HUE028355T2 - Fagyasztva szárított FGF-18 készítmények - Google Patents

Fagyasztva szárított FGF-18 készítmények Download PDF

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Publication number
HUE028355T2
HUE028355T2 HUE12728509A HUE12728509A HUE028355T2 HU E028355 T2 HUE028355 T2 HU E028355T2 HU E12728509 A HUE12728509 A HU E12728509A HU E12728509 A HUE12728509 A HU E12728509A HU E028355 T2 HUE028355 T2 HU E028355T2
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HU
Hungary
Prior art keywords
fgf
freeze
stable
dried
formulation
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HUE12728509A
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English (en)
Inventor
Alessandra Cerreti
Rio Alessandra Del
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Ares Trading Sa
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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=HUE028355(T2) "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 HUE028355T2 publication Critical patent/HUE028355T2/hu

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    • 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]

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (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)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (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 (5)

  1. FAGYASZTVA SZÁRÍTOTT FGF-18 KÉSZÍTMÉNYEK Szabadalmi igénypontok: % Stabil fogyásaivá szárított készítmény, amely tartalmaz FGF-1 8-ats: fesztit paffért, amply a pH-t 7 fi és ?,S közöl# értéken tartja, pOiexamer 1 SS-st és szaebprazt.
  2. 2, Az 1 Igénypont szerinti stabil fegyasztva szápfetieszltménf, abél a feszté! puffer a pH-t 7,2 vagy kb. 7,2 értéken tar|a.:
  3. 3.. Az előző Igénypontok bármelyike szerinti stabil fagyasztva szárított készítmény, ahol a paffer koncentrációja 5 - 13Û rM vagy kb. &«· 4 Az előzi igénypontok: bármelyike szerint staü fagyasztva szárítói készítmény, ahol 0 poiozameriSB koncentrációja fit - 6,4 mgfeola vagy Ih, fit « 0,4 mg/íloia $, Az előzi igénypontok bármelyike ezéríntl stabil fagyasztva szárított készítmény, ahol a szacharóz konæntréoiôia 10 -#§ mg/fioia vagy kb. lé ~ 60 mg/áola.
    0, Az előző igénypontok bármelyike szerinti stabil fagyasztva szárított készítmény, aboi az FBF~18 koncentrációja 20 ~ 300 mogrtfoia vagy kb, 20 ~ 3öi mcgAiota, T, Az előzi igénypontok bármelyike szedni stabil fegyaszira szárított készítmény, aboi a Niszfeniny tartalmaz 20, 30, 60,100, 200 vagy 300 mcg/fíola FGF-18-at, 1(1 mP loszfit pttfei, amely a pH--t 7,2 vagy kb. 7,2 értéken tartja, 30 mg/tiola szaebarozt és i J: mg/fiola poloxamer 188-at. I< Az előző igénypontok bármelyike szerinti stabil fagyasztva szárítói; készítmény, aboi a készítmény tartalmaz továbbá az FGF~18~bői 5 % felesleget (overage). % Az előző igénypontok bármelyike szerinti stabil fagyasztva szárított készítmény, ahol az FGF-18~at a következik által alkotott csoportból válaszunk: a) polipeptkt, amely tartalmazza a SEQ ID Mö: 1 szerinti szekvencia 28-2.07 amlnosav-marartékát: vagy abból él, b) potipeptü, amely tartalmazza a SEB ID RÖ:1 szerinti szekvencla 28-1§8 amiinosáv-maradéklt vagy abból áll, és c) pöíípaptkf,, amely tartalmazza a SEQ ID RO:2 szekvenciát vagy abból áll.
  4. 10, Épris az előző igénypontok bármelyike szerinti stabil fagyasztva szántott készítmény előállítására, amely tartalmazza a kővetkező lépéseket: m) elegye! készítünk FGF-18-bőí a foszfát pyffenei, a poloxsmer 1S8-caí ésa szacharózzal, és b) az elegye!: iefizálf A
  5. 11. Termék, amely tartalmaz egy első tartályt, amely tartalmazza az 1 -9.. igénypontok bármelyike szedni stabil fagyasztja: száriét készítményt:, és tartalmaz: egy második tartályt, amely tartalmaz oldószert a rekoneiluoléliblr 12, A 11. Igénypont szerinti termék, ahol a tartály, amely tartalmazza a stabil: fagyasztja^ szárítói készítményt és az a tartály, amely tartalmazza az oldószert a rekonsiítucíéboz, egy két-kamrás rendszer két rekesze.
HUE12728509A 2011-06-17 2012-06-15 Fagyasztva szárított FGF-18 készítmények HUE028355T2 (hu)

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
HUE028355T2 true HUE028355T2 (hu) 2016-12-28

Family

ID=47356563

Family Applications (1)

Application Number Title Priority Date Filing Date
HUE12728509A HUE028355T2 (hu) 2011-06-17 2012-06-15 Fagyasztva szárított FGF-18 készítmények

Country Status (31)

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US (2) US9326944B2 (hu)
EP (2) EP2720710B1 (hu)
JP (1) JP5981538B2 (hu)
KR (1) KR102019520B1 (hu)
CN (2) CN103619347A (hu)
AR (1) AR086956A1 (hu)
AU (1) AU2012268987B2 (hu)
BR (1) BR112013032400B1 (hu)
CA (1) CA2836667C (hu)
CL (1) CL2013003618A1 (hu)
CO (1) CO6940377A2 (hu)
CY (1) CY1117933T1 (hu)
DK (1) DK2720710T3 (hu)
EA (1) EA024937B1 (hu)
EC (1) ECSP14013157A (hu)
ES (1) ES2575732T3 (hu)
HR (1) HRP20160566T1 (hu)
HU (1) HUE028355T2 (hu)
IL (1) IL229977A (hu)
MX (1) MX338017B (hu)
MY (1) MY170630A (hu)
PE (1) PE20141265A1 (hu)
PL (1) PL2720710T3 (hu)
PT (1) PT2720710E (hu)
RS (1) RS54875B1 (hu)
SG (1) SG195021A1 (hu)
SI (1) SI2720710T1 (hu)
TW (1) TWI527590B (hu)
UA (1) UA113174C2 (hu)
WO (1) WO2012172072A1 (hu)
ZA (1) ZA201308698B (hu)

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* 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
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
KR20180035911A (ko) * 2015-08-13 2018-04-06 메르크 파텐트 게엠베하 Fgf-18 화합물을 포함하는 조합 조성물
WO2019092637A1 (en) * 2017-11-10 2019-05-16 Novartis Ag Extended release formulations for intra-articular applications
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

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Publication number Publication date
DK2720710T3 (en) 2016-06-27
SI2720710T1 (sl) 2016-07-29
UA113174C2 (xx) 2016-12-26
ZA201308698B (en) 2016-02-24
EP2720710A1 (en) 2014-04-23
ES2575732T3 (es) 2016-06-30
KR102019520B1 (ko) 2019-11-04
RS54875B1 (sr) 2016-10-31
BR112013032400A2 (pt) 2016-11-22
HRP20160566T1 (hr) 2016-06-17
IL229977A (en) 2017-01-31
TWI527590B (zh) 2016-04-01
EA201490032A1 (ru) 2014-05-30
US20160228374A1 (en) 2016-08-11
CN103619347A (zh) 2014-03-05
CA2836667A1 (en) 2012-12-20
CO6940377A2 (es) 2014-05-09
JP2014522807A (ja) 2014-09-08
AU2012268987B2 (en) 2016-09-08
EA024937B1 (ru) 2016-11-30
EP3056211A1 (en) 2016-08-17
ECSP14013157A (es) 2014-02-28
NZ617992A (en) 2015-09-25
WO2012172072A1 (en) 2012-12-20
KR20140041600A (ko) 2014-04-04
JP5981538B2 (ja) 2016-08-31
MX2013014894A (es) 2014-09-01
MY170630A (en) 2019-08-21
TW201302217A (zh) 2013-01-16
CN107715104A (zh) 2018-02-23
US9326944B2 (en) 2016-05-03
CL2013003618A1 (es) 2014-07-04
CY1117933T1 (el) 2017-05-17
EP2720710B1 (en) 2016-03-23
AR086956A1 (es) 2014-02-05
PL2720710T3 (pl) 2016-09-30
PE20141265A1 (es) 2014-09-29
BR112013032400B1 (pt) 2021-07-20
SG195021A1 (en) 2013-12-30
MX338017B (es) 2016-03-29
CA2836667C (en) 2020-01-14
PT2720710E (pt) 2016-06-17
US20140121162A1 (en) 2014-05-01

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