RU2018137841A - Наноалюмочастицы, содержащие агент, регулирующий размер - Google Patents
Наноалюмочастицы, содержащие агент, регулирующий размер Download PDFInfo
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- RU2018137841A RU2018137841A RU2018137841A RU2018137841A RU2018137841A RU 2018137841 A RU2018137841 A RU 2018137841A RU 2018137841 A RU2018137841 A RU 2018137841A RU 2018137841 A RU2018137841 A RU 2018137841A RU 2018137841 A RU2018137841 A RU 2018137841A
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- nanoaluminum
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- 239000002245 particle Substances 0.000 title claims 17
- 229910052782 aluminium Inorganic materials 0.000 title 1
- 239000000203 mixture Substances 0.000 claims 16
- 239000003795 chemical substances by application Substances 0.000 claims 15
- 238000000034 method Methods 0.000 claims 12
- AZDRQVAHHNSJOQ-UHFFFAOYSA-N alumane Chemical class [AlH3] AZDRQVAHHNSJOQ-UHFFFAOYSA-N 0.000 claims 9
- 230000028993 immune response Effects 0.000 claims 8
- 150000002632 lipids Chemical class 0.000 claims 7
- 108090000765 processed proteins & peptides Proteins 0.000 claims 5
- 239000007788 liquid Substances 0.000 claims 4
- 229920001661 Chitosan Polymers 0.000 claims 3
- 239000002671 adjuvant Substances 0.000 claims 3
- 239000000427 antigen Substances 0.000 claims 3
- 102000036639 antigens Human genes 0.000 claims 3
- 108091007433 antigens Proteins 0.000 claims 3
- 239000012867 bioactive agent Substances 0.000 claims 3
- 150000003904 phospholipids Chemical class 0.000 claims 3
- 229920000083 poly(allylamine) Polymers 0.000 claims 3
- 229920001184 polypeptide Polymers 0.000 claims 3
- 102000004196 processed proteins & peptides Human genes 0.000 claims 3
- LVNGJLRDBYCPGB-LDLOPFEMSA-N (R)-1,2-distearoylphosphatidylethanolamine Chemical compound CCCCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[NH3+])OC(=O)CCCCCCCCCCCCCCCCC LVNGJLRDBYCPGB-LDLOPFEMSA-N 0.000 claims 2
- QFMZQPDHXULLKC-UHFFFAOYSA-N 1,2-bis(diphenylphosphino)ethane Chemical compound C=1C=CC=CC=1P(C=1C=CC=CC=1)CCP(C=1C=CC=CC=1)C1=CC=CC=C1 QFMZQPDHXULLKC-UHFFFAOYSA-N 0.000 claims 2
- ZLGYVWRJIZPQMM-HHHXNRCGSA-N 2-azaniumylethyl [(2r)-2,3-di(dodecanoyloxy)propyl] phosphate Chemical compound CCCCCCCCCCCC(=O)OC[C@H](COP(O)(=O)OCCN)OC(=O)CCCCCCCCCCC ZLGYVWRJIZPQMM-HHHXNRCGSA-N 0.000 claims 2
- 229910017119 AlPO Inorganic materials 0.000 claims 2
- 229920002307 Dextran Polymers 0.000 claims 2
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 claims 2
- 229940024545 aluminum hydroxide Drugs 0.000 claims 2
- 229940024546 aluminum hydroxide gel Drugs 0.000 claims 2
- SMYKVLBUSSNXMV-UHFFFAOYSA-K aluminum;trihydroxide;hydrate Chemical compound O.[OH-].[OH-].[OH-].[Al+3] SMYKVLBUSSNXMV-UHFFFAOYSA-K 0.000 claims 2
- 229940035032 monophosphoryl lipid a Drugs 0.000 claims 2
- 108091033319 polynucleotide Proteins 0.000 claims 2
- 102000040430 polynucleotide Human genes 0.000 claims 2
- 239000002157 polynucleotide Substances 0.000 claims 2
- 239000011148 porous material Substances 0.000 claims 2
- 230000001105 regulatory effect Effects 0.000 claims 2
- 229930182490 saponin Natural products 0.000 claims 2
- 150000007949 saponins Chemical class 0.000 claims 2
- 235000017709 saponins Nutrition 0.000 claims 2
- 239000003970 toll like receptor agonist Substances 0.000 claims 2
- 230000029069 type 2 immune response Effects 0.000 claims 2
- 208000023275 Autoimmune disease Diseases 0.000 claims 1
- 230000003844 B-cell-activation Effects 0.000 claims 1
- 241000283690 Bos taurus Species 0.000 claims 1
- 102000004127 Cytokines Human genes 0.000 claims 1
- 108090000695 Cytokines Proteins 0.000 claims 1
- 206010012335 Dependence Diseases 0.000 claims 1
- 241000283073 Equus caballus Species 0.000 claims 1
- 241000282326 Felis catus Species 0.000 claims 1
- 108010040721 Flagellin Proteins 0.000 claims 1
- 206010020751 Hypersensitivity Diseases 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- 108091034117 Oligonucleotide Proteins 0.000 claims 1
- 229910019142 PO4 Inorganic materials 0.000 claims 1
- 241000009328 Perro Species 0.000 claims 1
- 230000006044 T cell activation Effects 0.000 claims 1
- 230000029662 T-helper 1 type immune response Effects 0.000 claims 1
- 102000002689 Toll-like receptor Human genes 0.000 claims 1
- 108020000411 Toll-like receptor Proteins 0.000 claims 1
- JLCPHMBAVCMARE-UHFFFAOYSA-N [3-[[3-[[3-[[3-[[3-[[3-[[3-[[3-[[3-[[3-[[3-[[5-(2-amino-6-oxo-1H-purin-9-yl)-3-[[3-[[3-[[3-[[3-[[3-[[5-(2-amino-6-oxo-1H-purin-9-yl)-3-[[5-(2-amino-6-oxo-1H-purin-9-yl)-3-hydroxyoxolan-2-yl]methoxy-hydroxyphosphoryl]oxyoxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxyoxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(4-amino-2-oxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(4-amino-2-oxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(4-amino-2-oxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(4-amino-2-oxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(4-amino-2-oxopyrimidin-1-yl)oxolan-2-yl]methyl [5-(6-aminopurin-9-yl)-2-(hydroxymethyl)oxolan-3-yl] hydrogen phosphate Polymers Cc1cn(C2CC(OP(O)(=O)OCC3OC(CC3OP(O)(=O)OCC3OC(CC3O)n3cnc4c3nc(N)[nH]c4=O)n3cnc4c3nc(N)[nH]c4=O)C(COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3CO)n3cnc4c(N)ncnc34)n3ccc(N)nc3=O)n3cnc4c(N)ncnc34)n3ccc(N)nc3=O)n3ccc(N)nc3=O)n3ccc(N)nc3=O)n3cnc4c(N)ncnc34)n3cnc4c(N)ncnc34)n3cc(C)c(=O)[nH]c3=O)n3cc(C)c(=O)[nH]c3=O)n3ccc(N)nc3=O)n3cc(C)c(=O)[nH]c3=O)n3cnc4c3nc(N)[nH]c4=O)n3cnc4c(N)ncnc34)n3cnc4c(N)ncnc34)n3cnc4c(N)ncnc34)n3cnc4c(N)ncnc34)O2)c(=O)[nH]c1=O JLCPHMBAVCMARE-UHFFFAOYSA-N 0.000 claims 1
- 239000000556 agonist Substances 0.000 claims 1
- 230000007815 allergy Effects 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 239000000032 diagnostic agent Substances 0.000 claims 1
- 229940039227 diagnostic agent Drugs 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 108020001507 fusion proteins Proteins 0.000 claims 1
- 102000037865 fusion proteins Human genes 0.000 claims 1
- -1 garquimod Chemical compound 0.000 claims 1
- 238000001502 gel electrophoresis Methods 0.000 claims 1
- 229960002751 imiquimod Drugs 0.000 claims 1
- DOUYETYNHWVLEO-UHFFFAOYSA-N imiquimod Chemical compound C1=CC=CC2=C3N(CC(C)C)C=NC3=C(N)N=C21 DOUYETYNHWVLEO-UHFFFAOYSA-N 0.000 claims 1
- 230000016784 immunoglobulin production Effects 0.000 claims 1
- 230000015788 innate immune response Effects 0.000 claims 1
- 239000003446 ligand Substances 0.000 claims 1
- GZQKNULLWNGMCW-PWQABINMSA-N lipid A (E. coli) Chemical compound O1[C@H](CO)[C@@H](OP(O)(O)=O)[C@H](OC(=O)C[C@@H](CCCCCCCCCCC)OC(=O)CCCCCCCCCCCCC)[C@@H](NC(=O)C[C@@H](CCCCCCCCCCC)OC(=O)CCCCCCCCCCC)[C@@H]1OC[C@@H]1[C@@H](O)[C@H](OC(=O)C[C@H](O)CCCCCCCCCCC)[C@@H](NC(=O)C[C@H](O)CCCCCCCCCCC)[C@@H](OP(O)(O)=O)O1 GZQKNULLWNGMCW-PWQABINMSA-N 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000002105 nanoparticle 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
- 108090000623 proteins and genes Proteins 0.000 claims 1
- 102000004169 proteins and genes Human genes 0.000 claims 1
- 239000001397 quillaja saponaria molina bark Substances 0.000 claims 1
- 229950010550 resiquimod Drugs 0.000 claims 1
- BXNMTOQRYBFHNZ-UHFFFAOYSA-N resiquimod Chemical compound C1=CC=CC2=C(N(C(COCC)=N3)CC(C)(C)O)C3=C(N)N=C21 BXNMTOQRYBFHNZ-UHFFFAOYSA-N 0.000 claims 1
- 230000004936 stimulating effect Effects 0.000 claims 1
- 230000000638 stimulation Effects 0.000 claims 1
- 229940124597 therapeutic agent Drugs 0.000 claims 1
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- 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
- A61K47/02—Inorganic compounds
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/127—Liposomes
- A61K9/1271—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers
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- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
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- A61K9/513—Organic macromolecular compounds; Dendrimers
- A61K9/5138—Organic macromolecular compounds; Dendrimers obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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Claims (36)
1. Наноалюмочастица, содержащая:
(a) соль алюминия; и
(b) агент, регулирующий размер;
причем размер указанной частицы находится в диапазоне от приблизительно 1 нм до приблизительно 450 нм.
2. Наноалюмочастица по п. 1, характеризующаяся тем, что указанная соль алюминия выбрана из группы, состоящей из гидроксида алюминия, геля гидроксида алюминия, AlPO4, AlO(OH), Al(OH)(PO4) и KAl(SO4)2.
3. Наноалюмочастица по п. 1, характеризующаяся тем, что указанный агент, регулирующий размер, выбран из группы, состоящей из ПАК, ПЭГ, ПЭГ, соединенного с липидом, хитозана, декстрана или полиаллиламина, причем ПЭГ, соединенный с липидом, необязательно представляет собой ПЭГ, соединенный с фосфолипидом.
4. Наноалюмочастица по п. 1, характеризующаяся тем, что
(a) указанный агент, регулирующий размер, представляет собой ПЭГ, и средняя молекулярная масса ПЭГ находится в диапазоне от приблизительно 750 дальтон до приблизительно 5000 дальтон; или
(b) указанный агент, регулирующий размер, представляет собой ПЭГ, соединенный с липидом (необязательно фосфолипидом), и средняя молекулярная масса ПЭГ находится в диапазоне от приблизительно 750 дальтон до приблизительно 5000 дальтон, причем указанный липид необязательно выбран из группы, состоящей из DSPE, DPPE, DMPE и DLPE; или
(c) указанный агент, регулирующий размер, представляет собой ПАК, и средняя молекулярная масса ПАК находится в диапазоне от приблизительно 750 дальтон до приблизительно 7000 дальтон.
5. Наноалюмочастица по любому из пп. 1-4, характеризующаяся тем, что указанная наноалюмочастица находится в жидком составе, стерилизованном путем фильтрации; причем необязательно указанная наноалюмочастица стабильна в жидком составе при температуре от приблизительно 0°С до приблизительно 8°С по меньшей мере приблизительно 1 месяц, по меньшей мере приблизительно 6 месяцев или по меньшей мере приблизительно 1 год; или указанная наноалюмочастица стабильна в жидком составе при температуре приблизительно 37°С в течение по меньшей мере приблизительно 1 месяца.
6. Способ изготовления наноалюмочастицы, включающий воздействие источником высокой энергии на соль алюминия в присутствии агента, регулирующего размер, с получением наноалюмочастицы, причем размер указанной наноалюмочастицы находится в диапазоне от приблизительно 1 нм до приблизительно 450 нм.
7. Способ по п. 6, характеризующийся тем, что указанный источник высокой энергии получают с применением одного, двух или более из микрофлюидизатора, экструдера, соникатора, смесителя с высоким усилием сдвига (например, смесителя Silverson) или гомогенизатора.
8. Способ по п. 6, характеризующийся тем, что указанный источник высокой энергии получают с применением микрофлюидизатора и смесителя с высоким усилием сдвига, и указанную смесь, содержащую соль алюминия и агент, регулирующий размер, пропускают через микрофлюидизатор от одного раза до приблизительно 30 раз, или указанный источник высокой энергии получают с применением микрофлюидизатора, и указанную смесь, содержащую соль алюминия и агент, регулирующий размер, пропускают через микрофлюидизатор от одного раза до приблизительно 15 раз.
9. Способ по любому из пп. 6-8, характеризующийся тем, что указанная соль алюминия состоит из частиц с размером от 0,5 до 10 мкм или от 0,5 до 20 мкм; при этом необязательно указанная соль алюминия выбрана из группы, состоящей из гидроксида алюминия, геля гидроксида алюминия, AlPO4, AlO(OH), Al(OH)x(PO4)y и KAl(SO4)2.
10. Способ по любому из пп. 6-9, характеризующийся тем, что указанный агент, регулирующий размер, выбран из группы, состоящей из ПАК, ПЭГ, ПЭГ, соединенного с липидом, хитозана, декстрана или полиаллиламина.
11. Способ по любому из пп. 6-10, характеризующийся тем, что
(а) указанный агент, регулирующий размер, представляет собой хитозан или полиаллиламин, и указанную соль алюминия подвергают модификации поверхности путем обмена фосфатного лиганда перед воздействием на нее источником высокой энергии в присутствии агента, регулирующего размер; или
(b) указанный агент, регулирующий размер, представляет собой ПЭГ, и средняя молекулярная масса ПЭГ находится в диапазоне от приблизительно 750 дальтон до приблизительно 5000 дальтон, или указанный агент, регулирующий размер, представляет собой ПЭГ, соединенный с липидом (необязательно фосфолипидом), и средняя молекулярная масса ПЭГ находится в диапазоне от приблизительно 750 дальтон до приблизительно 5000 дальтон, при этом необязательно указанный липид выбран из группы, состоящей из DSPE, DPPE, DMPE и DLPE; или
(c) указанный агент, регулирующий размер, представляет собой ПАК, и средняя молекулярная масса ПАК находится в диапазоне от приблизительно 750 дальтон до приблизительно 7000 дальтон; причем если указанный агент, регулирующий размер, представляет собой ПЭГ, соотношение соли алюминия и ПЭГ необязательно составляет от приблизительно 2:1 до приблизительно 7,5:1.
12. Наноалюмочастица, которая может быть получена или которая получена способом в соответствии с любым из пп. 6-11, характеризующаяся тем, что размер указанной наноалюмочастицы находится в диапазоне от приблизительно 1 нм до приблизительно 450 нм.
13. Композиция, содержащая наноалюмочастицу по любому из пп. 1-5 и 12.
14. Композиция по п. 13, дополнительно содержащая биоактивный агент, при этом необязательно указанный биоактивный агент ассоциирован с указанной наноалюмочастицей в композиции согласно результатам определения методом гель-электрофореза.
15. Композиция по п. 14, характеризующаяся тем, что указанный биоактивный агент представляет собой полипептид, полинуклеотид, антиген, адъювант, диагностический агент, терапевтический агент или организм; причем указанный полипептид необязательно представляет собой гибридный белок, полноразмерный белок, пептид или пептидный миметик; при этом полинуклеотид необязательно представляет собой ДНК или РНК, которая необязательно кодирует полипептид; при этом указанный антиген представляет собой агонист Rig-I или ID97.
16. Композиция по любому ил пп. 13-15, характеризующаяся тем, что указанная композиция дополнительно содержит адъювант, причем указанный адъювант выбран из группы, состоящей из AS-2, монофосфориллипида А, 3-де-О-ацилированного монофосфориллипида A, IFA, QS21, CWS, ТОМ, AGP, CpG-содержащих олигонуклеотидов, агонистов Toll-подобных рецепторов (TLR), Leif, сапонинов, миметиков сапонинов, биологического и синтетического липида А, имиквимода, гардиквимода, резиквимода, полиI:С, флагеллина, GLA, SLA, STING и их комбинаций.
17. Композиция по любому из пп. 13-16, причем указанная композиция:
(a) представляет собой жидкий состав, который может быть профильтрован через фильтр с размером пор 0,45 мкм или фильтр с размером пор 0,20 мкм; и/или
(b) может быть окончательно стерилизована перед внесением во флаконы;
(c) стабильна при температуре от приблизительно 0°С до приблизительно 8°С в течение по меньшей мере приблизительно 1 месяца, по меньшей мере приблизительно 6 месяцев или по меньшей мере приблизительно 1 года; и/или
(d) стабильна при температуре приблизительно 37°С в течение по меньшей мере приблизительно 1 месяца.
18. Способ стимуляции иммунного ответа у субъекта, включающий введение субъекту композиции по любому из пп. 13-17, что приводит к стимуляции иммунного ответа у указанного субъекта.
19. Способ по п. 18, характеризующийся тем, что указанный иммунный ответ представляет собой неспецифический иммунный ответ или антигенспецифический иммунный ответ.
20. Способ по п. 19, характеризующийся тем, что указанный иммунный ответ представляет собой преимущественно ТН1 иммунный ответ, или указанный иммунный ответ представляет собой преимущественно ТН2 иммунный ответ, или указанный иммунный ответ представляет собой как ТН1, так и ТН2 иммунный ответ.
21. Способ по п. 19, характеризующийся тем, что указанный иммунный ответ включает активацию В-клеток, активацию Т-клеток, выработку антител или высвобождение цитокинов.
22. Способ по любому из пп. 18-21, характеризующийся тем, что указанную композицию применяют для лечения аллергии, зависимости, рака или аутоиммунного заболевания.
23. Способ по любому из пп. 18-21, характеризующийся тем, что указанный субъект представляет собой человека или млекопитающее, отличное от человека, причем млекопитающее, отличное от человека, представляет собой собаку, кошку, корову или лошадь.
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IL262877B2 (en) | 2023-05-01 |
JP7140684B2 (ja) | 2022-09-21 |
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JP2024063036A (ja) | 2024-05-10 |
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BR112018074352A2 (pt) | 2019-03-06 |
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CA3023271A1 (en) | 2017-12-07 |
WO2017210364A1 (en) | 2017-12-07 |
AU2017273650B2 (en) | 2022-08-18 |
JP2019521960A (ja) | 2019-08-08 |
CN109195587A (zh) | 2019-01-11 |
EP3463300A1 (en) | 2019-04-10 |
BR112018074352B1 (pt) | 2021-11-30 |
RU2753874C2 (ru) | 2021-08-24 |
IL262877A (en) | 2018-12-31 |
KR102472026B1 (ko) | 2022-11-30 |
BR132022001907E2 (pt) | 2022-11-16 |
RU2018137841A3 (ru) | 2020-07-24 |
US11173126B2 (en) | 2021-11-16 |
IL262877B1 (en) | 2023-01-01 |
JP2022130524A (ja) | 2022-09-06 |
US20200085757A1 (en) | 2020-03-19 |
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