HRP20211286T1 - Fine čestice epinefrina i metode njihove korištenja za liječenje stanja koja odgovaraju na epinefrin - Google Patents
Fine čestice epinefrina i metode njihove korištenja za liječenje stanja koja odgovaraju na epinefrin Download PDFInfo
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- HRP20211286T1 HRP20211286T1 HRP20211286TT HRP20211286T HRP20211286T1 HR P20211286 T1 HRP20211286 T1 HR P20211286T1 HR P20211286T T HRP20211286T T HR P20211286TT HR P20211286 T HRP20211286 T HR P20211286T HR P20211286 T1 HRP20211286 T1 HR P20211286T1
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- Croatia
- Prior art keywords
- microcrystals
- epinephrine bitartrate
- pharmaceutical preparation
- epinephrine
- pharmaceutically effective
- Prior art date
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- UCTWMZQNUQWSLP-VIFPVBQESA-N (R)-adrenaline Chemical compound CNC[C@H](O)C1=CC=C(O)C(O)=C1 UCTWMZQNUQWSLP-VIFPVBQESA-N 0.000 title claims 5
- 229930182837 (R)-adrenaline Natural products 0.000 title claims 5
- 229960005139 epinephrine Drugs 0.000 title claims 5
- 238000000034 method Methods 0.000 title claims 4
- 239000010419 fine particle Substances 0.000 title 1
- YLXIPWWIOISBDD-NDAAPVSOSA-N (2r,3r)-2,3-dihydroxybutanedioic acid;4-[(1r)-1-hydroxy-2-(methylamino)ethyl]benzene-1,2-diol Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O.CNC[C@H](O)C1=CC=C(O)C(O)=C1 YLXIPWWIOISBDD-NDAAPVSOSA-N 0.000 claims 20
- 229960003157 epinephrine bitartrate Drugs 0.000 claims 20
- 239000013081 microcrystal Substances 0.000 claims 20
- 239000000825 pharmaceutical preparation Substances 0.000 claims 15
- 208000006673 asthma Diseases 0.000 claims 6
- 239000003623 enhancer Substances 0.000 claims 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 6
- 230000003232 mucoadhesive effect Effects 0.000 claims 4
- 239000002245 particle Substances 0.000 claims 4
- 230000035515 penetration Effects 0.000 claims 4
- 239000004094 surface-active agent Substances 0.000 claims 4
- 206010002198 Anaphylactic reaction Diseases 0.000 claims 3
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 3
- 230000000172 allergic effect Effects 0.000 claims 3
- 230000036783 anaphylactic response Effects 0.000 claims 3
- 208000003455 anaphylaxis Diseases 0.000 claims 3
- 208000010668 atopic eczema Diseases 0.000 claims 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid group Chemical group C(CC(O)(C(=O)O)CC(=O)O)(=O)O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 3
- 239000003937 drug carrier Substances 0.000 claims 3
- 208000030603 inherited susceptibility to asthma Diseases 0.000 claims 3
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims 3
- 235000019359 magnesium stearate Nutrition 0.000 claims 3
- 229940057948 magnesium stearate Drugs 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
- 206010020751 Hypersensitivity Diseases 0.000 claims 2
- 208000030961 allergic reaction Diseases 0.000 claims 2
- 235000019264 food flavour enhancer Nutrition 0.000 claims 2
- 235000003599 food sweetener Nutrition 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 230000029058 respiratory gaseous exchange Effects 0.000 claims 2
- 239000003765 sweetening agent Substances 0.000 claims 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- 206010014561 Emphysema Diseases 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 206010057190 Respiratory tract infections Diseases 0.000 claims 1
- 206010006451 bronchitis Diseases 0.000 claims 1
- 239000000969 carrier Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 239000000314 lubricant Substances 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
Classifications
-
- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- 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
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- 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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Emergency Medicine (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Physical Or Chemical Processes And Apparatus (AREA)
Claims (15)
1. Farmaceutski pripravak formuliran za bukalnu ili sublingvalnu primjenu, koji sadrži:
farmaceutski učinkovitu dozu od približno 10 mg do približno 40 mg mikrokristala epinefrin bitartrata; i
barem jedan od farmaceutski učinkovitih nosača, surfaktanta, pojačivača penetracije i mukoadheziva.
2. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što farmaceutski učinkovita doza iznosi približno 10 mg ili približno 20 mg mikrokristala epinefrin bitartrata.
3. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što nadalje sadrži najmanje jedno punilo, lubrikant, sredstvo za dezintegraciju, sredstvo za zaslađivanje i pojačivač osjećaja u ustima i pojačivač okusa; po mogućnosti gdje je zaslađivač i pojačivač osjećaja u ustima manitol, a pojačivač okusa limunska kiselina.
4. Farmaceutski pripravak prema zahtjevu 1, naznačen time, da sadrži:
farmaceutski učinkovitu dozu od približno 10 mg do približno 40 mg mikrokristala epinefrin bitartrata, po mogućnosti približno 10 mg ili približno 20 mg mikrokristala epinefrin bitartrata;
i
mikrokristalnu celulozu, nisko supstituiranu hidroksipropil celuloza i magnezijev stearat.
5. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što mikrokristali epinefrin bitartrata imaju srednju raspodjelu veličine čestica po intenzitetu i volumenu, Pdi i zeta potencijal (n = 3) mikrokristala epinefrin bitartrata, nakon obrade uporabom mikrofluidizator za jedan ciklus pri 30,000 Psi, od 2.4 ± 0.4 µm, 2.5 ± 0.4 µm, 0.185 ± 0.019 µm, odnosno - 4.5± 1.4 mV.
6. Farmaceutski pripravak prema zahtjevu 1, naznačen time, da sadrži:
farmaceutski učinkovitu dozu od približno 10 mg do približno 40 mg mikrokristala epinefrin bitartrata, po mogućnosti približno 10 mg ili približno 20 mg mikrokristala epinefrina bitartrata;
mikrokristali epinefrin bitartrata imaju srednju raspodjelu veličine čestica po intenzitetu i volumenu, Pdi i zeta potencijal (n = 3) mikrokristala epinefrin bitartrata, nakon obrade uporabom mikrofluidizator za jedan ciklus pri 30,000 Psi, od 2.4 ± 0.4 µm, 2.5 ± 0.4 µm, 0.185 ± 0.019 µm, odnosno - 4.5± 1.4 mV; i mikrokristalna celuloza, nisko supstituirana hidroksipropil celuloza i magnezijev stearat.
7. Farmaceutski pripravak formuliran za bukalnu ili sublingvalnu primjenu, koji sadrži:
farmaceutski učinkovitu dozu od približno 10 mg do približno 40 mg mikrokristala epinefrin bitartrata; i
najmanje jedan od farmaceutski prihvatljivih nosača, surfaktanta, pojačivača penetracije i mukoadheziva;
pri čemu je pripravak namijenjen upotrebi u metodi za povećanje sublingvalne bioraspoloživosti epinefrina kod subjekta kojem je to potrebno.
8. Farmaceutski pripravak formuliran za bukalnu ili sublingvalnu primjenu, koji sadrži:
farmaceutski učinkovitu dozu od približno 10 mg do približno 40 mg mikrokristala epinefrin bitartrata; i
najmanje jedan od farmaceutski prihvatljivih nosača, surfaktanta, pojačivača penetracije i mukoadheziva;
pri čemu je pripravak namijenjen upotrebi u metodi za liječenje stanja koje reagira na epinefrin kod subjekta kojem je to potrebno.
9. Farmaceutski pripravak za uporabu prema zahtjevu 8, naznačen time da je stanje koje reagira na epinefrin alergijska reakcija.
10. Farmaceutski pripravak za uporabu prema zahtjevu 9, naznačen time, da je alergijska reakcija anafilaksija, astma ili bronhijalna astma.
11. Farmaceutski pripravak formuliran za bukalnu ili sublingvalnu primjenu, koji sadrži:
farmaceutski učinkovita doza od približno 10 mg do približno 40 mg mikrokristala epinefrin bitartrata; i
najmanje jedan od farmaceutski prihvatljivih nosača, surfaktanta, pojačivača penetracije i mukoadheziva;
pri čemu je pripravak namijenjen upotrebi u metodi za liječenje poteškoća s disanjem kod subjekta kojem je to potrebno; ili
liječenje hitne alergijske bolesti kod subjekta kojem je dijagnosticirana ili se sumnja da ima alergijski hitni slučaj.
12. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 11, naznačen time što su poteškoće s disanjem povezane s anafilaksijom, astmom, bronhijalnom astmom, bronhitisom, emfizemom ili respiratornom infekcijom; ili
hitna alergijska situacija je anafilaksija, astma ili bronhijalna astma.
13. Farmaceutski pripravak za uporabu prema zahtjevu 7, 8 ili 11, naznačen time, da farmaceutski učinkovita doza iznosi približno 10 mg ili približno 20 mg mikrokristala epinefrin bitartrata.
14. Farmaceutski pripravak za uporabu prema zahtjevu 7, 8 ili 11, naznačen time, da mikrokristali epinefrin bitartrata imaju srednju raspodjelu veličine čestica po intenzitetu i volumenu, Pdi i zeta potencijal (n = 3) mikrokristala epinefrin bitartrata, nakon obrade uporabom mikrofluidizator za jedan ciklus pri 30,000 Psi, od 2.4 ± 0.4 µm, 2.5 ± 0.4 µm, 0.185 ± 0.019 µm, odnosno - 4.5± 1.4 mV.
15. Farmaceutski pripravak za uporabu prema zahtjevu 7, 8 ili 11, naznačen time, da sadrži:
farmaceutski učinkovitu dozu od približno 10 mg do približno 40 mg mikrokristala epinefrin bitartrata, po mogućnosti približno 10 mg ili približno 20 mg mikrokristala epinefrina bitartrata;
pri čemu mikrokristali epinefrin bitartrata imaju srednju raspodjelu veličine čestica po intenzitetu i volumenu, Pdi i zeta potencijal (n = 3) mikrokristala epinefrin bitartrata, nakon obrade uporabom mikrofluidizator za jedan ciklus pri 30,000 Psi, od 2.4 ± 0.4 µm, 2.5 ± 0.4 µm, 0.185 ± 0.019 µm, odnosno -4.5± 1.4 mV;
i
mikrokristalnu celulozu, nisko supstituiranu hidroksipropil celulozu i magnezijev stearat.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201361804519P | 2013-03-22 | 2013-03-22 | |
US201361804892P | 2013-03-25 | 2013-03-25 | |
PCT/US2014/031579 WO2014153559A1 (en) | 2013-03-22 | 2014-03-24 | Epinephrine fine particles and methods for use thereof for treatment of conditions responsive to epinephrine |
EP14768584.6A EP2976072B9 (en) | 2013-03-22 | 2014-03-24 | Epinephrine fine particles and methods for use thereof for treatment of conditions responsive to epinephrine |
Publications (1)
Publication Number | Publication Date |
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HRP20211286T1 true HRP20211286T1 (hr) | 2021-12-24 |
Family
ID=51581536
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20211286TT HRP20211286T1 (hr) | 2013-03-22 | 2014-03-24 | Fine čestice epinefrina i metode njihove korištenja za liječenje stanja koja odgovaraju na epinefrin |
Country Status (10)
Country | Link |
---|---|
US (2) | US11229613B2 (hr) |
EP (2) | EP3888642A1 (hr) |
CA (1) | CA2907770C (hr) |
DK (1) | DK2976072T3 (hr) |
ES (1) | ES2882530T3 (hr) |
HR (1) | HRP20211286T1 (hr) |
HU (1) | HUE055773T2 (hr) |
PL (1) | PL2976072T3 (hr) |
PT (1) | PT2976072T (hr) |
WO (1) | WO2014153559A1 (hr) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2013059629A1 (en) | 2011-10-21 | 2013-04-25 | Nova Southeastern University | Epinephrine nanoparticles, methods of fabrication thereof, and methods for use thereof for treatment of conditions responsive to epinephrine |
US20160045457A1 (en) | 2005-09-09 | 2016-02-18 | Ousama Rachid | Epinephrine fine particles and methods for use thereof for treatment of conditions responsive to epinephrine |
US9877921B2 (en) | 2005-09-09 | 2018-01-30 | Nova Southeastern University | Epinephrine nanoparticles, methods of fabrication thereof, and methods for use thereof for treatment of conditions responsive to epinephrine |
US20120322884A1 (en) | 2010-03-01 | 2012-12-20 | University Of Manitoba | Epinephrine nanoparticles, methods of fabrication thereof, and methods for use thereof for treatment of conditions responsive to epinephrine |
CA3169368A1 (en) | 2012-06-15 | 2014-01-09 | Nova Southeastern University | Epinephrine nanoparticles, methods of fabrication thereof, and methods for use thereof for treatment of conditions responsive to epinephrine |
DK2976072T3 (da) | 2013-03-22 | 2021-08-16 | Univ Nova Southeastern | Epinephrinfinpartikler og fremgangsmåder til anvendelse deraf til behandling af tilstande, der reagerer på epinephrin |
US11253488B2 (en) | 2017-09-06 | 2022-02-22 | pHase Pharmaceuticals LLC | Sublingual epinephrine tablets |
AU2022241136A1 (en) | 2021-03-16 | 2023-11-09 | Robert C H CHISHOLM | Composite oromucosal film compositions comprising epinephrine particles |
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CN101669917B (zh) | 2009-09-23 | 2013-07-24 | 中国人民解放军第二军医大学 | 一种基于“NiMS”系统的氢溴酸东莨菪碱口腔速崩微囊片 |
CN101841990B (zh) | 2010-01-28 | 2012-05-30 | 鸿富锦精密工业(深圳)有限公司 | 带支撑架的电子设备 |
US20120322884A1 (en) * | 2010-03-01 | 2012-12-20 | University Of Manitoba | Epinephrine nanoparticles, methods of fabrication thereof, and methods for use thereof for treatment of conditions responsive to epinephrine |
KR20130076015A (ko) | 2011-12-28 | 2013-07-08 | 주식회사 삼양바이오팜 | 높은 경도를 갖는 속붕정 및 이의 제조 방법 |
CA3169368A1 (en) | 2012-06-15 | 2014-01-09 | Nova Southeastern University | Epinephrine nanoparticles, methods of fabrication thereof, and methods for use thereof for treatment of conditions responsive to epinephrine |
DK2976072T3 (da) | 2013-03-22 | 2021-08-16 | Univ Nova Southeastern | Epinephrinfinpartikler og fremgangsmåder til anvendelse deraf til behandling af tilstande, der reagerer på epinephrin |
CN104666401B (zh) | 2015-03-17 | 2019-03-05 | 成都乾坤动物药业股份有限公司 | 一种兽用中西药复方口崩微粉片及其制备方法 |
PL3280447T3 (pl) | 2015-04-08 | 2019-07-31 | Torrent Pharmaceuticals Limited | Preparaty farmaceutyczne |
CA3116730A1 (en) | 2018-10-19 | 2020-04-23 | Nova Southeastern University | Sublingual epinephrine compositions including ph-modifying excipients and penetration enhancers and methods for use thereof |
-
2014
- 2014-03-24 DK DK14768584.6T patent/DK2976072T3/da active
- 2014-03-24 WO PCT/US2014/031579 patent/WO2014153559A1/en active Application Filing
- 2014-03-24 HU HUE14768584A patent/HUE055773T2/hu unknown
- 2014-03-24 ES ES14768584T patent/ES2882530T3/es active Active
- 2014-03-24 EP EP21170027.3A patent/EP3888642A1/en active Pending
- 2014-03-24 HR HRP20211286TT patent/HRP20211286T1/hr unknown
- 2014-03-24 PL PL14768584T patent/PL2976072T3/pl unknown
- 2014-03-24 EP EP14768584.6A patent/EP2976072B9/en active Active
- 2014-03-24 CA CA2907770A patent/CA2907770C/en active Active
- 2014-03-24 PT PT147685846T patent/PT2976072T/pt unknown
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2018
- 2018-12-19 US US16/225,609 patent/US11229613B2/en active Active
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2022
- 2022-01-24 US US17/582,045 patent/US20220218629A1/en active Pending
Also Published As
Publication number | Publication date |
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PL2976072T3 (pl) | 2021-11-22 |
WO2014153559A1 (en) | 2014-09-25 |
EP2976072A1 (en) | 2016-01-27 |
HUE055773T2 (hu) | 2021-12-28 |
DK2976072T3 (da) | 2021-08-16 |
EP2976072A4 (en) | 2016-09-07 |
CA2907770A1 (en) | 2014-09-25 |
ES2882530T3 (es) | 2021-12-02 |
EP2976072B9 (en) | 2021-10-13 |
EP2976072B1 (en) | 2021-05-12 |
US20220218629A1 (en) | 2022-07-14 |
PT2976072T (pt) | 2021-08-12 |
US11229613B2 (en) | 2022-01-25 |
EP3888642A1 (en) | 2021-10-06 |
CA2907770C (en) | 2022-02-15 |
US20190125698A1 (en) | 2019-05-02 |
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