HRP20200614T1 - Pripravci koji sadrže amlodipin i bisoprolol - Google Patents

Pripravci koji sadrže amlodipin i bisoprolol Download PDF

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Publication number
HRP20200614T1
HRP20200614T1 HRP20200614TT HRP20200614T HRP20200614T1 HR P20200614 T1 HRP20200614 T1 HR P20200614T1 HR P20200614T T HRP20200614T T HR P20200614TT HR P20200614 T HRP20200614 T HR P20200614T HR P20200614 T1 HRP20200614 T1 HR P20200614T1
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HR
Croatia
Prior art keywords
packaged
dosage form
amlodipine
moisture
blister
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HRP20200614TT
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English (en)
Inventor
László WAGNER
Zsolt Zsigmond
György UJFALUSSY
Magdolna LEVENTISZNÉ HUSZÁR
Péter TONKA-NAGY
Erzsébet Bárczay
Lászlóné GÓRA
Edit Szeleczki
Ágnes FÜLÖP
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Egis Gyógyszergyár Zrt.
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Publication of HRP20200614T1 publication Critical patent/HRP20200614T1/hr

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    • 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
    • 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
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • 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
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42Oxazoles
    • A61K31/422Oxazoles not condensed and containing further heterocyclic rings
    • 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
    • A61K31/44221,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • 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
    • 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
    • A61K9/2027Organic 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
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/08Vasodilators for multiple indications
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Packages (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Hydrogenated Pyridines (AREA)
  • Peptides Or Proteins (AREA)

Claims (10)

1. Ambalažirani oblik doziranja, naznačen time što sadrži i) homogeni stabilni čvrsti farmaceutski pripravak koji sadrži amlodipin-besilat, bisoprolol-fumarat, organska ili anorganska punila, sredstva za raspadanje, maziva, antiadhezive i izborno vezivo, koji dodatno sadrži manje od 0,5% spoja formule [image] na osnovi težine aktivnih sastojaka, ii) gdje je homogeni pripravak u obliku tablete ili kapsule, iii) tabletu ili kapsulu ambalažiranu u ambalažu otpornu na vlagu, iv) gdje se ambalažu otpornu na vlagu bira iz skupine koju čine hladno oblikovani blister načinjen od kompozitne folije pokrivene aluminijskom pokrovnom folijom, gdje se blister pripravlja iz kompozitne folije koju se može toplinski oblikovati otporne na vlagu, pokrivene aluminijskom pokrovnom folijom, i staklena ili polipropilenska posuda koja ima poklopac od polietilena ili polipropilena nepropustan za zrak.
2. Ambalažirani oblik doziranja u skladu s patentnim zahtjevom 1, naznačen time što homogeni pripravak sadrži manje od 0,3% spoja formule (3).
3. Ambalažirani oblik doziranja u skladu s patentnim zahtjevom 1, naznačen time što homogeni pripravak sadrži manje od 0,2% spoja formule (3).
4. Ambalažirani oblik doziranja u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time što se tabletu ambalažira u ambalažu otpornu na vlagu, gdje homogeni pripravak sadrži 2%-20%, po mogućnosti 2%-10%, poželjnije, 1-6% amlodipin-besilata, 2%-20%, po mogućnosti 2%-10%, poželjnije 1%-6% bisoprolol-fumarata, koji dodatno sadrži 60%-90%, po mogućnosti 70%-90%, poželjnije 80%-90% punila, 1%-10%, po mogućnosti 4%-6% sredstva za raspadanje, 0,5%-3%, po mogućnosti 1%-2% maziva, 0,3%-2%, po mogućnosti 0,1%-5% veziva na osnovi težine tablete.
5. Ambalažirani oblik doziranja u skladu s patentnim zahtjevom 4, naznačen time što se tabletu ambalažira u hladno oblikovani blister (tzv. hladni blister /CFF/) od OPA/AL/PVC kompozitne folije, pokrivene aluminijskom pokrovnom folijom, ili u blister od kompozitne folije koju se može toplinski oblikovati otporne na vlagu i pokrivene aluminijskom pokrovnom folijom, ili u staklenu ili polipropilensku posudu opremljenu poklopcem od polietilena ili polipropilena za spremnike nepropustnim za zrak, gdje homogeni pripravak sadrži 1%-6% amlodipin-besilata, 1%-6% bisoprolol-fumarata, 80%-90% mikrokristalne celuloze, 4%-6% karboksimetilškrob-natrija, 1%-2% magnezijevog stearata, 0,5%-1% koloidnog silicijevog dioksida na osnovi težine tablete.
6. Ambalažirani oblik doziranja u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačen time što je ambalaža otporna na vlagu OPA/AL/PVC kompozitna folija, pokrivena aluminijskom pokrovnom folijom.
7. Ambalažirani oblik doziranja u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time što se kapsulu ambalažira u hladno oblikovani blister (tzv. hladni blister /CFF/) od OPA/AL/PVC kompozitne folije, pokrivene aluminijskom pokrovnom folijom, ili u blister od kompozitne folije koju se može toplinski oblikovati otporne na vlagu i pokrivene aluminijskom pokrovnom folijom, ili u staklenu ili polipropilensku posudu opremljenu poklopcem od polietilena ili polipropilena za spremnike nepropusnim za zrak, gdje homogeni pripravak sadrži 10%-15% amlodipin-besilata, 10%-15% bisoprolol-fumarata, dodatno 55%-65% mikrokristalne celuloze, 4%-6% karboksimetilškrob-natrija, 1%-2% magnezijevog stearata, 0,5%-1% koloidnog silicijevog dioksida na osnovi težine tvari za punjenje kapsule.
8. Postupak priprave stabilnog čvrstog ambalažiranog oblika doziranja koji sadrži homogeni pripravak koji sadrži amlodipinsku bazu, ili njezinu farmaceutski prihvatljivu sol, i bisoprolol-fumarat, naznačen time što se amlodipinsku bazu, ili njezinu farmaceutski prihvatljivu sol, i bisoprolol-fumarat, sredstvo za raspadanje, mazivo i po potrebi dodatne pomoćne tvari koje se upotrebljava u farmaceutskoj industriji homogenizira, zatim se dodaje antiadheziv, nastavi se s homogeniziranjem, zatim se a.) homogenizat komprimira u tablete postupkom izravnog komprimiranja ili, b.) homogenizat puni u tvrde želatinske kapsule na poznati način, zatim se dobivene tablete ili kapsule ambalažira u zaštitna pakiranja otporna na vlagu na poznati način.
9. Postupak priprave stabilnog čvrstog ambalažiranog oblika doziranja u obliku tableta u skladu s patentnim zahtjevom 8, naznačen time što se za homogeni pripravak na osnovi težine tableta upotrebljava 2%-20%, po mogućnosti 2%-10%, poželjnije 1-6% amlodipinske baze, ili njezine farmaceutski prihvatljive adicijske soli s kiselinom, po mogućnosti amlodipin-besilata, 2%-20%, po mogućnosti 2%-10%, poželjnije 1%-6% bisoprolol-fumarata, dodatno 60%-90%, po mogućnosti 70%-90%, poželjnije 80%-90% punila, 1%-10%, po mogućnosti 4%-6% sredstva za raspadanje, 0,5%-3%, po mogućnosti 1%-2% maziva, 0,3%-2%, po mogućnosti 1%-10%, po mogućnosti 0,5%-1% veziva.
10. Postupak priprave stabilnog čvrstog ambalažiranog oblika doziranja u obliku kapsula u skladu s patentnim zahtjevom 8, naznačen time što se za homogeni pripravak na osnovi težine tvari za punjenje kapsule upotrebljava 5%-80%, po mogućnosti 5%-18%, poželjnije, 10-15% amlodipinske baze, ili njezine farmaceutski prihvatljive adicijske soli s kiselinom, po mogućnosti amlodipin-besilata, 5%-80%, po mogućnosti 5%-15%, poželjnije 10%-15% bisoprolol-fumarata, dodatno 1%-10%, po mogućnosti 4%-6% sredstva za raspadanje, 0,5%-3%, po mogućnosti 1%-2% maziva, 0,3%-2%, po mogućnosti 0,5%-1% of antiadheziv agent, i po potrebi 10%-90%, po mogućnosti 45%-75%, poželjnije 55%-65% punila.
HRP20200614TT 2008-09-30 2020-04-08 Pripravci koji sadrže amlodipin i bisoprolol HRP20200614T1 (hr)

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Application Number Priority Date Filing Date Title
HU0800591A HU230877B1 (hu) 2008-09-30 2008-09-30 Stabil kombinációs gyógyszerkészítmény
EP11003486.5A EP2359815B1 (en) 2008-09-30 2009-09-30 Compositions comprising amlodipine and bisoprolol

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HRP20200614T1 true HRP20200614T1 (hr) 2020-10-02

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HRP20110162AA HRP20110162B1 (hr) 2008-09-30 2011-03-04 Spojevi koji sadrže amlodipin i bisoprolol
HRP20191373 HRP20191373T1 (hr) 2008-09-30 2019-07-31 Pripravci koji sadrže amlodipin i bisoprolol
HRP20200614TT HRP20200614T1 (hr) 2008-09-30 2020-04-08 Pripravci koji sadrže amlodipin i bisoprolol

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HRP20191373 HRP20191373T1 (hr) 2008-09-30 2019-07-31 Pripravci koji sadrže amlodipin i bisoprolol

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EP (2) EP2359815B1 (hr)
KR (1) KR101772619B1 (hr)
CN (1) CN102164585B (hr)
AT (2) AT510866A3 (hr)
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CH (1) CH702345B1 (hr)
CY (1) CY1122084T1 (hr)
CZ (2) CZ30825U1 (hr)
DE (1) DE202009019152U1 (hr)
DK (1) DK2344141T3 (hr)
EA (2) EA026238B9 (hr)
EE (1) EE05723B1 (hr)
ES (2) ES2739900T3 (hr)
GE (1) GEP20135859B (hr)
HK (1) HK1155976A1 (hr)
HR (3) HRP20110162B1 (hr)
HU (3) HU230877B1 (hr)
LT (3) LT2344141T (hr)
ME (1) ME03774B (hr)
MX (1) MX2011003407A (hr)
MY (1) MY175270A (hr)
PL (3) PL2359815T3 (hr)
PT (3) PT2359815T (hr)
RO (1) RO127490B1 (hr)
RS (3) RS60784B1 (hr)
RU (2) RU2549437C2 (hr)
SG (1) SG194392A1 (hr)
SI (2) SI2344141T1 (hr)
SK (2) SK288593B6 (hr)
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HUP1300496A2 (hu) 2013-08-16 2015-03-02 Egis Gyogyszergyar Nyilvanosan Muekoedoe Reszvenytarsasag Stabil kombinációs gyógyszerkészítmény
FR3027803B1 (fr) * 2014-11-05 2018-02-09 Les Laboratoires Servier Composition pharmaceutique comprenant un betabloquant et un inhibiteur de l'enzyme de conversion
FR3050380B1 (fr) 2016-04-20 2020-07-10 Les Laboratoires Servier Composition pharmaceutique comprenant un betabloquant, un inhibiteur de l'enzyme de conversion et un antihypertenseur ou un ains.
WO2024052498A1 (en) 2022-09-07 2024-03-14 Kinast Lasse An immediate-release oral pharmaceutical form of amlodipine with increased api content
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CZ308237B6 (cs) 2020-03-18
EA026238B9 (ru) 2017-05-31
EP2359815A1 (en) 2011-08-24
RS60686B1 (sr) 2020-09-30
PT2344141T (pt) 2019-08-06
MY175270A (en) 2020-06-17
HUE045326T2 (hu) 2019-12-30
EE05723B1 (et) 2014-10-15
EA026238B1 (ru) 2017-03-31
WO2010038091A3 (en) 2010-09-23
PT2010038091Y (pt) 2020-02-10
EP2359815B1 (en) 2020-01-08
HU230877B1 (hu) 2018-11-29
EP2344141B1 (en) 2019-05-01
ME03774B (me) 2021-04-20
HUE049948T2 (hu) 2020-11-30
RS60784B1 (sr) 2020-10-30
LT5815B (lt) 2012-02-27
HU0800591D0 (en) 2008-11-28
SK7997Y1 (sk) 2018-02-05
HRP20110162A2 (hr) 2011-06-30
GEP20135859B (en) 2013-06-25
RO127490A2 (ro) 2012-06-29
AT510866A3 (de) 2014-06-15
ES2385988B2 (es) 2013-12-11
RU2687282C2 (ru) 2019-05-13
EA038392B1 (ru) 2021-08-20
RU2549437C2 (ru) 2015-04-27
AT14769U1 (de) 2016-05-15
LT2011012A (lt) 2011-10-25
EP2344141A2 (en) 2011-07-20
AT510866A2 (de) 2012-07-15
DK2344141T3 (da) 2019-08-05
CN102164585A (zh) 2011-08-24
EA201100430A1 (ru) 2011-10-31
RU2014139476A (ru) 2015-06-20
SK50232011A3 (sk) 2011-08-04
DE202009019152U1 (de) 2017-03-06
KR101772619B1 (ko) 2017-08-29
HRP20110162A8 (hr) 2019-03-22
CZ30825U1 (cs) 2017-07-11
HUP0800591A2 (en) 2010-10-28
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