HRP20190677T4 - Optimizirana farmaceutska formula za liječenje upalnih promjena u jednjaku - Google Patents
Optimizirana farmaceutska formula za liječenje upalnih promjena u jednjaku Download PDFInfo
- Publication number
- HRP20190677T4 HRP20190677T4 HRP20190677TT HRP20190677T HRP20190677T4 HR P20190677 T4 HRP20190677 T4 HR P20190677T4 HR P20190677T T HRP20190677T T HR P20190677TT HR P20190677 T HRP20190677 T HR P20190677T HR P20190677 T4 HRP20190677 T4 HR P20190677T4
- Authority
- HR
- Croatia
- Prior art keywords
- effervescent tablet
- orodispersible effervescent
- weight
- amount
- tablet according
- Prior art date
Links
- 210000003238 esophagus Anatomy 0.000 title claims 2
- 230000002757 inflammatory effect Effects 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 239000007938 effervescent tablet Substances 0.000 claims 11
- 239000002253 acid Substances 0.000 claims 7
- 239000003826 tablet Substances 0.000 claims 6
- 150000003839 salts Chemical class 0.000 claims 4
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims 2
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims 2
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims 2
- 230000004968 inflammatory condition Effects 0.000 claims 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- HNSDLXPSAYFUHK-UHFFFAOYSA-N 1,4-bis(2-ethylhexyl) sulfosuccinate Chemical compound CCCCC(CC)COC(=O)CC(S(O)(=O)=O)C(=O)OCC(CC)CCCC HNSDLXPSAYFUHK-UHFFFAOYSA-N 0.000 claims 1
- VOVIALXJUBGFJZ-KWVAZRHASA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- 206010064212 Eosinophilic oesophagitis Diseases 0.000 claims 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 1
- -1 K2CO2 Chemical compound 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 229920003080 Povidone K 25 Polymers 0.000 claims 1
- 239000004376 Sucralose Substances 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 229960004436 budesonide Drugs 0.000 claims 1
- 235000010216 calcium carbonate Nutrition 0.000 claims 1
- 229910000019 calcium carbonate Inorganic materials 0.000 claims 1
- 235000019262 disodium citrate Nutrition 0.000 claims 1
- 239000002526 disodium citrate Substances 0.000 claims 1
- CEYULKASIQJZGP-UHFFFAOYSA-L disodium;2-(carboxymethyl)-2-hydroxybutanedioate Chemical compound [Na+].[Na+].[O-]C(=O)CC(O)(C(=O)O)CC([O-])=O CEYULKASIQJZGP-UHFFFAOYSA-L 0.000 claims 1
- 229940018602 docusate Drugs 0.000 claims 1
- 201000000708 eosinophilic esophagitis Diseases 0.000 claims 1
- 229960003511 macrogol Drugs 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- HWPKGOGLCKPRLZ-UHFFFAOYSA-M monosodium citrate Chemical compound [Na+].OC(=O)CC(O)(C([O-])=O)CC(O)=O HWPKGOGLCKPRLZ-UHFFFAOYSA-M 0.000 claims 1
- 235000018342 monosodium citrate Nutrition 0.000 claims 1
- 239000002524 monosodium citrate Substances 0.000 claims 1
- 239000011736 potassium bicarbonate Substances 0.000 claims 1
- 235000015497 potassium bicarbonate Nutrition 0.000 claims 1
- 229910000028 potassium bicarbonate Inorganic materials 0.000 claims 1
- TYJJADVDDVDEDZ-UHFFFAOYSA-M potassium hydrogencarbonate Chemical compound [K+].OC([O-])=O TYJJADVDDVDEDZ-UHFFFAOYSA-M 0.000 claims 1
- 229940100487 povidone k25 Drugs 0.000 claims 1
- 235000017557 sodium bicarbonate Nutrition 0.000 claims 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims 1
- 235000017550 sodium carbonate Nutrition 0.000 claims 1
- 229910000029 sodium carbonate Inorganic materials 0.000 claims 1
- 239000000243 solution Substances 0.000 claims 1
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 claims 1
- 235000019408 sucralose Nutrition 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
-
- 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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0007—Effervescent
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Claims (10)
1. Orodisperzibilna pjenušava tableta koja sadrži 0,4 mg do 3 mg budezonida, gdje sol najmanje jedne farmakološki prihvatljive kiseline koja u vodenom okolišu može otpustiti plin s dodatnom kiselinom, kao i sol dodatne slabe kiseline ili dodatna slaba kiselina koja snižava pH vrijednost u vodenoj otopini, i sukralozu u količini od 0,1 do 1,0%, težinski, na osnovi gotove tablete, naznačena time što dvorazinska pjenušava tableta ima masu od 100 mg do 200 mg, promjer od 6,0 do 8,0 mm, te visinu od 1,6 do 2,8 mm, kao i čvrstoću na lomljenje od 10 N do 100 N i drobljivost određenu u skladu s Europskom farmakopejom, prema monografiji 2.9.7 od najviše 5%.
2. Orodisperzibilna pjenušava tableta u skladu s patentnim zahtjevom 1, naznačena time što je sol farmaceutski prihvatljive kiseline koja u vodenom okolišu može otpustiti plin s kiselinom NaHCO3, Na2CO3, KHCO3, K2CO2, CaCO3, ili njihova smjesa.
3. Orodisperzibilna pjenušava tableta u skladu s patentnim zahtjevom 1 ili 2, naznačena time što sol dodatne farmaceutski prihvatljive slabe kiseline koja snižava pH vrijednost u vodenoj otopini je dinatrijev citrat, mononatrijev citrat ili njihova smjesa.
4. Orodisperzibilna pjenušava tableta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što sadrži povidon K25 u količini od 0,5 do 10%, težinski, na osnovi gotove tablete.
5. Orodisperzibilna pjenušava tableta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što sadrži dokusat Na u količini od 0,01 do 0,2%, težinski, na osnovi gotove tablete.
6. Orodisperzibilna pjenušava tableta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što sadrži manitol u količini od 2,0 do 10,0%, težinski, na osnovi gotove tablete.
7. Orodisperzibilna pjenušava tableta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što sadrži makrogol 6000 u količini od 1,0 do 10,0%, težinski, na osnovi gotove tablete.
8. Orodisperzibilna pjenušava tableta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što sadrži magnezijev stearat u količini od 0,05 do 0,5%, težinski, na osnovi gotove tablete.
9. Orodisperzibilna pjenušava tableta u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačena time što je namijenjena upotrebi u liječenju upalnih stanja jednjaka.
10. Orodisperzibilna pjenušava tableta namijenjena upotrebi u skladu s patentnim zahtjevom 9, naznačena time što je upalno stanje eozinofilni ezofagitis.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP13199278.6A EP2886108B2 (de) | 2013-12-23 | 2013-12-23 | Optimierte pharmazeutische Formulierung zur Behandlung von entzündlichen Veränderungen des Ösophagus |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20190677T1 HRP20190677T1 (hr) | 2019-05-31 |
| HRP20190677T4 true HRP20190677T4 (hr) | 2023-02-03 |
Family
ID=49911300
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20190677TT HRP20190677T4 (hr) | 2013-12-23 | 2013-12-23 | Optimizirana farmaceutska formula za liječenje upalnih promjena u jednjaku |
| HRP20181799TT HRP20181799T1 (hr) | 2013-12-23 | 2018-10-30 | Optimizirana farmaceutska formula, namijenjena liječenju upalnih promjena jednjaka |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20181799TT HRP20181799T1 (hr) | 2013-12-23 | 2018-10-30 | Optimizirana farmaceutska formula, namijenjena liječenju upalnih promjena jednjaka |
Country Status (24)
| Country | Link |
|---|---|
| US (4) | US9867780B2 (hr) |
| EP (2) | EP2886108B2 (hr) |
| JP (3) | JP6522626B2 (hr) |
| CN (1) | CN105848648B (hr) |
| AU (1) | AU2014372739B2 (hr) |
| CA (1) | CA2934009C (hr) |
| CY (2) | CY1121168T1 (hr) |
| DK (2) | DK2886108T4 (hr) |
| EA (1) | EA029166B1 (hr) |
| ES (2) | ES2716990T5 (hr) |
| FI (1) | FI2886108T4 (hr) |
| HK (1) | HK1209362A1 (hr) |
| HR (2) | HRP20190677T4 (hr) |
| HU (2) | HUE042009T2 (hr) |
| IL (1) | IL246172B (hr) |
| LT (2) | LT2886108T (hr) |
| PL (2) | PL2886108T5 (hr) |
| PT (2) | PT2886108T (hr) |
| RS (2) | RS58543B2 (hr) |
| SI (2) | SI2886108T2 (hr) |
| TR (1) | TR201815823T4 (hr) |
| UA (1) | UA117162C2 (hr) |
| WO (1) | WO2015097053A1 (hr) |
| ZA (1) | ZA201604225B (hr) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2940931C (en) | 2009-10-01 | 2019-04-30 | Adare Pharmaceuticals, Inc. | Orally administered corticosteroid compositions |
| WO2015034678A2 (en) | 2013-09-06 | 2015-03-12 | Aptalis Pharmatech, Inc. | Corticosteroid containing orally disintegrating tablet compositions for eosinophilic esophagitis |
| LT2886108T (lt) | 2013-12-23 | 2019-03-25 | Dr. Falk Pharma Gmbh | Optimizuota farmacinė kompozicija, skirta stemplės uždegiminių pakitimų gydymui |
| TWI777515B (zh) * | 2016-08-18 | 2022-09-11 | 美商愛戴爾製藥股份有限公司 | 治療嗜伊紅性食道炎之方法 |
| EP4091615A1 (en) | 2021-05-20 | 2022-11-23 | Dr. Falk Pharma Gmbh | Orodispersible effervescent tablet comprising budesonide for use in the treatment of eosinophilic esophagitis |
| CN116869927B (zh) * | 2023-09-06 | 2023-11-10 | 中国医学科学院北京协和医院 | 一种用于治疗嗜酸性食管炎的食道温敏凝胶 |
Family Cites Families (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3937455A1 (de) * | 1989-11-10 | 1991-05-16 | Nordmark Arzneimittel Gmbh | Antacidatabletten |
| DK0481294T4 (da) * | 1990-10-19 | 2001-06-18 | Spirig Ag | Fast, hurtigt-opløseligt lægemiddelpræparat indeholdende N-acetylcystein |
| DE4332394A1 (de) | 1993-09-23 | 1995-03-30 | Falk Pharma Gmbh | Budesonid-Pellets mit kontrolliertem Freigabeprofil und Verfahren zu ihrer Herstellung |
| US5639475A (en) | 1995-02-03 | 1997-06-17 | Eurand America, Incorporated | Effervescent microcapsules |
| US5607697A (en) | 1995-06-07 | 1997-03-04 | Cima Labs, Incorporated | Taste masking microparticles for oral dosage forms |
| US5807578A (en) | 1995-11-22 | 1998-09-15 | Lab Pharmaceutical Research International Inc. | Fast-melt tablet and method of making same |
| US5807577A (en) | 1995-11-22 | 1998-09-15 | Lab Pharmaceutical Research International Inc. | Fast-melt tablet and method of making same |
| US6350470B1 (en) | 1998-04-29 | 2002-02-26 | Cima Labs Inc. | Effervescent drug delivery system for oral administration |
| FR2834893B1 (fr) * | 2002-01-23 | 2004-02-27 | Servier Lab | Composition pharmaceutique orodispersible de perindopril |
| JP2005526095A (ja) | 2002-03-20 | 2005-09-02 | エラン ファーマ インターナショナル，リミティド | 脆砕性の低い急速溶解投与剤型 |
| JP4475233B2 (ja) † | 2003-01-21 | 2010-06-09 | 日本新薬株式会社 | 口腔内速崩性錠剤 |
| SE0401031D0 (sv) | 2004-04-22 | 2004-04-22 | Duocort Ab | A new glucocorticoid replacement therapy |
| US20060013873A1 (en) | 2004-07-16 | 2006-01-19 | Chih-Chiang Yang | Bioadhesive dosage form of steroids |
| US20070020330A1 (en) † | 2004-11-24 | 2007-01-25 | Medpointe Healthcare Inc. | Compositions comprising azelastine and methods of use thereof |
| US20070071817A1 (en) | 2005-09-26 | 2007-03-29 | Phyzz, Inc. | Effervescent oral care compositions and method of use |
| US8679545B2 (en) * | 2005-11-12 | 2014-03-25 | The Regents Of The University Of California | Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract |
| US8324192B2 (en) | 2005-11-12 | 2012-12-04 | The Regents Of The University Of California | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract |
| JP2009526619A (ja) | 2006-02-15 | 2009-07-23 | ティカ レーケメデル アーベー | 質量減量を伴うコルチコステロイドの滅菌 |
| KR101626873B1 (ko) | 2007-10-01 | 2016-06-02 | 라보라토리오스 레스비, 에스.엘. | 구강붕해정제 |
| WO2009064458A2 (en) | 2007-11-13 | 2009-05-22 | Meritage Pharma, Inc. | Compositions for the treatment of inflammation of the gastrointestinal tract |
| US20090264392A1 (en) | 2008-04-21 | 2009-10-22 | Meritage Pharma, Inc. | Treating eosinophilic esophagitis |
| ME01256B (me) * | 2008-07-21 | 2013-06-20 | Dr Falk Pharma Gmbh | Farmaceutska formulacija za lečenje gornjeg digestivnog trakta |
| CA2732105A1 (en) † | 2008-08-08 | 2010-02-11 | Mcneil-Ppc, Inc. | Use of sucralose as a granulating agent |
| US20110097401A1 (en) * | 2009-06-12 | 2011-04-28 | Meritage Pharma, Inc. | Methods for treating gastrointestinal disorders |
| LT2886108T (lt) | 2013-12-23 | 2019-03-25 | Dr. Falk Pharma Gmbh | Optimizuota farmacinė kompozicija, skirta stemplės uždegiminių pakitimų gydymui |
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2013
- 2013-12-23 LT LTEP13199278.6T patent/LT2886108T/lt unknown
- 2013-12-23 RS RS20190347A patent/RS58543B2/sr unknown
- 2013-12-23 PT PT13199278T patent/PT2886108T/pt unknown
- 2013-12-23 EP EP13199278.6A patent/EP2886108B2/de active Active
- 2013-12-23 SI SI201331391T patent/SI2886108T2/sl unknown
- 2013-12-23 HU HUE13199278A patent/HUE042009T2/hu unknown
- 2013-12-23 HR HRP20190677TT patent/HRP20190677T4/hr unknown
- 2013-12-23 PL PL13199278.6T patent/PL2886108T5/pl unknown
- 2013-12-23 DK DK13199278.6T patent/DK2886108T4/da active
- 2013-12-23 ES ES13199278T patent/ES2716990T5/es active Active
- 2013-12-23 FI FIEP13199278.6T patent/FI2886108T4/fi active
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2014
- 2014-12-18 UA UAA201608055A patent/UA117162C2/uk unknown
- 2014-12-18 EA EA201600497A patent/EA029166B1/ru not_active IP Right Cessation
- 2014-12-18 AU AU2014372739A patent/AU2014372739B2/en active Active
- 2014-12-18 PT PT14814872T patent/PT3086782T/pt unknown
- 2014-12-18 TR TR2018/15823T patent/TR201815823T4/tr unknown
- 2014-12-18 HU HUE14814872A patent/HUE041911T2/hu unknown
- 2014-12-18 PL PL14814872T patent/PL3086782T3/pl unknown
- 2014-12-18 US US15/107,735 patent/US9867780B2/en active Active
- 2014-12-18 CN CN201480070548.1A patent/CN105848648B/zh active Active
- 2014-12-18 WO PCT/EP2014/078391 patent/WO2015097053A1/de active Application Filing
- 2014-12-18 CA CA2934009A patent/CA2934009C/en active Active
- 2014-12-18 EP EP14814872.9A patent/EP3086782B1/de active Active
- 2014-12-18 SI SI201430930T patent/SI3086782T1/sl unknown
- 2014-12-18 DK DK14814872.9T patent/DK3086782T3/en active
- 2014-12-18 JP JP2016542264A patent/JP6522626B2/ja active Active
- 2014-12-18 RS RS20181398A patent/RS58112B1/sr unknown
- 2014-12-18 ES ES14814872.9T patent/ES2694331T3/es active Active
- 2014-12-18 LT LTEP14814872.9T patent/LT3086782T/lt unknown
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2015
- 2015-10-16 HK HK15110188.4A patent/HK1209362A1/xx active IP Right Maintenance
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2016
- 2016-06-13 IL IL246172A patent/IL246172B/en active IP Right Grant
- 2016-06-22 ZA ZA2016/04225A patent/ZA201604225B/en unknown
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2017
- 2017-12-06 US US15/833,428 patent/US10369100B2/en active Active
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2018
- 2018-10-30 HR HRP20181799TT patent/HRP20181799T1/hr unknown
- 2018-11-21 CY CY20181101233T patent/CY1121168T1/el unknown
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2019
- 2019-04-08 CY CY20191100386T patent/CY1121523T1/el unknown
- 2019-04-24 JP JP2019082802A patent/JP6757444B2/ja active Active
- 2019-06-17 US US16/442,756 patent/US10695291B2/en active Active
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2020
- 2020-05-15 US US16/875,573 patent/US11382860B2/en active Active
- 2020-08-28 JP JP2020144070A patent/JP7009575B2/ja active Active
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