TR201816462T4 - Doğrudan preslenebilir polivinil alkoller. - Google Patents
Doğrudan preslenebilir polivinil alkoller. Download PDFInfo
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- TR201816462T4 TR201816462T4 TR2018/16462T TR201816462T TR201816462T4 TR 201816462 T4 TR201816462 T4 TR 201816462T4 TR 2018/16462 T TR2018/16462 T TR 2018/16462T TR 201816462 T TR201816462 T TR 201816462T TR 201816462 T4 TR201816462 T4 TR 201816462T4
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- Prior art keywords
- pvas
- active ingredient
- polyvinyl alcohols
- composition according
- pressable
- Prior art date
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- 229920002451 polyvinyl alcohol Polymers 0.000 title claims abstract 23
- 235000019422 polyvinyl alcohol Nutrition 0.000 title claims abstract 23
- 230000003111 delayed effect Effects 0.000 claims abstract description 6
- 239000000203 mixture Substances 0.000 claims abstract 20
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract 14
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract 14
- 239000004480 active ingredient Substances 0.000 claims abstract 12
- 238000003825 pressing Methods 0.000 claims description 3
- 239000004372 Polyvinyl alcohol Substances 0.000 claims 2
- 150000001298 alcohols Chemical class 0.000 claims 2
- 230000007062 hydrolysis Effects 0.000 claims 2
- 238000006460 hydrolysis reaction Methods 0.000 claims 2
- XTXRWKRVRITETP-UHFFFAOYSA-N Vinyl acetate Chemical compound CC(=O)OC=C XTXRWKRVRITETP-UHFFFAOYSA-N 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
- 150000002148 esters Chemical class 0.000 claims 1
- 238000013266 extended drug release Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 125000000963 oxybis(methylene) group Chemical group [H]C([H])(*)OC([H])([H])* 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 238000006116 polymerization reaction Methods 0.000 claims 1
- 229920002689 polyvinyl acetate Polymers 0.000 claims 1
- 239000011118 polyvinyl acetate Substances 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 229920005989 resin Polymers 0.000 claims 1
- 239000011347 resin Substances 0.000 claims 1
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 4
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 229960005070 ascorbic acid Drugs 0.000 description 2
- 235000010323 ascorbic acid Nutrition 0.000 description 2
- 239000011668 ascorbic acid Substances 0.000 description 2
- 238000005299 abrasion Methods 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940126534 drug product Drugs 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L1/00—Compositions of cellulose, modified cellulose or cellulose derivatives
- C08L1/02—Cellulose; Modified cellulose
- C08L1/04—Oxycellulose; Hydrocellulose, e.g. microcrystalline cellulose
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L29/00—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by an alcohol, ether, aldehydo, ketonic, acetal or ketal radical; Compositions of hydrolysed polymers of esters of unsaturated alcohols with saturated carboxylic acids; Compositions of derivatives of such polymers
- C08L29/02—Homopolymers or copolymers of unsaturated alcohols
- C08L29/04—Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2203/00—Applications
- C08L2203/02—Applications for biomedical use
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- 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)
- Chemical Kinetics & Catalysis (AREA)
- Polymers & Plastics (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Mevcut buluş, geciktirilmiş etken madde salımlı tabletleri üretmek için, polivinil alkoller (PVAlar) ve mikrokristalin selülozlar (MCCler) içeren doğrudan preslenebilir eş-karışımlarla ilgilidir. Buluş, ayrıca, buna uygun doğrudan preslenebilir eş-karışımları hazırlamak için bir yöntemle ilgilidir.
Description
Tarifnamede belirtilen patentlestirilmemis literatür:
o AMIDON GL ; LENNERNAS H ; ° S. BRUNAUER et al. BET Surface
SHAl-I VP ; CRlSON JR. A Area by Nitrogen Absorption. Journal
theoretical basis for a biopharinaceutic of American Chemical Society, 1983,
drug classification: the correlation of in vol. 60, 9 [0063]
vitro drug product dissolution and in 0 Friabilitât von nicht überzogenen
vivo bioavailability. Pharm Res., 1995, Tabletten. Ger'ateparaineter und
vol. 12, 413 [0019] Ausfuhrung der Messungen gem'aß
SEKILLERDEKI YAZILARIN ANLAMLARI
B = Presleme kuvveti
C = Tablet sertligi
D : Asinma
E = Ornek A-C ve Karsilastirma D-I
F : Ornek
G : Karsilastirma Örnegi
H = Numune l°den askorbik asitin geciktirilmis salimi
J : Salim
K = Zaman [dak.]
L : Numune 2”den askorbik asitin gecktirilmis salimi
M = Numune 2 (20 kN ile preslenmis)
*5:52
22 o ola,, i U& R 93?
o oil u :if w nin.. 4 5.3.2.
02.: ..ößg _ 0 u.. : U.
si. .....,...;... . it!-. :IL: : 1.01. ;iEiiiîsê ri..- s. :iii
1.... . n
Claims (18)
1.Mikr0kristalin selülozlarin (MCCler) ve polivinil alkollerin (PVAlar) bir es-karisimini içeren, uzatilmis etken madde salimli, dogrudan preslenebilir bilesimdir.
2. Istem l”e göre, dogrudan preslenebilir bilesim olup, mikrokristalin selülozlarin (MCCler) ve polivinil alkollerin (PVAlar) bir es- karisiinini içerir ve bunlardan sonuncusu PhEur, USP veya JPE farmakopelerinin sartlarini karsilar.
3. Istem l”e veya 23ye göre, dogrudan preslenebilir bilesim olup, 18- sartlarina uygun 28-99 tipi de dâhil olmak 'uzere, buiilarin arasindaki tüm kalitelerde, PhEur, USP veya JPE farmakopelerinin sartlarina uygun polivinil alkolleri (PVAlar) içerir.
4. 1”den 3,e kadar olan istemlerden birine veya birden çoguna göre, dogrudan preslenebilir bilesim olup, PhEur°a uygun olan ve Vinil asetatin polimerlestirilmesi ve ardindan polivinil asetatin kismen veya hemen hemen tamamen hidrolizi yoluyla elde edilmis olan polivinil alkolleri (PVAlar) içerir.
5. Istem 1, 2, 3 veya 4,e göre, dogrudan preslenebilir bilesim olup, alkolleri (PVAlar) içerir.
6. l°den 5°e kadar olan isteinlerden birine veya birden çoguna göre, araliginda bir ortalama bagi] molekül kütlesine, PhEur”a göre 3 - 70 mPa.s araliginda bir Viskoziteye (bir % 4”l'1'1k çözelti içinde 20 °C”de ölçül'ur) sahip olan polivinil alkolleri (PVAlar) içerir.
7. l'den 67ya kadar olan istemlerden birine veya birden çoguna göre, dogrudan preslenebilir bilesim olup, ester sayisi 280 mg KOH/g seviyesini asmayan (hidroliz derecesi > % 72,2 mol) polivinil alkolleri (PVAlar) içerir.
8. 1'den 7°ye kadar olan isteinlerden birine veya birden çoguna göre, dogrudan preslenebilir bilesim olup, USP uyarinca, n°in 500 ilâ 5 000 araligindaki bir tamsayi anlamina geldigi (C2H4O)n formülüyle karakterize olan, suda-çözünür reçineler formunda polivinil alkolleri (PVAlar) içerir.
9. lsden 8”e kadar olan isteinlerden birine veya birden çoguna göre, dogrudan preslenebilir bilesim olup, 2 : 1 ila l:2 araligindaki bir oranda, tercihen 2 : l ilâ l:l araligindaki bir oranda es-karisim halinde PVA ve MCC içerir.
10. l”den 9”a kadar olan istenilerden birine veya birden çoguna göre, dogrudan preslenebilir bilesim olup, karakterize edici 'özelligi, PVAHnn MCCler ile es-karisimmin, 0,55 - 0,63 g/ml araligindaki sikistirilmis yogunluklarda 0,40 - 0,48 g/ml araliginda bulk yogunluklara sahip olmasidir.
11.1”den 10”a kadar olan istemlerden birine veya birden çoguna uygun bir bilesim içeren tabletler olup, 19,5 kN düzeyinde bir presleme kuvveti kullanildiginda bile 295,7 N tablet sertligine sahip olan tabletleri meydana getirir ve yaklasik olarak 66,7 N ejeksiyon kuvvetini gerektirir.
12. Etken madde salimi birkaç saat uzatilmis, etkeii madde içerikli tabletler olup, poliviiiil alkollerin (PVAlar) ve mikrokristalin selülozlarin (MCCler) l”den 10”a kadar olan istemlerden birine veya birden çoguna uygun bir es-karisimini içerir.
13. Istem 12”ye göre, etken madde içerikli tabletler olup, laden 10”a kadar olan istemlerden birine veya birden çoguna uygun bir es-karisim formundaki, dogrudan preslenebilir bir bilesimi tabletlerin t0plain agirligina göre % 1-99 agirlik oraninda bir miktarda, tercihen % 5-95 agirlik oraninda bir miktarda, Özellikle tercihli olarak % 10-90 agirlik oraninda bir miktarda içerirler.
14. Istem 12°ye veya 13'e göre, etken madde içerikli tabletler olup, düsük presleme kuvvetleri kullanildiginda bile 'Özellikle yüksek tablet sertlikleri gösterirler ve düsük ejeksiyon kuvvetlerini gerektirirler.
15.12”den 14°e kadar olan istemlerden birine göre, etken madde içerikli tabletler olup, agirlikça % l°in altinda, tercihen agirlikça % 0,5°in altinda, özellikle de agirlikça % 0,1”in altinda asinma gösterirler.
16. ll”den 15'e kadar olan istemlerden birine veya birden çoguna göre, etken inadde içerikli tabletler olup, en az 2 saat, tercihen en az 6 saatin üzerinde, 'Özellikle tercihen en az 8 saat, bilhassa tercihen en az 10 saat ve 'Özel olarak tercihen en az 12 saat ölçüsünde geciktirilmis etken madde salimi gösterirler.
17. 11°den 16°ya kadar olan istemlerden birine veya birden çoguna göre, geciktirilmis etken inadde salimli etken madde içerikli tabletler olup, tek basina veya baska etken maddelerle kombine olarak BCS-I sinifi etken maddeler içerirler.
18. Mikrokristalin selülozlarin (MCCler) ve polivinil alkollerin (PVAlar) bir es-karisimini içeren, l”den ll”e kadar olan istemlerden birine veya birden çoguna uygun, geciktirilmis etken madde salimli, dogrudan preslenebilir bilesimleri üretmek için yöntem olup, karakterize edici 'Özelligi, polivinil alkolün ince-taneli bir toz halinde ögütülmesi ve bir 800um elekten geçirilmesi ve 60 ilâ 250 um araliginda ortalama partikül büyüklügüne dvso ve 0,22 ilâ 0,38 g/cm3 araliginda bulk yogunluga sahip mikrokristalin selülozla (MCCler) iyice karistirilmasidir.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14002666 | 2014-07-30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| TR201816462T4 true TR201816462T4 (tr) | 2018-11-21 |
Family
ID=51260568
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TR2018/16462T TR201816462T4 (tr) | 2014-07-30 | 2015-07-03 | Doğrudan preslenebilir polivinil alkoller. |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US20170216213A1 (tr) |
| EP (1) | EP3174530B1 (tr) |
| JP (1) | JP6629835B2 (tr) |
| KR (1) | KR20170038021A (tr) |
| CN (1) | CN106572977A (tr) |
| AU (1) | AU2015295845B2 (tr) |
| BR (1) | BR112017001758A2 (tr) |
| CA (1) | CA2956527C (tr) |
| DK (1) | DK3174530T3 (tr) |
| ES (1) | ES2700153T3 (tr) |
| IL (1) | IL250135B (tr) |
| PT (1) | PT3174530T (tr) |
| TR (1) | TR201816462T4 (tr) |
| WO (1) | WO2016015812A1 (tr) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017045743A1 (de) * | 2015-09-14 | 2017-03-23 | Merck Patent Gmbh | Tabletten mit medienunabhängiger wirkstoffabgabe |
| CA3042770A1 (en) * | 2016-11-07 | 2018-05-11 | Merck Patent Gmbh | Anti-alcohol-induced dose dumping tablet based on polyvinyl alcohol |
| KR20190095373A (ko) * | 2016-12-14 | 2019-08-14 | 메르크 파텐트 게엠베하 | 연장된 활성 물질 전달을 갖는 정제를 제조하기 위한 직접 타정성 매트릭스 |
| JP7238509B2 (ja) * | 2019-03-19 | 2023-03-14 | 三菱ケミカル株式会社 | 医薬錠剤 |
| US11872231B2 (en) | 2019-12-09 | 2024-01-16 | Nicoventures Trading Limited | Moist oral product comprising an active ingredient |
| US11793230B2 (en) * | 2019-12-09 | 2023-10-24 | Nicoventures Trading Limited | Oral products with improved binding of active ingredients |
| US11617744B2 (en) | 2019-12-09 | 2023-04-04 | Nico Ventures Trading Limited | Moist oral compositions |
| US11826462B2 (en) | 2019-12-09 | 2023-11-28 | Nicoventures Trading Limited | Oral product with sustained flavor release |
| US11969502B2 (en) | 2019-12-09 | 2024-04-30 | Nicoventures Trading Limited | Oral products |
| WO2021148362A1 (en) * | 2020-01-21 | 2021-07-29 | Merck Patent Gmbh | Directly compressible polymer combinations for matrix tablets with extended drug release |
| WO2021205887A1 (ja) * | 2020-04-10 | 2021-10-14 | 日本酢ビ・ポバール株式会社 | 徐放性基剤 |
| EP4393512A4 (en) * | 2021-08-25 | 2024-10-23 | Mitsubishi Chem Corp | COMPOSITION FOR MEDICINAL TABLET, MEDICINAL TABLET OBTAINED USING THE SAME, AND PRODUCTION METHOD THEREFOR |
| WO2023171730A1 (ja) * | 2022-03-10 | 2023-09-14 | 三菱ケミカル株式会社 | 医薬用組成物、医薬錠剤およびその製造方法 |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0359746B1 (en) * | 1987-03-25 | 1992-06-03 | E.I. Du Pont De Nemours And Company | Use of vinyl alcohol homopolymers and copolymers for tableting active materials |
| US5733578A (en) * | 1995-11-15 | 1998-03-31 | Edward Mendell Co., Inc. | Directly compressible high load acetaminophen formulations |
| US8168616B1 (en) | 2000-11-17 | 2012-05-01 | Novartis Ag | Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension |
| US20060039967A1 (en) * | 2002-08-12 | 2006-02-23 | Motohiro Ohta | Amino acid-containing chewable |
| US20080152595A1 (en) | 2004-11-24 | 2008-06-26 | Acura Pharmaceuticals, Inc. | Methods and compositions for deterring abuse of orally administered pharmaceutical products |
| BRPI0612802A2 (pt) * | 2005-07-07 | 2010-11-30 | Farnam Co Inc | composições farmacêuticas de liberação sustentada para medicamentos extremamente hidrossolúveis |
| KR100762847B1 (ko) * | 2006-01-27 | 2007-10-04 | 씨제이 주식회사 | 멀티플 유닛 타입 서방성 경구 제제 및 그 제조방법 |
| NZ573174A (en) * | 2006-06-01 | 2012-01-12 | Msd Consumer Care Inc | Sustained release pharmaceutical dosage form containing phenylephrine |
| US20080138404A1 (en) * | 2006-12-06 | 2008-06-12 | Biovail Laboratories International S.R.L. | Extended release formulations of carvedilol |
| DE102008023345B4 (de) | 2008-05-13 | 2014-12-04 | Lts Lohmann Therapie-Systeme Ag | Filmförmige Zubereitung mit öligen Substanzen zur oralen Verabreichung |
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2015
- 2015-07-03 JP JP2017505108A patent/JP6629835B2/ja active Active
- 2015-07-03 CA CA2956527A patent/CA2956527C/en active Active
- 2015-07-03 TR TR2018/16462T patent/TR201816462T4/tr unknown
- 2015-07-03 AU AU2015295845A patent/AU2015295845B2/en active Active
- 2015-07-03 KR KR1020177005415A patent/KR20170038021A/ko not_active Application Discontinuation
- 2015-07-03 ES ES15733632T patent/ES2700153T3/es active Active
- 2015-07-03 BR BR112017001758A patent/BR112017001758A2/pt not_active IP Right Cessation
- 2015-07-03 PT PT15733632T patent/PT3174530T/pt unknown
- 2015-07-03 WO PCT/EP2015/001355 patent/WO2016015812A1/de active Application Filing
- 2015-07-03 US US15/329,421 patent/US20170216213A1/en not_active Abandoned
- 2015-07-03 DK DK15733632.2T patent/DK3174530T3/en active
- 2015-07-03 EP EP15733632.2A patent/EP3174530B1/de active Active
- 2015-07-03 CN CN201580040685.5A patent/CN106572977A/zh active Pending
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2017
- 2017-01-16 IL IL250135A patent/IL250135B/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| JP6629835B2 (ja) | 2020-01-15 |
| BR112017001758A2 (pt) | 2017-11-21 |
| CN106572977A (zh) | 2017-04-19 |
| EP3174530A1 (de) | 2017-06-07 |
| JP2017521471A (ja) | 2017-08-03 |
| AU2015295845A1 (en) | 2017-03-23 |
| AU2015295845B2 (en) | 2020-03-05 |
| ES2700153T3 (es) | 2019-02-14 |
| CA2956527A1 (en) | 2016-02-04 |
| PT3174530T (pt) | 2018-12-05 |
| WO2016015812A1 (de) | 2016-02-04 |
| IL250135A0 (en) | 2017-03-30 |
| CA2956527C (en) | 2022-08-23 |
| US20170216213A1 (en) | 2017-08-03 |
| DK3174530T3 (en) | 2018-11-26 |
| KR20170038021A (ko) | 2017-04-05 |
| IL250135B (en) | 2020-01-30 |
| EP3174530B1 (de) | 2018-08-29 |
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