JP2017516847A5 - - Google Patents
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- Publication number
- JP2017516847A5 JP2017516847A5 JP2017513323A JP2017513323A JP2017516847A5 JP 2017516847 A5 JP2017516847 A5 JP 2017516847A5 JP 2017513323 A JP2017513323 A JP 2017513323A JP 2017513323 A JP2017513323 A JP 2017513323A JP 2017516847 A5 JP2017516847 A5 JP 2017516847A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- aqueous pharmaceutical
- composition according
- histidine
- concentration
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
- 239000008194 pharmaceutical composition Substances 0.000 claims 17
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 13
- 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 5
- 150000001413 amino acids Chemical class 0.000 claims 5
- 239000008363 phosphate buffer Substances 0.000 claims 5
- 239000000600 sorbitol Substances 0.000 claims 5
- 229920001213 Polysorbate 20 Polymers 0.000 claims 4
- 229960002964 adalimumab Drugs 0.000 claims 4
- 239000000872 buffer Substances 0.000 claims 4
- 239000007853 buffer solution Substances 0.000 claims 4
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 4
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 4
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 4
- 229940068977 polysorbate 20 Drugs 0.000 claims 4
- 239000003381 stabilizer Substances 0.000 claims 4
- 239000004094 surface-active agent Substances 0.000 claims 3
- HEBKCHPVOIAQTA-QWWZWVQMSA-N D-arabinitol Chemical compound OC[C@@H](O)C(O)[C@H](O)CO HEBKCHPVOIAQTA-QWWZWVQMSA-N 0.000 claims 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 2
- 239000004386 Erythritol Substances 0.000 claims 2
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 claims 2
- SQUHHTBVTRBESD-UHFFFAOYSA-N Hexa-Ac-myo-Inositol Natural products CC(=O)OC1C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C1OC(C)=O SQUHHTBVTRBESD-UHFFFAOYSA-N 0.000 claims 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims 2
- 235000019414 erythritol Nutrition 0.000 claims 2
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 claims 2
- 229940009714 erythritol Drugs 0.000 claims 2
- CDAISMWEOUEBRE-GPIVLXJGSA-N inositol Chemical compound O[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@H](O)[C@@H]1O CDAISMWEOUEBRE-GPIVLXJGSA-N 0.000 claims 2
- 229960000367 inositol Drugs 0.000 claims 2
- 239000000832 lactitol Substances 0.000 claims 2
- 235000010448 lactitol Nutrition 0.000 claims 2
- VQHSOMBJVWLPSR-JVCRWLNRSA-N lactitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-JVCRWLNRSA-N 0.000 claims 2
- 229960003451 lactitol Drugs 0.000 claims 2
- 239000000845 maltitol Substances 0.000 claims 2
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims 2
- 235000010449 maltitol Nutrition 0.000 claims 2
- 229940035436 maltitol Drugs 0.000 claims 2
- CDAISMWEOUEBRE-UHFFFAOYSA-N scyllo-inosotol Natural products OC1C(O)C(O)C(O)C(O)C1O CDAISMWEOUEBRE-UHFFFAOYSA-N 0.000 claims 2
- 239000000811 xylitol Substances 0.000 claims 2
- 235000010447 xylitol Nutrition 0.000 claims 2
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 2
- 229960002675 xylitol Drugs 0.000 claims 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 1
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- 206010002556 Ankylosing Spondylitis Diseases 0.000 claims 1
- 206010009900 Colitis ulcerative Diseases 0.000 claims 1
- 208000011231 Crohn disease Diseases 0.000 claims 1
- 208000003456 Juvenile Arthritis Diseases 0.000 claims 1
- 206010059176 Juvenile idiopathic arthritis Diseases 0.000 claims 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims 1
- 201000004681 Psoriasis Diseases 0.000 claims 1
- 201000001263 Psoriatic Arthritis Diseases 0.000 claims 1
- 208000036824 Psoriatic arthropathy Diseases 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 1
- 201000006704 Ulcerative Colitis Diseases 0.000 claims 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims 1
- 230000001684 chronic effect Effects 0.000 claims 1
- 239000007979 citrate buffer Substances 0.000 claims 1
- 238000012377 drug delivery Methods 0.000 claims 1
- 239000007951 isotonicity adjuster Substances 0.000 claims 1
- 201000002215 juvenile rheumatoid arthritis Diseases 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
- 229920000053 polysorbate 80 Polymers 0.000 claims 1
- 229940068968 polysorbate 80 Drugs 0.000 claims 1
- 206010039073 rheumatoid arthritis Diseases 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- 150000005846 sugar alcohols Chemical group 0.000 claims 1
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2019187090A JP6962984B2 (ja) | 2014-05-23 | 2019-10-10 | 液体医薬組成物 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14169754.0 | 2014-05-23 | ||
| EP14169754.0A EP2946766B1 (en) | 2014-05-23 | 2014-05-23 | Liquid pharmaceutical composition |
| PCT/EP2015/060817 WO2015177058A1 (en) | 2014-05-23 | 2015-05-15 | Liquid pharmaceutical composition |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019187090A Division JP6962984B2 (ja) | 2014-05-23 | 2019-10-10 | 液体医薬組成物 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2017516847A JP2017516847A (ja) | 2017-06-22 |
| JP2017516847A5 true JP2017516847A5 (enExample) | 2018-06-28 |
Family
ID=50774705
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017513323A Withdrawn JP2017516847A (ja) | 2014-05-23 | 2015-05-15 | 液体医薬組成物 |
| JP2019187090A Active JP6962984B2 (ja) | 2014-05-23 | 2019-10-10 | 液体医薬組成物 |
| JP2021167297A Pending JP2022003091A (ja) | 2014-05-23 | 2021-10-12 | 液体医薬組成物 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019187090A Active JP6962984B2 (ja) | 2014-05-23 | 2019-10-10 | 液体医薬組成物 |
| JP2021167297A Pending JP2022003091A (ja) | 2014-05-23 | 2021-10-12 | 液体医薬組成物 |
Country Status (21)
| Country | Link |
|---|---|
| US (5) | US10493152B2 (enExample) |
| EP (6) | EP2946766B1 (enExample) |
| JP (3) | JP2017516847A (enExample) |
| CN (2) | CN106659781A (enExample) |
| AU (4) | AU2015263246B2 (enExample) |
| CA (2) | CA3050875A1 (enExample) |
| CY (1) | CY1120488T1 (enExample) |
| DE (2) | DE23189888T1 (enExample) |
| DK (3) | DK3148510T3 (enExample) |
| ES (5) | ES2572919T3 (enExample) |
| HK (1) | HK1257026A1 (enExample) |
| HR (1) | HRP20181226T1 (enExample) |
| HU (1) | HUE040097T2 (enExample) |
| IL (1) | IL249117B2 (enExample) |
| LT (1) | LT3148510T (enExample) |
| PL (1) | PL3148510T3 (enExample) |
| PT (1) | PT3148510T (enExample) |
| RS (1) | RS57772B1 (enExample) |
| SI (1) | SI3148510T1 (enExample) |
| SM (1) | SMT201800413T1 (enExample) |
| WO (1) | WO2015177058A1 (enExample) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HUE029849T2 (en) | 2014-05-23 | 2017-04-28 | Ares Trading Sa | Liquid pharmaceutical composition |
| EP2946766B1 (en) | 2014-05-23 | 2016-03-02 | Ares Trading S.A. | Liquid pharmaceutical composition |
| ES2607489T3 (es) | 2014-05-23 | 2017-03-31 | Ares Trading S.A. | Composición farmacéutica líquida |
| EP3824906A1 (en) | 2016-12-21 | 2021-05-26 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| EP3459527B1 (en) * | 2017-09-20 | 2022-11-23 | Tillotts Pharma Ag | Method for preparing a solid dosage form comprising antibodies by wet granulation, extrusion and spheronization |
| CA3094966A1 (en) | 2018-03-29 | 2019-10-03 | Airway Therapeutics, Inc. | Systems and methods for characterizing surfactant protein d (sp-d) oligomers |
| EP3774875B1 (en) * | 2018-03-29 | 2026-03-18 | Airway Therapeutics, Inc. | Methods and compositions comprising surfactant protein d (sp-d) |
| WO2020138517A1 (ko) * | 2018-12-24 | 2020-07-02 | 삼성바이오에피스 주식회사 | 항-TNFα 항체를 포함하는 약제학적 조성물 |
| CA3125927A1 (en) * | 2019-01-11 | 2020-07-16 | Samsung Bioepis Co., Ltd. | Pharmaceutical composition comprising antibody, device comprising same, and use thereof |
| JP2022525556A (ja) * | 2019-03-18 | 2022-05-17 | アルヴォテック エイチエフ | Ｔｎｆ－アルファ抗体の高濃度水性製剤 |
| CN115429751B (zh) * | 2022-09-21 | 2023-11-17 | 景泽生物医药(合肥)股份有限公司 | 一种人重组卵泡刺激素注射剂及其制备方法 |
| AU2024325145A1 (en) * | 2023-08-15 | 2026-02-05 | Amgen Inc. | Acidic buffered intravenous solution stabilizers for use in methods of treatment |
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| JPS6388197A (ja) * | 1986-09-30 | 1988-04-19 | Tosoh Corp | モノクロナル抗体の安定化方法 |
| US6090382A (en) | 1996-02-09 | 2000-07-18 | Basf Aktiengesellschaft | Human antibodies that bind human TNFα |
| DE122004000004I1 (de) | 1996-02-09 | 2004-08-12 | Abott Biotechnology Ltd | Humane Antikörper welche an Humanen TNFalpha binden. |
| US6171586B1 (en) | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| US5900404A (en) | 1997-08-15 | 1999-05-04 | Amgen Inc. | Chemical modification of proteins to improve biocompatibility and bioactivity |
| US20040033228A1 (en) | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
| HRP20050934B1 (hr) | 2003-04-04 | 2014-09-26 | Genentech, Inc. | Formulacije s visokom koncentracijom antitijela i proteina |
| WO2005072772A1 (en) | 2004-01-30 | 2005-08-11 | Suomen Punainen Risti Veripalvelu | Pharmaceutical compositions |
| CN101048427B (zh) | 2004-07-23 | 2015-01-14 | 健泰科生物技术公司 | 抗体或其片段的结晶 |
| JO3000B1 (ar) | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| WO2006096461A2 (en) | 2005-03-08 | 2006-09-14 | Pharmacia & Upjohn Company Llc | Composition comprising an antibody against macrophage colony-stimulating factor (m-csf) and a chelating agent |
| JP5089582B2 (ja) | 2005-06-07 | 2012-12-05 | エスバテック、アン アルコン バイオメディカル リサーチ ユニット、エルエルシー | ＴＮＦαを阻害する安定な可溶性抗体 |
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| EP2362767B1 (en) | 2008-10-29 | 2017-12-06 | Ablynx N.V. | Formulations of single domain antigen binding molecules |
| KR20110097772A (ko) | 2008-11-17 | 2011-08-31 | 제넨테크, 인크. | 생리적 조건하에 거대분자의 응집을 감소시키는 방법 및 제제 |
| RU2560701C2 (ru) | 2009-05-04 | 2015-08-20 | Эббви Байотекнолоджи Лтд. | Стабильные композиции с высокими концентрациями белков антител человека против tnf-альфа |
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| US20110223208A1 (en) | 2010-03-09 | 2011-09-15 | Beth Hill | Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations |
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| CA2944330A1 (en) | 2014-04-02 | 2015-10-08 | Intas Pharmaceuticals Limited | Liquid pharmaceutical composition of adalimumab |
| HUE029849T2 (en) | 2014-05-23 | 2017-04-28 | Ares Trading Sa | Liquid pharmaceutical composition |
| EP2946766B1 (en) | 2014-05-23 | 2016-03-02 | Ares Trading S.A. | Liquid pharmaceutical composition |
| ES2607489T3 (es) | 2014-05-23 | 2017-03-31 | Ares Trading S.A. | Composición farmacéutica líquida |
| EP3411401A1 (en) * | 2016-02-03 | 2018-12-12 | Oncobiologics, Inc. | Buffer formulations for enhanced antibody stability |
| CN120392659A (zh) | 2017-01-11 | 2025-08-01 | 赛特瑞恩股份有限公司 | 稳定的液体调配物 |
| WO2021182874A1 (ko) | 2020-03-13 | 2021-09-16 | 삼성바이오에피스 주식회사 | 안정성이 증진된 액상 약제학적 조성물 |
-
2014
- 2014-05-23 EP EP14169754.0A patent/EP2946766B1/en not_active Not-in-force
- 2014-05-23 ES ES14169754.0T patent/ES2572919T3/es active Active
-
2015
- 2015-05-15 DE DE23189888.3T patent/DE23189888T1/de active Pending
- 2015-05-15 SM SM20180413T patent/SMT201800413T1/it unknown
- 2015-05-15 CA CA3050875A patent/CA3050875A1/en not_active Abandoned
- 2015-05-15 HR HRP20181226TT patent/HRP20181226T1/hr unknown
- 2015-05-15 ES ES15724974.9T patent/ES2683194T3/es active Active
- 2015-05-15 EP EP15724974.9A patent/EP3148510B1/en not_active Revoked
- 2015-05-15 AU AU2015263246A patent/AU2015263246B2/en not_active Revoked
- 2015-05-15 EP EP25179059.8A patent/EP4585614A3/en active Pending
- 2015-05-15 LT LTEP15724974.9T patent/LT3148510T/lt unknown
- 2015-05-15 ES ES25179059T patent/ES3053508T2/es active Pending
- 2015-05-15 EP EP19215036.5A patent/EP3659582B1/en active Active
- 2015-05-15 PT PT157249749T patent/PT3148510T/pt unknown
- 2015-05-15 ES ES19215036T patent/ES2955316T3/es active Active
- 2015-05-15 WO PCT/EP2015/060817 patent/WO2015177058A1/en not_active Ceased
- 2015-05-15 CN CN201580039868.5A patent/CN106659781A/zh active Pending
- 2015-05-15 IL IL249117A patent/IL249117B2/en unknown
- 2015-05-15 HU HUE15724974A patent/HUE040097T2/hu unknown
- 2015-05-15 US US15/313,480 patent/US10493152B2/en active Active
- 2015-05-15 EP EP18169979.4A patent/EP3403646B1/en active Active
- 2015-05-15 SI SI201530341T patent/SI3148510T1/sl unknown
- 2015-05-15 DK DK15724974.9T patent/DK3148510T3/en active
- 2015-05-15 ES ES18169979T patent/ES2928738T3/es active Active
- 2015-05-15 JP JP2017513323A patent/JP2017516847A/ja not_active Withdrawn
- 2015-05-15 RS RS20180919A patent/RS57772B1/sr unknown
- 2015-05-15 CN CN201810768437.8A patent/CN108785670A/zh active Pending
- 2015-05-15 CA CA2947487A patent/CA2947487C/en active Active
- 2015-05-15 PL PL15724974T patent/PL3148510T3/pl unknown
- 2015-05-15 EP EP23189888.3A patent/EP4249060A3/en active Pending
- 2015-05-15 DE DE25179059.8T patent/DE25179059T1/de active Pending
-
2018
- 2018-08-06 CY CY20181100812T patent/CY1120488T1/el unknown
- 2018-08-27 AU AU2018222887A patent/AU2018222887B2/en active Active
- 2018-09-07 DK DKBA201800071U patent/DK201800071Y4/da not_active IP Right Cessation
- 2018-09-07 DK DKBA201800070U patent/DK201800070Y8/da not_active IP Right Cessation
- 2018-12-17 HK HK18116149.6A patent/HK1257026A1/zh unknown
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2019
- 2019-10-10 JP JP2019187090A patent/JP6962984B2/ja active Active
- 2019-11-25 US US16/694,627 patent/US10772961B2/en active Active
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2020
- 2020-02-14 AU AU2020201090A patent/AU2020201090B2/en active Active
- 2020-08-11 US US16/990,954 patent/US11752208B2/en active Active
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2021
- 2021-10-12 JP JP2021167297A patent/JP2022003091A/ja active Pending
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2022
- 2022-06-03 AU AU2022203863A patent/AU2022203863A1/en not_active Abandoned
- 2022-11-02 US US17/979,272 patent/US11752209B2/en active Active
- 2022-11-02 US US17/979,309 patent/US12109267B2/en active Active
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