HRP20120483T1 - Formulacije peg interferona beta - Google Patents
Formulacije peg interferona beta Download PDFInfo
- Publication number
- HRP20120483T1 HRP20120483T1 HRP20120483AT HRP20120483T HRP20120483T1 HR P20120483 T1 HRP20120483 T1 HR P20120483T1 HR P20120483A T HRP20120483A T HR P20120483AT HR P20120483 T HRP20120483 T HR P20120483T HR P20120483 T1 HRP20120483 T1 HR P20120483T1
- Authority
- HR
- Croatia
- Prior art keywords
- preparation according
- concentration
- present
- peg
- preparation
- Prior art date
Links
- 229960001388 interferon-beta Drugs 0.000 title claims 2
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 229920005862 polyol Polymers 0.000 claims abstract 7
- 150000003077 polyols Chemical group 0.000 claims abstract 7
- 239000000872 buffer Substances 0.000 claims abstract 5
- 239000007788 liquid Substances 0.000 claims abstract 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract 3
- 239000004094 surface-active agent Substances 0.000 claims abstract 3
- 108090000467 Interferon-beta Proteins 0.000 claims abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract 2
- CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical compound CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 claims 5
- 239000000825 pharmaceutical preparation Substances 0.000 claims 5
- 229920001993 poloxamer 188 Polymers 0.000 claims 5
- 229940044519 poloxamer 188 Drugs 0.000 claims 5
- 239000000126 substance Substances 0.000 claims 5
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims 4
- 235000017281 sodium acetate Nutrition 0.000 claims 4
- 239000001632 sodium acetate Substances 0.000 claims 4
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 2
- 229930182817 methionine Natural products 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 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 1
- 102000003996 Interferon-beta Human genes 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 229940090047 auto-injector Drugs 0.000 claims 1
- 239000007853 buffer solution Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 229940071643 prefilled syringe Drugs 0.000 claims 1
- 102100026720 Interferon beta Human genes 0.000 abstract 1
- 239000002736 nonionic surfactant Substances 0.000 abstract 1
- 239000007974 sodium acetate buffer 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
- A61K9/0012—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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/21—Interferons [IFN]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/21—Interferons [IFN]
- A61K38/215—IFN-beta
-
- 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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/59—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
- A61K47/60—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
-
- 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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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]
-
- 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]
- C07K14/565—IFN-beta
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP07150258 | 2007-12-20 | ||
| US1025808P | 2008-01-07 | 2008-01-07 | |
| PCT/EP2008/067876 WO2009080699A2 (en) | 2007-12-20 | 2008-12-18 | Peg-interferon-beta formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20120483T1 true HRP20120483T1 (hr) | 2012-07-31 |
Family
ID=39760852
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20120483AT HRP20120483T1 (hr) | 2007-12-20 | 2012-06-08 | Formulacije peg interferona beta |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US9138403B2 (es) |
| EP (1) | EP2234645B1 (es) |
| JP (2) | JP5563475B2 (es) |
| KR (1) | KR20100099298A (es) |
| CN (1) | CN101878043A (es) |
| AT (1) | ATE555812T1 (es) |
| AU (1) | AU2008340058A1 (es) |
| BR (1) | BRPI0821029A2 (es) |
| CY (1) | CY1112820T1 (es) |
| DK (1) | DK2234645T3 (es) |
| EA (1) | EA201070773A1 (es) |
| ES (1) | ES2387236T3 (es) |
| HR (1) | HRP20120483T1 (es) |
| IL (1) | IL206441A0 (es) |
| PL (1) | PL2234645T3 (es) |
| PT (1) | PT2234645E (es) |
| RS (1) | RS52417B (es) |
| SI (1) | SI2234645T1 (es) |
| WO (1) | WO2009080699A2 (es) |
| ZA (1) | ZA201001908B (es) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SI2234645T1 (sl) * | 2007-12-20 | 2012-07-31 | Merck Serono Sa | Formulacije peg interferon beta |
| US20120269770A1 (en) * | 2010-11-22 | 2012-10-25 | Mark Brader | Stable Preserved Compositions of Interferon-Beta |
| AU2014243839B2 (en) * | 2013-03-13 | 2019-01-03 | Buzzard Pharmaceuticals AB | Chimeric cytokine formulations for ocular delivery |
| WO2016052584A1 (ja) * | 2014-09-30 | 2016-04-07 | 東レ株式会社 | ポリエチレングリコール修飾インターフェロン－βの検出及び定量に使用する試料液の前処理方法、ポリエチレングリコール修飾インターフェロン－βの検出方法及び定量方法 |
| PE20170922A1 (es) * | 2014-11-10 | 2017-07-12 | Glaxosmithkline Intellectual Property (No 2) Ltd | Composiciones de accion prolongada de combinacion y procedimientos para hepatitis c |
| WO2016163764A2 (ko) * | 2015-04-07 | 2016-10-13 | 에이비온 주식회사 | 인터페론 베타 변이체의 안정화 제제 |
| KR101943160B1 (ko) * | 2016-10-06 | 2019-01-30 | 에이비온 주식회사 | 인터페론 베타 변이체의 안정화 제제 |
| CN116023466B (zh) * | 2023-03-30 | 2023-06-27 | 北京生物制品研究所有限责任公司 | 纯化PEG修饰重组人干扰素β1b蛋白的方法 |
Family Cites Families (57)
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| US6936694B1 (en) * | 1982-05-06 | 2005-08-30 | Intermune, Inc. | Manufacture and expression of large structural genes |
| DE3380726D1 (en) | 1982-06-24 | 1989-11-23 | Japan Chem Res | Long-acting composition |
| US4588585A (en) * | 1982-10-19 | 1986-05-13 | Cetus Corporation | Human recombinant cysteine depleted interferon-β muteins |
| US4737462A (en) * | 1982-10-19 | 1988-04-12 | Cetus Corporation | Structural genes, plasmids and transformed cells for producing cysteine depleted muteins of interferon-β |
| US4432895A (en) * | 1982-11-24 | 1984-02-21 | Hoffmann-La Roche Inc. | Monomeric interferons |
| US4469228A (en) * | 1983-05-31 | 1984-09-04 | Schering Corporation | Interferon kit |
| US4636383A (en) | 1984-08-29 | 1987-01-13 | Schering Corporation | Interferon-cyclaradine combination |
| 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 |
| US5997856A (en) * | 1988-10-05 | 1999-12-07 | Chiron Corporation | Method and compositions for solubilization and stabilization of polypeptides, especially proteins |
| IT1244511B (it) | 1991-04-15 | 1994-07-15 | Isi Ist Sierovaccinogeno Ital | Idrogeli a base di policarbossilati sintetici e proteine per il rilascio controllato di farmaci e procedimento per la loro preparazione. |
| KR950014915B1 (ko) * | 1991-06-19 | 1995-12-18 | 주식회사녹십자 | 탈시알로당단백-포함화합물 |
| US6582728B1 (en) * | 1992-07-08 | 2003-06-24 | Inhale Therapeutic Systems, Inc. | Spray drying of macromolecules to produce inhaleable dry powders |
| IT1272252B (it) * | 1994-05-16 | 1997-06-16 | Applied Research Systems | Formulazioni liquide di interferone beta |
| 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 |
| US5814485A (en) * | 1995-06-06 | 1998-09-29 | Chiron Corporation | Production of interferon-β (IFN-β) in E. coli |
| US5858001A (en) * | 1995-12-11 | 1999-01-12 | Elan Medical Technologies Limited | Cartridge-based drug delivery device |
| JP2002512597A (ja) * | 1996-12-20 | 2002-04-23 | アルザ コーポレイション | 注射可能な貯留槽ゲル組成物およびこの組成物の製造方法 |
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| US6013253A (en) * | 1997-08-15 | 2000-01-11 | Amgen, Inc. | Treatment of multiple sclerosis using consensus interferon and IL-1 receptor antagonist |
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| CN1849141A (zh) * | 2003-05-12 | 2006-10-18 | 阿费麦克斯公司 | 用于聚(乙二醇)修饰的肽的间隔臂部分 |
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| CA2536643C (en) | 2003-08-25 | 2013-11-12 | Toray Industries, Inc. | Interferon-.beta. complex |
| AU2004298781B2 (en) * | 2003-12-11 | 2010-04-01 | Ares Trading S.A. | Stabilized interferon liquid formulations |
| EP1734988A4 (en) * | 2004-03-01 | 2009-08-05 | Enzon Pharmaceuticals Inc | INTERFERON BETA-polymer |
| CN1984673A (zh) * | 2004-05-17 | 2007-06-20 | 阿雷斯贸易股份有限公司 | 干扰素水凝胶制剂 |
| MXPA06014078A (es) | 2004-06-01 | 2007-02-15 | Ares Trading Sa | Formulaciones liquidas estabilizadas de interferon. |
| CN1993138B (zh) * | 2004-06-01 | 2010-12-15 | 阿雷斯贸易股份有限公司 | 稳定蛋白质的方法 |
| ES2349472T3 (es) * | 2004-08-12 | 2011-01-03 | Schering Corporation | Formulación estable de interferón pegilado. |
| SI2234645T1 (sl) * | 2007-12-20 | 2012-07-31 | Merck Serono Sa | Formulacije peg interferon beta |
-
2008
- 2008-12-18 SI SI200830666T patent/SI2234645T1/sl unknown
- 2008-12-18 RS RSP20120318 patent/RS52417B/en unknown
- 2008-12-18 PT PT08863833T patent/PT2234645E/pt unknown
- 2008-12-18 CN CN2008801185845A patent/CN101878043A/zh active Pending
- 2008-12-18 DK DK08863833T patent/DK2234645T3/da active
- 2008-12-18 ES ES08863833T patent/ES2387236T3/es active Active
- 2008-12-18 JP JP2010538728A patent/JP5563475B2/ja not_active Expired - Fee Related
- 2008-12-18 AU AU2008340058A patent/AU2008340058A1/en not_active Abandoned
- 2008-12-18 WO PCT/EP2008/067876 patent/WO2009080699A2/en active Application Filing
- 2008-12-18 AT AT08863833T patent/ATE555812T1/de active
- 2008-12-18 US US12/738,375 patent/US9138403B2/en not_active Expired - Fee Related
- 2008-12-18 BR BRPI0821029-2A patent/BRPI0821029A2/pt not_active IP Right Cessation
- 2008-12-18 PL PL08863833T patent/PL2234645T3/pl unknown
- 2008-12-18 KR KR20107015882A patent/KR20100099298A/ko not_active Application Discontinuation
- 2008-12-18 EA EA201070773A patent/EA201070773A1/ru unknown
- 2008-12-18 EP EP08863833A patent/EP2234645B1/en active Active
-
2010
- 2010-03-17 ZA ZA2010/01908A patent/ZA201001908B/en unknown
- 2010-06-17 IL IL206441A patent/IL206441A0/en unknown
-
2012
- 2012-06-06 CY CY20121100509T patent/CY1112820T1/el unknown
- 2012-06-08 HR HRP20120483AT patent/HRP20120483T1/hr unknown
-
2014
- 2014-04-07 JP JP2014078691A patent/JP2014159445A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| EP2234645B1 (en) | 2012-05-02 |
| EP2234645A2 (en) | 2010-10-06 |
| IL206441A0 (en) | 2010-12-30 |
| JP5563475B2 (ja) | 2014-07-30 |
| RS52417B (en) | 2013-02-28 |
| PL2234645T3 (pl) | 2012-10-31 |
| WO2009080699A2 (en) | 2009-07-02 |
| DK2234645T3 (da) | 2012-07-09 |
| US9138403B2 (en) | 2015-09-22 |
| US20100239529A1 (en) | 2010-09-23 |
| AU2008340058A1 (en) | 2009-07-02 |
| KR20100099298A (ko) | 2010-09-10 |
| ATE555812T1 (de) | 2012-05-15 |
| WO2009080699A3 (en) | 2009-11-26 |
| ES2387236T3 (es) | 2012-09-18 |
| ZA201001908B (en) | 2011-05-25 |
| BRPI0821029A2 (pt) | 2015-06-16 |
| JP2014159445A (ja) | 2014-09-04 |
| SI2234645T1 (sl) | 2012-07-31 |
| CN101878043A (zh) | 2010-11-03 |
| PT2234645E (pt) | 2012-05-21 |
| JP2011506562A (ja) | 2011-03-03 |
| CY1112820T1 (el) | 2016-02-10 |
| EA201070773A1 (ru) | 2010-12-30 |
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