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

Oralno primjenjive farmaceutske pelete s epidermalnim faktorom rasta Download PDF

Info

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
Authority
HR
Croatia
Prior art keywords
weight
pellets
core
pellets according
growth factor
Prior art date
Application number
HRP20150643TT
Other languages
English (en)
Inventor
Raimundo UBIETA GÓMEZ
Ana Aguilera Barreto
Eduardo Martínez Díaz
Rolando Paez Meireles
Antonio Sereno Guerra
Original Assignee
Centro De Ingeniería Genética Y Biotecnología (Cigb)
Biorec S.A.
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
Application filed by Centro De Ingeniería Genética Y Biotecnología (Cigb), Biorec S.A. filed Critical Centro De Ingeniería Genética Y Biotecnología (Cigb)
Publication of HRP20150643T1 publication Critical patent/HRP20150643T1/hr

Links

Classifications

    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (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

Family

ID=42355395

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)

Families Citing this family (3)

* 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
EP3482771B1 (en) * 2013-03-14 2023-01-18 Société des Produits Nestlé S.A. 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

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS62149622A (ja) 1985-12-24 1987-07-03 Wakunaga Pharmaceut Co Ltd 腸機能改善剤
US4743679A (en) * 1986-02-24 1988-05-10 Creative Biomolecules, Inc. Process for producing human epidermal growth factor and analogs thereof
DE3778275D1 (de) * 1986-08-07 1992-05-21 Roehm Gmbh Verfahren zur herstellung eines redispergierbaren kunststoffpulvers.
JPH01246223A (ja) 1988-03-28 1989-10-02 Hitachi Chem Co Ltd 潰瘍治療剤
US5272135A (en) * 1991-03-01 1993-12-21 Chiron Ophthalmics, Inc. Method for the stabilization of methionine-containing polypeptides
WO1999030671A2 (en) * 1997-12-15 1999-06-24 Ron Eyal S Aspected particles for oral delivery
US20030104996A1 (en) 2001-08-30 2003-06-05 Tiansheng Li L-methionine as a stabilizer for NESP/EPO in HSA-free formulations
CN101912601B (zh) 2002-06-21 2012-08-29 诺和诺德医疗保健公司 因子vii多肽的稳定化固体组合物
US20040126358A1 (en) 2002-09-16 2004-07-01 Warne Nicholas W. Delayed release formulations for oral administration of a polypeptide therapeutic agent and methods of using same
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
WO2005058345A1 (en) 2003-12-16 2005-06-30 University Technologies International Inc. A treatment for necrotizing enterocolitis
WO2007095288A2 (en) * 2006-02-13 2007-08-23 Nektar Therapeutics Methionine-containing protein or peptide compositions and methods of making and using
MXPA06013015A (es) * 2006-11-09 2007-02-07 Gastronomia Molecular S A Nuevo proceso de elaboracion y estabilidad de un producto nutritivo de amaranto.
CA2734275A1 (en) * 2008-09-10 2010-03-18 Genentech, Inc. Compositions and methods for the prevention of oxidative degradation of proteins

Also Published As

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

Similar Documents

Publication Publication Date Title
HRP20150643T1 (hr) Oralno primjenjive farmaceutske pelete s epidermalnim faktorom rasta
HRP20120766T4 (hr) Formulacija za isporuku lijeka u kolonu
JOP20200146B1 (ar) تركيبة عقار ذو إطلاق متأخر
AU2007267159B2 (en) Lipoic acid pellets
EP1453487B1 (en) Pharmaceutical dosage form with multiple coatings
WO2012091153A3 (en) Orally disintegrating tablet
BR112012008626A2 (pt) forma farmacêutica oral sólida com liberação modificada de pelo menos um ingrediente ativo
JP2016532655A5 (hr)
BR112014005646A2 (pt) produto fixador para cabelos em aerossol para pentear e/ou dar forma aos cabelos
JP2010270128A5 (hr)
RU2008137766A (ru) Твердые дозированные формы
RU2015110825A (ru) Устойчивая к действию желудочного сока фармацевтическая или нутрицевтическая композиция со стойкостью к влиянию этанола
IT9020054A1 (hr)
CL2013003363A1 (es) Tableta de liberacion inmediata a prueba de alteracion que comprende (i) una matriz, y (ii) una pluralidad de material particulado recubierto que comprende un opioide y un polimero fisiologicamente aceptable, recubierto con un polimero soluble en agua; donde el multiparticulado forma una fase discontinua dentro de la matriz.
ATE531368T1 (de) Tacrolimus enthaltende zusammensetzungen mit modifizierter freisetzung
RU2013141534A (ru) Составы l-ментола, состоящие из множества частиц, и связанные с ними способы
JP2008507483A (ja) 安定な作用物質放出プロフィールを有するコーティングされた剤形の製造方法
HRP20240033T1 (hr) Formulacija koja sadrži inhibitor mek
PT828480E (pt) Nova formulacao farmaceutica em micropastilhas
CN101108171A (zh) 一种布地奈德肠溶缓释微丸及其制备方法
JP2019513800A5 (hr)
JP2007509891A5 (hr)
CA2797812A1 (en) Enteric tablet
UA93530C2 (ru) Композиция c пролонгированным высвобождением активного вещества, способ ee получения и применения
HRP20171149T1 (hr) Oralni farmaceutski pripravak koji sadrži tvar za prikrivanje ukusa n-acetilcisteina