HRP20150643T1 - Oralno primjenjive farmaceutske pelete s epidermalnim faktorom rasta - Google Patents

Oralno primjenjive farmaceutske pelete s epidermalnim faktorom rasta Download PDF

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Publication number
HRP20150643T1
HRP20150643T1 HRP20150643TT HRP20150643T HRP20150643T1 HR P20150643 T1 HRP20150643 T1 HR P20150643T1 HR P20150643T T HRP20150643T T HR P20150643TT HR P20150643 T HRP20150643 T HR P20150643T HR P20150643 T1 HRP20150643 T1 HR P20150643T1
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Croatia
Prior art keywords
weight
pellets
core
pellets according
growth factor
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HRP20150643TT
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English (en)
Inventor
Raimundo UBIETA GÓMEZ
Ana Aguilera Barreto
Eduardo Martínez Díaz
Rolando Paez Meireles
Antonio Sereno Guerra
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Centro De Ingeniería Genética Y Biotecnología (Cigb)
Biorec S.A.
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Publication of HRP20150643T1 publication Critical patent/HRP20150643T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K38/1808Epidermal growth factor [EGF] urogastrone
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12Antidiarrhoeals

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (20)

1. Oralno primjenjive farmaceutske pelete koje imaju jezgru i gastrorezistentnu ovojnicu, gdje jezgra sadrži farmaceutski učinkovitu količinu epidermalnog faktora rasta i antioksidans koji u svom sastavu ima sumpor, izabran iz skupine koja obuhvaća metionin i K2S2O7.
2. Pelete prema zahtjevu 1, gdje je molarni omjer između epidermalnog faktora rasta i antioksidansa od 1:20 do 1:60.
3. Pelete prema bilo kojem od zahtjeva 1-2, gdje jezgra dalje sadrži vezivo, alkalno sredstvo, sredstvo za podmazivanje, surfaktant ili njihove mješavine.
4. Pelete prema zahtjevu 3, gdje je vezivo hidroksipropilmetilceluloza.
5. Pelete prema zahtjevu 3, gdje je alkalno sredstvo dinatrijev fosfat.
6. Pelete prema zahtjevu 3, gdje je sredstvo za podmazivanje talk.
7. Pelete prema zahtjevu 3, gdje je surfaktant natrijev lauril sulfat.
8. Pelete prema bilo kojem od zahtjeva 1-7, gdje jezgra sadrži: 60-80% težine inertne jezgre; 0.05-1 % težine epidermalnog faktora rasta; 0.5-3% težine antioksidansa; 0.02-0.07% težine surfaktanta; 1.5-5% težine veziva; 0.02-0.07% težine alkalnog sredstva; i 2-5% težine sredstva za podmazivanje.
9. Pelete prema zahtjevu 8, gdje jezgra sadrži: 69% težine inertne jezgre; 0.10% težine epidermalnog faktora rasta; 1.3 % težine metionina; 0.05% težine natrijevog lauril sulfata; 2% težine hidroksipropilmetilceluloze; 0.05% težine dinatrijevog fosfata; i 4% težine talka.
10. Pelete prema zahtjevu 8, gdje jezgra sadrži: 69 % težine inertne jezgre; 0.10 % težine epidermalnog faktora rasta; 2 % težine K2S2O7; 0.05 % težine natrijevog lauril sulfata; 2 % težine hidroksipropilmetilceluloze; 0.05 % težine dinatrijevog fosfata; i 4 % težine talka.
11. Pelete prema bilo kojem od zahtjeva 1-10, gdje gastrorezistentna ovojnica sadrži polimer od poli(metakrilne kiseline/ metilakrilata/ metil metakrilata), trietilcitrata, natrijevog lauril sulfata, talka ili njihovih mješavina.
12. Pelete prema bilo kojem od zahtjeva 1-11, dalje sadrže međusloj ovojnice koji obuhvaća barem polimer s prilagođenim oslobađanjem.
13. Pelete prema zahtjevu 12, gdje međusloj ovojnice dalje obuhvaća sredstvo za podmazivanje.
14. Pelete prema bilo kojem od zahtjeva 12-13, gdje se polimer s prilagođenim oslobađanjem izabire iz skupine koja obuhvaća poliakrilate, polimetakrilate, etilcelulozu, hidroksipropilcelulozu, hidroksipropilmetilcelulozu i njihove mješavine.
15. Pelete prema bilo kojem od zahtjeva 12-14, gdje je polimer s prilagođenim oslobađanjem polimer od estera poli(etilakrilata/metilmetakrilata).
16. Pelete prema bilo kojem od zahtjeva 12-15, gdje je sredstvo za podmazivanje talk.
17. Postupak pripreme peleta kako su definirani prema bilo kojem od zahtjeva 1-16, a koji obuhvaća: (a) oblaganje inertne jezgre putem sprejanja vodene suspenzije koja sadrži epidermalni faktor rasta, antioksidans i farmaceutski prikladne pomoćne tvari; (b) sušenje aktivnog sloja nastalog u koraku (a); (c) oblaganje jezgre iz koraka (b) sprejanjem suspenzije koja sadrži gastrorezistentni polimer za ovojnicu i farmaceutski prikladnu pomoćnu tvar; i (d) sušenje obložene pelete nastale u koraku (c); gdje je temperatura svakog koraka postupka do 40°C.
18. Postupak prema zahtjevu 17, za pripremu peleta kako su definirani prema bilo kojem od zahtjeva 12-16, dalje obuhvaća dodatni korak oblaganja jezgre iz koraka (b) putem sprejanja suspenzije koja sadrži polimer s prilagođenim oslobađanjem i farmaceutski prikladnu pomoćnu tvar; i sušenje nastalog sloja.
19. Farmaceutski oblik kapsule koja sadrži pelete kako su definirani prema bilo kojem od zahtjeva 1-16.
20. Farmaceutske pelete kako su definirani prema bilo kojem od zahtjeva 1-16, za uporabu u liječenju ulceroznog kolitisa.
HRP20150643TT 2010-02-12 2015-06-15 Oralno primjenjive farmaceutske pelete s epidermalnim faktorom rasta HRP20150643T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP10382033A EP2364690A1 (en) 2010-02-12 2010-02-12 Orally administrable pharmaceutical pellet of epidermal growth factor
EP11702645.0A EP2533758B1 (en) 2010-02-12 2011-02-10 Orally administrable pharmaceutical pellet of epidermal growth factor
PCT/EP2011/051918 WO2011098499A1 (en) 2010-02-12 2011-02-10 Orally administrable pharmaceutical pellet of epidermal growth factor

Publications (1)

Publication Number Publication Date
HRP20150643T1 true HRP20150643T1 (hr) 2015-08-14

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Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20150643TT HRP20150643T1 (hr) 2010-02-12 2015-06-15 Oralno primjenjive farmaceutske pelete s epidermalnim faktorom rasta

Country Status (21)

Country Link
US (1) US9205130B2 (hr)
EP (2) EP2364690A1 (hr)
JP (1) JP5778184B2 (hr)
KR (1) KR101745750B1 (hr)
CN (1) CN102753146B (hr)
AR (1) AR080144A1 (hr)
AU (1) AU2011214421B8 (hr)
BR (1) BR112012020223B8 (hr)
CA (1) CA2789055C (hr)
DK (1) DK2533758T3 (hr)
ES (1) ES2537704T3 (hr)
HR (1) HRP20150643T1 (hr)
HU (1) HUE024986T2 (hr)
MX (1) MX2012009217A (hr)
PL (1) PL2533758T3 (hr)
PT (1) PT2533758E (hr)
RS (1) RS54098B1 (hr)
RU (1) RU2540503C2 (hr)
SI (1) SI2533758T1 (hr)
SM (1) SMT201500158B (hr)
WO (1) WO2011098499A1 (hr)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102432737B (zh) * 2011-09-07 2015-02-25 张绍国 一种缓释肠溶丙烯酸树脂乳胶液及其制法
EP2968529B1 (en) 2013-03-14 2020-08-05 Aimmune Therapeutics, Inc. Manufacture of peanut formulations for oral desensitization
CN113966229A (zh) 2019-05-10 2022-01-21 爱沐疗法公司 用于改善花生过敏患者的生活质量的方法

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BR0314356A (pt) 2002-09-16 2005-07-19 Wyeth Corp Formulações de liberação retardada para administração oral de um agente terapêutico polipetìdeo e métodos utilizando as mesmas
DE10332160A1 (de) * 2003-07-15 2005-02-03 Röhm GmbH & Co. KG Multipartikuläre Arzneiform, enthaltend mucoadhaesiv formulierte Peptid- oder Protein-Wirkstoffe, sowie ein Verfahren zur Herstellung der Arzneiform
AR045068A1 (es) * 2003-07-23 2005-10-12 Univ Missouri Formulacion de liberacion inmediata de composiciones farmaceuticas
JP2007513983A (ja) * 2003-12-16 2007-05-31 ユニバーシティー・テクノロジーズ・インターナショナル・インコーポレイテッド 壊死性腸炎のための治療
EP1986674A4 (en) 2006-02-13 2009-11-11 Nektar Therapeutics PROTEIN OR PEPTIDE COMPOSITIONS PROTEIN CONTAINING METHIONINE AND METHOD FOR MANUFACTURING AND USING SAME
MXPA06013015A (es) * 2006-11-09 2007-02-07 Gastronomia Molecular S A Nuevo proceso de elaboracion y estabilidad de un producto nutritivo de amaranto.
CN102209554A (zh) * 2008-09-10 2011-10-05 弗·哈夫曼-拉罗切有限公司 用于防止蛋白质氧化降解的组合物和方法

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Publication number Publication date
MX2012009217A (es) 2012-11-23
CA2789055A1 (en) 2011-08-18
JP5778184B2 (ja) 2015-09-16
AU2011214421A8 (en) 2014-01-30
JP2013519649A (ja) 2013-05-30
HUE024986T2 (en) 2016-01-28
US20120308661A1 (en) 2012-12-06
EP2533758A1 (en) 2012-12-19
ES2537704T3 (es) 2015-06-11
AU2011214421B2 (en) 2013-12-19
CA2789055C (en) 2017-07-18
KR20120114402A (ko) 2012-10-16
BR112012020223A2 (pt) 2017-07-04
CN102753146A (zh) 2012-10-24
CN102753146B (zh) 2014-11-26
AR080144A1 (es) 2012-03-14
PT2533758E (pt) 2015-08-26
SMT201500158B (it) 2015-09-07
EP2533758B1 (en) 2015-04-08
RS54098B1 (en) 2015-10-30
US9205130B2 (en) 2015-12-08
KR101745750B1 (ko) 2017-06-09
WO2011098499A1 (en) 2011-08-18
AU2011214421A1 (en) 2012-08-23
RU2540503C2 (ru) 2015-02-10
EP2364690A1 (en) 2011-09-14
BR112012020223B1 (pt) 2021-05-11
RU2012139030A (ru) 2014-03-20
DK2533758T3 (da) 2015-06-22
AU2011214421B8 (en) 2014-01-30
BR112012020223B8 (pt) 2021-05-25
PL2533758T3 (pl) 2015-10-30
SI2533758T1 (sl) 2015-08-31

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