HRP20230337T1 - Smanjivanje veličine čestica antimuskarinskih spojeva - Google Patents
Smanjivanje veličine čestica antimuskarinskih spojeva Download PDFInfo
- Publication number
- HRP20230337T1 HRP20230337T1 HRP20230337TT HRP20230337T HRP20230337T1 HR P20230337 T1 HRP20230337 T1 HR P20230337T1 HR P20230337T T HRP20230337T T HR P20230337TT HR P20230337 T HRP20230337 T HR P20230337T HR P20230337 T1 HRP20230337 T1 HR P20230337T1
- Authority
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- Croatia
- Prior art keywords
- particles
- salt
- glycopyrronium
- solvent
- process according
- Prior art date
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- 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 10
- 239000002245 particle Substances 0.000 claims 7
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 claims 6
- IMNFDUFMRHMDMM-UHFFFAOYSA-N N-Heptane Chemical compound CCCCCCC IMNFDUFMRHMDMM-UHFFFAOYSA-N 0.000 claims 6
- 239000012296 anti-solvent Substances 0.000 claims 5
- ANGKOCUUWGHLCE-HKUYNNGSSA-N [(3s)-1,1-dimethylpyrrolidin-1-ium-3-yl] (2r)-2-cyclopentyl-2-hydroxy-2-phenylacetate Chemical class C1[N+](C)(C)CC[C@@H]1OC(=O)[C@](O)(C=1C=CC=CC=1)C1CCCC1 ANGKOCUUWGHLCE-HKUYNNGSSA-N 0.000 claims 4
- 229960002462 glycopyrronium bromide Drugs 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
- 229940079593 drug Drugs 0.000 claims 1
- 239000003814 drug Substances 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
- 238000002955 isolation Methods 0.000 claims 1
- 239000000203 mixture Substances 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
- 238000010298 pulverizing process Methods 0.000 claims 1
- 150000003839 salts Chemical class 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
- 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
- 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
- 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
-
- 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 (9)
1. Postupak priprave usitnjenih kristaliničnih čestica farmaceutski prihvatljive soli glikopironija, postupak obuhvaća sljedeće korake:
(a) dodavanje u komoru za usitnjavanje aparata za mokro mljevenje, koji po izboru sadrži medij za usitnjavanje, anti-otapala koje se ne miješa s vodom, a odabran je od n-heptana ili diklormetana;
(b) suspendiranje čestica glikopironijeve soli i spomenutog anti-otapala,
(c) usitnjavanje spomenutih suspendiranih čestica pri tlaku između 50 i 200 kPa i pri sobnoj temperturi (20 ± 2 °C);
(d) sušenje dobivenih usitnjenih čestica;
pri čemu najmanje 90% spomenutih čestica ima volumni promjer manji od 10 mikrona, određen laserskom difrakcijom upotrebom Malvernovog aparata.
2. Postupak prema patentom zahtjevu 1, nadalje obuhvaća korak izolacije dobivenih usitnjenih čestica.
3. Postupak prema patentom zahtjevu 1 ili 2, naznačen time da je farmaceutski prihvatljiva sol organska ili anorganska.
4. Postupak prema patentom zahtjevu 3, naznačen time da je anorganska sol odabrana iz grupe koja se sastoji od fluorid, klorid, bromid, jodid, fosfat, nitrat i sulfat.
5. Postupak prema patentom zahtjevu 4, naznačen time da je glikopironij u obliku bromidne soli.
6. Postupak prema patentom zahtjevu 5, naznačen time da je glikopironij u obliku racemične smjese enantiomera (3S,2'R), (3R,2'S).
7. Postupak prema patentom zahtjevu 1, naznačen time da n-alkansko anti-otapalo jest n- heptan.
8. Postupak prema patentom zahtjevu 1, naznačen time da antiotapalo jest diklormetan.
9. Postupak prema bilo kojem prethodnom patentom zahtjevu, nadalje obuhvaća korak pranja u kojem se upotrebljava drugo anti-otapalo za pranje usitnjenih čestica lijeka.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13165483 | 2013-04-26 | ||
| EP19182996.9A EP3574895B1 (en) | 2013-04-26 | 2014-04-24 | Particle size reduction of an antimuscarinic compound |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20230337T1 true HRP20230337T1 (hr) | 2023-06-09 |
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 After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20191882TT HRP20191882T1 (hr) | 2013-04-26 | 2019-10-17 | Smanjivanje veličine čestice antimuskarinskog spoja |
Country Status (28)
| Country | Link |
|---|---|
| US (2) | US9393202B2 (hr) |
| EP (2) | EP2988728B1 (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) | DK3574895T3 (hr) |
| ES (2) | ES2754255T3 (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) | PH12015502449B1 (hr) |
| PL (2) | PL3574895T3 (hr) |
| PT (2) | PT3574895T (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 |
| SI3019153T1 (sl) | 2013-07-11 | 2018-12-31 | Chiesi Farmaceutici S.P.A. | Formulacija suhega praška, obsegajoča antiholinergik, kortikosteroid in beta-adrenergik, za dajanje z inhalacijo |
| AU2015331912A1 (en) | 2014-10-16 | 2017-05-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Inhalable formulation |
| 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 |
| HUE049751T2 (hu) | 2015-11-16 | 2020-10-28 | Chiesi Farm Spa | Eljárás antikolinerg szert, kortikoszteroidot és béta-adrenerg szert tartalmazó száraz porkészítmény elõállítására |
| ES2789365T3 (es) | 2015-11-16 | 2020-10-26 | Chiesi Farm Spa | Un procedimiento para la preparación de una formulación de polvo seco que comprende un anticolinérgico, un corticoesteroide y un 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 |
| ES2805434T3 (es) * | 2016-07-29 | 2021-02-12 | Inke Sa | Procedimiento de estabilización de tamaño de partícula |
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 |
| DK0644755T3 (da) * | 1992-06-10 | 1997-09-22 | Nanosystems Llc | Overflademodificerede NSAID-nanopartikler |
| GB0008660D0 (en) | 2000-04-07 | 2000-05-31 | Arakis Ltd | The treatment of respiratory diseases |
| EP1562551A1 (en) * | 2002-11-18 | 2005-08-17 | E.I. du Pont de Nemours and Company | Media milling using nonspherical grinding media |
| 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 |
| PL2229148T3 (pl) | 2007-12-13 | 2014-08-29 | Novartis Ag | Sposób otrzymywania krystalicznych cząstek stałych substancji leczniczej |
| CN101896162B (zh) * | 2007-12-13 | 2013-06-05 | 诺瓦提斯公司 | 有机化合物 |
| DE102008000482A1 (de) | 2008-03-03 | 2009-09-10 | Zf Friedrichshafen Ag | Ölgekühltes Reibschaltelement |
| BRPI0915783A2 (pt) * | 2008-07-18 | 2018-05-22 | Prosonix Ltd | processo para aumentar a cristalinidade de pelo menos um material sólido, partícula, composição farmacêutica ou agroquímica , e, inalador |
| CA2763939A1 (en) * | 2009-05-29 | 2010-12-02 | Pearl Therapeutics, Inc. | Compositions for pulmonary delivery of long-acting muscarinic antagonists and long-acting b2 adrenergic receptor agonists and associated methods and systems |
| US20150093440A1 (en) * | 2010-10-15 | 2015-04-02 | Glaxo Group Limited | Aggregate nanoparticulate medicament formulations, manufacture and use thereof |
| 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 AR ARP140101710A patent/AR096087A1/es not_active Application Discontinuation
- 2014-04-24 EP EP14724332.3A patent/EP2988728B1/en active Active
- 2014-04-24 PL PL19182996.9T patent/PL3574895T3/pl unknown
- 2014-04-24 SG SG11201508760VA patent/SG11201508760VA/en unknown
- 2014-04-24 EP EP19182996.9A patent/EP3574895B1/en active Active
- 2014-04-24 JP JP2016509457A patent/JP6449246B2/ja active Active
- 2014-04-24 CN CN201480022369.0A patent/CN105120841B/zh active Active
- 2014-04-24 PT PT191829969T patent/PT3574895T/pt unknown
- 2014-04-24 ES ES14724332T patent/ES2754255T3/es active Active
- 2014-04-24 PT PT147243323T patent/PT2988728T/pt unknown
- 2014-04-24 AU AU2014259443A patent/AU2014259443B2/en active Active
- 2014-04-24 HU HUE19182996A patent/HUE062002T2/hu unknown
- 2014-04-24 MX MX2015014904A patent/MX365295B/es active IP Right Grant
- 2014-04-24 RU RU2015145521A patent/RU2667636C2/ru active
- 2014-04-24 MY MYPI2015002624A patent/MY169127A/en unknown
- 2014-04-24 PL PL14724332T patent/PL2988728T3/pl unknown
- 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 HU HUE14724332A patent/HUE046213T2/hu unknown
- 2014-04-24 FI FIEP19182996.9T patent/FI3574895T3/fi active
- 2014-04-24 SI SI201432023T patent/SI3574895T1/sl unknown
- 2014-04-24 CA CA2910314A patent/CA2910314C/en active Active
- 2014-04-24 HR HRP20230337TT patent/HRP20230337T1/hr unknown
- 2014-04-24 ES ES19182996T patent/ES2943109T3/es active Active
- 2014-04-24 DK DK19182996.9T patent/DK3574895T3/da active
- 2014-04-24 DK DK14724332T patent/DK2988728T3/da active
- 2014-04-24 BR BR112015024626-5A patent/BR112015024626B1/pt active IP Right Grant
- 2014-04-24 TW TW103114823A patent/TWI630926B/zh active
- 2014-04-24 UA UAA201510382A patent/UA120418C2/uk unknown
- 2014-04-24 SI SI201431365T patent/SI2988728T1/sl unknown
-
2015
- 2015-10-22 IL IL242209A patent/IL242209A/en active IP Right Grant
- 2015-10-23 ZA ZA2015/07916A patent/ZA201507916B/en unknown
- 2015-10-23 PH PH12015502449A patent/PH12015502449B1/en unknown
-
2016
- 2016-06-08 HK HK16104300.9A patent/HK1216302A1/zh unknown
- 2016-06-10 US US15/179,048 patent/US9889094B2/en active Active
-
2019
- 2019-10-17 HR HRP20191882TT patent/HRP20191882T1/hr unknown
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