JP2015527402A5 - - Google Patents
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- JP2015527402A5 JP2015527402A5 JP2015531261A JP2015531261A JP2015527402A5 JP 2015527402 A5 JP2015527402 A5 JP 2015527402A5 JP 2015531261 A JP2015531261 A JP 2015531261A JP 2015531261 A JP2015531261 A JP 2015531261A JP 2015527402 A5 JP2015527402 A5 JP 2015527402A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- composition according
- adalimumab
- concentration
- buffer
- 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.)
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- 239000008194 pharmaceutical composition Substances 0.000 claims 34
- FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 14
- 108010007562 Adalimumab Proteins 0.000 claims 12
- 229960002964 adalimumab Drugs 0.000 claims 12
- DHMQDGOQFOQNFH-UHFFFAOYSA-N glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 12
- 239000000203 mixture Substances 0.000 claims 12
- 229920005862 polyol Polymers 0.000 claims 8
- 150000003077 polyols Chemical class 0.000 claims 8
- 239000011780 sodium chloride Substances 0.000 claims 8
- NBIIXXVUZAFLBC-UHFFFAOYSA-K [O-]P([O-])([O-])=O Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 7
- 239000010452 phosphate Substances 0.000 claims 7
- 239000004471 Glycine Substances 0.000 claims 6
- 150000001413 amino acids Chemical class 0.000 claims 6
- 230000000694 effects Effects 0.000 claims 6
- 239000003381 stabilizer Substances 0.000 claims 6
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 4
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 4
- KRKNYBCHXYNGOX-UHFFFAOYSA-K 2qpq Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 3
- 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 3
- FBPFZTCFMRRESA-KAZBKCHUSA-N D-Mannitol Natural products OC[C@@H](O)[C@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KAZBKCHUSA-N 0.000 claims 3
- 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 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 3
- 239000000594 mannitol Substances 0.000 claims 3
- 235000010355 mannitol Nutrition 0.000 claims 3
- PMZURENOXWZQFD-UHFFFAOYSA-L na2so4 Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 claims 3
- 229910052938 sodium sulfate Inorganic materials 0.000 claims 3
- 235000011152 sodium sulphate Nutrition 0.000 claims 3
- 239000000600 sorbitol Substances 0.000 claims 3
- 239000004475 Arginine 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 2
- 230000001747 exhibiting Effects 0.000 claims 2
- HDTRYLNUVZCQOY-LIZSDCNHSA-N 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
- 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
- 150000003839 salts Chemical class 0.000 claims 1
Claims (20)
- （ｉ）アダリムマブ；
（ｉｉ）ヒスチジン単独からなる緩衝剤；および
（ｉｉｉ）グリシン、アルギニン、メチオニンまたはこれらの組み合わせから選択されるアミノ酸から本質的になる安定剤からなる安定剤；
を含む、長期安定性を示す水性緩衝医薬組成物であって、
前記医薬組成物は、ポリオールを含有せず、少なくとも３ヶ月室温で貯蔵した後に、保存開始時の該組成物の活性と比較して、その活性の２０％超を喪失しない、前記医薬組成物。 - アミノ酸がグリシンである、請求項１に記載の医薬組成物。
- 塩化ナトリウムまたは硫酸ナトリウムを１５０ｍＭまでの濃度で含む、請求項１に記載の医薬組成物。
- ５から６のｐＨおよび１８０ｍＯｓＭから４２０ｍＯｓＭのオスモル濃度を有する、請求項１に記載の医薬組成物であって、
前記医薬組成物は、被験者に単回投与するのに適し；
前記医薬組成物は、３０ｍｇ／ｍｌから５０ｍｇ／ｍｌのアダリムマブ濃度を有し；
投薬量は、アダリムマブ１０ｍｇから８０ｍｇを含み；および
リン酸塩なしに前記組成物が５から６のｐＨを有するように、緩衝剤としてではなく、添加される安定剤としてフォスフェート単独を含んでもよい、請求項１に記載の医薬組成物。 - １００ｍＭ以下の濃度で塩化ナトリウムを含み、アミノ酸がグリシン単独からなる、請求項４に記載の医薬組成物。
- 投与量が約４０ｍｇであり、シトレートを含む緩衝剤を含むアダリムマブ組成物に比べ、被験体への投与時に痛みを起こす傾向が低い、請求項５に記載の医薬組成物。
- （ｉ）アダリムマブ；
（ｉｉ）ヒスチジン単独からなる緩衝剤；および
（ｉｉｉ）ポリオールから本質的になる安定剤；
を含む医薬組成物であって、
前記医薬組成物は、ヒスチジン以外のアミノ酸を含有せず、
少なくとも３ヶ月室温で貯蔵した後に、保存開始時の該組成物の活性と比較して、その活性の２０％超を喪失しない、前記医薬組成物。 - ポリオールが、マンニトール、ソルビトールまたはトレハロースである、請求項７に記載の医薬組成物。
- ポリオールがソルビトールである、請求項７に記載の医薬組成物。
- １５０ｍＭまでの濃度で塩化ナトリウムまたは硫酸ナトリウムを含む、請求項７に記載の医薬組成物。
- 前記医薬組成物は、約５から６のｐＨおよび１８０から４２０ｍＯｓＭのオスモル濃度を有する、請求項７に記載の医薬組成物であって、
前記医薬組成物は、被験者に単回投与するのに適し；
前記医薬組成物は、３０ｍｇ／ｍｌから５０ｍｇ／ｍｌのアダリムマブ濃度を有し；
投与量が、アダリムマブ１０ｍｇから８０ｍｇを含有し、
リン酸塩なしで組成物が約５から６のｐＨを有するように、緩衝剤としてではなく、
前記組成物がフォスフェートなしにｐＨが５から６のｐＨを有するように、フォスフェート単独を、緩衝剤としてではなく、添加される安定剤としてフォスフェートを含有してもよい、前記医薬組成物。 - １００ｍＭまでの濃度で塩化ナトリウムを含み、ポリオールがソルビトールである、請求項１１に記載の医薬組成物。
- １００ｍＭまでの濃度で塩化ナトリウムを含み、ポリオールがマンニトールである、請求項１１に記載の医薬組成物。
- 投与量が約４０ｍｇであり、シトレートを含む緩衝剤を含むアダリムマブ組成物に比べ、投与時の被験体への投与時に痛みを起こす傾向が低い、請求項１１に記載の医薬組成物。
- （ｉ）アダリムマブ；
（ｉｉ）ヒスチジン単独からなる緩衝剤；および
（ｉｉｉ）（ａ）グリシン、アルギニン、メチオニンまたはその組合せ；および（ｂ）ポリオールから本質的になる安定剤；
を含む、長期安定性を示す水性緩衝医薬組成物であって、
少なくとも３ヶ月室温で貯蔵した後に、保存開始時の該組成物の活性と比較して、その活性の２０％超を喪失しない、前記医薬組成物。 - アミノ酸がグリシンである、請求項１５に記載の医薬組成物。
- １５０ｍＭまでの濃度で存在する、塩化ナトリウムおよび硫酸ナトリウムから選択される塩を含む、請求項１６に記載の医薬組成物。
- ５から６のｐＨおよび１８０から４２０ｍＯｓＭを有する、請求項１５に記載の医薬組成物であって、
前記医薬組成物は、被験者に単回投与するのに適し；
前記医薬組成物は、３０ｍｇ／ｍｌから５０ｍｇ／ｍｌのアダリムマブ濃度を有し；
投与量が、アダリムマブ１０ｍｇから８０ｍｇを含有し、
前記組成物がフォスフェートなしにｐＨが５から６のｐＨを有するように、フォスフェート単独を、緩衝剤としてではなく、添加される安定剤として含有する、前記医薬組成物。 - １００ｍＭまでの濃度で存在する塩化ナトリウムを含み、ポリオールがマンニトールであり、アミノ酸がグリシンである、請求項１８に記載の医薬組成物。
- 投与量が約４０ｍｇであり、シトレートを含む緩衝剤を含むアダリムマブ組成物に比べ、被験体への投与時に痛みを起こす傾向が低い、請求項１９に記載の医薬組成物。
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261698138P | 2012-09-07 | 2012-09-07 | |
| US61/698,138 | 2012-09-07 | ||
| US201361769581P | 2013-02-26 | 2013-02-26 | |
| US61/769,581 | 2013-02-26 | ||
| US201361770421P | 2013-02-28 | 2013-02-28 | |
| US61/770,421 | 2013-02-28 | ||
| PCT/US2013/058618 WO2014039903A2 (en) | 2012-09-07 | 2013-09-06 | Stable aqueous formulations of adalimumab |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018244382A Division JP6783845B2 (ja) | 2012-09-07 | 2018-12-27 | 安定水性アダリムマブ製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2015527402A JP2015527402A (ja) | 2015-09-17 |
| JP2015527402A5 true JP2015527402A5 (ja) | 2016-10-27 |
| JP6463268B2 JP6463268B2 (ja) | 2019-01-30 |
Family
ID=50237778
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015531261A Expired - Fee Related JP6463268B2 (ja) | 2012-09-07 | 2013-09-06 | 安定水性アダリムマブ製剤 |
| JP2018244382A Expired - Fee Related JP6783845B2 (ja) | 2012-09-07 | 2018-12-27 | 安定水性アダリムマブ製剤 |
| JP2020176477A Ceased JP2021020930A (ja) | 2012-09-07 | 2020-10-21 | 安定水性アダリムマブ製剤 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018244382A Expired - Fee Related JP6783845B2 (ja) | 2012-09-07 | 2018-12-27 | 安定水性アダリムマブ製剤 |
| JP2020176477A Ceased JP2021020930A (ja) | 2012-09-07 | 2020-10-21 | 安定水性アダリムマブ製剤 |
Country Status (31)
| Country | Link |
|---|---|
| US (39) | US20140186361A1 (ja) |
| EP (2) | EP2892550B1 (ja) |
| JP (3) | JP6463268B2 (ja) |
| KR (3) | KR102362829B1 (ja) |
| CN (1) | CN104768576A (ja) |
| AR (1) | AR092470A1 (ja) |
| AU (3) | AU2013312300A1 (ja) |
| BR (1) | BR112015004984A2 (ja) |
| CA (2) | CA3153799A1 (ja) |
| CL (1) | CL2015000574A1 (ja) |
| CY (1) | CY1123407T1 (ja) |
| DK (1) | DK2892550T3 (ja) |
| DO (1) | DOP2015000051A (ja) |
| EA (2) | EA201791717A1 (ja) |
| EC (1) | ECSP15013227A (ja) |
| ES (1) | ES2784861T3 (ja) |
| HK (1) | HK1210601A1 (ja) |
| HR (1) | HRP20200434T1 (ja) |
| HU (1) | HUE049282T2 (ja) |
| IL (2) | IL237583B (ja) |
| LT (1) | LT2892550T (ja) |
| MX (1) | MX2015003007A (ja) |
| PE (2) | PE20191815A1 (ja) |
| PL (1) | PL2892550T3 (ja) |
| PT (1) | PT2892550T (ja) |
| RS (1) | RS60226B1 (ja) |
| SG (2) | SG10201705668XA (ja) |
| SI (1) | SI2892550T1 (ja) |
| TW (2) | TW202042841A (ja) |
| UY (1) | UY35351A (ja) |
| WO (1) | WO2014039903A2 (ja) |
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