JP2017519018A5 - - Google Patents
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- JP2017519018A5 JP2017519018A5 JP2016574175A JP2016574175A JP2017519018A5 JP 2017519018 A5 JP2017519018 A5 JP 2017519018A5 JP 2016574175 A JP2016574175 A JP 2016574175A JP 2016574175 A JP2016574175 A JP 2016574175A JP 2017519018 A5 JP2017519018 A5 JP 2017519018A5
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- Prior art keywords
- formulation
- protein
- liquid
- therapeutic
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- 239000000203 mixture Substances 0.000 claims 37
- 238000009472 formulation Methods 0.000 claims 36
- 239000007788 liquid Substances 0.000 claims 17
- 102000004169 proteins and genes Human genes 0.000 claims 16
- 108090000623 proteins and genes Proteins 0.000 claims 16
- 230000001225 therapeutic Effects 0.000 claims 12
- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 claims 6
- 150000001875 compounds Chemical class 0.000 claims 6
- 201000010099 disease Diseases 0.000 claims 4
- 229960001948 caffeine Drugs 0.000 claims 3
- RAXXELZNTBOGNW-UHFFFAOYSA-N Imidazole Chemical compound C1=CNC=N1 RAXXELZNTBOGNW-UHFFFAOYSA-N 0.000 claims 2
- 241000124008 Mammalia Species 0.000 claims 2
- DZGWFCGJZKJUFP-UHFFFAOYSA-N Tyramine Chemical compound NCCC1=CC=C(O)C=C1 DZGWFCGJZKJUFP-UHFFFAOYSA-N 0.000 claims 2
- 102000004965 antibodies Human genes 0.000 claims 2
- 108090001123 antibodies Proteins 0.000 claims 2
- 238000002347 injection Methods 0.000 claims 2
- 239000007924 injection Substances 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 238000003672 processing method Methods 0.000 claims 2
- 229960004998 Acesulfame potassium Drugs 0.000 claims 1
- WBZFUFAFFUEMEI-UHFFFAOYSA-N Acesulfame potassium Chemical compound [K+].CC1=CC(=O)NS(=O)(=O)O1 WBZFUFAFFUEMEI-UHFFFAOYSA-N 0.000 claims 1
- 239000004475 Arginine Substances 0.000 claims 1
- IAOZJIPTCAWIRG-QWRGUYRKSA-N Aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims 1
- 229960003438 Aspartame Drugs 0.000 claims 1
- 108010011485 Aspartame Proteins 0.000 claims 1
- 102000001974 Hyaluronidase Human genes 0.000 claims 1
- 108010074224 Hyaluronoglucosaminidase Proteins 0.000 claims 1
- ONIBWKKTOPOVIA-BYPYZUCNSA-N L-proline Chemical compound OC(=O)[C@@H]1CCCN1 ONIBWKKTOPOVIA-BYPYZUCNSA-N 0.000 claims 1
- MFDFERRIHVXMIY-UHFFFAOYSA-N Procaine Chemical compound CCN(CC)CCOC(=O)C1=CC=C(N)C=C1 MFDFERRIHVXMIY-UHFFFAOYSA-N 0.000 claims 1
- CVHZOJJKTDOEJC-UHFFFAOYSA-N Saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 claims 1
- 229940081974 Saccharin Drugs 0.000 claims 1
- NNJVILVZKWQKPM-UHFFFAOYSA-N Xylocaine Chemical compound CCN(CC)CC(=O)NC1=C(C)C=CC=C1C NNJVILVZKWQKPM-UHFFFAOYSA-N 0.000 claims 1
- 235000010358 acesulfame potassium Nutrition 0.000 claims 1
- 239000000619 acesulfame-K Substances 0.000 claims 1
- 239000000605 aspartame Substances 0.000 claims 1
- 235000010357 aspartame Nutrition 0.000 claims 1
- UIIMBOGNXHQVGW-UHFFFAOYSA-M buffer Substances [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims 1
- 150000001720 carbohydrates Chemical class 0.000 claims 1
- 238000005119 centrifugation Methods 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 238000004587 chromatography analysis Methods 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 150000004676 glycans Polymers 0.000 claims 1
- 229960002773 hyaluronidase Drugs 0.000 claims 1
- 238000010255 intramuscular injection Methods 0.000 claims 1
- 239000007927 intramuscular injection Substances 0.000 claims 1
- 238000010253 intravenous injection Methods 0.000 claims 1
- 229960004194 lidocaine Drugs 0.000 claims 1
- 239000012528 membrane Substances 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 229920001282 polysaccharide Polymers 0.000 claims 1
- 239000005017 polysaccharide Substances 0.000 claims 1
- 150000004804 polysaccharides Polymers 0.000 claims 1
- 230000002335 preservative Effects 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 229960004919 procaine Drugs 0.000 claims 1
- 238000005086 pumping Methods 0.000 claims 1
- 235000019204 saccharin Nutrition 0.000 claims 1
- 239000000901 saccharin and its Na,K and Ca salt Substances 0.000 claims 1
- 238000000926 separation method Methods 0.000 claims 1
- 239000003381 stabilizer Substances 0.000 claims 1
- 238000010254 subcutaneous injection Methods 0.000 claims 1
- 239000007929 subcutaneous injection Substances 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 229960003732 tyramine Drugs 0.000 claims 1
Claims (18)
- タンパク質および賦形剤化合物を含む液体配合物であって、前記賦形剤化合物がカフェインであり、粘度低減量で添加されている、液体配合物。
- 前記タンパク質が抗体である、請求項１に記載の液体配合物。
- 前記配合物が医薬組成物であり、前記医薬組成物が治療用タンパク質を含み、場合により治療用抗体を含む、請求項１に記載の液体配合物。
- 前記配合物が非治療用配合物であり、前記非治療用配合物が非治療用タンパク質を含む、請求項１に記載の液体配合物。
- 前記配合物の粘度が、前記対照配合物の粘度より少なくとも約５０％低い、場合により少なくとも約７０％低い、場合により少なくとも約９０％低い、請求項１に記載の配合物。
- 前記粘度が約１００ｃＰ未満である、場合により約５０ｃＰ未満である、場合により約２０ｃＰ未満である、場合により約１０ｃＰ未満である、請求項１〜５のいずれか１項に記載の配合物。
- 前記配合物が、少なくとも約２５ｍｇ／ｍＬの前記タンパク質を含む、場合により少なくとも約１００ｍｇ／ｍＬの前記タンパク質を含む、場合により少なくとも約２００ｍｇ／ｍＬの前記タンパク質を含む、場合により少なくとも約３００ｍｇ／ｍＬの前記タンパク質を含む、請求項１〜６のいずれか１項に記載の配合物。
- 約５ｍｇ／ｍＬ〜約３００ｍｇ／ｍＬの前記賦形剤化合物を含む、場合により約１０ｍｇ／ｍＬ〜約２００ｍｇ／ｍＬの前記賦形剤化合物を含む、請求項１〜７のいずれか１項に記載の配合物。
- 前記配合物が、前記対照配合物に比べて、向上した安定性を有する、請求項１〜８のいずれか１項に記載の配合物。
- 前記カフェインが、前記配合物の粘度をさらに低減させる第２の賦形剤化合物と組み合わされる、請求項１〜９のいずれか１項に記載の配合物。
- 前記第２の賦形剤化合物が、テオフィリン、チラミン、プロカイン、リドカイン、イミダゾール、アスパルテーム、サッカリン、およびアセスルファムカリウムからなる群から選択される、請求項１０に記載の配合物。
- 防腐剤、界面活性剤、糖類、多糖類、アルギニン、プロリン、ヒアルロニダーゼ、安定剤、および緩衝剤からなる群より選択される追加の薬剤をさらに含む、請求項１０に記載の配合物。
- 哺乳動物の疾患または障害の治療用の液体配合物であって、
前記治療用の液体配合物が、請求項１〜３及び５〜１２のいずれか１項に記載の配合物から選択される、哺乳動物の疾患または障害の治療用の液体配合物。 - 皮下注射用、筋肉内注射用、または静脈内注射用の、請求項１３に記載の液体配合物。
- 哺乳動物における治療用タンパク質の注射部位での疼痛を低減する用の注射可能な液体治療用配合物であって、前記注射可能な液体治療用配合物が、請求項１〜１２のいずれか１項に記載の配合物から選択される、哺乳動物における治療用タンパク質の注射部位での疼痛を低減する用の注射可能な液体治療用配合物。
- 治療用タンパク質およびカフェインを含有する液体タンパク質配合物を調製することを含む、液体タンパク質配合物の安定性を向上させる方法であって、
前記液体タンパク質配合物の安定性が、冷蔵状態安定性、室温安定性および高温安定性から選択される、液体タンパク質配合物の安定性を向上させる方法。 - タンパク質関連プロセスを改善する方法であって、請求項１〜１２のいずれか１項に記載の液体配合物を用意すること、およびそれを処理方法で用いることを含む方法。
- 前記処理方法が、濾過、圧送、混合、遠心分離、膜分離、凍結乾燥、およびクロマトグラフィーからなる群から選択される、請求項１７に記載の方法。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2020039681A JP6983266B2 (ja) | 2014-06-20 | 2020-03-09 | タンパク質配合物のための粘度低減賦形剤化合物 |
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462014784P | 2014-06-20 | 2014-06-20 | |
| US62/014,784 | 2014-06-20 | ||
| US201462083623P | 2014-11-24 | 2014-11-24 | |
| US62/083,623 | 2014-11-24 | ||
| US201562136763P | 2015-03-23 | 2015-03-23 | |
| US62/136,763 | 2015-03-23 | ||
| PCT/US2015/036899 WO2015196187A1 (en) | 2014-06-20 | 2015-06-22 | Viscosity-reducing excipient compounds for protein formulations |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020039681A Division JP6983266B2 (ja) | 2014-06-20 | 2020-03-09 | タンパク質配合物のための粘度低減賦形剤化合物 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2017519018A JP2017519018A (ja) | 2017-07-13 |
| JP2017519018A5 true JP2017519018A5 (ja) | 2018-08-02 |
| JP6674910B2 JP6674910B2 (ja) | 2020-04-01 |
Family
ID=54936144
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016574175A Active JP6674910B2 (ja) | 2014-06-20 | 2015-06-22 | タンパク質配合物のための粘度低減賦形剤化合物 |
| JP2020039681A Active JP6983266B2 (ja) | 2014-06-20 | 2020-03-09 | タンパク質配合物のための粘度低減賦形剤化合物 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020039681A Active JP6983266B2 (ja) | 2014-06-20 | 2020-03-09 | タンパク質配合物のための粘度低減賦形剤化合物 |
Country Status (9)
| Country | Link |
|---|---|
| US (6) | US20160074515A1 (ja) |
| EP (2) | EP4309643A3 (ja) |
| JP (2) | JP6674910B2 (ja) |
| KR (2) | KR20220153668A (ja) |
| CN (1) | CN106535918B (ja) |
| BR (1) | BR112016029906A8 (ja) |
| CA (1) | CA2951716C (ja) |
| ES (1) | ES2965722T3 (ja) |
| WO (2) | WO2015196091A1 (ja) |
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| AU2015325055B2 (en) | 2014-10-01 | 2021-02-25 | Eagle Biologics, Inc. | Polysaccharide and nucleic acid formulations containing viscosity-lowering agents |
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-
2015
- 2015-06-19 US US14/744,847 patent/US20160074515A1/en not_active Abandoned
- 2015-06-19 WO PCT/US2015/036724 patent/WO2015196091A1/en active Application Filing
- 2015-06-22 EP EP23194097.4A patent/EP4309643A3/en active Pending
- 2015-06-22 KR KR1020227038231A patent/KR20220153668A/ko not_active Application Discontinuation
- 2015-06-22 JP JP2016574175A patent/JP6674910B2/ja active Active
- 2015-06-22 CA CA2951716A patent/CA2951716C/en active Active
- 2015-06-22 WO PCT/US2015/036899 patent/WO2015196187A1/en active Application Filing
- 2015-06-22 BR BR112016029906A patent/BR112016029906A8/pt not_active Application Discontinuation
- 2015-06-22 KR KR1020177001786A patent/KR102463682B1/ko active IP Right Grant
- 2015-06-22 EP EP15809600.8A patent/EP3160484B1/en active Active
- 2015-06-22 CN CN201580039834.6A patent/CN106535918B/zh active Active
- 2015-06-22 ES ES15809600T patent/ES2965722T3/es active Active
- 2015-12-11 US US14/966,549 patent/US9605051B2/en active Active
-
2017
- 2017-02-16 US US15/434,379 patent/US9867881B2/en active Active
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2019
- 2019-02-25 US US16/284,583 patent/US11660343B2/en active Active
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2020
- 2020-03-09 JP JP2020039681A patent/JP6983266B2/ja active Active
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2022
- 2022-09-16 US US17/933,071 patent/US11672865B2/en active Active
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2023
- 2023-04-19 US US18/303,082 patent/US20230381318A1/en active Pending
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