MX2010002448A - Formulacion liquida del g-csf conjugado. - Google Patents
Formulacion liquida del g-csf conjugado.Info
- Publication number
- MX2010002448A MX2010002448A MX2010002448A MX2010002448A MX2010002448A MX 2010002448 A MX2010002448 A MX 2010002448A MX 2010002448 A MX2010002448 A MX 2010002448A MX 2010002448 A MX2010002448 A MX 2010002448A MX 2010002448 A MX2010002448 A MX 2010002448A
- Authority
- MX
- Mexico
- Prior art keywords
- composition
- salts
- stimulating factor
- colony stimulating
- granulocyte colony
- Prior art date
Links
Classifications
-
- 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
- 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
- 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
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- 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
- A61P37/04—Immunostimulants
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/06—Antianaemics
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K17/00—Carrier-bound or immobilised peptides; Preparation thereof
- C07K17/02—Peptides being immobilised on, or in, an organic carrier
- C07K17/08—Peptides being immobilised on, or in, an organic carrier the carrier being a synthetic polymer
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Molecular Biology (AREA)
- Neurology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Biomedical Technology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Neurosurgery (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Abstract
La presente invención se relaciona con una composición farmacéutica líquida que comprende un polipéptido del factor estimulador de colonias de granulocitos conjugado con un polímero, la composición tiene un valor de pH en la variación de 4.5 a 5.5. La composición comprende además un tensioactivo y opcionalmente uno o más de otros excipientes farmacéuticamente aceptables. Además, la composición de la invención está libre de ácido tartárico o las sales del mismo y de ácido succínico o. las sales del mismo como agentes amortiguadores y no contiene aminoácidos como estabilizante. La composición tiene una buena estabilidad en almacenamiento y es especialmente útil para la profilaxis y tratamiento de trastornos e indicaciones médicas donde se consideran como remedios útiles las preparaciones del factor estimulador de colonias de granulocitos.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP07115047 | 2007-08-27 | ||
| PCT/EP2008/061232 WO2009027437A1 (en) | 2007-08-27 | 2008-08-27 | Liquid formulation of g-csf conjugate |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2010002448A true MX2010002448A (es) | 2010-10-04 |
Family
ID=39862881
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2010002448A MX2010002448A (es) | 2007-08-27 | 2008-08-27 | Formulacion liquida del g-csf conjugado. |
Country Status (24)
| Country | Link |
|---|---|
| US (1) | US8546328B2 (es) |
| EP (2) | EP2578235A3 (es) |
| JP (2) | JP5570988B2 (es) |
| KR (1) | KR20100052501A (es) |
| CN (2) | CN101827864A (es) |
| AU (1) | AU2008292186B9 (es) |
| BR (1) | BRPI0815975B8 (es) |
| CA (1) | CA2696594C (es) |
| CY (1) | CY1115908T1 (es) |
| DE (1) | DE202008017456U1 (es) |
| DK (1) | DK2197919T3 (es) |
| EA (1) | EA020069B1 (es) |
| ES (1) | ES2476915T3 (es) |
| HR (1) | HRP20140590T1 (es) |
| IL (1) | IL204190A (es) |
| MX (1) | MX2010002448A (es) |
| NZ (1) | NZ583276A (es) |
| PL (1) | PL2197919T3 (es) |
| PT (1) | PT2197919E (es) |
| RS (1) | RS53404B (es) |
| SI (1) | SI2197919T1 (es) |
| UA (1) | UA98001C2 (es) |
| WO (1) | WO2009027437A1 (es) |
| ZA (1) | ZA201000798B (es) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9867777B2 (en) * | 2010-01-19 | 2018-01-16 | Hanmi Science Co., Ltd. | Liquid formulations for long-acting G-CSF conjugate |
| KR101853146B1 (ko) | 2010-03-17 | 2018-04-27 | 라티오팜 게엠베하 | 생물학적으로 활성인 재조합 인간 gcsf의 수득 방법 |
| EP2384759A1 (en) | 2010-05-06 | 2011-11-09 | Suomen Punainen Risti Veripalvelu | Sulphated hyaluronic acid in combination with G-CSF for use in mobilising blood stem cells |
| TWI751154B (zh) * | 2016-04-18 | 2022-01-01 | 大陸商江蘇恆瑞醫藥股份有限公司 | 一種重組人粒細胞集落刺激因子的製備方法 |
| IT201700108526A1 (it) * | 2017-09-28 | 2019-03-28 | Alfasigma Spa | Composizioni orali per il trattamento del refluso gastroesofageo. |
| KR102589578B1 (ko) * | 2018-05-04 | 2023-10-17 | 일코겐 일라익 사나이 비 티카렛 에이.에스. | 안정한 하이브리드 fc 융합 g-csf 제형 |
| KR102375269B1 (ko) * | 2021-01-27 | 2022-03-17 | 한미약품 주식회사 | 단백질 액상 제제 및 이의 제조방법 |
| CN114224853B (zh) * | 2022-01-04 | 2022-09-23 | 山东新时代药业有限公司 | 聚乙二醇化重组人粒细胞刺激因子注射用冻干制剂 |
| CN119698274A (zh) * | 2022-08-19 | 2025-03-25 | 亿一生物医药开发(上海)有限公司 | 包含g-csf的制剂及其用途 |
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| GB1479268A (en) | 1973-07-05 | 1977-07-13 | Beecham Group Ltd | Pharmaceutical compositions |
| US4179337A (en) | 1973-07-20 | 1979-12-18 | Davis Frank F | Non-immunogenic polypeptides |
| CH596313A5 (es) | 1975-05-30 | 1978-03-15 | Battelle Memorial Institute | |
| US4414147A (en) | 1981-04-17 | 1983-11-08 | Massachusetts Institute Of Technology | Methods of decreasing the hydrophobicity of fibroblast and other interferons |
| US5675941A (en) | 1983-12-09 | 1997-10-14 | Dykmans; Maximiliaan J. | Method and apparatus for constructing prestressed structures utilizing a membrane and floating dome assembly |
| US4496689A (en) | 1983-12-27 | 1985-01-29 | Miles Laboratories, Inc. | Covalently attached complex of alpha-1-proteinase inhibitor with a water soluble polymer |
| DE3676670D1 (de) | 1985-06-26 | 1991-02-07 | Cetus Corp | Solubilisierung von proteinen fuer pharmazeutische zusammensetzungen mittels polymerkonjugierung. |
| US6004548A (en) | 1985-08-23 | 1999-12-21 | Amgen, Inc. | Analogs of pluripotent granulocyte colony-stimulating factor |
| US4810643A (en) | 1985-08-23 | 1989-03-07 | Kirin- Amgen Inc. | Production of pluripotent granulocyte colony-stimulating factor |
| KR0133561B1 (ko) | 1988-05-13 | 1998-04-21 | 스티븐 엠. 오드레 | 과립구 군체 자극인자의 정제방법 |
| US5218092A (en) | 1988-09-29 | 1993-06-08 | Kyowa Hakko Kogyo Co., Ltd. | Modified granulocyte-colony stimulating factor polypeptide with added carbohydrate chains |
| US6166183A (en) | 1992-11-30 | 2000-12-26 | Kirin-Amgen, Inc. | Chemically-modified G-CSF |
| DE68925966T2 (de) | 1988-12-22 | 1996-08-29 | Kirin Amgen Inc | Chemisch modifizierte granulocytenkolonie erregender faktor |
| GB9107846D0 (en) | 1990-04-30 | 1991-05-29 | Ici Plc | Polypeptides |
| DE4014750A1 (de) | 1990-05-08 | 1991-11-14 | Boehringer Mannheim Gmbh | Muteine des granulozyten-stimulierenden faktors (g-csf) |
| US5399345A (en) | 1990-05-08 | 1995-03-21 | Boehringer Mannheim, Gmbh | Muteins of the granulocyte colony stimulating factor |
| US6565841B1 (en) | 1991-03-15 | 2003-05-20 | Amgen, Inc. | Pulmonary administration of granulocyte colony stimulating factor |
| DE4126983A1 (de) * | 1991-08-15 | 1993-02-18 | Boehringer Mannheim Gmbh | Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke |
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| KR100396983B1 (ko) | 2000-07-29 | 2003-09-02 | 이강춘 | 고반응성의 가지 달린 고분자 유도체 및 고분자와 단백질또는 펩타이드의 접합체 |
| WO2002011753A1 (en) | 2000-08-04 | 2002-02-14 | Chugai Seiyaku Kabushiki Kaisha | Protein injection preparations |
| AU8260701A (en) * | 2000-09-01 | 2002-03-13 | Chugai Pharmaceutical Co Ltd | Solution preparations stabilized over long time |
| US7265085B2 (en) | 2001-10-10 | 2007-09-04 | Neose Technologies, Inc. | Glycoconjugation methods and proteins/peptides produced by the methods |
| US7157277B2 (en) | 2001-11-28 | 2007-01-02 | Neose Technologies, Inc. | Factor VIII remodeling and glycoconjugation of Factor VIII |
| US7265084B2 (en) | 2001-10-10 | 2007-09-04 | Neose Technologies, Inc. | Glycopegylation methods and proteins/peptides produced by the methods |
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| SI21273A (sl) | 2002-07-31 | 2004-02-29 | LEK farmacevtska dru�ba d.d. | Priprava inkluzijskih teles z visokim deležem pravilno zvitega prekurzorja heterolognega proteina |
| PL1660134T3 (pl) | 2003-08-08 | 2011-05-31 | Fresenius Kabi Deutschland Gmbh | Koniugaty hydroksyalkiloskrobi i G-CSF |
| WO2005014655A2 (en) | 2003-08-08 | 2005-02-17 | Fresenius Kabi Deutschland Gmbh | Conjugates of hydroxyalkyl starch and a protein |
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| US7585496B2 (en) | 2003-11-04 | 2009-09-08 | Lek Pharmaceuticals D.D. | Stable pharmaceutical composition granulocyte-colony stimulating factor |
| KR101237884B1 (ko) | 2003-12-03 | 2013-02-27 | 바이오제너릭스 에이지 | 글리코 peg화 과립구 콜로니 자극인자 |
| JP5743368B2 (ja) * | 2004-01-08 | 2015-07-01 | ラショファーム ゲーエムベーハー | ペプチドのo結合型グリコシル化 |
| EP1725589A1 (en) | 2004-03-11 | 2006-11-29 | Fresenius Kabi Deutschland GmbH | Conjugates of hydroxyalkyl starch and a protein, prepared by reductive amination |
| CN1929865B (zh) | 2004-03-11 | 2011-11-16 | 费森尤斯卡比德国有限公司 | 羟烷基淀粉和蛋白质的接合物 |
| DE102004036909B4 (de) | 2004-07-29 | 2007-04-05 | Infineon Technologies Ag | Halbleiterbasisbauteil mit Verdrahtungssubstrat und Zwischenverdrahtungsplatte für einen Halbleiterbauteilstapel sowie Verfahren zu deren Herstellung |
| EP2514757A3 (en) * | 2005-01-10 | 2014-03-05 | ratiopharm GmbH | Glycopegylated granulocyte colony stimulating factor |
| EP1869078A2 (en) | 2005-03-17 | 2007-12-26 | Zenotech Laboratories Limited | Process for the purification of recombinant granulocyte-colony stimulating factor |
| BRPI0611221A2 (pt) | 2005-06-01 | 2010-08-24 | Maxygen Holdings Ltd | polipeptÍdeos de g-csf peguilados e mÉtodos de produÇço dos mesmos |
| EP1762250A1 (en) | 2005-09-12 | 2007-03-14 | Fresenius Kabi Deutschland GmbH | Conjugates of hydroxyalkyl starch and an active substance, prepared by chemical ligation via thiazolidine |
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| ITMI20061624A1 (it) | 2006-08-11 | 2008-02-12 | Bioker Srl | Mono-coniugati sito-specifici di g-csf |
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-
2008
- 2008-08-27 ES ES08787525.8T patent/ES2476915T3/es active Active
- 2008-08-27 CN CN200880104971A patent/CN101827864A/zh active Pending
- 2008-08-27 JP JP2010522361A patent/JP5570988B2/ja not_active Expired - Fee Related
- 2008-08-27 KR KR1020107004576A patent/KR20100052501A/ko not_active Ceased
- 2008-08-27 SI SI200831235T patent/SI2197919T1/sl unknown
- 2008-08-27 UA UAA201003493A patent/UA98001C2/uk unknown
- 2008-08-27 NZ NZ583276A patent/NZ583276A/en not_active IP Right Cessation
- 2008-08-27 DE DE202008017456U patent/DE202008017456U1/de not_active Expired - Lifetime
- 2008-08-27 CN CN201510065114.9A patent/CN104689333B/zh not_active Expired - Fee Related
- 2008-08-27 AU AU2008292186A patent/AU2008292186B9/en active Active
- 2008-08-27 HR HRP20140590AT patent/HRP20140590T1/hr unknown
- 2008-08-27 MX MX2010002448A patent/MX2010002448A/es unknown
- 2008-08-27 CA CA2696594A patent/CA2696594C/en not_active Expired - Fee Related
- 2008-08-27 WO PCT/EP2008/061232 patent/WO2009027437A1/en not_active Ceased
- 2008-08-27 EP EP12194213.0A patent/EP2578235A3/en not_active Withdrawn
- 2008-08-27 BR BRPI0815975A patent/BRPI0815975B8/pt not_active IP Right Cessation
- 2008-08-27 US US12/675,749 patent/US8546328B2/en active Active
- 2008-08-27 PT PT87875258T patent/PT2197919E/pt unknown
- 2008-08-27 PL PL08787525T patent/PL2197919T3/pl unknown
- 2008-08-27 EA EA201070315A patent/EA020069B1/ru not_active IP Right Cessation
- 2008-08-27 EP EP08787525.8A patent/EP2197919B1/en active Active
- 2008-08-27 DK DK08787525.8T patent/DK2197919T3/da active
- 2008-08-27 RS RS20140361A patent/RS53404B/sr unknown
-
2010
- 2010-02-03 ZA ZA201000798A patent/ZA201000798B/xx unknown
- 2010-02-25 IL IL204190A patent/IL204190A/en active IP Right Grant
-
2013
- 2013-11-05 JP JP2013229688A patent/JP5836351B2/ja not_active Expired - Fee Related
-
2014
- 2014-07-03 CY CY20141100501T patent/CY1115908T1/el unknown
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