2014-04-24 DK DK14724332T patent/DK2988728T3/da active
- 2014-04-24 SI SI201431365T patent/SI2988728T1/sl unknown
- 2014-04-24 JP JP2016509457A patent/JP6449246B2/ja active Active
- 2014-04-24 HU HUE14724332A patent/HUE046213T2/hu unknown
- 2014-04-24 AR ARP140101710A patent/AR096087A1/es not_active Application Discontinuation
- 2014-04-24 BR BR112015024626-5A patent/BR112015024626B1/pt active IP Right Grant
- 2014-04-24 CN CN201480022369.0A patent/CN105120841B/zh active Active
- 2014-04-24 MX MX2015014904A patent/MX365295B/es active IP Right Grant
- 2014-04-24 CA CA2910314A patent/CA2910314C/en active Active
- 2014-04-24 UA UAA201510382A patent/UA120418C2/uk unknown
- 2014-04-24 HR HRP20230337TT patent/HRP20230337T1/hr unknown
- 2014-04-24 DK DK19182996.9T patent/DK3574895T3/da active
- 2014-04-24 PT PT191829969T patent/PT3574895T/pt unknown
- 2014-04-24 EP EP14724332.3A patent/EP2988728B1/en active Active
-
2015
- 2015-10-22 IL IL242209A patent/IL242209A/en active IP Right Grant
- 2015-10-23 PH PH12015502449A patent/PH12015502449A1/en unknown
- 2015-10-23 ZA ZA2015/07916A patent/ZA201507916B/en unknown
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2016
- 2016-06-08 HK HK16104300.9A patent/HK1216302A1/zh unknown
- 2016-06-10 US US15/179,048 patent/US9889094B2/en active Active
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2019
- 2019-10-17 HR HRP20191882TT patent/HRP20191882T1/hr unknown
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