CL2013003618A1 - Formulacion liofilizada de factor de crecimiento de fibroblastos 18 (fgf-18); método para producir la formulación; artículo de manufactura. - Google Patents
Formulacion liofilizada de factor de crecimiento de fibroblastos 18 (fgf-18); método para producir la formulación; artículo de manufactura.Info
- Publication number
- CL2013003618A1 CL2013003618A1 CL2013003618A CL2013003618A CL2013003618A1 CL 2013003618 A1 CL2013003618 A1 CL 2013003618A1 CL 2013003618 A CL2013003618 A CL 2013003618A CL 2013003618 A CL2013003618 A CL 2013003618A CL 2013003618 A1 CL2013003618 A1 CL 2013003618A1
- Authority
- CL
- Chile
- Prior art keywords
- formulation
- fgf
- growth factor
- fibroblast growth
- article
- Prior art date
Links
- 102000003977 fibroblast growth factor 18 Human genes 0.000 title abstract 4
- 108090000370 fibroblast growth factor 18 Proteins 0.000 title abstract 4
- 238000009472 formulation Methods 0.000 title abstract 4
- 239000000203 mixture Substances 0.000 title abstract 4
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- 239000012931 lyophilized formulation Substances 0.000 title 1
- 238000000034 method Methods 0.000 title 1
- 210000000845 cartilage Anatomy 0.000 abstract 1
- 208000015100 cartilage disease Diseases 0.000 abstract 1
- 150000001875 compounds Chemical class 0.000 abstract 1
- 230000003902 lesion Effects 0.000 abstract 1
- 201000008482 osteoarthritis Diseases 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
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
- A61K38/18—Growth factors; Growth regulators
-
- 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
- A61K38/18—Growth factors; Growth regulators
- A61K38/1825—Fibroblast growth factor [FGF]
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
-
- 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
- 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
- A61P19/00—Drugs for skeletal disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/04—Drugs for skeletal disorders for non-specific disorders of the connective tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Physical Education & Sports Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Rheumatology (AREA)
- Biochemistry (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Biophysics (AREA)
- Biomedical Technology (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
Abstract
La invención se refiere al campo de las formulaciones farmacéuticas. Más particularmente se dirige a formulaciones de compuesto de Factor de Crecimiento de Fibroblastos 18 (18-FGF) y a métodos de producción de tales formulaciones liofilizadas. Las formulaciones liofilizadas de acuerdo con la invención son estables durante el almacenamiento durante un período adecuado de tiempo. Se pueden utilizar, después de la reconstitución, para el tratamiento de trastornos del cartílago, tales como osteoartritis o lesiones del cartílago.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP11170437 | 2011-06-17 | ||
| US201161499216P | 2011-06-21 | 2011-06-21 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CL2013003618A1 true CL2013003618A1 (es) | 2014-07-04 |
Family
ID=47356563
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CL2013003618A CL2013003618A1 (es) | 2011-06-17 | 2013-12-17 | Formulacion liofilizada de factor de crecimiento de fibroblastos 18 (fgf-18); método para producir la formulación; artículo de manufactura. |
Country Status (32)
| Country | Link |
|---|---|
| US (2) | US9326944B2 (es) |
| EP (2) | EP2720710B1 (es) |
| JP (1) | JP5981538B2 (es) |
| KR (1) | KR102019520B1 (es) |
| CN (2) | CN107715104A (es) |
| AR (1) | AR086956A1 (es) |
| AU (1) | AU2012268987B2 (es) |
| BR (1) | BR112013032400B1 (es) |
| CA (1) | CA2836667C (es) |
| CL (1) | CL2013003618A1 (es) |
| CO (1) | CO6940377A2 (es) |
| CY (1) | CY1117933T1 (es) |
| DK (1) | DK2720710T3 (es) |
| EA (1) | EA024937B1 (es) |
| EC (1) | ECSP14013157A (es) |
| ES (1) | ES2575732T3 (es) |
| HR (1) | HRP20160566T1 (es) |
| HU (1) | HUE028355T2 (es) |
| IL (1) | IL229977A (es) |
| MX (1) | MX338017B (es) |
| MY (1) | MY170630A (es) |
| PE (1) | PE20141265A1 (es) |
| PH (1) | PH12013502529A1 (es) |
| PL (1) | PL2720710T3 (es) |
| PT (1) | PT2720710E (es) |
| RS (1) | RS54875B1 (es) |
| SG (1) | SG195021A1 (es) |
| SI (1) | SI2720710T1 (es) |
| TW (1) | TWI527590B (es) |
| UA (1) | UA113174C2 (es) |
| WO (1) | WO2012172072A1 (es) |
| ZA (1) | ZA201308698B (es) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI527590B (zh) * | 2011-06-17 | 2016-04-01 | 艾瑞斯貿易公司 | Fgf-18之凍乾調配物 |
| BR112016014717B1 (pt) | 2013-12-24 | 2020-12-01 | Ares Trading S.A. | sistema de gelificação de dois componentes, método para produção de um hidrogel homogêneo, e artigo de produção |
| CN107209177A (zh) | 2015-01-29 | 2017-09-26 | 阿雷斯贸易股份有限公司 | 用于高正电荷蛋白的免疫测定法 |
| CN107921095A (zh) * | 2015-08-13 | 2018-04-17 | 默克专利有限公司 | 包含fgf‑18化合物的复方组合物 |
| WO2019063758A1 (en) | 2017-09-29 | 2019-04-04 | Merck Patent Gmbh | METABOLIC BIOMARKERS FOR PREDICTING RESPONSE TO FGF-18 COMPOUND |
| WO2019063756A1 (en) | 2017-09-29 | 2019-04-04 | Merck Patent Gmbh | INFLAMMATORY BIOMARKERS FOR PREDICTING REACTIVITY TO FGF-18 COMPOUND |
| TWI813597B (zh) * | 2017-11-10 | 2023-09-01 | 瑞士商諾華公司 | 用於關節內施用之延長釋放調配物 |
| ES2980597T3 (es) | 2018-09-10 | 2024-10-02 | Merck Patent Gmbh | Marcadores útiles en las estrategias de enriquecimiento para el tratamiento de la artrosis |
| CN109836487B (zh) * | 2019-03-01 | 2022-06-17 | 重庆派金生物科技有限公司 | 一种人成纤维细胞生长因子18及其可溶性重组表达方法、制备方法、制剂和应用 |
| CN112121150A (zh) * | 2019-06-24 | 2020-12-25 | 杭州生物医药创新研究中心 | 一种成纤维细胞生长因子10冻干粉 |
| SI4034115T1 (sl) * | 2019-09-25 | 2025-04-30 | Lumosa Therapeutics Co., Ltd. | Farmacevtski sestavek, ki obsega konjugat trombolitični peptid-tetrahidroizokinolin |
| CN113304063A (zh) * | 2021-04-23 | 2021-08-27 | 四川省恩乐生物工程有限公司 | 一种用于肌肤美容抗衰老的组合物及其制备方法 |
| CN118310835B (zh) * | 2024-04-16 | 2025-04-11 | 杭州百凌生物科技有限公司 | 一种质控品冻干粉及其制备方法和应用 |
Family Cites Families (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5217954A (en) * | 1990-04-04 | 1993-06-08 | Scios Nova Inc. | Formulations for stabilizing fibroblast growth factor |
| GB9015824D0 (en) | 1990-07-18 | 1990-09-05 | Erba Carlo Spa | Stable pharmaceutical compositions containing a fibroblast growth factor |
| DK1516628T3 (da) | 1995-07-27 | 2013-09-08 | Genentech Inc | Stabil, isotonisk lyofiliseret proteinformulering |
| US20010056066A1 (en) * | 1996-07-26 | 2001-12-27 | Smithkline Beecham Corporation | Method of treating immune cell mediated systemic diseases |
| DE69740074D1 (de) * | 1996-10-16 | 2011-01-20 | Zymogenetics Inc | Fibroblasten-Wachstumsfaktoren-Homologe |
| CN1184673A (zh) * | 1996-12-13 | 1998-06-17 | 中国医科大学 | Fgf粗提多肽生长因子混合物及其提取工艺 |
| JP2002527401A (ja) * | 1998-10-13 | 2002-08-27 | カイロン コーポレイション | Fgfの脈管形成的に有効な単位用量および投与方法 |
| WO2001039788A2 (en) | 1999-12-02 | 2001-06-07 | Zymogenetics, Inc. | Methods for targeting cells that express fibroblast growth receptor-3 or-2 |
| CN1303714A (zh) * | 2000-01-13 | 2001-07-18 | 重庆多泰制药有限公司 | Ii型胶原蛋白口服胃溶制剂 |
| WO2002017956A2 (en) * | 2000-08-31 | 2002-03-07 | Chiron Corporation | Stabilized fgf formulations containing reducing agents |
| JP4317010B2 (ja) * | 2001-07-25 | 2009-08-19 | ピーディーエル バイオファーマ,インコーポレイティド | IgG抗体の安定な凍結乾燥医薬製剤 |
| DE10204792A1 (de) * | 2002-02-06 | 2003-08-14 | Merck Patent Gmbh | Lyophilisierte Zubereitung enthaltend Immuncytokine |
| AU2003279835B2 (en) | 2002-10-07 | 2009-09-10 | Zymogenetics, Inc. | Methods of administering FGF18 |
| JP4607010B2 (ja) | 2003-02-28 | 2011-01-05 | 中外製薬株式会社 | タンパク質含有安定化製剤 |
| JP2008500995A (ja) * | 2004-06-01 | 2008-01-17 | アレス トレーディング ソシエテ アノニム | タンパク質安定化法 |
| EP2586456B1 (en) * | 2004-10-29 | 2016-01-20 | ratiopharm GmbH | Remodeling and glycopegylation of fibroblast growth factor (FGF) |
| DK1828239T3 (da) | 2004-12-10 | 2011-12-19 | Zymogenetics Inc | FGF18-produktion i prokaryote værter |
| KR101378194B1 (ko) * | 2005-12-20 | 2014-03-27 | 브리스톨-마이어스 스큅 컴퍼니 | 안정한 단백질 제제 |
| JP4729740B2 (ja) * | 2006-01-11 | 2011-07-20 | 独立行政法人産業技術総合研究所 | 受容体特異性を変化させたミュータント増殖因子およびそれを含有する医薬組成物 |
| SI1986612T1 (sl) | 2006-02-07 | 2013-01-31 | Shire Human Genetic Therapies, Inc. | Stabilizirana spojina glukocerebrosidaze |
| US8207115B2 (en) | 2006-08-25 | 2012-06-26 | Ares Trading S.A. | Treatment of cartilage disorders with FGF-18 |
| CN101663046B (zh) * | 2007-03-30 | 2017-07-28 | Ambrx公司 | 经修饰fgf‑21多肽和其用途 |
| EP2068909B1 (en) * | 2007-03-30 | 2012-04-25 | Ambrx, Inc. | Modified fgf-21 polypeptides and their uses |
| CN101181280B (zh) * | 2007-11-23 | 2010-07-14 | 深圳万乐药业有限公司 | 吡柔比星冻干制剂及其制备方法 |
| AU2008340429C1 (en) * | 2007-12-21 | 2016-09-08 | F. Hoffmann-La Roche Ag | Antibody formulation |
| TWI527590B (zh) * | 2011-06-17 | 2016-04-01 | 艾瑞斯貿易公司 | Fgf-18之凍乾調配物 |
-
2012
- 2012-06-11 TW TW101120864A patent/TWI527590B/zh active
- 2012-06-15 PE PE2013002832A patent/PE20141265A1/es not_active Application Discontinuation
- 2012-06-15 JP JP2014515216A patent/JP5981538B2/ja active Active
- 2012-06-15 EA EA201490032A patent/EA024937B1/ru not_active IP Right Cessation
- 2012-06-15 AU AU2012268987A patent/AU2012268987B2/en active Active
- 2012-06-15 SG SG2013085162A patent/SG195021A1/en unknown
- 2012-06-15 ES ES12728509.6T patent/ES2575732T3/es active Active
- 2012-06-15 US US14/126,937 patent/US9326944B2/en active Active
- 2012-06-15 EP EP12728509.6A patent/EP2720710B1/en active Active
- 2012-06-15 SI SI201230600A patent/SI2720710T1/sl unknown
- 2012-06-15 CN CN201710984784.XA patent/CN107715104A/zh active Pending
- 2012-06-15 UA UAA201314452A patent/UA113174C2/uk unknown
- 2012-06-15 RS RS20160453A patent/RS54875B1/sr unknown
- 2012-06-15 CN CN201280029683.2A patent/CN103619347A/zh active Pending
- 2012-06-15 HR HRP20160566TT patent/HRP20160566T1/hr unknown
- 2012-06-15 AR ARP120102140A patent/AR086956A1/es not_active Application Discontinuation
- 2012-06-15 PL PL12728509.6T patent/PL2720710T3/pl unknown
- 2012-06-15 MY MYPI2013702439A patent/MY170630A/en unknown
- 2012-06-15 MX MX2013014894A patent/MX338017B/es active IP Right Grant
- 2012-06-15 DK DK12728509.6T patent/DK2720710T3/en active
- 2012-06-15 KR KR1020137034615A patent/KR102019520B1/ko active Active
- 2012-06-15 CA CA2836667A patent/CA2836667C/en active Active
- 2012-06-15 PH PH1/2013/502529A patent/PH12013502529A1/en unknown
- 2012-06-15 HU HUE12728509A patent/HUE028355T2/en unknown
- 2012-06-15 PT PT127285096T patent/PT2720710E/pt unknown
- 2012-06-15 BR BR112013032400-7A patent/BR112013032400B1/pt active IP Right Grant
- 2012-06-15 EP EP16161448.2A patent/EP3056211A1/en not_active Withdrawn
- 2012-06-15 WO PCT/EP2012/061495 patent/WO2012172072A1/en not_active Ceased
-
2013
- 2013-11-20 ZA ZA2013/08698A patent/ZA201308698B/en unknown
- 2013-12-17 CL CL2013003618A patent/CL2013003618A1/es unknown
- 2013-12-17 IL IL229977A patent/IL229977A/en active IP Right Grant
-
2014
- 2014-01-15 CO CO14006968A patent/CO6940377A2/es unknown
- 2014-01-17 EC EC2014013157A patent/ECSP14013157A/es unknown
-
2016
- 2016-04-26 US US15/138,240 patent/US20160228374A1/en not_active Abandoned
- 2016-06-22 CY CY20161100564T patent/CY1117933T1/el unknown
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