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 (enExample) | 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 (enExample) |
| EP (1) | EP3518891A1 (enExample) |
| JP (3) | JP2019534863A (enExample) |
| KR (1) | KR102546471B1 (enExample) |
| CN (1) | CN109862880A (enExample) |
| AU (1) | AU2017333367A1 (enExample) |
| BR (1) | BR112019005328A2 (enExample) |
| CA (1) | CA3037440A1 (enExample) |
| MA (1) | MA46334A (enExample) |
| RU (1) | RU2019112680A (enExample) |
| WO (1) | WO2018060210A1 (enExample) |
| ZA (1) | ZA201901590B (enExample) |
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 |
| EP2787007A3 (en) | 2010-11-08 | 2015-03-11 | F. Hoffmann-La Roche AG | Subcutaneously administered ANTI-IL-6 receptor antibody |
| AU2017333367A1 (en) * | 2016-09-27 | 2019-04-04 | Fresenius Kabi Deutschland Gmbh | Liquid pharmaceutical composition |
| US20200087390A1 (en) | 2016-12-21 | 2020-03-19 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| MX2020005630A (es) * | 2017-11-30 | 2020-08-20 | Bio Thera Solutions Ltd | Formulacion liquida de anticuerpos humanizados para el tratamiento de enfermedades relacionadas con il-6. |
| US11427639B2 (en) * | 2018-04-02 | 2022-08-30 | Richter Gedeon Nyrt. | Antibody-containing aqueous formulation and use thereof |
| CA3117245A1 (en) * | 2018-10-31 | 2020-05-07 | Richter Gedeon Nyrt. | Aqueous pharmaceutical formulations |
| CN113711036B (zh) | 2019-01-30 | 2025-03-18 | 真和制药有限公司 | 抗gal3抗体及其用途 |
| 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 |
| ES2987347T3 (es) * | 2020-03-13 | 2024-11-14 | Lek Pharmaceuticals | Estabilización de composiciones farmacéuticas que comprenden polisorbato |
| 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 |
| CN116157151A (zh) * | 2020-05-26 | 2023-05-23 | 真和制药有限公司 | 通过阻断半乳凝素-3治疗炎性疾病的方法 |
| 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 |
| EP4199965A4 (en) * | 2020-08-19 | 2025-03-26 | Bio-Thera Solutions, Ltd. | LIQUID FORMULATIONS CONTAINING HIGHLY CONCENTRATED HUMANIZED ANTIBODIES FOR THE TREATMENT OF IL-6-ASSOCIATED DISEASES |
| 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 |
|---|---|---|---|---|
| ES2134212T3 (es) | 1991-04-25 | 1999-10-01 | Chugai Pharmaceutical Co Ltd | Anticuerpo humano reconstituido contra el receptor de la interleuquina 6 humano. |
| JP5485489B2 (ja) | 2000-08-11 | 2014-05-07 | 中外製薬株式会社 | 抗体含有安定化製剤 |
| EP3192528A1 (en) | 2002-02-14 | 2017-07-19 | Chugai Seiyaku Kabushiki Kaisha | Formulation of anti-il6r antibody-containing solutions comprising a sugar as a stabilizer |
| PE20091174A1 (es) * | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| MX2011005672A (es) * | 2008-11-28 | 2011-06-20 | Abbott Lab | Composiciones de anticuerpo estables y metodos para estabilizar a las mismas. |
| EP2196476A1 (en) * | 2008-12-10 | 2010-06-16 | Novartis Ag | Antibody formulation |
| CA2749200A1 (en) * | 2009-01-29 | 2010-08-05 | Michael Bowen | Human anti-il-6 antibodies with extended in vivo half-life and their use in treatment of oncology, autoimmune diseases and inflammatory diseases |
| WO2010106812A1 (en) * | 2009-03-19 | 2010-09-23 | Chugai Seiyaku Kabushiki Kaisha | Pharmaceutical formulation containing improved antibody molecules |
| BR112012012080B1 (pt) * | 2009-11-20 | 2022-11-29 | Biocon Limited | Formulações de histidina-trealose do anticorpo t1h |
| CN102686241A (zh) * | 2009-12-29 | 2012-09-19 | 霍夫曼-拉罗奇有限公司 | 抗体配制剂 |
| JO3417B1 (ar) * | 2010-01-08 | 2019-10-20 | Regeneron Pharma | الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r |
| EP2787007A3 (en) * | 2010-11-08 | 2015-03-11 | F. Hoffmann-La Roche AG | Subcutaneously administered ANTI-IL-6 receptor antibody |
| UY34105A (es) * | 2011-06-03 | 2012-07-31 | Lg Life Sciences Ltd | Formulación líquida estable de etanercept |
| WO2013063510A1 (en) | 2011-10-28 | 2013-05-02 | Integritybio Inc. | Protein formulations containing amino acids |
| CN104768578A (zh) * | 2012-10-25 | 2015-07-08 | 米迪缪尼有限公司 | 稳定的低粘度抗体配制品 |
| AU2017333367A1 (en) * | 2016-09-27 | 2019-04-04 | Fresenius Kabi Deutschland Gmbh | Liquid pharmaceutical composition |
| MX2020005630A (es) * | 2017-11-30 | 2020-08-20 | Bio Thera Solutions Ltd | Formulacion liquida de anticuerpos humanizados para el tratamiento de enfermedades relacionadas con il-6. |
| EP4199965A4 (en) * | 2020-08-19 | 2025-03-26 | Bio-Thera Solutions, Ltd. | LIQUID FORMULATIONS CONTAINING HIGHLY CONCENTRATED HUMANIZED ANTIBODIES FOR THE TREATMENT OF IL-6-ASSOCIATED DISEASES |
| WO2023020563A1 (en) * | 2021-08-18 | 2023-02-23 | Bio-Thera Solutions, Ltd. | Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases |
-
2017
- 2017-09-26 AU AU2017333367A patent/AU2017333367A1/en not_active Abandoned
- 2017-09-26 MA MA046334A patent/MA46334A/fr unknown
- 2017-09-26 RU RU2019112680A patent/RU2019112680A/ru unknown
- 2017-09-26 CA CA3037440A patent/CA3037440A1/en active Pending
- 2017-09-26 EP EP17780054.7A patent/EP3518891A1/en active Pending
- 2017-09-26 WO PCT/EP2017/074413 patent/WO2018060210A1/en not_active Ceased
- 2017-09-26 JP JP2019515630A patent/JP2019534863A/ja active Pending
- 2017-09-26 BR BR112019005328A patent/BR112019005328A2/pt not_active Application Discontinuation
- 2017-09-26 KR KR1020197010731A patent/KR102546471B1/ko active Active
- 2017-09-26 US US16/334,310 patent/US10961314B2/en active Active
- 2017-09-26 CN CN201780059493.8A patent/CN109862880A/zh 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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