TWI241193B - Human interferon-beta formulations - Google Patents
Human interferon-beta formulations Download PDFInfo
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- TWI241193B TWI241193B TW091115171A TW91115171A TWI241193B TW I241193 B TWI241193 B TW I241193B TW 091115171 A TW091115171 A TW 091115171A TW 91115171 A TW91115171 A TW 91115171A TW I241193 B TWI241193 B TW I241193B
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Classifications
-
- 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
- A61K47/16—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
- 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
- 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
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Dermatology (AREA)
- Organic Chemistry (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Psychiatry (AREA)
- Hospice & Palliative Care (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US30339501P | 2001-07-09 | 2001-07-09 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| TWI241193B true TWI241193B (en) | 2005-10-11 |
Family
ID=23171889
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TW091115171A TWI241193B (en) | 2001-07-09 | 2002-07-09 | Human interferon-beta formulations |
Country Status (7)
| Country | Link |
|---|---|
| US (2) | US20030118548A1 (enExample) |
| JP (1) | JP2004538275A (enExample) |
| AR (1) | AR034749A1 (enExample) |
| PE (1) | PE20030303A1 (enExample) |
| TW (1) | TWI241193B (enExample) |
| UY (1) | UY27373A1 (enExample) |
| WO (1) | WO2003006053A1 (enExample) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6887462B2 (en) * | 2001-04-09 | 2005-05-03 | Chiron Corporation | HSA-free formulations of interferon-beta |
| US20070148171A1 (en) * | 2002-09-27 | 2007-06-28 | Xencor, Inc. | Optimized anti-CD30 antibodies |
| TWI272948B (en) * | 2003-05-01 | 2007-02-11 | Ares Trading Sa | HSA-free stabilized interferon liquid formulations |
| MXPA06000460A (es) * | 2003-07-11 | 2006-04-07 | Schering Ag | Polipeptidos humanos, recombinantes, mejorados de interferon-beta-1b. |
| WO2006033453A1 (ja) * | 2004-09-22 | 2006-03-30 | Juntendo Educational Foundation | インターフェロン作用物質の活性増強剤 |
| MX2007004990A (es) * | 2004-11-10 | 2007-06-14 | Chiron Corp | Interferon beta desamidado. |
| KR20080030956A (ko) * | 2005-05-19 | 2008-04-07 | 바이엘 쉐링 파마 악티엔게젤샤프트 | 개선된 조절 발현 체계를 사용한 질병의 치료 |
| AR053284A1 (es) * | 2005-05-19 | 2007-04-25 | Schering Ag | Terapia genica de interferon -beta usando un sistema mejorado de expresion regulada |
| US20080076729A1 (en) * | 2005-05-19 | 2008-03-27 | Schering Aktiengesellachaft | Interferon-beta gene therapy using an improved, regulated expression system |
| US20070179113A1 (en) * | 2005-05-19 | 2007-08-02 | Schering Aktiengesellachaft | GM-CSF gene therapy for Crohn's disease using an improved regulated expression system |
| KR20080040674A (ko) * | 2005-07-29 | 2008-05-08 | 노파르티스 아게 | 시험관내 단백질 접힘을 위한 방법과 장치 |
Family Cites Families (28)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NL7404589A (nl) * | 1974-04-03 | 1975-10-07 | Stichting Rega V Z W | Werkwijze voor het stabiliseren van interferon. |
| DE2916711A1 (de) * | 1979-04-25 | 1980-11-06 | Behringwerke Ag | Blutgerinnungsfaktoren und verfahren zu ihrer herstellung |
| US4289689A (en) * | 1980-03-14 | 1981-09-15 | Hoffmann-La Roche Inc. | Preparation of homogeneous human fibroblast interferon |
| DE2943016C2 (de) * | 1979-10-24 | 1984-09-06 | Dr. Rentschler Arzneimittel Gmbh & Co, 7958 Laupheim | Verfahren zur Reinigung von Interferon |
| JPS5651995A (en) * | 1979-10-05 | 1981-05-09 | Green Cross Corp:The | Preparation of interferon |
| NL7907791A (nl) * | 1979-10-23 | 1981-04-27 | Stichting Rega V Z W | Werkwijze voor het zuiveren van interferon. |
| US4315852A (en) * | 1980-11-26 | 1982-02-16 | Schering Corporation | Extraction of interferon from bacteria |
| JPS5821691A (ja) * | 1981-07-29 | 1983-02-08 | Mochida Pharmaceut Co Ltd | α−及びβ−インタ−フェロンの精製方法 |
| DE3262575D1 (en) * | 1981-12-23 | 1985-04-18 | Schering Corp | Stabilised interferon formulations and their preparation |
| US4450103A (en) * | 1982-03-01 | 1984-05-22 | Cetus Corporation | Process for recovering human IFN-β from a transformed microorganism |
| AU1234383A (en) * | 1982-03-17 | 1983-09-22 | Inter-Yeda Ltd. | Interferon stabilised with polyvinyl-pyrrolidone |
| US5643566A (en) * | 1982-09-23 | 1997-07-01 | Cetus Corporation | Formulation processes for lipophilic proteins |
| US4462940A (en) * | 1982-09-23 | 1984-07-31 | Cetus Corporation | Process for the recovery of human β-interferon-like polypeptides |
| US4588585A (en) * | 1982-10-19 | 1986-05-13 | Cetus Corporation | Human recombinant cysteine depleted interferon-β muteins |
| IL90047A (en) * | 1982-10-19 | 1992-12-01 | Cetus Oncology Corp | Cysteine-depleted biologically active muteins other than interferon - ' |
| US4485017A (en) * | 1982-12-22 | 1984-11-27 | Cetus Corporation | Isolation of human interferon by immunosorbent and high performance liquid chromatography |
| JPS60243028A (ja) * | 1984-04-28 | 1985-12-03 | Kyowa Hakko Kogyo Co Ltd | インタ−フエロンの可溶化方法 |
| US4643566A (en) * | 1984-07-20 | 1987-02-17 | Canon Kabushiki Kaisha | Particle analyzing apparatus |
| DE3628468A1 (de) * | 1986-08-21 | 1988-03-03 | Thomae Gmbh Dr K | Neue applikationsformen fuer (alpha)-interferone |
| US5004605A (en) * | 1987-12-10 | 1991-04-02 | Cetus Corporation | Low pH pharmaceutical compositions of recombinant β-interferon |
| FR2687843A1 (fr) * | 1992-02-24 | 1993-08-27 | Motorola Semiconducteurs | Transistor bipolaire lateral pnp et procede de fabrication. |
| US5358708A (en) * | 1993-01-29 | 1994-10-25 | Schering Corporation | Stabilization of protein formulations |
| IT1272252B (it) * | 1994-05-16 | 1997-06-16 | Applied Research Systems | Formulazioni liquide di interferone beta |
| JP3466765B2 (ja) * | 1994-07-27 | 2003-11-17 | キッコーマン株式会社 | ビオチン化ホタルルシフェラーゼ、ビオチン化ホタルルシフェラーゼ遺伝子、新規な組み換え体ｄｎａ、ビオチン化ホタルルシフェラーゼの製造法及び生物発光分析法 |
| US5731168A (en) * | 1995-03-01 | 1998-03-24 | Genentech, Inc. | Method for making heteromultimeric polypeptides |
| US5814485A (en) * | 1995-06-06 | 1998-09-29 | Chiron Corporation | Production of interferon-β (IFN-β) in E. coli |
| NZ336548A (en) * | 1996-12-24 | 2001-09-28 | Biogen Inc | Stable liquid interferon formulations comprising an amino acid as the stabilising agent |
| US6887462B2 (en) * | 2001-04-09 | 2005-05-03 | Chiron Corporation | HSA-free formulations of interferon-beta |
-
2002
- 2002-07-08 AR ARP020102558A patent/AR034749A1/es unknown
- 2002-07-08 UY UY27373A patent/UY27373A1/es not_active Application Discontinuation
- 2002-07-09 PE PE2002000613A patent/PE20030303A1/es not_active Application Discontinuation
- 2002-07-09 US US10/190,838 patent/US20030118548A1/en not_active Abandoned
- 2002-07-09 JP JP2003511859A patent/JP2004538275A/ja active Pending
- 2002-07-09 WO PCT/US2002/021464 patent/WO2003006053A1/en not_active Ceased
- 2002-07-09 TW TW091115171A patent/TWI241193B/zh not_active IP Right Cessation
-
2005
- 2005-02-24 US US11/063,597 patent/US20050163752A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| US20050163752A1 (en) | 2005-07-28 |
| PE20030303A1 (es) | 2003-06-21 |
| AR034749A1 (es) | 2004-03-17 |
| UY27373A1 (es) | 2003-02-28 |
| WO2003006053A1 (en) | 2003-01-23 |
| JP2004538275A (ja) | 2004-12-24 |
| US20030118548A1 (en) | 2003-06-26 |
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| MM4A | Annulment or lapse of patent due to non-payment of fees |