HRP20120754T1 - Dozirni oblik koji sadrži pantoprazol kao aktivni sastojak - Google Patents

Dozirni oblik koji sadrži pantoprazol kao aktivni sastojak Download PDF

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Publication number
HRP20120754T1
HRP20120754T1 HRP20120754TT HRP20120754T HRP20120754T1 HR P20120754 T1 HRP20120754 T1 HR P20120754T1 HR P20120754T T HRP20120754T T HR P20120754TT HR P20120754 T HRP20120754 T HR P20120754T HR P20120754 T1 HRP20120754 T1 HR P20120754T1
Authority
HR
Croatia
Prior art keywords
dosage form
pantoprazole
form according
pvp
prophylaxis
Prior art date
Application number
HRP20120754TT
Other languages
English (en)
Inventor
Isabel Anstett-Klein
Rango Dietrich
Hartmut Ney
Marc Schiller
Sabine SCHÄFER-PREUSS
Manfred Hartmann
Original Assignee
Nycomed Gmbh
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=33436112&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20120754(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Nycomed Gmbh filed Critical Nycomed Gmbh
Publication of HRP20120754T1 publication Critical patent/HRP20120754T1/hr

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Classifications

    • 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
    • A61K9/2886Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (11)

1. Dozirni oblik, naznačen time, da je za oralnu primjenu pantoprazol magnezij dihidrata u obliku tablete koja obuhvaća jezgru tablete, međusloj i gastrorezistentnu oblogu, pri čemu jezgra tablete sadrži pantoprazol magnezij dihidrat, natrijev karbonat, manitol, krospovidon, PVP 90 (povidon) i kalcijev stearat, međusloj je oblikovan od HPMC, PVP 25, titan dioksida, žutog željeznog oksida i propilen glikola, i gastrorezistentna obloga je oblikovana od smjese koja obuhvaća kopolimer metakrilne kiseline, natrijev dodecilsulfat, polisorbat i trietil citrat.
2. Dozirni oblik prema zahtjevu 1, naznačen time, da je PVP 90 (povidon) prisutan u količini u rasponu od oko 0,5 do oko 15 masenih %.
3. Dozirni oblik prema zahtjevu 1, naznačen time, da je PVP 90 (povidon) prisutan u količini u rasponu od oko 1 do oko 5 masenih %.
4. Dozirni oblik prema bilo kojem od zahtjeva 1 do 3, naznačen time, da jezgra sadrži od 5mg do 100mg pantoprazol magnezij dihidrata.
5. Dozirni oblik prema zahtjevu 4, naznačen time, da sadrži jednu količinu magnezijeve soli pantoprazola, koja odgovara za 10, 20, 40, 50, 80 ili 100 mg pantoprazola (slobodna kiselina).
6. Dozirni oblik prema zahtjevu 5, naznačen time, da sadrži jednu količinu pantoprazol magnezij dihidrata, koja odgovara za 40 mg pantoprazola (slobodna kiselina).
7. Dozirni oblik prema zahtjevu 5, naznačen time, da sadrži jednu količinu pantoprazol magnezij dihidrata, koja odgovara za 80 mg pantoprazola (slobodna kiselina).
8. Uporaba dozirnog oblika prema bilo kojem od zahtjeva 1 do 7, naznačena time, da je za proizvodnju lijeka za profilaksu ili liječenje kliničkog stanja kod sisavaca, kao što je čovjek, za koje se upućuje inhibitor protonske pumpe.
9. Uporaba prema zahtjevu 8, naznačena time, da je kliničko stanje odabrano iz skupine koju čine: benigni gastrični ulkus, bolest gastrofagealnog refluksa, Zollinger-Ellison-sindrom, duodenalni ulkus, duodenalni ulkus povezan s bakterijom Helicobacter pylori, profilaksa za gastrični ili duodenalni ulkus povezan s NSAID kod pacijenata s povećanim rizikom za gastroduodenalne komplikacije koje zahtijevaju sustavno NSAID liječenje i kombinacijsku terapiju s antibioticima za eradikaciju bakterije Heliobacter pylori.
10. Uporaba dozirnog oblika prema bilo kojem od zahtjeva 1 do 7, naznačena time, da je za proizvodnju lijeka za profilaksu ili liječenje bolesti gastroezofagealnog refluksa (GERD).
11. Uporaba dozirnog oblika prema bilo kojem od zahtjeva 1 do 7, naznačena time, da je za proizvodnju lijeka za profilaksu ili liječenje bolesti gastroezofagealnog refluksa (GERD) I do III (prema Savary/Miller klasifikaciji).
HRP20120754TT 2003-05-08 2012-09-24 Dozirni oblik koji sadrži pantoprazol kao aktivni sastojak HRP20120754T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP03010328 2003-05-08
EP04001754 2004-01-28
PCT/EP2004/050729 WO2004098594A2 (en) 2003-05-08 2004-05-07 Dosage form containing pantoprazole as active ingredient

Publications (1)

Publication Number Publication Date
HRP20120754T1 true HRP20120754T1 (hr) 2012-11-30

Family

ID=33436112

Family Applications (2)

Application Number Title Priority Date Filing Date
HRP20120754TT HRP20120754T1 (hr) 2003-05-08 2012-09-24 Dozirni oblik koji sadrži pantoprazol kao aktivni sastojak
HRP20121005TT HRP20121005T1 (hr) 2003-05-08 2012-12-06 Dozirani oblik koji sadrži pantoprazol kao aktivni sastojak

Family Applications After (1)

Application Number Title Priority Date Filing Date
HRP20121005TT HRP20121005T1 (hr) 2003-05-08 2012-12-06 Dozirani oblik koji sadrži pantoprazol kao aktivni sastojak

Country Status (27)

Country Link
US (2) US20060240100A1 (hr)
EP (2) EP2316454B9 (hr)
JP (2) JP4878284B2 (hr)
KR (2) KR20110104124A (hr)
AR (1) AR044264A1 (hr)
AU (2) AU2004237363B2 (hr)
BR (2) BR122016006880B8 (hr)
CA (1) CA2489140C (hr)
CL (1) CL2004000983A1 (hr)
CY (2) CY1113128T1 (hr)
DK (2) DK2316454T3 (hr)
EA (2) EA027734B1 (hr)
ES (2) ES2396197T3 (hr)
HK (1) HK1090546A1 (hr)
HR (2) HRP20120754T1 (hr)
IL (2) IL171365A (hr)
MX (1) MXPA05000411A (hr)
NO (1) NO337921B1 (hr)
NZ (1) NZ543181A (hr)
PE (1) PE20050199A1 (hr)
PL (2) PL1624869T3 (hr)
PT (2) PT2316454E (hr)
RS (1) RS53443B (hr)
SI (2) SI2316454T1 (hr)
TW (1) TW200509992A (hr)
WO (1) WO2004098594A2 (hr)
ZA (1) ZA200508202B (hr)

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Publication number Publication date
BRPI0410044B1 (pt) 2019-05-07
MXPA05000411A (es) 2005-03-23
PT1624869E (pt) 2012-09-18
BR122016006880B8 (pt) 2021-05-25
ZA200508202B (en) 2006-12-27
ES2396197T3 (es) 2013-02-19
CA2489140A1 (en) 2004-11-18
WO2004098594A2 (en) 2004-11-18
BR122016006880B1 (pt) 2020-11-10
US20060240100A1 (en) 2006-10-26
HRP20121005T1 (hr) 2013-01-31
EP1624869A2 (en) 2006-02-15
NO20055631L (no) 2005-11-29
CL2004000983A1 (es) 2005-03-04
PL1624869T3 (pl) 2012-11-30
DK1624869T3 (da) 2012-10-01
AU2010200905A1 (en) 2010-04-01
EP2316454A1 (en) 2011-05-04
EP1624869B1 (en) 2012-07-04
KR20060010774A (ko) 2006-02-02
PT2316454E (pt) 2012-12-06
BRPI0410044B8 (pt) 2021-05-25
RS20050818A (en) 2008-04-04
EP2316454B9 (en) 2013-01-02
CY1113462T1 (el) 2016-06-22
IL171365A (en) 2014-08-31
PL2316454T3 (pl) 2013-03-29
IL229510A0 (en) 2013-12-31
HK1090546A1 (en) 2006-12-29
AU2010200905B2 (en) 2012-04-05
AU2004237363A1 (en) 2004-11-18
CA2489140C (en) 2006-10-17
SI1624869T1 (sl) 2012-10-30
SI2316454T1 (sl) 2013-01-31
RS53443B (en) 2014-12-31
AR044264A1 (es) 2005-09-07
KR101237742B1 (ko) 2013-02-26
EP2316454B1 (en) 2012-09-26
WO2004098594A3 (en) 2004-12-09
JP2006525286A (ja) 2006-11-09
KR20110104124A (ko) 2011-09-21
EA027734B1 (ru) 2017-08-31
EA201101119A1 (ru) 2011-12-30
ES2390342T3 (es) 2012-11-12
DK2316454T3 (da) 2013-01-21
US8703192B2 (en) 2014-04-22
NO337921B1 (no) 2016-07-11
NZ543181A (en) 2009-10-30
BRPI0410044A (pt) 2006-04-25
JP5162689B2 (ja) 2013-03-13
CY1113128T1 (el) 2016-04-13
US20090208571A1 (en) 2009-08-20
PE20050199A1 (es) 2005-03-26
TW200509992A (en) 2005-03-16
JP2011126912A (ja) 2011-06-30
EA200501697A1 (ru) 2006-06-30
AU2004237363B2 (en) 2009-12-10
EA016824B1 (ru) 2012-07-30
JP4878284B2 (ja) 2012-02-15
IL229510A (en) 2016-09-29

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