BRPI0510527A - método de estabilização de proteìnas - Google Patents
método de estabilização de proteìnasInfo
- Publication number
- BRPI0510527A BRPI0510527A BRPI0510527-7A BRPI0510527A BRPI0510527A BR PI0510527 A BRPI0510527 A BR PI0510527A BR PI0510527 A BRPI0510527 A BR PI0510527A BR PI0510527 A BRPI0510527 A BR PI0510527A
- Authority
- BR
- Brazil
- Prior art keywords
- bulk
- stabilization method
- monomeric protein
- protein stabilization
- excipient
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 2
- 230000029983 protein stabilization Effects 0.000 title 1
- 102000004169 proteins and genes Human genes 0.000 abstract 3
- 108090000623 proteins and genes Proteins 0.000 abstract 3
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 2
- 102100026720 Interferon beta Human genes 0.000 abstract 1
- 108090000467 Interferon-beta Proteins 0.000 abstract 1
- 150000001413 amino acids Chemical class 0.000 abstract 1
- 239000003963 antioxidant agent Substances 0.000 abstract 1
- 239000000022 bacteriostatic agent Substances 0.000 abstract 1
- 239000007853 buffer solution Substances 0.000 abstract 1
- 239000008364 bulk solution Substances 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 abstract 1
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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/52—Cytokines; Lymphokines; Interferons
- C07K14/555—Interferons [IFN]
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Gastroenterology & Hepatology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Epidemiology (AREA)
- Toxicology (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Virology (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Abstract
MéTODO DE ESTABILIZAçãO DE PROTEìNAS. Um método de preparar uma solução a granel estabilizada de uma proteína monomérica é descrito, que consiste em fornecer um a granel de uma proteína monomérica em uma solução tampão e adicionar um excipiente ao a granel, em que o excipiente é selecionado a partir do grupo que consiste em agentes bacteriostáticos, tensoativos, agentes de isotonicidade, aminoácidos, antioxidantes e combinações dos mesmos. Preferivelmente a proteína monomérica é IFN-beta.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP04076627 | 2004-06-01 | ||
| PCT/EP2005/052413 WO2005117948A1 (en) | 2004-06-01 | 2005-05-27 | Method of stabilizing proteins |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BRPI0510527A true BRPI0510527A (pt) | 2007-10-30 |
Family
ID=34928262
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0510527-7A BRPI0510527A (pt) | 2004-06-01 | 2005-05-27 | método de estabilização de proteìnas |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US7858082B2 (pt) |
| EP (1) | EP1750750B1 (pt) |
| JP (1) | JP2008500995A (pt) |
| CN (1) | CN1993138B (pt) |
| AT (1) | ATE543506T1 (pt) |
| AU (1) | AU2005249232B2 (pt) |
| BR (1) | BRPI0510527A (pt) |
| CA (1) | CA2567309A1 (pt) |
| EA (1) | EA012281B1 (pt) |
| ES (1) | ES2381674T3 (pt) |
| IL (1) | IL179617A0 (pt) |
| MX (1) | MXPA06014079A (pt) |
| NO (1) | NO20065861L (pt) |
| UA (1) | UA93349C2 (pt) |
| WO (1) | WO2005117948A1 (pt) |
| ZA (1) | ZA200610041B (pt) |
Families Citing this family (58)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7407955B2 (en) | 2002-08-21 | 2008-08-05 | Boehringer Ingelheim Pharma Gmbh & Co., Kg | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
| TWI272948B (en) * | 2003-05-01 | 2007-02-11 | Ares Trading Sa | HSA-free stabilized interferon liquid formulations |
| CA2531988C (en) | 2003-08-05 | 2016-06-28 | Novo Nordisk A/S | Novel insulin derivatives |
| US7501426B2 (en) | 2004-02-18 | 2009-03-10 | Boehringer Ingelheim International Gmbh | 8-[3-amino-piperidin-1-yl]-xanthines, their preparation and their use as pharmaceutical compositions |
| DE102004054054A1 (de) | 2004-11-05 | 2006-05-11 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Verfahren zur Herstellung chiraler 8-(3-Amino-piperidin-1-yl)-xanthine |
| DE102005035891A1 (de) | 2005-07-30 | 2007-02-08 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | 8-(3-Amino-piperidin-1-yl)-xanthine, deren Herstellung und deren Verwendung als Arzneimittel |
| 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. |
| TW200806317A (en) * | 2006-03-20 | 2008-02-01 | Wyeth Corp | Methods for reducing protein aggregation |
| AR060487A1 (es) * | 2006-04-21 | 2008-06-18 | Xoma Technology Ltd | Composiciones farmaceuticas de antagonistas del anticuerpo anti- cd40 |
| EP2540725A1 (de) | 2006-05-04 | 2013-01-02 | Boehringer Ingelheim International GmbH | Polymorphe von 1-((4-Methyl-chinazolin-2-yl)methyl)-3-methyl-7-(2-butin-1-yl)-8-(3-(R)-amino-piperidin-1-yl)xanthin |
| PE20080251A1 (es) | 2006-05-04 | 2008-04-25 | Boehringer Ingelheim Int | Usos de inhibidores de dpp iv |
| EP1852108A1 (en) | 2006-05-04 | 2007-11-07 | Boehringer Ingelheim Pharma GmbH & Co.KG | DPP IV inhibitor formulations |
| 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 |
| ES2520046T3 (es) | 2007-08-24 | 2014-11-11 | Novo Nordisk Health Care Ag | Reducción del contenido de dímeros en composiciones de polipéptidos del factor VII por tratamiento térmico |
| US8883146B2 (en) | 2007-11-30 | 2014-11-11 | Abbvie Inc. | Protein formulations and methods of making same |
| JP5563475B2 (ja) * | 2007-12-20 | 2014-07-30 | メルク セローノ ソシエテ アノニム | Pegインターフェロン−ベータ製剤 |
| PE20091730A1 (es) | 2008-04-03 | 2009-12-10 | Boehringer Ingelheim Int | Formulaciones que comprenden un inhibidor de dpp4 |
| BRPI0916997A2 (pt) | 2008-08-06 | 2020-12-15 | Boehringer Ingelheim International Gmbh | Inibidor de dpp-4 e seu uso |
| UY32030A (es) | 2008-08-06 | 2010-03-26 | Boehringer Ingelheim Int | "tratamiento para diabetes en pacientes inapropiados para terapia con metformina" |
| CN102149407A (zh) | 2008-09-10 | 2011-08-10 | 贝林格尔.英格海姆国际有限公司 | 治疗糖尿病和相关病症的组合疗法 |
| WO2010045168A1 (en) | 2008-10-16 | 2010-04-22 | Andrew Desbarats | Method and apparatus for producing alcohol or sugar using a commercial-scale bioreactor |
| US20200155558A1 (en) | 2018-11-20 | 2020-05-21 | Boehringer Ingelheim International Gmbh | Treatment for diabetes in patients with insufficient glycemic control despite therapy with an oral antidiabetic drug |
| RS59913B1 (sr) | 2008-10-17 | 2020-03-31 | Sanofi Aventis Deutschland | Kombinacija insulina i glp-1-agonista |
| JP4959005B2 (ja) | 2008-10-30 | 2012-06-20 | ノボ・ノルデイスク・エー/エス | 毎日の注射頻度より少ないインスリン注射での真性糖尿病の治療 |
| WO2010057259A1 (en) * | 2008-11-19 | 2010-05-27 | James Cook University | Protein stability assay using a fluorescent reporter of protein folding |
| CN102256976A (zh) | 2008-12-23 | 2011-11-23 | 贝林格尔.英格海姆国际有限公司 | 有机化合物的盐形式 |
| AR074990A1 (es) | 2009-01-07 | 2011-03-02 | Boehringer Ingelheim Int | Tratamiento de diabetes en pacientes con un control glucemico inadecuado a pesar de la terapia con metformina |
| CN102596175A (zh) | 2009-07-06 | 2012-07-18 | 赛诺菲-安万特德国有限公司 | 含有甲硫氨酸的水性胰岛素制备物 |
| MY180661A (en) | 2009-11-13 | 2020-12-04 | Sanofi Aventis Deutschland | Pharmaceutical composition comprising a glp-1 agonist, an insulin and methionine |
| PT3345593T (pt) | 2009-11-13 | 2023-11-27 | Sanofi Aventis Deutschland | Composição farmacêutica compreendendo despro36exendina- 4(1-39)-lys6-nh2 e metionina |
| KR20240090632A (ko) | 2009-11-27 | 2024-06-21 | 베링거 인겔하임 인터내셔날 게엠베하 | 리나글립틴과 같은 dpp-iv 억제제를 사용한 유전자형 검사된 당뇨병 환자의 치료 |
| CN102946875A (zh) | 2010-05-05 | 2013-02-27 | 贝林格尔.英格海姆国际有限公司 | 组合疗法 |
| WO2011161161A1 (en) | 2010-06-24 | 2011-12-29 | Boehringer Ingelheim International Gmbh | Diabetes therapy |
| PL2611458T3 (pl) | 2010-08-30 | 2017-02-28 | Sanofi-Aventis Deutschland Gmbh | Zastosowanie AVE0010 do produkcji leku do leczenia cukrzycy typu 2 |
| CN103816115B (zh) * | 2010-08-31 | 2017-06-27 | 成都康弘生物科技有限公司 | 一种含有抑制血管增生的融合蛋白的药物组合物及用途 |
| DK2632478T3 (da) | 2010-10-27 | 2019-10-07 | Novo Nordisk As | Behandling af diabetes melitus under anvendelse af insulinindsprøjtninger indgivet med varierende indsprøjtningsintervaller |
| US8821865B2 (en) | 2010-11-11 | 2014-09-02 | Abbvie Biotechnology Ltd. | High concentration anti-TNFα antibody liquid formulations |
| AR083878A1 (es) | 2010-11-15 | 2013-03-27 | Boehringer Ingelheim Int | Terapia antidiabetica vasoprotectora y cardioprotectora, linagliptina, metodo de tratamiento |
| US9821032B2 (en) | 2011-05-13 | 2017-11-21 | Sanofi-Aventis Deutschland Gmbh | Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin |
| TWI527590B (zh) * | 2011-06-17 | 2016-04-01 | 艾瑞斯貿易公司 | Fgf-18之凍乾調配物 |
| US8883800B2 (en) | 2011-07-15 | 2014-11-11 | Boehringer Ingelheim International Gmbh | Substituted quinazolines, the preparation thereof and the use thereof in pharmaceutical compositions |
| AR087693A1 (es) | 2011-08-29 | 2014-04-09 | Sanofi Aventis Deutschland | Combinacion farmaceutica para uso en el control glucemico en pacientes con diabetes de tipo 2 |
| TWI559929B (en) | 2011-09-01 | 2016-12-01 | Sanofi Aventis Deutschland | Pharmaceutical composition for use in the treatment of a neurodegenerative disease |
| US9555001B2 (en) | 2012-03-07 | 2017-01-31 | Boehringer Ingelheim International Gmbh | Pharmaceutical composition and uses thereof |
| JP6218811B2 (ja) | 2012-05-14 | 2017-10-25 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | Sirs及び/又は敗血症の治療に用いるdpp−4阻害薬としてのキサンチン誘導体 |
| JP6224084B2 (ja) | 2012-05-14 | 2017-11-01 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | 糸球体上皮細胞関連障害及び/又はネフローゼ症候群の治療に用いるdpp−4阻害薬としてのキサンチン誘導体 |
| WO2013174767A1 (en) | 2012-05-24 | 2013-11-28 | Boehringer Ingelheim International Gmbh | A xanthine derivative as dpp -4 inhibitor for use in modifying food intake and regulating food preference |
| CN103271871A (zh) * | 2013-03-18 | 2013-09-04 | 长春海伯尔生物技术有限责任公司 | 一种重组人干扰素注射液及其制备方法 |
| EP2991672A1 (en) | 2013-04-30 | 2016-03-09 | Novo Nordisk A/S | Novel administration regime |
| EP3110449B1 (en) | 2014-02-28 | 2023-06-28 | Boehringer Ingelheim International GmbH | Medical use of a dpp-4 inhibitor |
| EP3229828B1 (en) | 2014-12-12 | 2023-04-05 | Sanofi-Aventis Deutschland GmbH | Insulin glargine/lixisenatide fixed ratio formulation |
| TWI748945B (zh) | 2015-03-13 | 2021-12-11 | 德商賽諾菲阿凡提斯德意志有限公司 | 第2型糖尿病病患治療 |
| TW201705975A (zh) | 2015-03-18 | 2017-02-16 | 賽諾菲阿凡提斯德意志有限公司 | 第2型糖尿病病患之治療 |
| CN109310697A (zh) | 2016-06-10 | 2019-02-05 | 勃林格殷格翰国际有限公司 | 利格列汀和二甲双胍的组合 |
| AR109621A1 (es) * | 2016-10-24 | 2018-12-26 | Janssen Pharmaceuticals Inc | Formulaciones de vacunas contra glucoconjugados de expec |
| MY202872A (en) * | 2017-11-20 | 2024-05-28 | Just Evotec Biologics Inc | Aflibercept formulations containing a lysine salt as tonicifying agent and uses thereof |
| 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 (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6936694B1 (en) | 1982-05-06 | 2005-08-30 | Intermune, Inc. | Manufacture and expression of large structural genes |
| US4737462A (en) | 1982-10-19 | 1988-04-12 | Cetus Corporation | Structural genes, plasmids and transformed cells for producing cysteine depleted muteins of interferon-β |
| US4588585A (en) | 1982-10-19 | 1986-05-13 | Cetus Corporation | Human recombinant cysteine depleted interferon-β muteins |
| US4432895A (en) * | 1982-11-24 | 1984-02-21 | Hoffmann-La Roche Inc. | Monomeric interferons |
| US4959314A (en) | 1984-11-09 | 1990-09-25 | Cetus Corporation | Cysteine-depleted muteins of biologically active proteins |
| US5116943A (en) | 1985-01-18 | 1992-05-26 | Cetus Corporation | Oxidation-resistant muteins of Il-2 and other protein |
| US5017691A (en) | 1986-07-03 | 1991-05-21 | Schering Corporation | Mammalian interleukin-4 |
| US4879111A (en) | 1986-04-17 | 1989-11-07 | Cetus Corporation | Treatment of infections with lymphokines |
| US4965195A (en) | 1987-10-26 | 1990-10-23 | Immunex Corp. | Interleukin-7 |
| US4904584A (en) | 1987-12-23 | 1990-02-27 | Genetics Institute, Inc. | Site-specific homogeneous modification of polypeptides |
| JP2758154B2 (ja) | 1995-04-06 | 1998-05-28 | エフ・ホフマン−ラ ロシユ アーゲー | インターフェロンを含む液体製剤 |
| US5656730A (en) * | 1995-04-07 | 1997-08-12 | Enzon, Inc. | Stabilized monomeric protein compositions |
| TR199901968T2 (xx) * | 1996-12-24 | 1999-12-21 | Biogen, Inc. | Sabit s�v� interferon form�lleri. |
| US6013253A (en) | 1997-08-15 | 2000-01-11 | Amgen, Inc. | Treatment of multiple sclerosis using consensus interferon and IL-1 receptor antagonist |
| EP1426058A3 (de) * | 1997-09-23 | 2004-07-28 | Dr. Rentschler Biotechnologie GmbH | Flüssige Interferon-Beta Formulierungen |
| EE05214B1 (et) | 1998-04-28 | 2009-10-15 | Applied Research Systems ARS Holding N.V. | Polool-IFN- β konjugaat, selle valmistamismeetod ja farmatseutiline kompositsioon |
| US6887462B2 (en) * | 2001-04-09 | 2005-05-03 | Chiron Corporation | HSA-free formulations of interferon-beta |
| MXPA03011793A (es) * | 2001-06-29 | 2004-04-02 | Maxygen Holdings Ltd | Formulaciones de interferon. |
| WO2004028557A1 (ja) * | 2002-09-26 | 2004-04-08 | Shionogi & Co., Ltd. | 安定化されたタンパク組成物 |
| TWI272948B (en) * | 2003-05-01 | 2007-02-11 | Ares Trading Sa | HSA-free stabilized interferon liquid formulations |
-
2005
- 2005-05-27 CA CA002567309A patent/CA2567309A1/en not_active Withdrawn
- 2005-05-27 EP EP05749282A patent/EP1750750B1/en not_active Expired - Lifetime
- 2005-05-27 ES ES05749282T patent/ES2381674T3/es not_active Expired - Lifetime
- 2005-05-27 US US11/597,982 patent/US7858082B2/en not_active Expired - Fee Related
- 2005-05-27 EA EA200602254A patent/EA012281B1/ru not_active IP Right Cessation
- 2005-05-27 UA UAA200612403A patent/UA93349C2/ru unknown
- 2005-05-27 AT AT05749282T patent/ATE543506T1/de active
- 2005-05-27 MX MXPA06014079A patent/MXPA06014079A/es active IP Right Grant
- 2005-05-27 ZA ZA200610041A patent/ZA200610041B/en unknown
- 2005-05-27 BR BRPI0510527-7A patent/BRPI0510527A/pt not_active IP Right Cessation
- 2005-05-27 JP JP2007513937A patent/JP2008500995A/ja not_active Ceased
- 2005-05-27 AU AU2005249232A patent/AU2005249232B2/en not_active Ceased
- 2005-05-27 CN CN2005800256604A patent/CN1993138B/zh not_active Expired - Fee Related
- 2005-05-27 WO PCT/EP2005/052413 patent/WO2005117948A1/en not_active Ceased
-
2006
- 2006-11-27 IL IL179617A patent/IL179617A0/en unknown
- 2006-12-19 NO NO20065861A patent/NO20065861L/no not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| CA2567309A1 (en) | 2005-12-15 |
| MXPA06014079A (es) | 2007-02-15 |
| US7858082B2 (en) | 2010-12-28 |
| CN1993138B (zh) | 2010-12-15 |
| UA93349C2 (ru) | 2011-02-10 |
| EP1750750A1 (en) | 2007-02-14 |
| HK1102561A1 (en) | 2007-11-30 |
| EP1750750B1 (en) | 2012-02-01 |
| US20070244299A1 (en) | 2007-10-18 |
| ES2381674T3 (es) | 2012-05-30 |
| AU2005249232A1 (en) | 2005-12-15 |
| ATE543506T1 (de) | 2012-02-15 |
| IL179617A0 (en) | 2007-05-15 |
| JP2008500995A (ja) | 2008-01-17 |
| WO2005117948A1 (en) | 2005-12-15 |
| EA012281B1 (ru) | 2009-08-28 |
| CN1993138A (zh) | 2007-07-04 |
| NO20065861L (no) | 2007-03-01 |
| EA200602254A1 (ru) | 2007-06-29 |
| AU2005249232B2 (en) | 2010-08-05 |
| ZA200610041B (en) | 2008-07-30 |
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