DE60038386D1 - Stabile proteinlösung abgefüllt in einem behältnis aus hydrophobem harz und eine methode zur stabilisierung derselben - Google Patents
Stabile proteinlösung abgefüllt in einem behältnis aus hydrophobem harz und eine methode zur stabilisierung derselbenInfo
- Publication number
- DE60038386D1 DE60038386D1 DE60038386T DE60038386T DE60038386D1 DE 60038386 D1 DE60038386 D1 DE 60038386D1 DE 60038386 T DE60038386 T DE 60038386T DE 60038386 T DE60038386 T DE 60038386T DE 60038386 D1 DE60038386 D1 DE 60038386D1
- Authority
- DE
- Germany
- Prior art keywords
- protein solution
- hydrophobic resin
- stabilizing
- reservoir
- same
- 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.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Non-Alcoholic Beverages (AREA)
- Distillation Of Fermentation Liquor, Processing Of Alcohols, Vinegar And Beer (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Physical Or Chemical Processes And Apparatus (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP25489699 | 1999-09-08 | ||
| JP25489699 | 1999-09-08 | ||
| PCT/JP2000/006144 WO2001017542A1 (fr) | 1999-09-08 | 2000-09-08 | Preparation de solution de proteines et procede de stabilisation associe |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| DE60038386D1 true DE60038386D1 (de) | 2008-04-30 |
| DE60038386T2 DE60038386T2 (de) | 2009-04-23 |
Family
ID=17271358
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE60038386T Expired - Lifetime DE60038386T2 (de) | 1999-09-08 | 2000-09-08 | Stabile proteinlösung abgefüllt in einem behältnis aus hydrophobem harz und eine methode zur stabilisierung derselben |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US7253142B1 (de) |
| EP (1) | EP1232753B1 (de) |
| JP (3) | JP5450508B2 (de) |
| AT (1) | ATE389414T1 (de) |
| AU (1) | AU6875900A (de) |
| DE (1) | DE60038386T2 (de) |
| TW (1) | TWI245645B (de) |
| WO (1) | WO2001017542A1 (de) |
Families Citing this family (35)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1232753B1 (de) * | 1999-09-08 | 2008-03-19 | Chugai Seiyaku Kabushiki Kaisha | Stabile proteinlösung abgefüllt in einem behältnis aus hydrophobem harz und eine methode zur stabilisierung derselben |
| DE60109625T3 (de) † | 2000-05-15 | 2017-08-03 | F. Hoffmann-La Roche Ag | Flüssige arzneizubereitung enthaltend ein erythropoietin derivat |
| CA2385745C (en) | 2001-06-08 | 2015-02-17 | Abbott Laboratories (Bermuda) Ltd. | Methods of administering anti-tnf.alpha. antibodies |
| WO2003055512A1 (en) | 2001-12-21 | 2003-07-10 | Novo Nordisk Health Care Ag | Liquid composition of factor vii polypeptides |
| PL207018B1 (pl) | 2002-06-21 | 2010-10-29 | Novo Nordisk Helth Care Ag | Kompozycja farmaceutyczna, sposób przygotowania stabilnego polipeptydu czynnika VII i zastosowanie polipeptydu czynnika VII |
| EP1541165A4 (de) * | 2002-08-27 | 2009-06-24 | Chugai Pharmaceutical Co Ltd | Verfahren zur stabilisierung einer proteinl sungszubereitung |
| AU2004222625A1 (en) * | 2003-03-18 | 2004-09-30 | Novo Nordisk Health Care Ag | Liquid, aqueous, pharmaceutical compositions of factor VII polypeptides |
| US7897734B2 (en) | 2003-03-26 | 2011-03-01 | Novo Nordisk Healthcare Ag | Method for the production of proteins |
| ATE454900T1 (de) * | 2003-05-23 | 2010-01-15 | Novo Nordisk Healthcare Ag | Stabilisierung von proteinen in lösung |
| CA2528988C (en) * | 2003-06-10 | 2012-05-01 | Lg Life Sciences Ltd. | Stable, aqueous solution of human erythropoietin, not containing serum albumin |
| JP4658041B2 (ja) * | 2003-06-25 | 2011-03-23 | ノボ ノルディスク ヘルス ケア アクチェンゲゼルシャフト | Vii因子ポリペプチドの液体組成物 |
| KR20120104619A (ko) | 2003-08-14 | 2012-09-21 | 노보 노르디스크 헬스 케어 악티엔게젤샤프트 | 인자 vii 폴리펩티드의 액상 수성 약학적 조성물 |
| CN1917861B (zh) | 2003-12-19 | 2012-03-21 | 诺和诺德医疗保健公司 | 因子vii多肽的稳定化固体组合物 |
| TWI556829B (zh) * | 2004-04-09 | 2016-11-11 | 艾伯維生物技術有限責任公司 | 用於治療TNFα相關失調症之多重可變劑量療法 |
| JP2006182960A (ja) * | 2004-12-28 | 2006-07-13 | Nipro Corp | 医療用潤滑剤およびこれを塗布したシリンジ |
| WO2006125229A2 (en) | 2005-05-16 | 2006-11-23 | Abbott Biotechnology Ltd. | Use of tnf inhibitor for treatment of erosive polyarthritis |
| US9605064B2 (en) | 2006-04-10 | 2017-03-28 | Abbvie Biotechnology Ltd | Methods and compositions for treatment of skin disorders |
| MX2010008696A (es) * | 2008-02-07 | 2010-08-30 | Amgen Inc | Composiciones de proteina estabilizadas. |
| CA2895198A1 (en) * | 2012-12-20 | 2014-06-26 | Medimmune, Llc | Liquid antibody formulation with improved aggregation properties |
| KR20220140025A (ko) | 2013-03-12 | 2022-10-17 | 더 트러스티스 오브 더 유니버시티 오브 펜실베니아 | 인간 파밀로마 바이러스용 개선된 백신 및 이것을 사용하는 방법 |
| CN107106409A (zh) * | 2014-10-02 | 2017-08-29 | 泰尔茂株式会社 | 用于容纳蛋白质溶液制剂的医疗用容器 |
| CN107109493A (zh) * | 2014-12-31 | 2017-08-29 | 皇家飞利浦有限公司 | 经由物理吸附将修饰的寡核苷酸固定至聚合物基体上 |
| RU2732109C2 (ru) | 2016-02-10 | 2020-09-11 | Бектон Дикинсон Франс | Способ оценки стабильности композиции на основе белка |
| JP7071914B2 (ja) | 2016-03-24 | 2022-05-19 | テルモ株式会社 | シリンジ用外筒およびシリンジ |
| JP7153999B2 (ja) * | 2016-04-22 | 2022-10-17 | ロート製薬株式会社 | 水性組成物 |
| WO2017188267A1 (ja) * | 2016-04-25 | 2017-11-02 | テルモ株式会社 | プレフィルドシリンジ用のシリンジ本体、シリンジシステム及びプレフィルドシリンジ |
| WO2018117242A1 (ja) | 2016-12-22 | 2018-06-28 | 日本ゼオン株式会社 | オリゴペプチドの探索方法、オリゴペプチド、修飾ペプチド、及び免疫測定方法 |
| US20190099489A1 (en) * | 2017-09-29 | 2019-04-04 | Janssen Biotech, Inc. | Novel Formulations Which Stabilize Low Dose Antibody Compositions |
| PL3797752T3 (pl) * | 2018-05-21 | 2024-10-28 | Chugai Seiyaku Kabushiki Kaisha | Preparat liofilizowany szczelnie zamknięty w pojemniku szklanym |
| CN112243423B (zh) | 2018-05-28 | 2022-11-04 | 中外制药株式会社 | 填充喷嘴 |
| US12466881B2 (en) * | 2018-07-31 | 2025-11-11 | Zeon Corporation | Pre-filled syringe and method of producing pre-filled syringe |
| US20210260297A1 (en) * | 2018-07-31 | 2021-08-26 | Zeon Corporation | Pre-filled syringe and method of producing pre-filled syringe |
| JPWO2021006057A1 (de) | 2019-07-05 | 2021-01-14 | ||
| CN114980851A (zh) * | 2020-01-28 | 2022-08-30 | 日本瑞翁株式会社 | 预填充药剂包装和预填充药剂包装的制造方法 |
| IL302317A (en) * | 2020-10-28 | 2023-06-01 | Dompe Farm Spa | Pharmaceutical packaging including polypropylene containers and aqueous formulations of NGF packed in them |
Family Cites Families (40)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3788319A (en) * | 1971-07-30 | 1974-01-29 | Univ Iowa State Res Found Inc | System for exchanging blood ultrafiltrate |
| JPS54135215A (en) * | 1978-04-10 | 1979-10-20 | Ss Pharmaceutical Co | Stable aqueous lisozyme solution |
| US4732889A (en) | 1985-02-06 | 1988-03-22 | Chugai Seiyaku Kabushiki Kaisha | Pharmaceutical composition for the treatment of the anemia of rheumatoid arthritis |
| DE3777845D1 (de) | 1986-01-22 | 1992-05-07 | Chugai Pharmaceutical Co Ltd | Pharmazeutischer stoff fuer die behandlung von myelogener leukaemie. |
| US4838861A (en) * | 1986-05-02 | 1989-06-13 | Sharp David E | Blood preservation by ultrahemodilution |
| GR871067B (en) | 1986-07-18 | 1987-11-19 | Chugai Pharmaceutical Co Ltd | Process for producing stable pharmaceutical preparation containing granulocyte colony stimulating factor |
| JP2629000B2 (ja) * | 1986-07-18 | 1997-07-09 | 中外製薬株式会社 | 安定な顆粒球コロニー刺激因子含有製剤 |
| US4810249A (en) * | 1987-03-12 | 1989-03-07 | Habley Medical Technology Corp. | Linear and Vernier-type syringe |
| DE3729863A1 (de) | 1987-09-05 | 1989-03-16 | Boehringer Mannheim Gmbh | Stabilisierte erythropoietin-lyophilisate |
| US5728437A (en) | 1987-08-26 | 1998-03-17 | Astra Meditec Aktiebolag | Articles exhibiting a blood-compatible surface layer and process for providing articles with such a surface layer |
| SE8703310D0 (sv) | 1987-08-26 | 1987-08-26 | Astra Meditec Ab | Articles exhibiting a blood-compatible surface layer and process for providing articles with such a surface layer |
| ES2008948A6 (es) * | 1988-01-07 | 1989-08-16 | Martinez Gimeno Carlos Vicente | Jeringa de un solo uso auto-inutilizable. |
| US5213814A (en) * | 1989-04-10 | 1993-05-25 | Cryopharm Corporation | Lyophilized and reconstituted blood platelet compositions |
| JPH0669956B2 (ja) * | 1988-09-30 | 1994-09-07 | 旭化成工業株式会社 | ポリペプタイド類の吸着防止剤 |
| JP3179538B2 (ja) * | 1990-12-11 | 2001-06-25 | ノバルティス アクチエンゲゼルシャフト | 安定なヒトカルシトニンの水性溶液 |
| ATE145661T1 (de) * | 1991-07-22 | 1996-12-15 | Daikyo Gomu Seiko Kk | Behälter für hygienische artikel |
| US5571788A (en) | 1991-12-09 | 1996-11-05 | Ciba-Geigy Corporation | Stable calcitonin pharmaceutical compositions |
| US6007520A (en) | 1992-02-12 | 1999-12-28 | Daikyo Gomu Seiko, Ltd. | Medical instrument |
| ES2159516T5 (es) | 1992-02-12 | 2005-05-01 | Daikyo Gomu Seiko Ltd. | Un instrumento medico. |
| JP3666884B2 (ja) * | 1992-05-21 | 2005-06-29 | 日本ゼオン株式会社 | 医療用器材 |
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| DE69332756T2 (de) * | 1992-05-29 | 2004-02-19 | University Of North Carolina At Chapel Hill | Im immobilisierten zustand getrocknete pharmazeutische verträgliche menschliche blutplättchen |
| US5496718A (en) | 1992-06-26 | 1996-03-05 | Seikagaku Kogyo Kabushiki Kaisha (Seikagaku Corporation) | Chondroitinase ABC isolated from proteus vulgaris ATCC 6896 |
| JP3895782B2 (ja) * | 1992-10-26 | 2007-03-22 | 生化学工業株式会社 | コンドロイチナーゼ組成物およびそれを含有する注射用製剤 |
| US5661125A (en) | 1992-08-06 | 1997-08-26 | Amgen, Inc. | Stable and preserved erythropoietin compositions |
| NZ260909A (en) | 1993-07-05 | 1995-04-27 | Takeda Chemical Industries Ltd | Production of sustained release preparation by allowing a water-soluble polypeptide to permeate into a biodegradable matrix in an aqueous solution |
| JP2747979B2 (ja) * | 1994-08-19 | 1998-05-06 | 雪印乳業株式会社 | ヒト由来の糖蛋白質からなる生理活性因子を有効成分とする医薬 |
| JPH08155007A (ja) * | 1994-12-02 | 1996-06-18 | Mitsui Petrochem Ind Ltd | 薬剤充填容器製剤及びこれに用いる容器 |
| TW434020B (en) * | 1995-03-15 | 2001-05-16 | Kirin Brewery | Methods for preventing adsorption of thrombopoietin (TPO), and stable top-containing compositions |
| BE1009403A3 (fr) | 1995-06-02 | 1997-03-04 | Solvay | Composition souple a base de polymere de chlorure de vinyle, utilisation de cette composition pour la fabrication d'un article et article comprenant cette composition. |
| TW518219B (en) * | 1996-04-26 | 2003-01-21 | Chugai Pharmaceutical Co Ltd | Erythropoietin solution preparation |
| IL130433A0 (en) * | 1996-12-23 | 2000-06-01 | Novo Nordisk As | A medicament container of polymer of linear olefin for storing a liquid medicament |
| JP3480672B2 (ja) * | 1997-04-25 | 2003-12-22 | 稔 寺野 | 生体適合性ポリオレフィン成形品、及び生体適合性高分子材料 |
| JP3387775B2 (ja) * | 1997-05-22 | 2003-03-17 | 株式会社大協精工 | 注射器用密封栓及びプレフィルド注射器 |
| JP3568398B2 (ja) * | 1997-09-11 | 2004-09-22 | 中外製薬株式会社 | アポトーシスを誘起するモノクローナル抗体 |
| JP3103535B2 (ja) * | 1998-05-29 | 2000-10-30 | 大洋薬品工業株式会社 | カルシトニン類のプレフィルドシリンジ製剤 |
| WO2000015241A1 (fr) | 1998-09-11 | 2000-03-23 | Chugai Seiyaku Kabushiki Kaisha | Preparation d'une solution proteinique et son procede de stabilisation |
| EP1232753B1 (de) * | 1999-09-08 | 2008-03-19 | Chugai Seiyaku Kabushiki Kaisha | Stabile proteinlösung abgefüllt in einem behältnis aus hydrophobem harz und eine methode zur stabilisierung derselben |
| JP5271481B2 (ja) * | 1999-09-08 | 2013-08-21 | 中外製薬株式会社 | タンパク質溶液製剤およびその安定化方法 |
| JP5765281B2 (ja) * | 2012-03-27 | 2015-08-19 | 株式会社Jvcケンウッド | 復号装置、復号方法、及び、プログラム |
-
2000
- 2000-09-08 EP EP00957046A patent/EP1232753B1/de not_active Expired - Lifetime
- 2000-09-08 DE DE60038386T patent/DE60038386T2/de not_active Expired - Lifetime
- 2000-09-08 AU AU68759/00A patent/AU6875900A/en not_active Abandoned
- 2000-09-08 AT AT00957046T patent/ATE389414T1/de not_active IP Right Cessation
- 2000-09-08 US US09/720,757 patent/US7253142B1/en not_active Expired - Lifetime
- 2000-09-08 TW TW089118513A patent/TWI245645B/zh not_active IP Right Cessation
- 2000-09-08 WO PCT/JP2000/006144 patent/WO2001017542A1/ja not_active Ceased
-
2011
- 2011-05-13 JP JP2011108579A patent/JP5450508B2/ja not_active Expired - Lifetime
-
2013
- 2013-10-02 JP JP2013207358A patent/JP6076226B2/ja not_active Expired - Lifetime
-
2015
- 2015-11-04 JP JP2015216695A patent/JP6134370B2/ja not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| JP2011168610A (ja) | 2011-09-01 |
| JP2016056176A (ja) | 2016-04-21 |
| JP2014051502A (ja) | 2014-03-20 |
| JP6134370B2 (ja) | 2017-05-24 |
| AU6875900A (en) | 2001-04-10 |
| ATE389414T1 (de) | 2008-04-15 |
| JP5450508B2 (ja) | 2014-03-26 |
| EP1232753B1 (de) | 2008-03-19 |
| EP1232753A4 (de) | 2004-08-11 |
| JP6076226B2 (ja) | 2017-02-08 |
| DE60038386T2 (de) | 2009-04-23 |
| TWI245645B (en) | 2005-12-21 |
| EP1232753A1 (de) | 2002-08-21 |
| US7253142B1 (en) | 2007-08-07 |
| WO2001017542A1 (fr) | 2001-03-15 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 8381 | Inventor (new situation) |
Inventor name: WATANABE, YOSHIROU, TOKYO, JP Inventor name: HIRAISHI, TAKAYA, TOKYO, JP Inventor name: MITSUI, NAOKI, TOKYO, JP Inventor name: SUZUKI, NOBUYUKI, TOKYO, JP |
|
| 8364 | No opposition during term of opposition |