HRP20180177T1 - Proizvod namijenjen oralnom unosu - Google Patents
Proizvod namijenjen oralnom unosu Download PDFInfo
- Publication number
- HRP20180177T1 HRP20180177T1 HRP20180177TT HRP20180177T HRP20180177T1 HR P20180177 T1 HRP20180177 T1 HR P20180177T1 HR P20180177T T HRP20180177T T HR P20180177TT HR P20180177 T HRP20180177 T HR P20180177T HR P20180177 T1 HRP20180177 T1 HR P20180177T1
- Authority
- HR
- Croatia
- Prior art keywords
- alginate salt
- monovalent cation
- active substance
- biologically active
- solid particles
- Prior art date
Links
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical class O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 claims 30
- 239000007787 solid Substances 0.000 claims 23
- 239000002245 particle Substances 0.000 claims 22
- 150000001768 cations Chemical class 0.000 claims 21
- 229940088623 biologically active substance Drugs 0.000 claims 17
- 239000011159 matrix material Substances 0.000 claims 8
- 239000007864 aqueous solution Substances 0.000 claims 6
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 3
- 239000007853 buffer solution Substances 0.000 claims 3
- 238000001035 drying Methods 0.000 claims 3
- 238000000034 method Methods 0.000 claims 3
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 3
- 239000008108 microcrystalline cellulose Substances 0.000 claims 3
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 3
- AEMOLEFTQBMNLQ-BZINKQHNSA-N D-Guluronic Acid Chemical compound OC1O[C@H](C(O)=O)[C@H](O)[C@@H](O)[C@H]1O AEMOLEFTQBMNLQ-BZINKQHNSA-N 0.000 claims 2
- AEMOLEFTQBMNLQ-VANFPWTGSA-N D-mannopyranuronic acid Chemical compound OC1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@@H]1O AEMOLEFTQBMNLQ-VANFPWTGSA-N 0.000 claims 2
- IAJILQKETJEXLJ-UHFFFAOYSA-N Galacturonsaeure Natural products O=CC(O)C(O)C(O)C(O)C(O)=O IAJILQKETJEXLJ-UHFFFAOYSA-N 0.000 claims 2
- -1 alginate salt cation Chemical class 0.000 claims 2
- AEMOLEFTQBMNLQ-UHFFFAOYSA-N beta-D-galactopyranuronic acid Natural products OC1OC(C(O)=O)C(O)C(O)C1O AEMOLEFTQBMNLQ-UHFFFAOYSA-N 0.000 claims 2
- 239000000945 filler Substances 0.000 claims 2
- 210000000214 mouth Anatomy 0.000 claims 2
- 238000007789 sealing Methods 0.000 claims 2
- SNICXCGAKADSCV-JTQLQIEISA-N (-)-Nicotine Chemical compound CN1CCC[C@H]1C1=CC=CN=C1 SNICXCGAKADSCV-JTQLQIEISA-N 0.000 claims 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 229960002715 nicotine Drugs 0.000 claims 1
- SNICXCGAKADSCV-UHFFFAOYSA-N nicotine Natural products CN1CCCC1C1=CC=CN=C1 SNICXCGAKADSCV-UHFFFAOYSA-N 0.000 claims 1
- 239000008363 phosphate buffer Substances 0.000 claims 1
- 239000004014 plasticizer Substances 0.000 claims 1
- 239000011148 porous material Substances 0.000 claims 1
- 239000000600 sorbitol Substances 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
- A61K9/14—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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K31/465—Nicotine; Derivatives thereof
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Confectionery (AREA)
Claims (15)
1. Proizvod namijenjen oralnom unosu (1), naznačen tome što sadrži:
polupropusni džep (10), dizajniran da se može staviti u usnu šupljinu subjekta; i
više čvrstih čestica (20) najmanje jedne alginatne soli i sadrži najmanje jednu biološki aktivnu tvar, gdje je navedenih više čvrstih čestica (20) zatvoreno u navedenom polupropusnom džepu (10), naznačen time što je navedena najmanje jedna alginatna sol najmanje jedna alginatna sol jednovalentnog kationa, a navedena najmanje jedna biološki aktivna tvar se nalazi u matriksu kojeg tvori navedena najmanje jedna alginatna sol jednovalentnog kationa i predstavlja uglavnom izolirani okoliš za navedenu najmanje jednu biološki aktivnu tvar.
2. Proizvod u skladu s patentnim zahtjevom 1, naznačen time što dodatno sadrži čestice punila (30) u obliku čestica mikrokristalne celuloze.
3. Proizvod u skladu s patentnim zahtjevom 2, naznačen time što navedene čestice mikrokristalne celuloze sorbiraju količinu navedene najmanje jedne biološki aktivne tvari u šupljinama i porama unutar navedene mikrokristalne celuloze.
4. Proizvod u skladu s patentnim zahtjevom 2 ili 3, naznačen time što navedeni polupropusni džep (10) sadrži 10 do 30%, težinski, navedenih više čvrstih čestica (20) i 70 do 90%, težinski, navedenih čestica punila (30).
5. Proizvod u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time što navedenih više čvrstih čestica (20) navedene najmanje jedne alginatne soli jednovalentnog kationa dodatno sadrži najmanje jedan plastifikator, poput sorbitola.
6. Proizvod u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačen time što navedenih više čvrstih čestica (20) navedene najmanje jedne alginatne soli jednovalentnog kationa dodatno sadrži puferski sustav unutar navedenog matriksa, poput puferskog sustava koji osigurava bazični pH navedenih više čvrstih čestica, po mogućnosti fosfatni puferski sustav ili karbonatni puferski sustav.
7. Proizvod u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što se navedeni jednovalentni kation bira između Na+, K+ i NH4+.
8. Proizvod u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što navedenih više čvrstih čestica (20) navedene najmanje jedne alginatne soli jednovalentnog kationa sadrži navedenu najmanje jednu biološki aktivnu tvar u razini od 0,000001 do 85%, težinski, ukupne težine navedenih više čvrstih čestica.
9. Proizvod u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što navedenih više čvrstih čestica (20) navedene najmanje jedne alginatne soli jednovalentnog kationa ima prosječni promjer u rasponu od 10 µm do 10 mm, po mogućnosti od 100 µm do 5 mm.
10. Proizvod u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačen time što je navedena najmanje jedna biološki aktivna tvar nikotin.
11. Proizvod u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačen time što navedenih više čvrstih čestica (20) navedene najmanje jedne alginatne soli jednovalentnog kationa sadrži:
prvi skup od više čvrstih čestica prve alginatne soli jednovalentnog kationa koji sadrži navedenu najmanje jednu biološki aktivnu tvar unutar matriksa kojeg tvori navedena prva alginatna sol jednovalentnog kationa, gdje navedena prva alginatna sol ima prvu prosječnu molekulsku težinu; i
drugi skup od više čvrstih čestica druge alginatne soli jednovalentnog kationa koji sadrži navedenu najmanje jednu biološki aktivnu tvar unutar matriksa kojeg tvori navedena druga alginatna sol jednovalentnog kationa, gdje navedena druga alginatna sol ima drugu prosječnu molekulsku težinu koja je relativno veća od navedene prve prosječne molekulske težine.
12. Proizvod u skladu s patentnim zahtjevom 11, naznačen time što
navedena prva alginatna sol je alginatna sol jednovalentnog kationa koja ima sadržaj guluronske kiseline od 65% do 75% i sadržaj manuronske kiseline od 25% do 35%, a njezina 10%-tna vodena otopina na temperaturi od 20 °C ima viskoznost od 300-700 mPas, što je izmjereno pri brzini smicanja od 20 okretaja u minuti, uz pomoć viskozimetra Brookfield s vretenom br. 2, poput PROTANAL® LFR 5/60; i
navedena druga alginatna sol je alginatna sol jednovalentnog kationa PROTANAL® LF 10/60 koja ima sadržaj guluronske kiseline od 40% do 45% i sadržaj manuronske kiseline od 55% do 60%, a njezina 1%-tna vodena otopina na temperaturi od 20 °C ima viskoznost od 20-70 mPas, što je izmjereno pri brzini smicanja od 20 okretaja u minuti, uz pomoć viskozimetra Brookfield s vretenom br. 2.
13. Postupak proizvodnje proizvoda namijenjenog oralnom unosu (1), koji se sastoji u:
formiranju više čvrstih čestica (20) iz vodene otopine najmanje jedne alginatne soli i najmanje jedne biološki aktivne tvari; i
zatvaranja navedenih više čvrstih čestica (20) u polupropusni džep (10), dizajniran da se može staviti u usnu šupljinu subjekta, naznačen time što je navedena najmanje jedna alginatna sol najmanje jedna alginatna sol jednovalentnog kationa, a navedena najmanje jedna biološki aktivna tvar se nalazi unutar matriksa kojeg tvori navedena najmanje jedna alginatna sol jednovalentnog kationa i predstavlja uglavnom izolirani okoliš za navedenu najmanje jednu biološki aktivnu tvar.
14. Postupak u skladu s patentnim zahtjevom 13, naznačen time što se navedeni korak formiranja sastoji u:
sušenju prve vodene otopine prve alginatne soli jednovalentnog kationa i navedene najmanje jedne biološki aktivne tvari kako bi se dobilo prvo čvrsto tijelo s navedenom najmanje jednom biološki aktivnom tvari koja se nalazi unutar matriksa kojeg tvori navedena prva alginatna sol jednovalentnog kationa, gdje navedena prva alginatna sol ima prvu prosječnu molekulsku težinu; i
sušenju druge vodene otopine druge alginatne soli jednovalentnog kationa i navedene najmanje jedne biološki aktivne tvari kako bi se dobilo drugo tijelo s navedenom najmanje jednom biološki aktivnom tvari koja se nalazi unutar matriksa kojeg tvori navedena druga alginatna sol jednovalentnog kationa, gdje navedena druga alginatna sol ima drugu prosječnu molekulsku težinu koja je relativno veća od navedene prve prosječne molekulske težine;
rezanju prvog skupa od više čvrstih čestica iz navedenog prvog čvrstog tijela; i
rezanju drugog skupa od više čvrstih čestica iz navedenog drugog čvrstog tijela, gdje se navedeni korak zatvaranja sastoji u zatvaranju navedenih više čvrstih čestica navedenog prvog skupa i navedenog drugog skupa u navedenom polupropusnom džepu.
15. Postupak u skladu s patentnim zahtjevom 13, naznačen time što se navedeni korak formiranja sastoji u:
sušenju vodene otopine prve alginatne soli jednovalentnog kationa s prvom prosječnom molekulskom težinom, druge alginatne soli jednovalentnog kationa s drugom prosječnom molekulskom težinom koja je relativno veća od navedene prve prosječne molekulske težine, te navedene najmanje jedne biološki aktivne tvari kako bi se dobilo čvrsto tijelo s navedenom najmanje jednom biološki aktivnom tvari koja se nalazi unutar matriksa kojeg tvori navedena prva i druga alginatna sol jednovalentnog kationa; i
rezanju navedenih više čvrstih čestica (20) iz navedenog čvrstog tijela.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE0950153 | 2009-03-13 | ||
PCT/SE2010/050269 WO2010104464A1 (en) | 2009-03-13 | 2010-03-10 | Oral delivery product |
EP10751097.6A EP2405942B1 (en) | 2009-03-13 | 2010-03-10 | Oral delivery product |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20180177T1 true HRP20180177T1 (hr) | 2018-03-23 |
Family
ID=42728572
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20180177TT HRP20180177T1 (hr) | 2009-03-13 | 2018-01-30 | Proizvod namijenjen oralnom unosu |
Country Status (13)
Country | Link |
---|---|
US (2) | US9925145B2 (hr) |
EP (1) | EP2405942B1 (hr) |
CY (1) | CY1120230T1 (hr) |
DK (1) | DK2405942T3 (hr) |
ES (1) | ES2658166T3 (hr) |
HR (1) | HRP20180177T1 (hr) |
HU (1) | HUE038093T2 (hr) |
LT (1) | LT2405942T (hr) |
NO (1) | NO2405942T3 (hr) |
PL (1) | PL2405942T3 (hr) |
PT (1) | PT2405942T (hr) |
SI (1) | SI2405942T1 (hr) |
WO (1) | WO2010104464A1 (hr) |
Families Citing this family (40)
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PT2563316T (pt) * | 2010-04-30 | 2019-05-27 | Allovate Llc | Pasta de dentes para desensibilização alérgica através da mucosa oral |
SE535587C2 (sv) | 2011-03-29 | 2012-10-02 | Chill Of Sweden Ab | Produkt innehållande ett fritt nikotinsalt och en ej vattenlöslig påse |
DK177435B1 (en) | 2011-06-03 | 2013-05-21 | Biotek Holding Aps S | An aqueous diet product, a unit dosage and a kit comprising at least one alginate, and a method for the preparation of said diet product |
SE536491C2 (sv) | 2012-03-26 | 2013-12-27 | Bionicotine Ab | Påse innehållande nikotin och en tuggummikomposition |
RS58677B1 (sr) * | 2012-03-27 | 2019-06-28 | Nicoccino Ab | Formulacija nikotina |
US10799451B2 (en) | 2012-03-27 | 2020-10-13 | Nicoccino Ab | Nicotine formulation |
WO2014102801A1 (en) | 2012-12-30 | 2014-07-03 | Hadasit Medical Research Services And Development Ltd. | Use of alginate compositions in preventing or reducing liver damage caused by a hepatotoxic agent |
US10130120B2 (en) * | 2013-03-15 | 2018-11-20 | Altria Client Services Llc | Use of pectin or other anionic polymers in the stabilization and controlled release of nicotine in oral sensorial tobacco products or nicotine containing non-tobacco oral sensorial products |
EP3046633A4 (en) | 2013-09-19 | 2017-03-15 | Allovate, LLC | Toothpaste for delivering allergens to oral mucosa |
US20160157515A1 (en) | 2014-12-05 | 2016-06-09 | R.J. Reynolds Tobacco Company | Smokeless tobacco pouch |
US9930914B2 (en) | 2014-12-16 | 2018-04-03 | Read Fisher Goode, JR. | Seamless oral pouch product |
SI3087852T1 (sl) * | 2015-04-17 | 2019-03-29 | Swedish Match North Europe Ab | Oralni vrečast proizvod, ki ima pravokotno obliko |
USD837447S1 (en) | 2015-04-17 | 2019-01-01 | Swedish Match North Europe Ab | Oral snuff package |
US20180057229A1 (en) | 2016-08-31 | 2018-03-01 | Pro-Dip, Llc | Oral and/or Buccal Delivery Pouch and Method of Making Same |
CA3062704A1 (en) * | 2017-05-08 | 2018-11-15 | Intelgenx Corp. | Film dosage form with extended release mucoadhesive particles |
USD908896S1 (en) | 2018-10-05 | 2021-01-26 | Joseph Bajor | Infant nutritional dispenser |
JP7486569B2 (ja) | 2019-07-05 | 2024-05-17 | スウィーディッシュ・マッチ・ノース・ヨーロップ・アーベー | ニコチン含有粒子を含有する充填材を含む経口袋状ニコチン製品 |
SE1951054A1 (en) * | 2019-09-18 | 2021-03-19 | Enorama Pharma Ab | Nicotine pouch |
US11617744B2 (en) | 2019-12-09 | 2023-04-04 | Nico Ventures Trading Limited | Moist oral compositions |
US11883527B2 (en) | 2019-12-09 | 2024-01-30 | Nicoventures Trading Limited | Oral composition and method of manufacture |
US11793230B2 (en) | 2019-12-09 | 2023-10-24 | Nicoventures Trading Limited | Oral products with improved binding of active ingredients |
US11872231B2 (en) | 2019-12-09 | 2024-01-16 | Nicoventures Trading Limited | Moist oral product comprising an active ingredient |
US11672862B2 (en) | 2019-12-09 | 2023-06-13 | Nicoventures Trading Limited | Oral products with reduced irritation |
US11969502B2 (en) | 2019-12-09 | 2024-04-30 | Nicoventures Trading Limited | Oral products |
US11826462B2 (en) | 2019-12-09 | 2023-11-28 | Nicoventures Trading Limited | Oral product with sustained flavor release |
US11889856B2 (en) | 2019-12-09 | 2024-02-06 | Nicoventures Trading Limited | Oral foam composition |
CA3160750A1 (en) | 2019-12-09 | 2021-06-17 | Anthony Richard Gerardi | Oral product comprising a cannabinoid |
US11712059B2 (en) | 2020-02-24 | 2023-08-01 | Nicoventures Trading Limited | Beaded tobacco material and related method of manufacture |
US12016369B2 (en) | 2020-04-14 | 2024-06-25 | Nicoventures Trading Limited | Regenerated cellulose substrate for aerosol delivery device |
SE544672C2 (en) * | 2020-05-07 | 2022-10-11 | Liw Innovation Ab | New compositions for oral or nasal use |
US11839602B2 (en) | 2020-11-25 | 2023-12-12 | Nicoventures Trading Limited | Oral cannabinoid product with lipid component |
EP4018848A1 (en) * | 2020-12-22 | 2022-06-29 | Swedish Match North Europe AB | A pouched product for oral use comprising a liquid permeable cover material and a filling material |
EP4018846A1 (en) * | 2020-12-22 | 2022-06-29 | Swedish Match North Europe AB | A pouched product for oral use comprising a liquid permeable cover material and a filling material comprising a first type of particles |
EP4018847A1 (en) * | 2020-12-22 | 2022-06-29 | Swedish Match North Europe AB | A pouched product for oral use |
EP4018849A1 (en) * | 2020-12-22 | 2022-06-29 | Swedish Match North Europe AB | A pouched product for oral use |
CZ309812B6 (cs) * | 2021-05-25 | 2023-11-01 | Consumer Brands International s.r.o | Směs pro výrobu nikotinových sáčků a způsob její výroby |
EP4094594A1 (en) | 2021-05-25 | 2022-11-30 | Consumer Brands International s.r.o. | A filing of a nicotine formulation, in particular a nicotine sachet and the method of its manufacture, and a mixture of nicotine salts and the method of its manufacture |
WO2023112150A1 (ja) * | 2021-12-14 | 2023-06-22 | 日本たばこ産業株式会社 | 低分子量アルギン酸化合物を含有するオーラル製品および当該製品用の組成物 |
EP4322772A1 (en) | 2022-03-15 | 2024-02-21 | Habit Factory in Sweden AB | Nicotine composition |
WO2023187225A1 (en) | 2022-04-01 | 2023-10-05 | Amplicon Ab | Alkaline intraoral products |
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2010
- 2010-03-10 DK DK10751097.6T patent/DK2405942T3/en active
- 2010-03-10 NO NO10751097A patent/NO2405942T3/no unknown
- 2010-03-10 US US13/255,980 patent/US9925145B2/en active Active
- 2010-03-10 EP EP10751097.6A patent/EP2405942B1/en active Active
- 2010-03-10 ES ES10751097.6T patent/ES2658166T3/es active Active
- 2010-03-10 PL PL10751097T patent/PL2405942T3/pl unknown
- 2010-03-10 HU HUE10751097A patent/HUE038093T2/hu unknown
- 2010-03-10 SI SI201031631T patent/SI2405942T1/en unknown
- 2010-03-10 LT LTEP10751097.6T patent/LT2405942T/lt unknown
- 2010-03-10 PT PT107510976T patent/PT2405942T/pt unknown
- 2010-03-10 WO PCT/SE2010/050269 patent/WO2010104464A1/en active Application Filing
-
2018
- 2018-01-30 HR HRP20180177TT patent/HRP20180177T1/hr unknown
- 2018-01-31 CY CY20181100120T patent/CY1120230T1/el unknown
- 2018-03-07 US US15/914,352 patent/US20180193272A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
HUE038093T2 (hu) | 2018-09-28 |
US20180193272A1 (en) | 2018-07-12 |
CY1120230T1 (el) | 2018-12-12 |
PL2405942T3 (pl) | 2018-04-30 |
SI2405942T1 (en) | 2018-04-30 |
EP2405942A1 (en) | 2012-01-18 |
WO2010104464A1 (en) | 2010-09-16 |
US20120128734A1 (en) | 2012-05-24 |
NO2405942T3 (hr) | 2018-03-31 |
US9925145B2 (en) | 2018-03-27 |
PT2405942T (pt) | 2018-02-07 |
DK2405942T3 (en) | 2018-02-05 |
LT2405942T (lt) | 2018-02-26 |
ES2658166T3 (es) | 2018-03-08 |
EP2405942B1 (en) | 2017-11-01 |
EP2405942A4 (en) | 2014-02-19 |
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