JP2008510716A5 - - Google Patents
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- Publication number
- JP2008510716A5 JP2008510716A5 JP2007528019A JP2007528019A JP2008510716A5 JP 2008510716 A5 JP2008510716 A5 JP 2008510716A5 JP 2007528019 A JP2007528019 A JP 2007528019A JP 2007528019 A JP2007528019 A JP 2007528019A JP 2008510716 A5 JP2008510716 A5 JP 2008510716A5
- Authority
- JP
- Japan
- Prior art keywords
- formulation
- antagonist
- lyophilized
- reconstituted
- sucrose
- 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
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Claims (10)
- 5〜100mMヒスチジン、0.5〜3.0％PEG、0.25〜3％グリシン、5〜50mMアルギニン、0.5〜30％スクロース、およびSEQ ID NO：10の融合タンパク質配列を含む5〜50mg/mlのIL-1タンパク質アンタゴニストを含む、凍結乾燥に適した製剤。
- 約20mMヒスチジン、約1.5％PEG3350、約0.5％グリシン、約25mMアルギニン、約1.0％スクロース、および約40mg/mlのIL-1アンタゴニストを含む、請求項1記載の製剤。
- リン酸緩衝剤、約1.5％を上回るスクロース、約0.15mMを上回るクエン酸塩、および約0.005％を上回るポリソルベート20を含まない、請求項1または2記載の製剤。
- pHが6〜6.75、好ましくは6〜6.5、より好ましくは6.5である、前記請求項のいずれか一項記載の製剤。
- 請求項1〜4のいずれか一項記載の凍結乾燥前の製剤の凍結乾燥によって得られる、凍結乾燥製剤。
- 前記請求項のいずれか一項記載の凍結乾燥前の製剤を凍結乾燥して、凍結乾燥IL-1アンタゴニスト製剤を生成する工程を含む、凍結乾燥IL-1アンタゴニスト製剤を生産する方法。
- 請求項5記載の凍結乾燥製剤、または請求項6記載の方法によって得られる凍結乾燥製剤を再構成製剤へと再構成する工程を含む、再構成凍結乾燥IL-1アンタゴニスト製剤を生産する方法。
- 再構成製剤が約20〜120mg/mlのIL-1アンタゴニストを含む、請求項7記載の方法。
- 再構成製剤が凍結乾燥前の製剤の2倍または3倍の濃度である、請求項7記載の方法。
- SEQ ID NO：10の融合タンパク質配列を含むIL-1タンパク質アンタゴニストの再構成凍結乾燥製剤であって、約40mMヒスチジン、約3％PEG3350、約1％グリシン、約50mMアルギニン、約2.0％スクロース、および約80mg/mlの該IL-1タンパク質アンタゴニストを含む再構成凍結乾燥製剤。
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US60213704P | 2004-08-17 | 2004-08-17 | |
| US60/602,137 | 2004-08-17 | ||
| PCT/US2005/029428 WO2006023665A2 (en) | 2004-08-17 | 2005-08-17 | Il-1 antagonist formulations |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012013973A Division JP2012121894A (ja) | 2004-08-17 | 2012-01-26 | Ｉｌ−１アンタゴニスト製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2008510716A JP2008510716A (ja) | 2008-04-10 |
| JP2008510716A5 true JP2008510716A5 (ja) | 2008-05-22 |
| JP4948410B2 JP4948410B2 (ja) | 2012-06-06 |
Family
ID=35968186
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2007528019A Expired - Fee Related JP4948410B2 (ja) | 2004-08-17 | 2005-08-17 | Ｉｌ−１アンタゴニスト製剤 |
| JP2012013973A Pending JP2012121894A (ja) | 2004-08-17 | 2012-01-26 | Ｉｌ−１アンタゴニスト製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012013973A Pending JP2012121894A (ja) | 2004-08-17 | 2012-01-26 | Ｉｌ−１アンタゴニスト製剤 |
Country Status (15)
| Country | Link |
|---|---|
| US (1) | US7365165B2 (ja) |
| EP (2) | EP2311871A3 (ja) |
| JP (2) | JP4948410B2 (ja) |
| CN (1) | CN101014617B (ja) |
| AU (1) | AU2005277357B2 (ja) |
| BR (1) | BRPI0514411B8 (ja) |
| CA (1) | CA2576519C (ja) |
| DK (1) | DK1778723T3 (ja) |
| ES (1) | ES2395035T3 (ja) |
| HK (1) | HK1105421A1 (ja) |
| PL (1) | PL1778723T3 (ja) |
| PT (1) | PT1778723E (ja) |
| SI (1) | SI1778723T1 (ja) |
| WO (1) | WO2006023665A2 (ja) |
| ZA (1) | ZA200701529B (ja) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL2107069T3 (pl) | 2003-08-05 | 2013-06-28 | Novo Nordisk As | Nowe pochodne insuliny |
| ES2371361T3 (es) | 2005-12-28 | 2011-12-30 | Novo Nordisk A/S | Composiciones que comprenden una insulina acilada y zinc y método de producción de dichas composiciones. |
| AU2008260483A1 (en) * | 2007-06-01 | 2008-12-11 | Acologix, Inc. | High temperature stable peptide formulation |
| WO2008152106A1 (en) | 2007-06-13 | 2008-12-18 | Novo Nordisk A/S | Pharmaceutical formulation comprising an insulin derivative |
| PE20091174A1 (es) * | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| US9492375B2 (en) * | 2008-07-23 | 2016-11-15 | Warsaw Orthopedic, Inc. | Foam carrier for bone grafting |
| MX2011004357A (es) | 2008-10-30 | 2011-05-23 | Novo Nordisk As | Tratamiento de diabetes mellitus utilizando inyecciones de insulina con una frecuencia de inyeccion menor que a diario. |
| KR102080704B1 (ko) | 2010-07-29 | 2020-02-24 | 세센 바이오, 아이엔씨. | 키메라 il-1 수용체 유형 i 항진제 및 길항제들 |
| DK2632478T3 (da) | 2010-10-27 | 2019-10-07 | Novo Nordisk As | Behandling af diabetes melitus under anvendelse af insulinindsprøjtninger indgivet med varierende indsprøjtningsintervaller |
| AU2012340107B2 (en) | 2011-11-18 | 2017-06-15 | Regeneron Pharmaceuticals, Inc. | Polymer protein microparticles |
| TW201611843A (en) * | 2012-04-04 | 2016-04-01 | Polaris Group | Methods of treatment with arginine deiminase |
| WO2014035361A1 (en) * | 2012-08-26 | 2014-03-06 | R-PHARM, CJSC (Closed Joint Stock Company) | IL-1β INHIBITOR COMPOSITION AND USE THEREOF |
| JP6450364B2 (ja) | 2013-03-13 | 2019-01-09 | セセン バイオ， インコーポレイテッド | 眼送達のためのキメラサイトカイン製剤 |
| JP2016519127A (ja) | 2013-04-30 | 2016-06-30 | ノヴォ ノルディスク アー／エス | 新規投与レジメン |
| WO2018050870A1 (en) | 2016-09-16 | 2018-03-22 | Leukocare Ag | A novel method for stabilization of a biopharmaceutical drug product during processing |
| US10335464B1 (en) | 2018-06-26 | 2019-07-02 | Novo Nordisk A/S | Device for titrating basal insulin |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2309692A (en) | 1991-07-03 | 1993-02-11 | Cryolife, Inc. | Method for stabilization of biomaterials |
| JP3822383B2 (ja) * | 1993-12-17 | 2006-09-20 | 持田製薬株式会社 | 可溶性トロンボモジュリン含有組成物 |
| AU695129B2 (en) * | 1995-02-06 | 1998-08-06 | Genetics Institute, Llc | Formulations for IL-12 |
| US5763401A (en) * | 1996-07-12 | 1998-06-09 | Bayer Corporation | Stabilized albumin-free recombinant factor VIII preparation having a low sugar content |
| JP4172842B2 (ja) * | 1997-05-02 | 2008-10-29 | 生化学工業株式会社 | コンドロイチナーゼ組成物 |
| US6436897B2 (en) | 1998-06-01 | 2002-08-20 | Celtrix Pharmaceuticals, Inc. | Pharmaceutical formulations for IGF/IGFBP |
| US6472179B2 (en) * | 1998-09-25 | 2002-10-29 | Regeneron Pharmaceuticals, Inc. | Receptor based antagonists and methods of making and using |
| US6927044B2 (en) * | 1998-09-25 | 2005-08-09 | Regeneron Pharmaceuticals, Inc. | IL-1 receptor based cytokine traps |
| US20030113316A1 (en) * | 2001-07-25 | 2003-06-19 | Kaisheva Elizabet A. | Stable lyophilized pharmaceutical formulation of IgG antibodies |
| DE10204792A1 (de) * | 2002-02-06 | 2003-08-14 | Merck Patent Gmbh | Lyophilisierte Zubereitung enthaltend Immuncytokine |
| ATE404176T1 (de) * | 2003-01-08 | 2008-08-15 | Novartis Vaccines & Diagnostic | Stabilisierte lyophilisierte zubereitungen mit gewebefaktor-inhibitor (tfpi) oder varianten des gewebefaktor-inhibitors |
-
2005
- 2005-08-17 CN CN2005800281894A patent/CN101014617B/zh active Active
- 2005-08-17 WO PCT/US2005/029428 patent/WO2006023665A2/en active Application Filing
- 2005-08-17 PT PT57892523T patent/PT1778723E/pt unknown
- 2005-08-17 SI SI200531654T patent/SI1778723T1/sl unknown
- 2005-08-17 PL PL05789252T patent/PL1778723T3/pl unknown
- 2005-08-17 US US11/205,935 patent/US7365165B2/en active Active
- 2005-08-17 ES ES05789252T patent/ES2395035T3/es active Active
- 2005-08-17 EP EP10010576A patent/EP2311871A3/en not_active Withdrawn
- 2005-08-17 JP JP2007528019A patent/JP4948410B2/ja not_active Expired - Fee Related
- 2005-08-17 CA CA2576519A patent/CA2576519C/en not_active Expired - Fee Related
- 2005-08-17 BR BRPI0514411A patent/BRPI0514411B8/pt not_active IP Right Cessation
- 2005-08-17 DK DK05789252.3T patent/DK1778723T3/da active
- 2005-08-17 AU AU2005277357A patent/AU2005277357B2/en not_active Ceased
- 2005-08-17 EP EP05789252A patent/EP1778723B1/en active Active
-
2007
- 2007-02-21 ZA ZA2007/01529A patent/ZA200701529B/en unknown
- 2007-10-04 HK HK07110745.0A patent/HK1105421A1/xx not_active IP Right Cessation
-
2012
- 2012-01-26 JP JP2012013973A patent/JP2012121894A/ja active Pending
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