PE20141265A1 - Formulaciones liofilizadas de fgf-18 - Google Patents

Formulaciones liofilizadas de fgf-18

Info

Publication number
PE20141265A1
PE20141265A1 PE2013002832A PE2013002832A PE20141265A1 PE 20141265 A1 PE20141265 A1 PE 20141265A1 PE 2013002832 A PE2013002832 A PE 2013002832A PE 2013002832 A PE2013002832 A PE 2013002832A PE 20141265 A1 PE20141265 A1 PE 20141265A1
Authority
PE
Peru
Prior art keywords
concentration
fgf
vial
seq
freeze
Prior art date
Application number
PE2013002832A
Other languages
English (en)
Inventor
Alessandra Cerreti
Rio Alessandra Del
Original Assignee
Ares Trading Sa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=47356563&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE20141265(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ares Trading Sa filed Critical Ares Trading Sa
Publication of PE20141265A1 publication Critical patent/PE20141265A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1825Fibroblast growth factor [FGF]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/04Drugs for skeletal disorders for non-specific disorders of the connective tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-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)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (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

REFERIDO A UNA FORMULACION LIOFILIZADA ESTABLE QUE COMPRENDE: A) FACTOR DE CRECIMIENTO DE FIBROBLASTOS 18 (FGF-18), CON UNA CONCENTRACION DE 20 A 300 mcg/VIAL, EL CUAL SE SELECCIONA DE: a) UN POLIPEPTIDO QUE COMPRENDE LOS RESIDUOS DE AMINOACIDO 28-207 DE SEQ ID NO:1, b) UN POLIPETIDO QUE COMPRENDE LOS RESIDUOS DE AMINOACIDOS 28-196 DE SEQ ID NO:1 Y c) UN POLIPEPTIDO QUE COMPRENDE LA SEQ ID NO:2; B) UN TAMPON QUE MANTIENE UN pH ENTRE 6 Y 8, TAL COMO FOSFATO, CON UNA CONCENTRACION DE 5 A 100 mM; C) UN TENSIOACTIVO DE POLOXAMERO, TAL COMO POLOXAMERO 188, CON UNA CONCENTRACION DE 0,1 A 0,4 mg/VIAL; Y D) UN AZUCAR COMO AGENTE ESTABILIZANTE, TAL COMO SACAROSA, CON UNA CONCENTRACION DE 10 A 60 mg/ VIAL. REFERIDO ADEMAS A UN METODO PARA PRODUCIR LA FORMULACION LIOFILIZADA. DICHA FORMULACION ES UTIL PARA EL TRATAMIENTO DE TRASTORNOS DE LOS CARTILAGOS TALES COMO OSTEOARTRITIS O LESION DE LOS CARTILAGOS
PE2013002832A 2011-06-17 2012-06-15 Formulaciones liofilizadas de fgf-18 PE20141265A1 (es)

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
PE20141265A1 true PE20141265A1 (es) 2014-09-29

Family

ID=47356563

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2013002832A PE20141265A1 (es) 2011-06-17 2012-06-15 Formulaciones liofilizadas de fgf-18

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 (14)

* Cited by examiner, † Cited by third party
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
NZ721597A (en) 2013-12-24 2022-07-01 Ares Trading Sa Fgf-18 formulation in alginate/collagen hydrogels
WO2016120387A1 (en) 2015-01-29 2016-08-04 Ares Trading S.A. Immunoassays for high positively charged proteins
BR112018002404A2 (pt) * 2015-08-13 2018-09-18 Merck Patent Gmbh composição de combinação compreendendo composto de fgf-18
LT3688468T (lt) 2017-09-29 2022-06-27 Merck Patent Gmbh Uždegiminiai biožymenys, skirti atsako į fgf-18 junginį numatymui
EP3687558B1 (en) 2017-09-29 2022-03-16 Merck Patent GmbH Metabolic biomarkers for predicting responsiveness to fgf-18 compound
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
PT4034115T (pt) * 2019-09-25 2025-03-25 Lumosa Therapeutics Co Ltd Composição farmacêutica compreendendo conjugado péptido trombolítico-tetra-hidroisoquinolina
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

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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
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
ATE539157T1 (de) 1999-12-02 2012-01-15 Zymogenetics Inc Methoden welche auf zellen zielen, die die fibroblasten wachtumsfaktor-rezeptoren-3 oder -2 exprimieren
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WO2002017956A2 (en) * 2000-08-31 2002-03-07 Chiron Corporation Stabilized fgf formulations containing reducing agents
CA2454587C (en) * 2001-07-25 2012-11-13 Protein Design Labs, Inc. Stable lyophilized pharmaceutical formulation of igg antibodies
DE10204792A1 (de) * 2002-02-06 2003-08-14 Merck Patent Gmbh Lyophilisierte Zubereitung enthaltend Immuncytokine
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KR101247418B1 (ko) * 2007-12-21 2013-03-25 에프. 호프만-라 로슈 아게 항체 제형
TWI527590B (zh) * 2011-06-17 2016-04-01 艾瑞斯貿易公司 Fgf-18之凍乾調配物

Also Published As

Publication number Publication date
HRP20160566T1 (hr) 2016-06-17
JP5981538B2 (ja) 2016-08-31
PL2720710T3 (pl) 2016-09-30
EA201490032A1 (ru) 2014-05-30
NZ617992A (en) 2015-09-25
TW201302217A (zh) 2013-01-16
PT2720710E (pt) 2016-06-17
MX2013014894A (es) 2014-09-01
MX338017B (es) 2016-03-29
EP3056211A1 (en) 2016-08-17
CA2836667C (en) 2020-01-14
ZA201308698B (en) 2016-02-24
KR102019520B1 (ko) 2019-11-04
EP2720710B1 (en) 2016-03-23
SI2720710T1 (sl) 2016-07-29
DK2720710T3 (en) 2016-06-27
IL229977A (en) 2017-01-31
BR112013032400A2 (pt) 2016-11-22
EA024937B1 (ru) 2016-11-30
CN107715104A (zh) 2018-02-23
AR086956A1 (es) 2014-02-05
ECSP14013157A (es) 2014-02-28
CY1117933T1 (el) 2017-05-17
MY170630A (en) 2019-08-21
PH12013502529A1 (en) 2014-01-27
HUE028355T2 (en) 2016-12-28
CL2013003618A1 (es) 2014-07-04
BR112013032400B1 (pt) 2021-07-20
US9326944B2 (en) 2016-05-03
RS54875B1 (sr) 2016-10-31
AU2012268987B2 (en) 2016-09-08
UA113174C2 (xx) 2016-12-26
ES2575732T3 (es) 2016-06-30
TWI527590B (zh) 2016-04-01
US20140121162A1 (en) 2014-05-01
CA2836667A1 (en) 2012-12-20
KR20140041600A (ko) 2014-04-04
CO6940377A2 (es) 2014-05-09
US20160228374A1 (en) 2016-08-11
CN103619347A (zh) 2014-03-05
EP2720710A1 (en) 2014-04-23
SG195021A1 (en) 2013-12-30
WO2012172072A1 (en) 2012-12-20
JP2014522807A (ja) 2014-09-08

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