JP2006512286A5 - - Google Patents
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- Publication number
- JP2006512286A5 JP2006512286A5 JP2004515828A JP2004515828A JP2006512286A5 JP 2006512286 A5 JP2006512286 A5 JP 2006512286A5 JP 2004515828 A JP2004515828 A JP 2004515828A JP 2004515828 A JP2004515828 A JP 2004515828A JP 2006512286 A5 JP2006512286 A5 JP 2006512286A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical formulation
- polysorbate
- viscosity
- pharmaceutical
- tnf inhibitor
- 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
- 238000000034 method Methods 0.000 claims 16
- 239000008194 pharmaceutical composition Substances 0.000 claims 12
- 239000000825 pharmaceutical preparation Substances 0.000 claims 6
- 229940046728 tumor necrosis factor alpha inhibitor Drugs 0.000 claims 6
- 239000002451 tumor necrosis factor inhibitor Substances 0.000 claims 6
- 230000003204 osmotic effect Effects 0.000 claims 5
- 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 4
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 4
- 229930195725 Mannitol Natural products 0.000 claims 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- 229930006000 Sucrose Natural products 0.000 claims 4
- 239000000594 mannitol Substances 0.000 claims 4
- 235000010355 mannitol Nutrition 0.000 claims 4
- 229920000136 polysorbate Polymers 0.000 claims 4
- 229950008882 polysorbate Drugs 0.000 claims 4
- 239000005720 sucrose Substances 0.000 claims 4
- 239000002202 Polyethylene glycol Substances 0.000 claims 3
- 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 3
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 229920001223 polyethylene glycol Polymers 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 2
- 239000004471 Glycine Substances 0.000 claims 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
- 229920000053 polysorbate 80 Polymers 0.000 claims 2
- 229940068968 polysorbate 80 Drugs 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 239000000600 sorbitol Substances 0.000 claims 2
- 239000004094 surface-active agent Substances 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 1
- 229910019142 PO4 Inorganic materials 0.000 claims 1
- 229920001213 Polysorbate 20 Polymers 0.000 claims 1
- 239000007979 citrate buffer Substances 0.000 claims 1
- 239000003607 modifier Substances 0.000 claims 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 1
- 239000008363 phosphate buffer Substances 0.000 claims 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 1
- 229940068977 polysorbate 20 Drugs 0.000 claims 1
- 239000001509 sodium citrate Substances 0.000 claims 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims 1
- 239000001488 sodium phosphate Substances 0.000 claims 1
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 1
- 125000000185 sucrose group Chemical group 0.000 claims 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/177,566 US20040002451A1 (en) | 2002-06-20 | 2002-06-20 | Compositions of pegylated soluble tumor necrosis factor receptors and methods of preparing |
| US10/177,566 | 2002-06-20 | ||
| PCT/US2003/018995 WO2004000211A2 (en) | 2002-06-20 | 2003-06-12 | Improved compositions of pegylated soluble tumor necrosis factor receptors and methods of preparing |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2011014985A Division JP2011137005A (ja) | 2002-06-20 | 2011-01-27 | ペグ化可溶性腫瘍壊死因子受容体の改良組成物とその製造方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2006512286A JP2006512286A (ja) | 2006-04-13 |
| JP2006512286A5 true JP2006512286A5 (enExample) | 2009-07-09 |
| JP4847011B2 JP4847011B2 (ja) | 2011-12-28 |
Family
ID=29734431
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2004515828A Expired - Fee Related JP4847011B2 (ja) | 2002-06-20 | 2003-06-12 | ペグ化可溶性腫瘍壊死因子受容体の改良組成物とその製造方法 |
| JP2011014985A Withdrawn JP2011137005A (ja) | 2002-06-20 | 2011-01-27 | ペグ化可溶性腫瘍壊死因子受容体の改良組成物とその製造方法 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2011014985A Withdrawn JP2011137005A (ja) | 2002-06-20 | 2011-01-27 | ペグ化可溶性腫瘍壊死因子受容体の改良組成物とその製造方法 |
Country Status (8)
| Country | Link |
|---|---|
| US (5) | US20040002451A1 (enExample) |
| EP (1) | EP1578355A4 (enExample) |
| JP (2) | JP4847011B2 (enExample) |
| AU (1) | AU2003245526B2 (enExample) |
| CA (1) | CA2490232C (enExample) |
| MX (1) | MXPA04012269A (enExample) |
| PL (1) | PL376862A1 (enExample) |
| WO (1) | WO2004000211A2 (enExample) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040002451A1 (en) | 2002-06-20 | 2004-01-01 | Bruce Kerwin | Compositions of pegylated soluble tumor necrosis factor receptors and methods of preparing |
| EP2264065B1 (en) * | 2003-08-05 | 2017-03-08 | Novo Nordisk A/S | Novel insulin derivatives |
| US20060046961A1 (en) * | 2004-09-02 | 2006-03-02 | Mckay William F | Controlled and directed local delivery of anti-inflammatory compositions |
| WO2006035444A2 (en) * | 2004-09-29 | 2006-04-06 | Tel Hashomer Medical Research Infrastructure And Services Ltd. | Composition for improving efficiency of drug delivery |
| FR2881139A1 (fr) * | 2005-01-26 | 2006-07-28 | Agronomique Inst Nat Rech | Composition pour la lyophilisation de proteines |
| EP1969004B1 (en) | 2005-12-28 | 2011-08-10 | Novo Nordisk A/S | Compositions comprising an acylated insulin and zinc and method of making the said compositions |
| JP5552046B2 (ja) * | 2007-06-13 | 2014-07-16 | ノボ・ノルデイスク・エー／エス | インスリン誘導体を含有する薬学的製剤 |
| WO2010049488A1 (en) * | 2008-10-30 | 2010-05-06 | Novo Nordisk A/S | Treating diabetes melitus using insulin injections with less than daily injection frequency |
| DK2632478T3 (da) | 2010-10-27 | 2019-10-07 | Novo Nordisk As | Behandling af diabetes melitus under anvendelse af insulinindsprøjtninger indgivet med varierende indsprøjtningsintervaller |
| US10137172B2 (en) | 2013-04-30 | 2018-11-27 | Novo Nordisk A/S | Administration regime |
| EP2910255A1 (en) * | 2014-02-19 | 2015-08-26 | MedSkin Solutions Dr. Suwelack AG | Methods for the production of biopolymers with defined average molecular weight |
| US9955802B2 (en) | 2015-04-08 | 2018-05-01 | Fasteners For Retail, Inc. | Divider with selectively securable track assembly |
| EP3307289B1 (en) * | 2015-06-09 | 2021-08-04 | Rebiotix, Inc. | Methods of manufacture of microbiota restoration therapy (mrt) compositions |
| KR20180095037A (ko) | 2015-12-18 | 2018-08-24 | 유니버시티 오브 피츠버그 - 오브 더 커먼웰쓰 시스템 오브 하이어 에듀케이션 | 수용성 종양괴사인자의 억제에 의한 암의 예방 및 치료 |
| US10335464B1 (en) | 2018-06-26 | 2019-07-02 | Novo Nordisk A/S | Device for titrating basal insulin |
| US12343383B2 (en) | 2019-07-12 | 2025-07-01 | Novo Nordisk A/S | High concentration insulin formulation |
Family Cites Families (40)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4002531A (en) * | 1976-01-22 | 1977-01-11 | Pierce Chemical Company | Modifying enzymes with polyethylene glycol and product produced thereby |
| US4362661A (en) | 1979-08-09 | 1982-12-07 | Teijin Limited | Immunoglobulin composition having a high monomer content, and process for production thereof |
| CA1153695A (en) | 1979-08-30 | 1983-09-13 | Syoji Ono | S-sulfonated immunoglobulin composition having a high monomer content and a process for production thereof |
| US4374763A (en) | 1979-09-17 | 1983-02-22 | Morishita Pharmaceutical Co., Ltd. | Method for producing gamma-globulin for use in intravenous administration and method for producing a pharmaceutical preparation thereof |
| FR2498187A1 (fr) * | 1981-01-16 | 1982-07-23 | Rhone Poulenc Sante | Procede de preparation d'amino-4 chloro-7 quinoleines |
| US4597966A (en) * | 1985-01-09 | 1986-07-01 | Ortho Diagnostic Systems, Inc. | Histidine stabilized immunoglobulin and method of preparation |
| US5237054A (en) | 1987-02-20 | 1993-08-17 | Akzo Pharma | Stabilized aqueous composition containing antibodies |
| IL83878A (en) | 1987-09-13 | 1995-07-31 | Yeda Res & Dev | Soluble protein corresponding to tnf inhibitory protein its preparation and pharmaceutical compositions containing it |
| US5234903A (en) * | 1989-11-22 | 1993-08-10 | Enzon, Inc. | Chemically modified hemoglobin as an effective, stable non-immunogenic red blood cell substitute |
| US6552170B1 (en) | 1990-04-06 | 2003-04-22 | Amgen Inc. | PEGylation reagents and compounds formed therewith |
| JPH0565233A (ja) | 1991-03-08 | 1993-03-19 | Mitsui Toatsu Chem Inc | モノクローナル抗体含有凍結乾燥製剤 |
| EP0575545B1 (en) | 1991-03-15 | 2003-05-21 | Amgen Inc. | Pegylation of polypeptides |
| US5595732A (en) * | 1991-03-25 | 1997-01-21 | Hoffmann-La Roche Inc. | Polyethylene-protein conjugates |
| US5474771A (en) * | 1991-11-15 | 1995-12-12 | The Trustees Of Columbia University In The City Of New York | Murine monoclonal antibody (5c8) recognizes a human glycoprotein on the surface of T-lymphocytes, compositions containing same |
| US5714350A (en) | 1992-03-09 | 1998-02-03 | Protein Design Labs, Inc. | Increasing antibody affinity by altering glycosylation in the immunoglobulin variable region |
| US5661125A (en) * | 1992-08-06 | 1997-08-26 | Amgen, Inc. | Stable and preserved erythropoietin compositions |
| US5955448A (en) | 1994-08-19 | 1999-09-21 | Quadrant Holdings Cambridge Limited | Method for stabilization of biological substances during drying and subsequent storage and compositions thereof |
| US5824784A (en) * | 1994-10-12 | 1998-10-20 | Amgen Inc. | N-terminally chemically modified protein compositions and methods |
| TW313568B (enExample) | 1994-12-20 | 1997-08-21 | Hoffmann La Roche | |
| US6267958B1 (en) | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| AU7169296A (en) | 1995-09-27 | 1997-04-17 | Board Of Trustees Of The Leland Stanford Junior University | Methods for determining t-cell profiles of immunocompromised subjects |
| TW555765B (en) * | 1996-07-09 | 2003-10-01 | Amgen Inc | Low molecular weight soluble tumor necrosis factor type-I and type-II proteins |
| GB9705810D0 (en) | 1997-03-20 | 1997-05-07 | Common Services Agency | Intravenous immune globulin |
| US6171586B1 (en) | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| US6177077B1 (en) * | 1999-02-24 | 2001-01-23 | Edward L. Tobinick | TNT inhibitors for the treatment of neurological disorders |
| AU2228901A (en) * | 1999-12-28 | 2001-07-09 | Chugai Seiyaku Kabushiki Kaisha | Stable antibody compositions and injection preparations |
| US6586398B1 (en) * | 2000-04-07 | 2003-07-01 | Amgen, Inc. | Chemically modified novel erythropoietin stimulating protein compositions and methods |
| JP5490972B2 (ja) * | 2000-08-04 | 2014-05-14 | 中外製薬株式会社 | タンパク質注射製剤 |
| WO2002030463A2 (en) | 2000-10-12 | 2002-04-18 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| PL209928B1 (pl) | 2000-11-07 | 2011-11-30 | Novartis Vaccines & Diagnostic | Kompozycja farmaceutyczna zawierająca biologicznie aktywny IFN-β i mannitol, wstępnie napełniona strzykawka zawierająca tę kompozycję oraz sposób wytwarzania preparatu IFN-β |
| GB0113179D0 (en) * | 2001-05-31 | 2001-07-25 | Novartis Ag | Organic compounds |
| JP4317010B2 (ja) | 2001-07-25 | 2009-08-19 | ピーディーエル バイオファーマ，インコーポレイティド | ＩｇＧ抗体の安定な凍結乾燥医薬製剤 |
| ES2392073T3 (es) * | 2001-11-08 | 2012-12-04 | Abbott Biotherapeutics Corp. | Formulación farmacéutica líquida estable de anticuerpos IGG |
| CA2476934C (en) * | 2002-02-27 | 2009-06-16 | Immunex Corporation | Stabilized tnfr-fc composition comprising arginine |
| US20040009168A1 (en) * | 2002-04-05 | 2004-01-15 | Elizabet Kaisheva | Multidose antibody formulation |
| US7425618B2 (en) * | 2002-06-14 | 2008-09-16 | Medimmune, Inc. | Stabilized anti-respiratory syncytial virus (RSV) antibody formulations |
| US20040002451A1 (en) | 2002-06-20 | 2004-01-01 | Bruce Kerwin | Compositions of pegylated soluble tumor necrosis factor receptors and methods of preparing |
| US20040033228A1 (en) * | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
| FR2853551B1 (fr) * | 2003-04-09 | 2006-08-04 | Lab Francais Du Fractionnement | Formulation stabilisante pour compositions d'immunoglobulines g sous forme liquide et sous forme lyophilisee |
| SMT202000095T1 (it) * | 2010-05-14 | 2020-03-13 | Amgen Inc | Formulazioni di anticorpi anti-sclerostina ad alta concentrazione |
-
2002
- 2002-06-20 US US10/177,566 patent/US20040002451A1/en not_active Abandoned
-
2003
- 2003-06-12 US US10/461,839 patent/US7700722B2/en not_active Expired - Fee Related
- 2003-06-12 WO PCT/US2003/018995 patent/WO2004000211A2/en not_active Ceased
- 2003-06-12 MX MXPA04012269A patent/MXPA04012269A/es active IP Right Grant
- 2003-06-12 JP JP2004515828A patent/JP4847011B2/ja not_active Expired - Fee Related
- 2003-06-12 AU AU2003245526A patent/AU2003245526B2/en not_active Ceased
- 2003-06-12 CA CA2490232A patent/CA2490232C/en not_active Expired - Lifetime
- 2003-06-12 PL PL376862A patent/PL376862A1/pl not_active Application Discontinuation
- 2003-06-12 EP EP03739154A patent/EP1578355A4/en not_active Withdrawn
-
2009
- 2009-04-29 US US12/432,452 patent/US20100197751A1/en not_active Abandoned
-
2011
- 2011-01-27 JP JP2011014985A patent/JP2011137005A/ja not_active Withdrawn
-
2015
- 2015-02-03 US US14/613,269 patent/US20150150984A1/en not_active Abandoned
-
2017
- 2017-02-07 US US15/426,402 patent/US20170151338A1/en not_active Abandoned
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