AR086956A1 - Formulaciones liofilizadas de fgf-18 - Google Patents
Formulaciones liofilizadas de fgf-18Info
- Publication number
- AR086956A1 AR086956A1 ARP120102140A ARP120102140A AR086956A1 AR 086956 A1 AR086956 A1 AR 086956A1 AR P120102140 A ARP120102140 A AR P120102140A AR P120102140 A ARP120102140 A AR P120102140A AR 086956 A1 AR086956 A1 AR 086956A1
- Authority
- AR
- Argentina
- Prior art keywords
- fgf
- formulations
- liofilized
- stable
- lyophilized
- 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
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 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
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 229940126864 fibroblast growth factor Drugs 0.000 abstract 1
- 239000012931 lyophilized formulation Substances 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 201000008482 osteoarthritis Diseases 0.000 abstract 1
- 229960000502 poloxamer Drugs 0.000 abstract 1
- 229920001983 poloxamer Polymers 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 abstract 1
Classifications
-
- 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
- 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
- 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)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (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)
- Pain & Pain Management (AREA)
- Biomedical Technology (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
Abstract
Formulaciones liofilizadas de compuesto de factor de crecimiento de fibroblastos 18 (FGF-18) y métodos de producción de tales formulaciones. Las formulaciones liofilizadas de acuerdo con la presente son estables después del almacenamiento durante un período apropiado. Se pueden usar, después de reconstituir, para el tratamiento de trastornos de los cartílagos tales como osteoartritis o lesión de los cartílagos.Reivindicación 1: Una formulación liofilizada estable que comprende FGF-18, un tampón, un tensioactivo de poloxámero y un azúcar como agente estabilizante.
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 |
|---|---|
| AR086956A1 true AR086956A1 (es) | 2014-02-05 |
Family
ID=47356563
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP120102140A AR086956A1 (es) | 2011-06-17 | 2012-06-15 | 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) | CN103619347A (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 |
| US9795714B2 (en) * | 2013-12-24 | 2017-10-24 | Ares Trading S.A. | FGF-18 formulation in alginate/collagen hydrogels |
| 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 |
| KR20180035911A (ko) * | 2015-08-13 | 2018-04-06 | 메르크 파텐트 게엠베하 | Fgf-18 화합물을 포함하는 조합 조성물 |
| RS63293B1 (sr) | 2017-09-29 | 2022-06-30 | Merck Patent Gmbh | Metabolički biomarkeri za predviđanje reakcije na jedinjenje fgf-18 |
| HUE058848T2 (hu) | 2017-09-29 | 2022-09-28 | Merck Patent Gmbh | FGF-18 vegyületre vonatkozó válaszkészség elõrejelzésére szolgáló gyulladásos biomarkerek |
| FI3706710T3 (fi) * | 2017-11-10 | 2024-07-08 | Novartis Ag | Pitkäkestoisesti vapautuvia formulaatioita nivelensisäisiin käyttötarkoituksiin |
| 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 |
| HRP20250453T1 (hr) * | 2019-09-25 | 2025-06-06 | Lumosa Therapeutics Co., Ltd. | Farmaceutski pripravak koji sadrži konjugat trombolitičkog peptida-tetrahidroizohinolina |
| 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 |
| ES2434840T3 (es) * | 1995-07-27 | 2013-12-17 | Genentech, Inc. | Formulación de proteína liofilizada isotónica estable |
| US20010056066A1 (en) * | 1996-07-26 | 2001-12-27 | Smithkline Beecham Corporation | Method of treating immune cell mediated systemic diseases |
| ES2403880T3 (es) * | 1996-10-16 | 2013-05-22 | Zymogenetics, Inc. | Homólogos de factor de crecimiento de fibroblastos |
| 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 |
| CA2393200C (en) | 1999-12-02 | 2011-07-12 | 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 |
| US7754686B2 (en) | 2000-08-31 | 2010-07-13 | Novartis Vaccines And Diagnostics, Inc. | Stabilized FGF formulations containing reducing agents |
| DE60235013D1 (de) * | 2001-07-25 | 2010-02-25 | 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 |
| US20040136970A1 (en) | 2002-10-07 | 2004-07-15 | Ellsworth Jeff L. | Methods for administering FGF18 |
| CA2517310C (en) | 2003-02-28 | 2015-11-24 | Chugai Seiyaku Kabushiki Kaisha | Stabilized protein-containing formulations comprising a poloxamer |
| AU2005249232B2 (en) * | 2004-06-01 | 2010-08-05 | Ares Trading S.A. | Method of stabilizing proteins |
| SI2586456T1 (sl) * | 2004-10-29 | 2016-05-31 | Ratiopharm Gmbh | Preoblikovanje in glikopegliacija fibroblastnega rastnega faktorja (FGF) |
| ES2371219T3 (es) * | 2004-12-10 | 2011-12-28 | Zymogenetics, Inc. | Producción de fgf18 en huéspedes procariotas. |
| WO2007076354A2 (en) * | 2005-12-20 | 2007-07-05 | Bristol-Myers Squibb Company | 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 |
| EP2054050B1 (en) | 2006-08-25 | 2012-08-08 | Ares Trading S.A. | Treatment of cartilage disorders with fgf-18 |
| EP2068909B1 (en) * | 2007-03-30 | 2012-04-25 | Ambrx, Inc. | Modified fgf-21 polypeptides and their uses |
| CN101663046B (zh) * | 2007-03-30 | 2017-07-28 | Ambrx公司 | 经修饰fgf‑21多肽和其用途 |
| 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 |
| MY171841A (en) * | 2007-12-21 | 2019-11-04 | Hoffmann La Roche | 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 EP EP16161448.2A patent/EP3056211A1/en not_active Withdrawn
- 2012-06-15 PT PT127285096T patent/PT2720710E/pt unknown
- 2012-06-15 KR KR1020137034615A patent/KR102019520B1/ko active Active
- 2012-06-15 AR ARP120102140A patent/AR086956A1/es not_active Application Discontinuation
- 2012-06-15 CA CA2836667A patent/CA2836667C/en active Active
- 2012-06-15 MY MYPI2013702439A patent/MY170630A/en unknown
- 2012-06-15 EP EP12728509.6A patent/EP2720710B1/en active Active
- 2012-06-15 PE PE2013002832A patent/PE20141265A1/es not_active Application Discontinuation
- 2012-06-15 HU HUE12728509A patent/HUE028355T2/en unknown
- 2012-06-15 BR BR112013032400-7A patent/BR112013032400B1/pt active IP Right Grant
- 2012-06-15 PH PH1/2013/502529A patent/PH12013502529A1/en unknown
- 2012-06-15 MX MX2013014894A patent/MX338017B/es active IP Right Grant
- 2012-06-15 US US14/126,937 patent/US9326944B2/en active Active
- 2012-06-15 SG SG2013085162A patent/SG195021A1/en unknown
- 2012-06-15 CN CN201280029683.2A patent/CN103619347A/zh active Pending
- 2012-06-15 HR HRP20160566TT patent/HRP20160566T1/hr unknown
- 2012-06-15 JP JP2014515216A patent/JP5981538B2/ja active Active
- 2012-06-15 DK DK12728509.6T patent/DK2720710T3/en active
- 2012-06-15 UA UAA201314452A patent/UA113174C2/uk unknown
- 2012-06-15 ES ES12728509.6T patent/ES2575732T3/es active Active
- 2012-06-15 EA EA201490032A patent/EA024937B1/ru not_active IP Right Cessation
- 2012-06-15 RS RS20160453A patent/RS54875B1/sr unknown
- 2012-06-15 PL PL12728509.6T patent/PL2720710T3/pl unknown
- 2012-06-15 WO PCT/EP2012/061495 patent/WO2012172072A1/en not_active Ceased
- 2012-06-15 AU AU2012268987A patent/AU2012268987B2/en active Active
- 2012-06-15 SI SI201230600A patent/SI2720710T1/sl unknown
- 2012-06-15 CN CN201710984784.XA patent/CN107715104A/zh active Pending
-
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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