JP2022174082A5 - - Google Patents
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- Publication number
- JP2022174082A5 JP2022174082A5 JP2022130994A JP2022130994A JP2022174082A5 JP 2022174082 A5 JP2022174082 A5 JP 2022174082A5 JP 2022130994 A JP2022130994 A JP 2022130994A JP 2022130994 A JP2022130994 A JP 2022130994A JP 2022174082 A5 JP2022174082 A5 JP 2022174082A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- liquid pharmaceutical
- composition according
- adalimumab
- present
- 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 44
- 239000008194 pharmaceutical composition Substances 0.000 claims 44
- 229960002964 adalimumab Drugs 0.000 claims 13
- 239000000203 mixture Substances 0.000 claims 7
- 239000004094 surface-active agent Substances 0.000 claims 7
- 239000003381 stabilizer Substances 0.000 claims 6
- 239000007979 citrate buffer Substances 0.000 claims 5
- 239000012929 tonicity agent Substances 0.000 claims 5
- 239000004475 Arginine Substances 0.000 claims 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 3
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 3
- 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 2
- 206010002556 Ankylosing Spondylitis Diseases 0.000 claims 2
- 206010009900 Colitis ulcerative Diseases 0.000 claims 2
- 208000011231 Crohn disease Diseases 0.000 claims 2
- 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 2
- 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
- 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
- 208000003456 Juvenile Arthritis Diseases 0.000 claims 2
- 206010059176 Juvenile idiopathic arthritis Diseases 0.000 claims 2
- 229930195725 Mannitol Natural products 0.000 claims 2
- 201000004681 Psoriasis Diseases 0.000 claims 2
- 201000001263 Psoriatic Arthritis Diseases 0.000 claims 2
- 208000036824 Psoriatic arthropathy Diseases 0.000 claims 2
- 229930006000 Sucrose Natural products 0.000 claims 2
- 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 2
- 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 2
- 201000006704 Ulcerative Colitis Diseases 0.000 claims 2
- 239000002253 acid Substances 0.000 claims 2
- 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 2
- 230000001684 chronic effect Effects 0.000 claims 2
- 239000012634 fragment Substances 0.000 claims 2
- 201000002215 juvenile rheumatoid arthritis Diseases 0.000 claims 2
- KDXKERNSBIXSRK-UHFFFAOYSA-N lysine Chemical compound NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 claims 2
- 239000000594 mannitol Substances 0.000 claims 2
- 235000010355 mannitol Nutrition 0.000 claims 2
- 230000003204 osmotic effect Effects 0.000 claims 2
- 239000008363 phosphate buffer Substances 0.000 claims 2
- 238000003998 size exclusion chromatography high performance liquid chromatography Methods 0.000 claims 2
- 239000000600 sorbitol Substances 0.000 claims 2
- 239000005720 sucrose Substances 0.000 claims 2
- 239000008215 water for injection Substances 0.000 claims 2
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims 1
- CKLJMWTZIZZHCS-REOHCLBHSA-N L-aspartic acid Chemical compound OC(=O)[C@@H](N)CC(O)=O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 claims 1
- 239000004472 Lysine Substances 0.000 claims 1
- 235000001014 amino acid Nutrition 0.000 claims 1
- 150000001413 amino acids Chemical class 0.000 claims 1
- 235000003704 aspartic acid Nutrition 0.000 claims 1
- OQFSQFPPLPISGP-UHFFFAOYSA-N beta-carboxyaspartic acid Natural products OC(=O)C(N)C(C(O)=O)C(O)=O OQFSQFPPLPISGP-UHFFFAOYSA-N 0.000 claims 1
- 210000001124 body fluid Anatomy 0.000 claims 1
- 239000010839 body fluid Substances 0.000 claims 1
- 238000012377 drug delivery Methods 0.000 claims 1
- 238000004848 nephelometry Methods 0.000 claims 1
- 238000010979 pH adjustment Methods 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 230000006432 protein unfolding Effects 0.000 claims 1
- 206010039073 rheumatoid arthritis Diseases 0.000 claims 1
- 238000004879 turbidimetry Methods 0.000 claims 1
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14169755.7 | 2014-05-23 | ||
| EP14169755.7A EP2946767B1 (en) | 2014-05-23 | 2014-05-23 | Liquid pharmaceutical composition |
| JP2017513324A JP2017516848A (ja) | 2014-05-23 | 2015-05-15 | 液体医薬組成物 |
| JP2021055560A JP2021107399A (ja) | 2014-05-23 | 2021-03-29 | 液体医薬組成物 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2021055560A Division JP2021107399A (ja) | 2014-05-23 | 2021-03-29 | 液体医薬組成物 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2022174082A JP2022174082A (ja) | 2022-11-22 |
| JP2022174082A5 true JP2022174082A5 (enExample) | 2023-01-27 |
Family
ID=50774706
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017513324A Withdrawn JP2017516848A (ja) | 2014-05-23 | 2015-05-15 | 液体医薬組成物 |
| JP2021055560A Withdrawn JP2021107399A (ja) | 2014-05-23 | 2021-03-29 | 液体医薬組成物 |
| JP2022130994A Pending JP2022174082A (ja) | 2014-05-23 | 2022-08-19 | 液体医薬組成物 |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017513324A Withdrawn JP2017516848A (ja) | 2014-05-23 | 2015-05-15 | 液体医薬組成物 |
| JP2021055560A Withdrawn JP2021107399A (ja) | 2014-05-23 | 2021-03-29 | 液体医薬組成物 |
Country Status (19)
| Country | Link |
|---|---|
| US (2) | US10426833B2 (enExample) |
| EP (4) | EP2946767B1 (enExample) |
| JP (3) | JP2017516848A (enExample) |
| CN (2) | CN106535935A (enExample) |
| AU (3) | AU2015263247A1 (enExample) |
| CA (2) | CA2948746C (enExample) |
| CY (1) | CY1124493T1 (enExample) |
| DK (3) | DK3145488T3 (enExample) |
| ES (2) | ES2607489T3 (enExample) |
| HK (1) | HK1231391A1 (enExample) |
| HR (1) | HRP20201242T1 (enExample) |
| HU (1) | HUE050779T2 (enExample) |
| IL (2) | IL277241B (enExample) |
| LT (1) | LT3145488T (enExample) |
| PT (1) | PT3145488T (enExample) |
| RS (1) | RS60801B1 (enExample) |
| SI (1) | SI3145488T1 (enExample) |
| SM (1) | SMT202000479T1 (enExample) |
| WO (1) | WO2015177059A1 (enExample) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2600488T3 (es) * | 2014-05-23 | 2017-02-09 | Ares Trading S.A. | Composición farmacéutica líquida |
| EP2946766B1 (en) | 2014-05-23 | 2016-03-02 | Ares Trading S.A. | Liquid pharmaceutical composition |
| CN105543204A (zh) * | 2015-12-30 | 2016-05-04 | 海口奇力制药股份有限公司 | 一种组合物及其应用、含有该组合物的稳定剂 |
| WO2017177160A1 (en) | 2016-04-07 | 2017-10-12 | Nevakar Llc | Formulation for use in a method of treatment of pain |
| EP3824906A1 (en) | 2016-12-21 | 2021-05-26 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| EP3612217A4 (en) * | 2017-04-18 | 2020-12-30 | Dr. Reddy's Laboratories Limited | STABLE LIQUID PHARMACEUTICAL COMPOSITION |
| CA3075414A1 (en) | 2017-10-03 | 2019-04-11 | Nevakar Inc. | Acetaminophen-pregabalin combinations and methods of treating pain |
| MX2017016884A (es) * | 2017-12-19 | 2019-06-20 | Probiomed S A De C V | Formulacion farmaceutica estable de una proteina anti-tnfa. |
| CA3106669A1 (en) * | 2018-07-20 | 2020-01-30 | Momenta Pharmaceuticals, Inc. | Compositions of fcrn antibodies and methods of use thereof |
| EP4598575A1 (en) * | 2022-10-07 | 2025-08-13 | Annexon, Inc. | Formulations for anti-c1q antibodies |
Family Cites Families (33)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6388197A (ja) | 1986-09-30 | 1988-04-19 | Tosoh Corp | モノクロナル抗体の安定化方法 |
| DE69721548T2 (de) | 1996-02-09 | 2004-04-01 | Abbott Laboratories(Bermuda)Ltd. | HUMANE ANTIKÖRPER WELCHE AN HUMANEN TNFalpha BINDEN |
| 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 |
| DK1610820T4 (da) | 2003-04-04 | 2013-11-04 | Genentech Inc | Høj-koncentration antistof- og proteinformuleringer |
| 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 . |
| ES2424042T3 (es) | 2005-06-07 | 2013-09-26 | Esbatech - A Novartis Company Llc | Anticuerpos estables y solubles que inhiben TNF± |
| TWI661833B (zh) | 2007-11-30 | 2019-06-11 | 百慕達商艾伯維生物技術有限責任公司 | 蛋白質調配物及製造其之方法 |
| US8080518B2 (en) | 2007-12-05 | 2011-12-20 | Arbor Vita Corporation | Co-administration of an agent linked to an internalization peptide with an anti-inflammatory |
| EP3011953A1 (en) * | 2008-10-29 | 2016-04-27 | Ablynx N.V. | Stabilised formulations of single domain antigen binding molecules |
| NZ613809A (en) * | 2009-05-04 | 2015-02-27 | Abbvie Biotechnology Ltd | Stable high protein concentration formulations of human anti-tnf-alpha-antibodies |
| WO2011104381A2 (en) * | 2010-02-26 | 2011-09-01 | Novo Nordisk A/S | Stable antibody containing compositions |
| RU2626512C2 (ru) | 2010-03-01 | 2017-07-28 | Цитодин, Инк. | Концентрированные белковые фармацевтические составы и их применение |
| US20110223208A1 (en) | 2010-03-09 | 2011-09-15 | Beth Hill | Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations |
| EP2399604A1 (en) | 2010-06-25 | 2011-12-28 | F. Hoffmann-La Roche AG | Novel antibody formulation |
| MX344727B (es) | 2010-11-11 | 2017-01-05 | Abbvie Biotechnology Ltd | Formulaciones liquidas de anticuerpos anti-tnf-alfa de alta concentracion mejoradas. |
| EP2471554A1 (en) | 2010-12-28 | 2012-07-04 | Hexal AG | Pharmaceutical formulation comprising a biopharmaceutical drug |
| WO2013006454A1 (en) | 2011-07-01 | 2013-01-10 | Biogen Idec Ma Inc. | Arginine - free tnfr : fc- fusion polypeptide compositions and methods of use |
| GB201112429D0 (en) | 2011-07-19 | 2011-08-31 | Glaxo Group Ltd | Antigen-binding proteins with increased FcRn binding |
| SG11201405475UA (en) * | 2012-03-07 | 2014-10-30 | Cadila Healthcare Ltd | Pharmaceutical formulations of tnf-alpha antibodies |
| EP2863951A1 (en) | 2012-06-12 | 2015-04-29 | Boehringer Ingelheim International GmbH | Pharmaceutical formulation for a therapeutic antibody |
| MX2015003007A (es) * | 2012-09-07 | 2015-06-05 | Coherus Biosciences Inc | Formulaciones acuosas estables de adalimumab. |
| BR112015008186A2 (pt) | 2012-10-25 | 2017-09-19 | Medimmune Llc | formulação de um anticorpo estável e de baixa viscosidade |
| EP2727602A1 (en) | 2012-10-31 | 2014-05-07 | Takeda GmbH | Method for preparation of a high concentration liquid formulation of an antibody |
| EP2914289B1 (en) | 2012-10-31 | 2019-05-22 | Takeda GmbH | Lyophilized formulation comprising gm-csf neutralizing compound |
| AR093297A1 (es) | 2012-10-31 | 2015-05-27 | Amgen Res Munich Gmbh | Formulacion liquida que comprende un compuesto neutralizante de gm-csf |
| BR112015009924A2 (pt) | 2012-11-01 | 2017-12-05 | Abbvie Inc | formulações de proteína imunoglobulina de domínio variável duplo estáveis |
| CN104707146B (zh) | 2013-12-16 | 2019-04-16 | 浙江海正药业股份有限公司 | 一种含有阿达木单抗的药物组合物 |
| US10688187B2 (en) | 2014-04-02 | 2020-06-23 | Intas Pharmaceuticals Ltd. | Liquid pharmaceutical composition of adalimumab |
| EP2946766B1 (en) * | 2014-05-23 | 2016-03-02 | Ares Trading S.A. | Liquid pharmaceutical composition |
| ES2600488T3 (es) * | 2014-05-23 | 2017-02-09 | Ares Trading S.A. | Composición farmacéutica líquida |
-
2014
- 2014-05-23 ES ES14169755.7T patent/ES2607489T3/es active Active
- 2014-05-23 EP EP14169755.7A patent/EP2946767B1/en not_active Not-in-force
-
2015
- 2015-05-15 EP EP15723695.1A patent/EP3145488B1/en active Active
- 2015-05-15 WO PCT/EP2015/060818 patent/WO2015177059A1/en not_active Ceased
- 2015-05-15 CN CN201580039972.4A patent/CN106535935A/zh active Pending
- 2015-05-15 AU AU2015263247A patent/AU2015263247A1/en not_active Abandoned
- 2015-05-15 RS RS20201035A patent/RS60801B1/sr unknown
- 2015-05-15 EP EP20186550.8A patent/EP3741358A1/en not_active Withdrawn
- 2015-05-15 ES ES15723695T patent/ES2815598T3/es active Active
- 2015-05-15 EP EP21175530.1A patent/EP3939566A1/en active Pending
- 2015-05-15 HR HRP20201242TT patent/HRP20201242T1/hr unknown
- 2015-05-15 LT LTEP15723695.1T patent/LT3145488T/lt unknown
- 2015-05-15 JP JP2017513324A patent/JP2017516848A/ja not_active Withdrawn
- 2015-05-15 CA CA2948746A patent/CA2948746C/en active Active
- 2015-05-15 HU HUE15723695A patent/HUE050779T2/hu unknown
- 2015-05-15 SM SM20200479T patent/SMT202000479T1/it unknown
- 2015-05-15 PT PT157236951T patent/PT3145488T/pt unknown
- 2015-05-15 IL IL277241A patent/IL277241B/en unknown
- 2015-05-15 CA CA3104940A patent/CA3104940A1/en not_active Abandoned
- 2015-05-15 HK HK17105117.8A patent/HK1231391A1/zh unknown
- 2015-05-15 SI SI201531313T patent/SI3145488T1/sl unknown
- 2015-05-15 CN CN202010856565.5A patent/CN111939257A/zh active Pending
- 2015-05-15 US US15/313,487 patent/US10426833B2/en active Active
- 2015-05-15 DK DK15723695.1T patent/DK3145488T3/da active
-
2016
- 2016-11-22 IL IL249116A patent/IL249116B/en active IP Right Grant
-
2019
- 2019-09-26 US US16/584,418 patent/US20200155677A1/en not_active Abandoned
-
2020
- 2020-04-08 DK DKBA202000030U patent/DK202000030Y3/da active IP Right Grant
- 2020-05-14 DK DKBA202000038U patent/DK202000038Y3/da not_active IP Right Cessation
- 2020-06-26 AU AU2020204269A patent/AU2020204269B2/en not_active Ceased
- 2020-09-08 CY CY20201100843T patent/CY1124493T1/el unknown
- 2020-12-10 AU AU2020286276A patent/AU2020286276B2/en not_active Expired - Fee Related
-
2021
- 2021-03-29 JP JP2021055560A patent/JP2021107399A/ja not_active Withdrawn
-
2022
- 2022-08-19 JP JP2022130994A patent/JP2022174082A/ja active Pending
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