ECSP14013157A - Formulaciones liofilizadas de fgf-18 - Google Patents
Formulaciones liofilizadas de fgf-18Info
- Publication number
- ECSP14013157A ECSP14013157A EC2014013157A ECSP14013157A ECSP14013157A EC SP14013157 A ECSP14013157 A EC SP14013157A EC 2014013157 A EC2014013157 A EC 2014013157A EC SP14013157 A ECSP14013157 A EC SP14013157A EC SP14013157 A ECSP14013157 A EC SP14013157A
- Authority
- EC
- Ecuador
- Prior art keywords
- formulations
- fgf
- liofilized
- cartilage
- lyophilized formulations
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 4
- 102000003977 fibroblast growth factor 18 Human genes 0.000 title 1
- 108090000370 fibroblast growth factor 18 Proteins 0.000 title 1
- 238000009472 formulation Methods 0.000 abstract 3
- 206010007710 Cartilage injury Diseases 0.000 abstract 1
- 102000018233 Fibroblast Growth Factor Human genes 0.000 abstract 1
- 108050007372 Fibroblast Growth Factor Proteins 0.000 abstract 1
- LNUFLCYMSVYYNW-ZPJMAFJPSA-N [(2r,3r,4s,5r,6r)-2-[(2r,3r,4s,5r,6r)-6-[(2r,3r,4s,5r,6r)-6-[(2r,3r,4s,5r,6r)-6-[[(3s,5s,8r,9s,10s,13r,14s,17r)-10,13-dimethyl-17-[(2r)-6-methylheptan-2-yl]-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-3-yl]oxy]-4,5-disulfo Chemical compound O([C@@H]1[C@@H](COS(O)(=O)=O)O[C@@H]([C@@H]([C@H]1OS(O)(=O)=O)OS(O)(=O)=O)O[C@@H]1[C@@H](COS(O)(=O)=O)O[C@@H]([C@@H]([C@H]1OS(O)(=O)=O)OS(O)(=O)=O)O[C@@H]1[C@@H](COS(O)(=O)=O)O[C@H]([C@@H]([C@H]1OS(O)(=O)=O)OS(O)(=O)=O)O[C@@H]1C[C@@H]2CC[C@H]3[C@@H]4CC[C@@H]([C@]4(CC[C@@H]3[C@@]2(C)CC1)C)[C@H](C)CCCC(C)C)[C@H]1O[C@H](COS(O)(=O)=O)[C@@H](OS(O)(=O)=O)[C@H](OS(O)(=O)=O)[C@H]1OS(O)(=O)=O LNUFLCYMSVYYNW-ZPJMAFJPSA-N 0.000 abstract 1
- 208000015100 cartilage disease Diseases 0.000 abstract 1
- 229940126864 fibroblast growth factor Drugs 0.000 abstract 1
- 238000004519 manufacturing process Methods 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 en particular, se refiere a formulaciones liofilizadas de compuesto de factor de crecimiento de fibroblastos 18 (FGF-18) y a métodos de producción de tales formulaciones. Las formulaciones liofilizadas de acuerdo con la invención son estables después del almacenamiento durante un periodo apropiado. Se pueden usar, después de reconstituir, para el tratamiento de trastornos de los cartílagos tales como osteoartritis o lesión de los cartílagos.
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 |
|---|---|
| ECSP14013157A true ECSP14013157A (es) | 2014-02-28 |
Family
ID=47356563
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EC2014013157A ECSP14013157A (es) | 2011-06-17 | 2014-01-17 | Formulaciones liofilizadas de fgf-18 |
Country Status (32)
| Country | Link |
|---|---|
| US (2) | US9326944B2 (es) |
| EP (2) | EP3056211A1 (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 (14)
| 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 |
| KR102434024B1 (ko) * | 2013-12-24 | 2022-08-22 | 아레스 트레이딩 에스.아. | 알지네이트/콜라겐 히드로겔 중의 fgf-18 제형물 |
| CA2971315C (en) | 2015-01-29 | 2023-02-14 | Ares Trading S.A. | Immunoassays for high positively charged proteins |
| CA2994638A1 (en) * | 2015-08-13 | 2017-02-16 | Merck Patent Gmbh | Combination composition comprising fgf-18 compound |
| LT3687558T (lt) | 2017-09-29 | 2022-06-27 | Merck Patent Gmbh | Metaboliniai biožymenys, skirti atsako į fgf-18 junginį numatymui |
| RS63292B1 (sr) | 2017-09-29 | 2022-06-30 | Merck Patent Gmbh | Inflamatorni biomarkeri za predviđanje responsivnosti na jedinjenje fgf-18 |
| EP3706710B1 (en) * | 2017-11-10 | 2024-04-10 | Novartis AG | Extended release formulations for intra-articular applications |
| IL281333B2 (en) | 2018-09-10 | 2025-11-01 | Merck Patent Gmbh | A method for reducing risk in a clinical trial |
| 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 |
| LT4034115T (lt) * | 2019-09-25 | 2025-04-10 | Lumosa Therapeutics Co., Ltd. | Farmacinė kompozicija, apimanti trombolizinio peptido ir tetrahidroizochinolino konjugatą |
| 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 |
| CN117338705A (zh) * | 2022-06-28 | 2024-01-05 | 中国医学科学院药物研究所 | 一种含有奥司他韦的粉液双室袋制剂及其制备方法 |
| 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 |
| CA2226575C (en) | 1995-07-27 | 2011-10-18 | Genentech, Inc. | Stabile isotonic lyophilized protein formulation |
| US20010056066A1 (en) * | 1996-07-26 | 2001-12-27 | Smithkline Beecham Corporation | Method of treating immune cell mediated systemic diseases |
| UA75316C2 (uk) * | 1996-10-16 | 2006-04-17 | Займодженетікс, Інк. | Гомологи з фактором росту фібробласта |
| 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 |
| AU6411199A (en) * | 1998-10-13 | 2000-05-01 | Chiron Corporation | Angiogenically effective unit dose of fgf and method of administering |
| ATE539157T1 (de) | 1999-12-02 | 2012-01-15 | Zymogenetics Inc | Methoden welche auf zellen zielen, die die fibroblasten wachtumsfaktor-rezeptoren-3 oder -2 exprimieren |
| 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 |
| ATE454137T1 (de) * | 2001-07-25 | 2010-01-15 | Facet Biotech Corp | Stabile lyophilisierte pharmazeutische formulierung des igg-antikörpers daclizumab |
| DE10204792A1 (de) * | 2002-02-06 | 2003-08-14 | Merck Patent Gmbh | Lyophilisierte Zubereitung enthaltend Immuncytokine |
| EP1551426B1 (en) | 2002-10-07 | 2014-06-25 | ZymoGenetics, Inc. | Methods of administering fgf18 |
| AU2004216298B2 (en) | 2003-02-28 | 2009-04-23 | Chugai Seiyaku Kabushiki Kaisha | Stabilized protein-containing formulations |
| EA012281B1 (ru) * | 2004-06-01 | 2009-08-28 | Арес Трейдинг С.А. | Способ стабилизации белков |
| EP1814573B1 (en) * | 2004-10-29 | 2016-03-09 | 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 |
| TW200738261A (en) * | 2005-12-20 | 2007-10-16 | Bristol Myers Squibb Co | Stable protein formulations |
| 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 |
| ES2391657T3 (es) * | 2006-02-07 | 2012-11-28 | Shire Human Genetic Therapies, Inc. | Composiciones estabilizadas de proteínas que tienen un resto tiol libre |
| US8207115B2 (en) | 2006-08-25 | 2012-06-26 | Ares Trading S.A. | Treatment of cartilage disorders with FGF-18 |
| SI2068909T1 (sl) * | 2007-03-30 | 2012-09-28 | Ambrx Inc | Modificirani fgf-21 polipeptidi in njihova uporaba |
| CA2682147C (en) | 2007-03-30 | 2017-08-08 | 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 |
| WO2009080541A1 (en) * | 2007-12-21 | 2009-07-02 | 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 CN CN201710984784.XA patent/CN107715104A/zh active Pending
- 2012-06-15 KR KR1020137034615A patent/KR102019520B1/ko active Active
- 2012-06-15 JP JP2014515216A patent/JP5981538B2/ja active Active
- 2012-06-15 PE PE2013002832A patent/PE20141265A1/es not_active Application Discontinuation
- 2012-06-15 AU AU2012268987A patent/AU2012268987B2/en active Active
- 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 ES ES12728509.6T patent/ES2575732T3/es active Active
- 2012-06-15 CA CA2836667A patent/CA2836667C/en active Active
- 2012-06-15 MX MX2013014894A patent/MX338017B/es active IP Right Grant
- 2012-06-15 PH PH1/2013/502529A patent/PH12013502529A1/en unknown
- 2012-06-15 PT PT127285096T patent/PT2720710E/pt unknown
- 2012-06-15 DK DK12728509.6T patent/DK2720710T3/en active
- 2012-06-15 MY MYPI2013702439A patent/MY170630A/en unknown
- 2012-06-15 SI SI201230600A patent/SI2720710T1/sl unknown
- 2012-06-15 EP EP16161448.2A patent/EP3056211A1/en not_active Withdrawn
- 2012-06-15 BR BR112013032400-7A patent/BR112013032400B1/pt active IP Right Grant
- 2012-06-15 EA EA201490032A patent/EA024937B1/ru not_active IP Right Cessation
- 2012-06-15 US US14/126,937 patent/US9326944B2/en active Active
- 2012-06-15 SG SG2013085162A patent/SG195021A1/en unknown
- 2012-06-15 WO PCT/EP2012/061495 patent/WO2012172072A1/en not_active Ceased
- 2012-06-15 RS RS20160453A patent/RS54875B1/sr unknown
- 2012-06-15 HR HRP20160566TT patent/HRP20160566T1/hr unknown
- 2012-06-15 HU HUE12728509A patent/HUE028355T2/en unknown
- 2012-06-15 EP EP12728509.6A patent/EP2720710B1/en active Active
- 2012-06-15 CN CN201280029683.2A patent/CN103619347A/zh active Pending
- 2012-06-15 UA UAA201314452A patent/UA113174C2/uk unknown
-
2013
- 2013-11-20 ZA ZA2013/08698A patent/ZA201308698B/en unknown
- 2013-12-17 IL IL229977A patent/IL229977A/en active IP Right Grant
- 2013-12-17 CL CL2013003618A patent/CL2013003618A1/es unknown
-
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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