DK0674524T3 - Stabile, lyofiliserede, farmaceutiske sammensætninger af G-CSF - Google Patents
Stabile, lyofiliserede, farmaceutiske sammensætninger af G-CSFInfo
- Publication number
- DK0674524T3 DK0674524T3 DK94902772T DK94902772T DK0674524T3 DK 0674524 T3 DK0674524 T3 DK 0674524T3 DK 94902772 T DK94902772 T DK 94902772T DK 94902772 T DK94902772 T DK 94902772T DK 0674524 T3 DK0674524 T3 DK 0674524T3
- Authority
- DK
- Denmark
- Prior art keywords
- csf
- pct
- lyophilized
- stable
- pharmaceutical compositions
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- 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
- 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
- A61K38/193—Colony stimulating factors [CSF]
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
-
- 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
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE4242863A DE4242863A1 (de) | 1992-12-18 | 1992-12-18 | Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF |
| PCT/EP1993/003543 WO1994014465A1 (de) | 1992-12-18 | 1993-12-15 | Stabile lyophilisierte pharmazeutische zubereitungen von g-csf |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK0674524T3 true DK0674524T3 (da) | 1999-02-01 |
Family
ID=6475691
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK94902772T DK0674524T3 (da) | 1992-12-18 | 1993-12-15 | Stabile, lyofiliserede, farmaceutiske sammensætninger af G-CSF |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US5919443A (ja) |
| EP (1) | EP0674524B1 (ja) |
| JP (1) | JPH08504784A (ja) |
| KR (1) | KR100266145B1 (ja) |
| AT (1) | ATE165007T1 (ja) |
| AU (1) | AU676573B2 (ja) |
| CA (1) | CA2151732C (ja) |
| DE (2) | DE4242863A1 (ja) |
| DK (1) | DK0674524T3 (ja) |
| ES (1) | ES2117781T3 (ja) |
| HU (1) | HU220256B (ja) |
| NZ (1) | NZ258912A (ja) |
| SG (1) | SG66740A1 (ja) |
| WO (1) | WO1994014465A1 (ja) |
Families Citing this family (39)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2180206A1 (en) * | 1995-06-30 | 1996-12-31 | Motoya Ohshika | Freeze-dried preparation for pharmaceutical use |
| US6267958B1 (en) | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
| DE19539574A1 (de) * | 1995-10-25 | 1997-04-30 | Boehringer Mannheim Gmbh | Zubereitungen und Verfahren zur Stabilisierung biologischer Materialien mittels Trocknungsverfahren ohne Einfrieren |
| US5770700A (en) * | 1996-01-25 | 1998-06-23 | Genetics Institute, Inc. | Liquid factor IX formulations |
| EP0852951A1 (de) | 1996-11-19 | 1998-07-15 | Roche Diagnostics GmbH | Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern |
| AU749815B2 (en) * | 1998-03-06 | 2002-07-04 | Chugai Seiyaku Kabushiki Kaisha | Protein-free preparations |
| PT1018345E (pt) * | 1998-06-26 | 2009-01-23 | Otsuka Pharma Co Ltd | Composições secas solúveis em água |
| PT2130554E (pt) * | 1999-02-22 | 2012-11-19 | Univ Connecticut | Formulações de factor viii isentas de albumina |
| JP2000247903A (ja) * | 1999-03-01 | 2000-09-12 | Chugai Pharmaceut Co Ltd | 長期安定化製剤 |
| CA2395438C (en) * | 1999-12-24 | 2009-10-13 | Otsuka Pharmaceutical Co., Ltd. | Dry compositions containing hydrophobic amino acid |
| PT1129720E (pt) | 2000-02-29 | 2004-08-31 | Pfizer Prod Inc | Factor estimulador de colonias de granulocitos estabilizado |
| CA2403962C (en) * | 2000-03-31 | 2009-12-15 | Kirin Beer Kabushiki Kaisha | Powdery preparation for transmucosal administration comprising a medicine of high molecular weight and exhibiting an improved storage stability |
| US7998929B2 (en) * | 2000-09-01 | 2011-08-16 | Chugai Seikyaku Kabushiki Kaisha | Solution preparations stabilized over long time |
| US20020150541A1 (en) * | 2000-09-12 | 2002-10-17 | Gene Trol Biotherapeutics, Inc. | Compositions comprising mixtures of therapeutic proteins and methods of producing the same |
| US20030129162A1 (en) * | 2000-09-12 | 2003-07-10 | Lau Allan S. | Compositions comprising mixtures of therapeutic proteins and methods of producing the same |
| CA2422060A1 (en) * | 2000-09-12 | 2002-03-21 | Genetrol Biotherapeutics, Inc. | Compositions comprising mixtures of human cytokines and methods of producing the same |
| US20020141970A1 (en) * | 2001-03-05 | 2002-10-03 | Pettit Dean K. | Stable aqueous solutions of granulocyte macrophage colony-stimulating factor |
| DE10163459A1 (de) * | 2001-12-21 | 2003-07-03 | Merck Patent Gmbh | Lyophilisierte Zubereitung enthaltend Antikörper gegen EGF-Rezeptor |
| DE10204792A1 (de) * | 2002-02-06 | 2003-08-14 | Merck Patent Gmbh | Lyophilisierte Zubereitung enthaltend Immuncytokine |
| JP5057648B2 (ja) * | 2002-09-26 | 2012-10-24 | 塩野義製薬株式会社 | 安定化されたタンパク組成物 |
| FR2857267B1 (fr) * | 2003-07-09 | 2006-03-10 | Lab Francais Du Fractionnement | Formulation stabilisante et solubilisante pour les proteines cryoprecipitables. |
| DE10348550A1 (de) * | 2003-10-20 | 2005-06-16 | Hexal Biotech Forschungsgmbh | Stabile wässrige G-CSF-haltige Zusammensetzungen |
| WO2005065079A2 (en) * | 2003-11-10 | 2005-07-21 | Angiotech International Ag | Medical implants and fibrosis-inducing agents |
| SI21639A (sl) * | 2003-12-23 | 2005-06-30 | LEK farmacevtska dru�ba d.d. | Farmacevtski pripravek, ki vsebuje nemicelarne sulfobetaine |
| DE102004022928A1 (de) * | 2004-05-10 | 2005-12-08 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Pulver enthaltend neuartige Oligosacharidgemische und Verfahren zu deren Herstellung |
| DK1658848T3 (da) | 2004-10-29 | 2007-11-26 | Pharma Mar Sa | Formuleringer omfattende ecteinascidin og et disaccharid |
| DE202006020194U1 (de) | 2006-03-01 | 2007-12-06 | Bioceuticals Arzneimittel Ag | G-CSF-Flüssigformulierung |
| KR101438839B1 (ko) * | 2006-04-14 | 2014-10-02 | 맨카인드 코포레이션 | 글루카곤 유사 펩타이드 1 （ｇｌｐ-1） 약제학적 제제 |
| ES2365832T3 (es) * | 2007-03-05 | 2011-10-11 | Cadila Healthcare Limited | Composiciones que comprenden conjugados de peg-interferón alfa y rafinosa como crioprotector. |
| EP2142207A4 (en) * | 2007-04-04 | 2013-01-16 | Theratechnologies Inc | PHARMACEUTICAL FORMULATIONS OF GHRH MOLECULES |
| CA2679551C (en) * | 2007-04-05 | 2014-10-21 | Sandoz Ag | Stable aqueous g-csf formulations |
| MX2010002348A (es) | 2007-08-27 | 2010-07-30 | Biogenerix Ag | Formulacion liquida de g-csf. |
| US20110212127A1 (en) * | 2008-09-24 | 2011-09-01 | Stabilitech Ltd. | Method for Preserving Polypeptides Using a Sugar and Polyethyleneimine |
| US20100168018A1 (en) * | 2008-11-07 | 2010-07-01 | Baxter International Inc. | Factor viii formulations |
| US8323634B2 (en) * | 2009-01-16 | 2012-12-04 | Teva Pharmaceutical Industries Ltd. | Stable formulations of highly concentrated recombinant human albumin-human granulocyte colony stimulating factor |
| WO2011134979A2 (en) * | 2010-04-27 | 2011-11-03 | Scil Technology Gmbh | Stable mia/cd-rap formulation |
| AR083006A1 (es) * | 2010-09-23 | 2013-01-23 | Lilly Co Eli | Formulaciones para el factor estimulante de colonias de granulocitos (g-csf) bovino y variantes de las mismas |
| DK3744319T3 (da) | 2019-05-28 | 2023-01-16 | Ilkogen Ilac Sanayi Ve Ticaret A S | Stabil lyofiliseret formulering til hybrid fc-fusioneret g-csf |
| CN112807281A (zh) * | 2019-10-31 | 2021-05-18 | 南京海维医药科技有限公司 | 包含血管紧张素ii的稳定组合物及其制备方法、使用方法 |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GR871067B (en) * | 1986-07-18 | 1987-11-19 | Chugai Pharmaceutical Co Ltd | Process for producing stable pharmaceutical preparation containing granulocyte colony stimulating factor |
| JP2577744B2 (ja) * | 1986-07-18 | 1997-02-05 | 中外製薬株式会社 | 安定な顆粒球コロニ−刺激因子含有製剤 |
| US5104651A (en) * | 1988-12-16 | 1992-04-14 | Amgen Inc. | Stabilized hydrophobic protein formulations of g-csf |
| JP3249147B2 (ja) * | 1990-06-01 | 2002-01-21 | キリン−アムジエン・インコーポレーテツド | 生理活性蛋白含有経口製剤 |
| US5416071A (en) * | 1991-03-12 | 1995-05-16 | Takeda Chemical Industries, Ltd. | Water-soluble composition for sustained-release containing epo and hyaluronic acid |
| DE4126984A1 (de) * | 1991-08-15 | 1993-02-18 | Boehringer Mannheim Gmbh | Verfahren zur herstellung von humanprotein-enthaltenden, gut vertraeglichen arzneimitteln fuer infusions- oder injektionszwecke |
| DE4126983A1 (de) * | 1991-08-15 | 1993-02-18 | Boehringer Mannheim Gmbh | Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke |
| CA2127877A1 (en) * | 1992-01-21 | 1993-07-22 | Robert M. Platz | Improved process for preparing micronized polypeptide drugs |
| DE4242919A1 (de) * | 1992-12-18 | 1994-06-23 | Boehringer Mannheim Gmbh | Verfahren zur Herstellung von lagerstabilen wässrigen pharmazeutischen Zubereitungen von G-CSF |
| AU3599995A (en) * | 1994-10-04 | 1996-04-26 | Csl Limited | Controlled-release pharmaceutical preparations |
-
1992
- 1992-12-18 DE DE4242863A patent/DE4242863A1/de not_active Withdrawn
-
1993
- 1993-12-15 AT AT94902772T patent/ATE165007T1/de active
- 1993-12-15 CA CA002151732A patent/CA2151732C/en not_active Expired - Lifetime
- 1993-12-15 ES ES94902772T patent/ES2117781T3/es not_active Expired - Lifetime
- 1993-12-15 US US08/454,186 patent/US5919443A/en not_active Expired - Lifetime
- 1993-12-15 KR KR1019950702588A patent/KR100266145B1/ko not_active IP Right Cessation
- 1993-12-15 SG SG1996001884A patent/SG66740A1/en unknown
- 1993-12-15 HU HU9501764A patent/HU220256B/hu not_active IP Right Cessation
- 1993-12-15 EP EP94902772A patent/EP0674524B1/de not_active Expired - Lifetime
- 1993-12-15 JP JP6514766A patent/JPH08504784A/ja not_active Ceased
- 1993-12-15 DE DE59308415T patent/DE59308415D1/de not_active Expired - Lifetime
- 1993-12-15 AU AU68086/94A patent/AU676573B2/en not_active Expired
- 1993-12-15 DK DK94902772T patent/DK0674524T3/da active
- 1993-12-15 NZ NZ258912A patent/NZ258912A/en not_active IP Right Cessation
- 1993-12-15 WO PCT/EP1993/003543 patent/WO1994014465A1/de active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| CA2151732A1 (en) | 1994-07-07 |
| KR100266145B1 (ko) | 2000-09-15 |
| SG66740A1 (en) | 1999-09-21 |
| HUT74269A (en) | 1996-11-28 |
| HU220256B (hu) | 2001-11-28 |
| DE59308415D1 (de) | 1998-05-20 |
| WO1994014465A1 (de) | 1994-07-07 |
| KR950703987A (ko) | 1995-11-17 |
| CA2151732C (en) | 2008-02-12 |
| AU676573B2 (en) | 1997-03-13 |
| EP0674524A1 (de) | 1995-10-04 |
| EP0674524B1 (de) | 1998-04-15 |
| JPH08504784A (ja) | 1996-05-21 |
| DE4242863A1 (de) | 1994-06-23 |
| ATE165007T1 (de) | 1998-05-15 |
| AU6808694A (en) | 1994-07-19 |
| ES2117781T3 (es) | 1998-08-16 |
| US5919443A (en) | 1999-07-06 |
| NZ258912A (en) | 1997-06-24 |
| HU9501764D0 (en) | 1995-08-28 |
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