HRP20231691T1 - Pripravak za upotrebu u liječenju promjena u crijevima - Google Patents

Pripravak za upotrebu u liječenju promjena u crijevima Download PDF

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Publication number
HRP20231691T1
HRP20231691T1 HRP20231691TT HRP20231691T HRP20231691T1 HR P20231691 T1 HRP20231691 T1 HR P20231691T1 HR P20231691T T HRP20231691T T HR P20231691TT HR P20231691 T HRP20231691 T HR P20231691T HR P20231691 T1 HRP20231691 T1 HR P20231691T1
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use according
core
extract
outside
preparation
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HRP20231691TT
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Andrea BIFFI
Ruggero ROSSI
Walter FIORE
Silvia SALAMINA
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Alfasigma S.P.A.
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Publication of HRP20231691T1 publication Critical patent/HRP20231691T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/45Ericaceae or Vacciniaceae (Heath or Blueberry family), e.g. blueberry, cranberry or bilberry
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/3533,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2813Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Medical Informatics (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Saccharide Compounds (AREA)

Claims (12)

1. Pripravak za oralnu primjenu, na koji se odnosi („CR”), koji sadrži ili se umjesto toga sastoji od: (i) jezgre koja sadrži ili se umjesto toga sastoji od ekstrakta (a) barem jedne biljke iz roda Vaccinium i barem jednog sastojka (b) prihvatljivog za upotrebu u farmaceutske ili prehrambene svrhe; (ii) želučanootpornog sloja izvan jezgre (i) koji potpuno oblaže (i) i sadrži barem jedan sastojak (c) prihvatljiv za upotrebu u farmaceutske ili prehrambene svrhe, pri čemu navedeni želučanootporni sloj (ii) može omogućavati oslobađanje ekstrakta (a) u debelom crijevu; pri čemu je navedeni pripravak za upotrebu u prevenciji i/ili liječenju divertikuloze debelog crijeva, patologija ili bolesti povezanih s prisutnošću divertikula, odabranih između divertikularne bolesti, SUDD-a (simptomatska nekomplicirana divertikularna bolest) i divertikulitisa debelog crijeva.
2. Pripravak za upotrebu prema zahtjevu 1, pri čemu je navedeni ekstrakt (a) barem jedne biljke iz roda Vaccinium poželjno suhi ekstrakt prisutan u količini od 150 mg do 600 mg u odnosu na ukupnu masu ekstrakta (a).
3. Pripravak za upotrebu prema zahtjevu 2, pri čemu je navedeni ekstrakt (a) prisutan u količini od 200 mg do 300 mg u odnosu na ukupnu masu ekstrakta (a) i sadrži od 80 % do 99 % proantocijanidina po masi u odnosu na ukupnu masu ekstrakta (a).
4. Pripravak za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu je navedeni ekstrakt (a) poželjno suhi ekstrakt brusnice, koji poželjno sadrži PAC-ove (proantocijanidini) u koncentraciji od 5 % do 30 % po masi ili volumenu, na primjer 10 % ili 15 % ili 20 % ili 25 %.
5. Pripravak za upotrebu prema zahtjevu 1, pri čemu navedeni želučanootporni sloj (ii) izvan jezgre (i) ima svojstvo razgradnje i otapanja ovisno o pH vrijednosti i/ili vremenu te se poželjno navedeni sloj (ii) može razgraditi i otopiti pri pH vrijednosti od oko 6,5 do oko 8.
6. Pripravak za upotrebu prema zahtjevu 5, pri čemu se navedeni želučanootporni sloj (ii) izvan jezgre (i) može razgraditi i otopiti pri pH vrijednosti od oko 7 do oko 7,5, poželjno u vremenu od 30 minuta do 120 minuta i još poželjnije od 45 minuta do 90 minuta.
7. Pripravak za upotrebu prema zahtjevu 1 ili 5 ili 6, pri čemu navedeni želučanootporni sloj (ii) izvan jezgre (i) sadrži ili se umjesto toga sastoji od barem jedne tvari odabrane između biotika Eudragard E1207, želučanootpornog polimera, kao što je poli(metil akrilat-ko-metil metakrilat-ko-metakrilna kiselina) 7:3:1, ili drugog anionskog metakrilnog kopolimera, trietil-citrata E1505, talka, etil-celuloze, anionskog metakrilatnog kopolimera i njihovih mješavina, šelaka, natrijeva alginata i njihovih mješavina, škroba i modificiranih škrobova, oleinske kiseline, stearinske kiseline i srednjelančanih triglicerida.
8. Pripravak za upotrebu prema bilo kojem zahtjevu 1 – 7, pri čemu navedeni želučanootporni sloj (ii) izvan jezgre (1) sadrži ili se umjesto toga sastoji od: – želučanootpornog polimera, kao što je poli(metil akrilat-ko-metil metakrilat-ko-metakrilna kiselina) 7:3:1, ili drugog anionskog metakrilatnog kopolimera: od 5 do 50 mg, od 10 do 35 mg, od 18 do 25 mg; – trietil-citrata E1505: od 0,1 do 5 mg, od 0,3 do 3 mg, od 0,5 do 2 mg; – talka: od 1 do 30 mg, od 3 do 20 mg, od 5 do 15 mg.
9. Pripravak za upotrebu prema bilo kojem zahtjevu 1 – 7, pri čemu navedeni želučanootporni sloj (ii) izvan jezgre (i) sadrži ili se umjesto toga sastoji od: – etil-celuloze: od 5 do 15 mg, od 8 do 12 mg, od 9,97 mg; – natrijeva alginata: od 5 do 15 mg, od 8 do 12 mg, od 9,30 mg; – amonijeva hidroksida: od 0,5 do 4 mg, od 1,5 do 3 mg, od 2,34 mg; – srednjelančanih triglicerida: od 0,5 do 5 mg, od 1,5 do 3 mg, od 2,12 mg; – oleinske kiseline: od 0,5 do 3 mg, od 1 do 2 mg, od 1,17 mg; – pročišćene stearinske kiseline: od 0,01 do 0,5 mg, od 0,05 do 0,3 mg, od 0,1 mg.
10. Pripravak za upotrebu prema bilo kojem zahtjevu 1 – 7, pri čemu navedeni želučanootporni sloj (ii) izvan jezgre (i) sadrži ili se umjesto toga sastoji od: – etil-celuloze: od 5 do 50 mg, od 10 do 30 mg, od 15 do 20 mg; – titanijeva dioksida: od 0,1 do 15 mg, od 0,5 do 10 mg, od 1 do 5 mg; – natrijeva alginata: od 0,1 do 5 mg, od 0,3 do 4 mg, od 0,5 do 2 mg; – oleinske kiseline, stearinske kiseline, srednjelančanih triglicerida: svaki od 0,01 do 3 mg, između 0,05 i 1 mg.
11. Pripravak za upotrebu prema bilo kojem prethodnom zahtjevu, pri čemu navedeni želučanootporni sloj (ii) izvan jezgre (i) sadrži ili se umjesto toga sastoji od: – biotika Eudragard ® E1207 (Evonik): na primjer, 20,4 mg; – trietil-citrata E1505: na primjer, 1 mg; – talka: na primjer, 10,2 mg.
12. Pripravak za upotrebu prema bilo kojem prethodnom zahtjevu, pri čemu navedeni želučanootporni sloj (ii) izvan jezgre (i) sadrži ili se umjesto toga sastoji od: – etil-celuloze: na primjer, 9,97 mg; – natrijeva alginata: na primjer, 9,30 mg; – amonijeva hidroksida: na primjer, 2,34 mg; – srednjelančanih triglicerida: na primjer, 2,12 mg; – oleinske kiseline: na primjer, 1,17 mg; – pročišćene stearinske kiseline: na primjer, 0,1 mg.
HRP20231691TT 2016-12-01 2017-12-01 Pripravak za upotrebu u liječenju promjena u crijevima HRP20231691T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IT102016000122310A IT201600122310A1 (it) 2016-12-01 2016-12-01 Composizione per uso nella terapia di alterazioni dell'intestino
PCT/IB2017/057580 WO2018100551A1 (en) 2016-12-01 2017-12-01 Composition for use in the treatment of intestinal alterations
EP17822783.1A EP3548006B1 (en) 2016-12-01 2017-12-01 Composition for use in the treatment of intestinal alterations

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HRP20231691T1 true HRP20231691T1 (hr) 2024-03-15

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US (2) US10881703B2 (hr)
EP (1) EP3548006B1 (hr)
JP (1) JP7321935B2 (hr)
KR (1) KR102508323B1 (hr)
CN (1) CN110430870B (hr)
AU (1) AU2017368931B2 (hr)
BR (1) BR112019011007A2 (hr)
CA (1) CA3045267A1 (hr)
DK (1) DK3548006T3 (hr)
ES (1) ES2968428T3 (hr)
FI (1) FI3548006T3 (hr)
HR (1) HRP20231691T1 (hr)
HU (1) HUE065202T2 (hr)
IT (1) IT201600122310A1 (hr)
LT (1) LT3548006T (hr)
PL (1) PL3548006T3 (hr)
PT (1) PT3548006T (hr)
RS (1) RS65009B1 (hr)
SI (1) SI3548006T1 (hr)
WO (1) WO2018100551A1 (hr)

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IT201900008394A1 (it) * 2019-06-07 2020-12-07 Sofar Spa Composizione per uso nel trattamento delle malattie infiammatorie croniche intestinali
JP2021045103A (ja) * 2019-09-20 2021-03-25 国立大学法人秋田大学 貪食能測定方法

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DK0935417T3 (da) * 1996-10-16 2009-08-10 Napo Pharmaceuticals Inc Enteroformuleringer af proanthocyanidin-polymer-sammensætninger mod diarré
US20020054924A1 (en) * 2000-04-13 2002-05-09 Leahy Margaret M. Novel compositions derived from cranberry and grapefruit and therapeutic uses therefor
US8101209B2 (en) * 2001-10-09 2012-01-24 Flamel Technologies Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles
US20070243268A1 (en) * 2005-11-07 2007-10-18 Jaffe Russell M Compositions for regulating intestinal disorders and methods of use thereof
US20070254050A1 (en) * 2006-05-01 2007-11-01 Quart Barry D Method for treatment of diarrhea-predominant irritable bowel syndrome
DE202010008308U1 (de) * 2010-08-18 2010-10-21 Rittinghausen, Reiner, Dr. Zusammensetzung zur nutritiven Ergänzung oder Behandlung bei Harnwegsinfekten und/oder bakteriellen Entzündungen der Schleimhäute
ITMI20110409A1 (it) * 2011-03-15 2012-09-16 Velleja Res Srl Impiego delle proantocianidine di tipo a2 in forma gastroprotetta per il trattamento della cistiti in fase acuta sostenute da forme batteriche fimbriate
WO2014032108A1 (en) * 2012-08-29 2014-03-06 Borody Thomas J Laxative compositions and methods for treating constipation and related gastrointestinal diseases and conditions
CN102823875A (zh) * 2012-09-10 2012-12-19 湖北强森魔芋科技有限公司 一种高膳食纤维代餐粉及其制备方法
CA2896795A1 (en) * 2012-11-26 2014-05-30 Thomas Julius Borody Compositions for the restoration of a fecal microbiota and methods for making and using them
ITMI20130793A1 (it) * 2013-05-14 2014-11-15 Probiotical Spa Composizione comprendente batteri lattici per uso nel trattamento preventivo e/o curativo delle cistiti ricorrenti.

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RU2019120187A (ru) 2021-01-11
CN110430870B (zh) 2023-05-23
AU2017368931A1 (en) 2019-07-04
HUE065202T2 (hu) 2024-05-28
BR112019011007A2 (pt) 2019-10-08
IT201600122310A1 (it) 2018-06-01
US11690889B2 (en) 2023-07-04
WO2018100551A1 (en) 2018-06-07
US20210077558A1 (en) 2021-03-18
EP3548006A1 (en) 2019-10-09
JP2020500934A (ja) 2020-01-16
EP3548006B1 (en) 2023-11-15
PL3548006T3 (pl) 2024-04-29
KR20190111913A (ko) 2019-10-02
SI3548006T1 (sl) 2024-02-29
AU2017368931B2 (en) 2022-12-22
ES2968428T3 (es) 2024-05-09
DK3548006T3 (da) 2024-01-02
PT3548006T (pt) 2024-01-16
LT3548006T (lt) 2024-01-10
KR102508323B1 (ko) 2023-03-08
CN110430870A (zh) 2019-11-08
US10881703B2 (en) 2021-01-05
CA3045267A1 (en) 2018-06-07
RS65009B1 (sr) 2024-01-31
RU2019120187A3 (hr) 2021-02-19
US20200061141A1 (en) 2020-02-27
FI3548006T3 (fi) 2023-12-19
JP7321935B2 (ja) 2023-08-07

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