JP2019534863A5 - - Google Patents
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- Publication number
- JP2019534863A5 JP2019534863A5 JP2019515630A JP2019515630A JP2019534863A5 JP 2019534863 A5 JP2019534863 A5 JP 2019534863A5 JP 2019515630 A JP2019515630 A JP 2019515630A JP 2019515630 A JP2019515630 A JP 2019515630A JP 2019534863 A5 JP2019534863 A5 JP 2019534863A5
- Authority
- JP
- Japan
- Prior art keywords
- liquid pharmaceutical
- pharmaceutical composition
- composition according
- delivery device
- drug delivery
- 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.)
- Pending
Links
- 239000007788 liquid Substances 0.000 claims 17
- 239000008194 pharmaceutical composition Substances 0.000 claims 16
- 238000012377 drug delivery Methods 0.000 claims 5
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 4
- 150000001413 amino acids Chemical class 0.000 claims 3
- 238000004519 manufacturing process Methods 0.000 claims 3
- 229920005862 polyol Polymers 0.000 claims 3
- 150000003077 polyols Chemical class 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- 239000004094 surface-active agent Substances 0.000 claims 3
- 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 2
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 2
- 229930195725 Mannitol Natural products 0.000 claims 2
- 239000000872 buffer Substances 0.000 claims 2
- 201000010099 disease Diseases 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 239000000594 mannitol Substances 0.000 claims 2
- 235000010355 mannitol Nutrition 0.000 claims 2
- 229930182817 methionine Natural products 0.000 claims 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
- 229920000136 polysorbate Polymers 0.000 claims 2
- 229950008882 polysorbate Drugs 0.000 claims 2
- 229920000053 polysorbate 80 Polymers 0.000 claims 2
- 229940068968 polysorbate 80 Drugs 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- 208000007465 Giant cell arteritis Diseases 0.000 claims 1
- 208000003456 Juvenile Arthritis Diseases 0.000 claims 1
- 206010059176 Juvenile idiopathic arthritis Diseases 0.000 claims 1
- 201000009594 Systemic Scleroderma Diseases 0.000 claims 1
- 206010042953 Systemic sclerosis Diseases 0.000 claims 1
- 239000007853 buffer solution Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 201000002215 juvenile rheumatoid arthritis Diseases 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 229940127557 pharmaceutical product Drugs 0.000 claims 1
- 206010039073 rheumatoid arthritis Diseases 0.000 claims 1
- 206010043207 temporal arteritis Diseases 0.000 claims 1
- 229960003989 tocilizumab Drugs 0.000 claims 1
- 239000008215 water for injection Substances 0.000 claims 1
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2022146770A JP2022188075A (ja) | 2016-09-27 | 2022-09-15 | 液体医薬組成物 |
| JP2024148123A JP2024178197A (ja) | 2016-09-27 | 2024-08-30 | 液体医薬組成物 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP16190957 | 2016-09-27 | ||
| EP16190957.7 | 2016-09-27 | ||
| PCT/EP2017/074413 WO2018060210A1 (en) | 2016-09-27 | 2017-09-26 | Liquid pharmaceutical composition |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022146770A Division JP2022188075A (ja) | 2016-09-27 | 2022-09-15 | 液体医薬組成物 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2019534863A JP2019534863A (ja) | 2019-12-05 |
| JP2019534863A5 true JP2019534863A5 (https=) | 2020-08-20 |
Family
ID=57047015
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019515630A Pending JP2019534863A (ja) | 2016-09-27 | 2017-09-26 | 液体医薬組成物 |
| JP2022146770A Pending JP2022188075A (ja) | 2016-09-27 | 2022-09-15 | 液体医薬組成物 |
| JP2024148123A Pending JP2024178197A (ja) | 2016-09-27 | 2024-08-30 | 液体医薬組成物 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022146770A Pending JP2022188075A (ja) | 2016-09-27 | 2022-09-15 | 液体医薬組成物 |
| JP2024148123A Pending JP2024178197A (ja) | 2016-09-27 | 2024-08-30 | 液体医薬組成物 |
Country Status (12)
| Country | Link |
|---|---|
| US (3) | US10961314B2 (https=) |
| EP (1) | EP3518891A1 (https=) |
| JP (3) | JP2019534863A (https=) |
| KR (1) | KR102546471B1 (https=) |
| CN (1) | CN109862880A (https=) |
| AU (1) | AU2017333367A1 (https=) |
| BR (1) | BR112019005328A2 (https=) |
| CA (1) | CA3037440A1 (https=) |
| MA (1) | MA46334A (https=) |
| RU (1) | RU2019112680A (https=) |
| WO (1) | WO2018060210A1 (https=) |
| ZA (1) | ZA201901590B (https=) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| TWI603738B (zh) | 2010-11-08 | 2017-11-01 | 建南德克公司 | 皮下投予抗－ｉｌ－６受體抗體 |
| US10961314B2 (en) * | 2016-09-27 | 2021-03-30 | Fresenius Kabi Deutschland Gmbh | Liquid pharmaceutical composition comprising an anti-IL-6 receptor antibody |
| WO2018119142A1 (en) | 2016-12-21 | 2018-06-28 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| BR112020010761A2 (pt) * | 2017-11-30 | 2020-11-24 | Bio-Thera Solutions, Ltd. | formulação líquida de anticorpo humanizado para o tratamento de doenças relacionadas à il-6 |
| US11427639B2 (en) * | 2018-04-02 | 2022-08-30 | Richter Gedeon Nyrt. | Antibody-containing aqueous formulation and use thereof |
| KR102917813B1 (ko) * | 2018-10-31 | 2026-01-26 | 리히터 게데온 닐트. | 수성 약학 제제 |
| AU2020214796A1 (en) | 2019-01-30 | 2021-07-29 | Truebinding, Inc. | Anti-Gal3 antibodies and uses thereof |
| CN110179746A (zh) * | 2019-05-17 | 2019-08-30 | 通化东宝生物科技有限公司 | 一种稳定的苏金单抗注射剂及其制备方法 |
| EP3714902B1 (en) * | 2020-03-13 | 2024-08-28 | LEK Pharmaceuticals d.d. | Stabilization of pharmaceutical compositions comprising polysorbate |
| CN113456582B (zh) * | 2020-03-30 | 2024-06-14 | 鲁南制药集团股份有限公司 | 重组人源化抗pd-1单克隆抗体的液体制剂 |
| JP2023520249A (ja) * | 2020-05-15 | 2023-05-16 | エフ． ホフマン－ラ ロシュ アーゲー | 非経口タンパク質溶液中の可視粒子形成の防止方法 |
| WO2021242776A2 (en) * | 2020-05-26 | 2021-12-02 | Truebinding, Inc. | Methods of treating inflammatory diseases by blocking galectin-3 |
| RU2745814C1 (ru) * | 2020-06-05 | 2021-04-01 | Закрытое Акционерное Общество "Биокад" | Водная фармацевтическая композиция левилимаба и ее применение |
| US11365248B2 (en) * | 2020-06-29 | 2022-06-21 | Anovent Pharmaceutical (U.S.), Llc | Formulation of tocilizumab and method for treating COVID-19 by inhalation |
| CN116261448A (zh) * | 2020-08-19 | 2023-06-13 | 百奥泰生物制药股份有限公司 | 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂 |
| KR20220028972A (ko) * | 2020-08-31 | 2022-03-08 | (주)셀트리온 | 안정한 약제학적 제제 |
| WO2022139457A1 (ko) * | 2020-12-24 | 2022-06-30 | 이니스트에스티 주식회사 | 봉독 추출물로부터 bvPLA2를 50~99% 함량으로 포함하는 봉독 주사제 조성물 및 이의 제조방법 |
| CN121240883A (zh) * | 2023-05-26 | 2025-12-30 | 百奥泰生物制药股份有限公司 | 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂 |
Family Cites Families (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0628639B1 (en) | 1991-04-25 | 1999-06-23 | Chugai Seiyaku Kabushiki Kaisha | Reconstituted human antibody against human interleukin 6 receptor |
| US8632778B2 (en) | 2000-08-11 | 2014-01-21 | Chugai Seiyaku Kabushiki Kaisha | Stabilized anti-interleukin-6 antibody-containing preparations |
| AU2003211990A1 (en) | 2002-02-14 | 2003-09-04 | Chugai Seiyaku Kabushiki Kaisha | Antibody-containing solution pharmaceuticals |
| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| WO2010062896A1 (en) | 2008-11-28 | 2010-06-03 | Abbott Laboratories | Stable antibody compositions and methods for stabilizing same |
| EP2196476A1 (en) * | 2008-12-10 | 2010-06-16 | Novartis Ag | Antibody formulation |
| CN104119438A (zh) * | 2009-01-29 | 2014-10-29 | 米迪缪尼有限公司 | 延长体内半衰期的人抗il-6抗体及其在治疗肿瘤、自身免疫性疾病和炎症性疾病中的应用 |
| JP4885308B2 (ja) * | 2009-03-19 | 2012-02-29 | 中外製薬株式会社 | 改良された抗体分子を含有する製剤 |
| AU2010320515B2 (en) * | 2009-11-20 | 2013-05-02 | Biocon Limited | Formulations of antibody |
| MX2012007676A (es) * | 2009-12-29 | 2012-08-03 | Hoffmann La Roche | Nueva formulacion de anticuerpo. |
| JO3417B1 (ar) * | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
| TWI603738B (zh) * | 2010-11-08 | 2017-11-01 | 建南德克公司 | 皮下投予抗－ｉｌ－６受體抗體 |
| UY34105A (es) * | 2011-06-03 | 2012-07-31 | Lg Life Sciences Ltd | Formulación líquida estable de etanercept |
| AU2012328524B2 (en) | 2011-10-28 | 2017-05-18 | Excelse Bio, Inc. | Protein formulations containing amino acids |
| US20150239970A1 (en) | 2012-10-25 | 2015-08-27 | Medimmune, Llc | Stable, Low Viscosity Antibody Formulation |
| US10961314B2 (en) * | 2016-09-27 | 2021-03-30 | Fresenius Kabi Deutschland Gmbh | Liquid pharmaceutical composition comprising an anti-IL-6 receptor antibody |
| BR112020010761A2 (pt) * | 2017-11-30 | 2020-11-24 | Bio-Thera Solutions, Ltd. | formulação líquida de anticorpo humanizado para o tratamento de doenças relacionadas à il-6 |
| CN116261448A (zh) * | 2020-08-19 | 2023-06-13 | 百奥泰生物制药股份有限公司 | 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂 |
| CN117858722A (zh) * | 2021-08-18 | 2024-04-09 | 百奥泰生物制药股份有限公司 | 用于治疗il-6相关疾病的包含高浓度人源化抗体的液体制剂 |
-
2017
- 2017-09-26 US US16/334,310 patent/US10961314B2/en active Active
- 2017-09-26 JP JP2019515630A patent/JP2019534863A/ja active Pending
- 2017-09-26 KR KR1020197010731A patent/KR102546471B1/ko active Active
- 2017-09-26 BR BR112019005328A patent/BR112019005328A2/pt not_active Application Discontinuation
- 2017-09-26 CN CN201780059493.8A patent/CN109862880A/zh active Pending
- 2017-09-26 WO PCT/EP2017/074413 patent/WO2018060210A1/en not_active Ceased
- 2017-09-26 RU RU2019112680A patent/RU2019112680A/ru unknown
- 2017-09-26 AU AU2017333367A patent/AU2017333367A1/en not_active Abandoned
- 2017-09-26 MA MA046334A patent/MA46334A/fr unknown
- 2017-09-26 EP EP17780054.7A patent/EP3518891A1/en active Pending
- 2017-09-26 CA CA3037440A patent/CA3037440A1/en active Pending
-
2019
- 2019-03-14 ZA ZA2019/01590A patent/ZA201901590B/en unknown
-
2021
- 2021-02-22 US US17/181,829 patent/US20210261673A1/en not_active Abandoned
-
2022
- 2022-09-15 JP JP2022146770A patent/JP2022188075A/ja active Pending
-
2023
- 2023-10-25 US US18/494,630 patent/US20240150479A1/en active Pending
-
2024
- 2024-08-30 JP JP2024148123A patent/JP2024178197A/ja active Pending
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