JP2015527402A5 - - Google Patents
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- Publication number
- 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.)
- Granted
Links
- 239000008194 pharmaceutical composition Substances 0.000 claims 34
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 14
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 12
- 229960002964 adalimumab Drugs 0.000 claims 12
- 239000000203 mixture Substances 0.000 claims 10
- 229920005862 polyol Polymers 0.000 claims 8
- 150000003077 polyols Chemical class 0.000 claims 8
- 229910019142 PO4 Inorganic materials 0.000 claims 7
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 7
- 239000010452 phosphate Substances 0.000 claims 7
- 239000011780 sodium chloride 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-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 4
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate 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-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 3
- 229930195725 Mannitol Natural products 0.000 claims 3
- PMZURENOXWZQFD-UHFFFAOYSA-L Sodium Sulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=O PMZURENOXWZQFD-UHFFFAOYSA-L 0.000 claims 3
- 239000000594 mannitol Substances 0.000 claims 3
- 235000010355 mannitol Nutrition 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
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 2
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 2
- 230000001747 exhibiting effect Effects 0.000 claims 2
- 230000007774 longterm Effects 0.000 claims 2
- 229930182817 methionine Natural products 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
- 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 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
- 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
- 150000003839 salts Chemical class 0.000 claims 1
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 (https=) | 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 (https=) |
| EP (2) | EP2892550B1 (https=) |
| JP (3) | JP6463268B2 (https=) |
| KR (3) | KR20220025196A (https=) |
| CN (1) | CN104768576A (https=) |
| AR (1) | AR092470A1 (https=) |
| AU (3) | AU2013312300A1 (https=) |
| BR (1) | BR112015004984A2 (https=) |
| CA (2) | CA3153799A1 (https=) |
| CL (1) | CL2015000574A1 (https=) |
| CY (1) | CY1123407T1 (https=) |
| DK (1) | DK2892550T3 (https=) |
| DO (1) | DOP2015000051A (https=) |
| EA (2) | EA029215B1 (https=) |
| EC (1) | ECSP15013227A (https=) |
| ES (1) | ES2784861T3 (https=) |
| HR (1) | HRP20200434T1 (https=) |
| HU (1) | HUE049282T2 (https=) |
| IL (2) | IL237583B (https=) |
| LT (1) | LT2892550T (https=) |
| MX (1) | MX2015003007A (https=) |
| PE (2) | PE20150964A1 (https=) |
| PL (1) | PL2892550T3 (https=) |
| PT (1) | PT2892550T (https=) |
| RS (1) | RS60226B1 (https=) |
| SG (2) | SG10201705668XA (https=) |
| SI (1) | SI2892550T1 (https=) |
| SM (1) | SMT202000147T1 (https=) |
| TW (2) | TWI698253B (https=) |
| UY (1) | UY35351A (https=) |
| WO (1) | WO2014039903A2 (https=) |
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