HRP20160566T1 - Liofilizirane formulacije fgf-18 - Google Patents
Liofilizirane formulacije fgf-18 Download PDFInfo
- Publication number
- HRP20160566T1 HRP20160566T1 HRP20160566TT HRP20160566T HRP20160566T1 HR P20160566 T1 HRP20160566 T1 HR P20160566T1 HR P20160566T T HRP20160566T T HR P20160566TT HR P20160566 T HRP20160566 T HR P20160566T HR P20160566 T1 HRP20160566 T1 HR P20160566T1
- Authority
- HR
- Croatia
- Prior art keywords
- lyophilized formulation
- stable lyophilized
- formulation according
- fgf
- vial
- Prior art date
Links
- 102000003977 fibroblast growth factor 18 Human genes 0.000 title claims 7
- 108090000370 fibroblast growth factor 18 Proteins 0.000 title claims 7
- 239000000203 mixture Substances 0.000 title claims 6
- 238000009472 formulation Methods 0.000 title claims 4
- 239000012931 lyophilized formulation Substances 0.000 claims 11
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 4
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 4
- 229930006000 Sucrose Natural products 0.000 claims 4
- 239000008363 phosphate buffer Substances 0.000 claims 4
- 239000005720 sucrose Substances 0.000 claims 4
- 238000004519 manufacturing process Methods 0.000 claims 3
- 229920001993 poloxamer 188 Polymers 0.000 claims 3
- 229940044519 poloxamer 188 Drugs 0.000 claims 3
- 229920001184 polypeptide Polymers 0.000 claims 3
- 102000004196 processed proteins & peptides Human genes 0.000 claims 3
- 108090000765 processed proteins & peptides Proteins 0.000 claims 3
- 125000000539 amino acid group Chemical group 0.000 claims 2
- 239000002904 solvent Substances 0.000 claims 2
- 239000000872 buffer Substances 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 229920001983 poloxamer Polymers 0.000 claims 1
- 229960000502 poloxamer Drugs 0.000 claims 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)
Claims (12)
1. Stabilna liofilizirana formulacija naznačena time da sadrži FGF-18, fosfatni pufer koji drži pH u rasponu između 7.0 i 7.5, poloksamer 188 i saharozu.
2. Stabilna liofilizirana formulacija prema zahtjevu 1, naznačena time da fosfatni pufer drži pH na ili oko 7.2.
3. Stabilna liofilizirana formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time da koncentracija pufera je na ili oko 5 do 100 mM.
4. Stabilna liofilizirana formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time da koncentracija poloksamera 188 je na ili oko 0.1 do 0.4 mg/bočici.
5. Stabilna liofilizirana formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time da koncentracija saharoze je na ili oko 10 do 60 mg/bočici.
6. Stabilna liofilizirana formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time da koncentracija FGF-18 je na ili oko 20 do 300 mcg/bočici.
7. Stabilna liofilizirana formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time da formulacija sadrži 20, 30, 60, 100, 200 ili 300 mcg/bočici FGF-18, 10 mM fosfatnog pufera koji drži pH na ili oko 7.2, 30 mg/bočici saharoze i 0.2 mg/bočici poloksamera 188.
8. Stabilna formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time da formulacija dodatno sadrži 5% suvišak FGF-18.
9. Stabilna liofilizirana formulacija prema bilo kojem od prethodnih zahtjeva, naznačena time da je FGF-18 odabran iz skupine koju čine:
a. polipeptid koji sadrži ili se sastoji od aminokiselinskih ostataka 28-207 iz SEQ ID NO:1,
b. polipeptid koji sadrži ili se sastoji od aminokiselinskih ostataka 28-196 iz SEQ ID NO:1 , i
c. polipeptid koji sadrži ili se sastoji od SEQ ID NO:2.
10. Postupak za proizvodnju stabilne liofilizirane formulacije prema bilo kojem od prethodnih zahtjeva, naznačen time da sadrži korake:
formiranje smjese FGF-18 zajedno sa fosfatnim puferom, poloksamerom i saharozom, i
podvrgavanje smjese liofilizaciji.
11. Proizvodni artikl naznačen time da sadrži prvi spremnik koji sadrži stabilnu liofiliziranu formulaciju prema bilo kojem od zahtjeva 1 - 9 i drugi spremnik koji sadrži otapalo za rekonstituciju.
12. Proizvodni artikl prema zahtjevu 11, naznačen time da spremnik koji sadrži stabilnu liofiliziranu formulaciju i onaj koji sadrži otapalo za rekonstituciju su dva odjeljka sustava sa dvije komore.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP11170437 | 2011-06-17 | ||
| US201161499216P | 2011-06-21 | 2011-06-21 | |
| PCT/EP2012/061495 WO2012172072A1 (en) | 2011-06-17 | 2012-06-15 | Freeze-dried formulations of fgf-18 |
| EP12728509.6A EP2720710B1 (en) | 2011-06-17 | 2012-06-15 | Freeze-dried formulations of fgf-18 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20160566T1 true HRP20160566T1 (hr) | 2016-06-17 |
Family
ID=47356563
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20160566TT HRP20160566T1 (hr) | 2011-06-17 | 2016-05-27 | Liofilizirane formulacije fgf-18 |
Country Status (31)
| Country | Link |
|---|---|
| US (2) | US9326944B2 (hr) |
| EP (2) | EP2720710B1 (hr) |
| JP (1) | JP5981538B2 (hr) |
| KR (1) | KR102019520B1 (hr) |
| CN (2) | CN103619347A (hr) |
| AR (1) | AR086956A1 (hr) |
| AU (1) | AU2012268987B2 (hr) |
| BR (1) | BR112013032400B1 (hr) |
| CA (1) | CA2836667C (hr) |
| CL (1) | CL2013003618A1 (hr) |
| CO (1) | CO6940377A2 (hr) |
| CY (1) | CY1117933T1 (hr) |
| DK (1) | DK2720710T3 (hr) |
| EA (1) | EA024937B1 (hr) |
| EC (1) | ECSP14013157A (hr) |
| ES (1) | ES2575732T3 (hr) |
| HR (1) | HRP20160566T1 (hr) |
| HU (1) | HUE028355T2 (hr) |
| IL (1) | IL229977A (hr) |
| MX (1) | MX338017B (hr) |
| MY (1) | MY170630A (hr) |
| PE (1) | PE20141265A1 (hr) |
| PL (1) | PL2720710T3 (hr) |
| PT (1) | PT2720710E (hr) |
| RS (1) | RS54875B1 (hr) |
| SG (1) | SG195021A1 (hr) |
| SI (1) | SI2720710T1 (hr) |
| TW (1) | TWI527590B (hr) |
| UA (1) | UA113174C2 (hr) |
| WO (1) | WO2012172072A1 (hr) |
| ZA (1) | ZA201308698B (hr) |
Families Citing this family (7)
| 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 |
| EP3086822B1 (en) * | 2013-12-24 | 2020-04-15 | Ares Trading SA | Fgf-18 formulation in alginate/collagen hydrogels |
| US20180236032A1 (en) * | 2015-08-13 | 2018-08-23 | Merck Patent Gmbh | Combination composition comprising fgf-18 compound |
| JP7284750B2 (ja) * | 2017-11-10 | 2023-05-31 | ノバルティス アーゲー | 関節内適用のための持続放出製剤 |
| 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 |
| 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 |
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 |
| EP1516628B1 (en) | 1995-07-27 | 2013-08-21 | Genentech, Inc. | Stable isotonic lyophilized protein formulation |
| US20010056066A1 (en) * | 1996-07-26 | 2001-12-27 | Smithkline Beecham Corporation | Method of treating immune cell mediated systemic diseases |
| JP4091122B2 (ja) | 1996-10-16 | 2008-05-28 | ザイモジェネティクス，インコーポレイティド | 繊維芽細胞増殖因子同族体 |
| 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 |
| AU2003279835B2 (en) * | 2002-10-07 | 2009-09-10 | Zymogenetics, Inc. | Methods of administering FGF18 |
| US8765124B2 (en) | 2003-02-28 | 2014-07-01 | Chugai Seiyaku Kabushiki Kaisha | Stabilized preparation containing protein |
| UA93349C2 (ru) * | 2004-06-01 | 2011-02-10 | Эйрэс Трейдинг C.A. | Способ стабилизации мономерного белка интерферона |
| EP1814573B1 (en) * | 2004-10-29 | 2016-03-09 | ratiopharm GmbH | Remodeling and glycopegylation of fibroblast growth factor (fgf) |
| US7858341B2 (en) | 2004-12-10 | 2010-12-28 | Zymogenetics, Inc. | FGF18 production in prokaryotic hosts |
| CN101584858A (zh) * | 2005-12-20 | 2009-11-25 | 布里斯托尔-迈尔斯斯奎布公司 | 稳定蛋白质制剂 |
| 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 |
| JP5364382B2 (ja) | 2006-02-07 | 2013-12-11 | シャイアー ヒューマン ジェネティック セラピーズ インコーポレイテッド | 遊離チオール部分を有するタンパク質の安定化された組成物 |
| 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 |
| UA101487C2 (en) * | 2007-12-21 | 2013-04-10 | Ф. Хоффманн-Ля Рош Аг | Humanized b-ly1 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 JP JP2014515216A patent/JP5981538B2/ja active Active
- 2012-06-15 KR KR1020137034615A patent/KR102019520B1/ko active IP Right Grant
- 2012-06-15 DK DK12728509.6T patent/DK2720710T3/en active
- 2012-06-15 RS RS20160453A patent/RS54875B1/sr unknown
- 2012-06-15 US US14/126,937 patent/US9326944B2/en active Active
- 2012-06-15 MX MX2013014894A patent/MX338017B/es active IP Right Grant
- 2012-06-15 BR BR112013032400-7A patent/BR112013032400B1/pt active IP Right Grant
- 2012-06-15 AU AU2012268987A patent/AU2012268987B2/en active Active
- 2012-06-15 PL PL12728509.6T patent/PL2720710T3/pl unknown
- 2012-06-15 EP EP12728509.6A patent/EP2720710B1/en active Active
- 2012-06-15 CA CA2836667A patent/CA2836667C/en active Active
- 2012-06-15 EP EP16161448.2A patent/EP3056211A1/en not_active Withdrawn
- 2012-06-15 SI SI201230600A patent/SI2720710T1/sl unknown
- 2012-06-15 HU HUE12728509A patent/HUE028355T2/en unknown
- 2012-06-15 SG SG2013085162A patent/SG195021A1/en unknown
- 2012-06-15 ES ES12728509.6T patent/ES2575732T3/es active Active
- 2012-06-15 AR ARP120102140A patent/AR086956A1/es not_active Application Discontinuation
- 2012-06-15 CN CN201280029683.2A patent/CN103619347A/zh active Pending
- 2012-06-15 WO PCT/EP2012/061495 patent/WO2012172072A1/en active Application Filing
- 2012-06-15 PE PE2013002832A patent/PE20141265A1/es not_active Application Discontinuation
- 2012-06-15 CN CN201710984784.XA patent/CN107715104A/zh active Pending
- 2012-06-15 MY MYPI2013702439A patent/MY170630A/en unknown
- 2012-06-15 EA EA201490032A patent/EA024937B1/ru not_active IP Right Cessation
- 2012-06-15 PT PT127285096T patent/PT2720710E/pt unknown
- 2012-06-15 UA UAA201314452A patent/UA113174C2/uk unknown
-
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
- 2016-05-27 HR HRP20160566TT patent/HRP20160566T1/hr unknown
- 2016-06-22 CY CY20161100564T patent/CY1117933T1/el unknown
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