HRP20191373T1 - Pripravci koji sadrže amlodipin i bisoprolol - Google Patents

Pripravci koji sadrže amlodipin i bisoprolol Download PDF

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Publication number
HRP20191373T1
HRP20191373T1 HRP20191373T HRP20191373T1 HR P20191373 T1 HRP20191373 T1 HR P20191373T1 HR P20191373 T HRP20191373 T HR P20191373T HR P20191373 T1 HRP20191373 T1 HR P20191373T1
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HR
Croatia
Prior art keywords
pharmaceutical preparation
amlodipine
blister
packed
preparation
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English (en)
Inventor
László Wagner
Zsolt Zsigmond
György Ujfalussy
Huszár Magdolna Leventiszné
Péter Tonka-Nagy
Erzsébet Bárczay
Lászlóné Góra
Edit Szeleczki
Ágnes Fülöp
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Egyt Gyogyszervegyeszeti Gyar
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Publication of HRP20191373T1 publication Critical patent/HRP20191373T1/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
    • A61K31/13Amines
    • 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
    • A61K31/435Heterocyclic 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
    • A61K31/41Heterocyclic 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
    • 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

Claims (14)

1. Stabilni čvrsti farmaceutski pripravak, naznačen time što sadrži homogeniziranu praškastu smjesu amlodipinske baze, ili njezine farmaceutski prihvatljive soli, i bisoprolol-fumarata, kao i farmaceutski prihvatljivih pomoćnih tvari, pakiranih u pakiranje otporno na vlagu i koje dodatno sadrži manje od 0,5% spoja formule na osnovi težine aktivnih sastojaka, gdje pripravak dodatno sadrži organsko ili anorgansko punilo, sredstvo za raspadanje, mazivo i izborno vezivo.
2. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što pripravak sadrži amlodipin-besilat.
3. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što pripravak sadrži manje od 0,3% spoja formule (3).
4. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što pripravak sadrži manje od 0,2% spoja formule (3).
5. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što se pripravak pakira u hladno oblikovani blister (tzv. hladni blister /CFF/) od OPA/AL/PVC kompozitne folije pokrivene aluminijskom pokrovnom folijom.
6. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što se pripravak pakira u blister od toplo oblikovane kompozitne folije otporne na vlagu, te pokriva aluminijskom pokrovnom folijom.
7. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što se pripravak pakira u staklenu ili polipropilensku posudu opremljenu hermetički zatvarajućim spremničkim poklopcem od polietilena ili polipropilena.
8. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1-7, naznačen time što je tableta ili kapsula.
9. Farmaceutski pripravak u skladu s patentnim zahtjevom 8, naznačen time što se tabletu pakira u pakiranje otporno na vlagu, naznačen time što sadrži 2%-20%, po mogućnosti 2%-10%, poželjnije, 1-6% amlodipin-besilata, 2%-20%, po mogućnosti 2%-10%, poželjnije 1%-6% bisoprolol-fumarata, te što 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.
10. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što se tabletu pakira u hladno oblikovani blister (tzv. hladni blister /CFF/) od OPA/AL/PVC kompozitne folije pokrivene aluminijskom pokrovnom folijom, ili u blister od kompozitne folije otporne na vlagu pogodne za toplo oblikovanje, te pokriva aluminijskom pokrovnom folijom, ili u staklenu ili polipropilensku posudu opremljenu hermetički zatvarajućim spremničkim poklopcem od polietilena ili polipropilena, što 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.
11. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što je kapsula pakirani into a hladno oblikovani blister (tzv. hladni blister /CFF/) od OPA/AL/PVC kompozitne folije pokrivene aluminijskom pokrovnom folijom, ili u blister od thermoformable kompozitna folija otporna na vlagu, te pokriva aluminijskom pokrovnom folijom, ili u staklenu ili polipropilensku posudu opremljenu hermetički zatvarajućim spremničkim poklopcem od polietilena ili polipropilena, što 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.
12. Postupak priprave stabilnog čvrstog farmaceutskog pripravka koji sadrži amlodipinsku bazu, ili njezinu farmaceutski prihvatljivu sol, i bisoprolol-fumarat, naznačen time što se amlodipinsku bazu, ili njezina 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 doda antiadheziv, nastavi s homogeniziranjem, te se a.) homogenizat komprimira u tablete postupkom izravnog komprimiranja ili, b.) puni u tvrde želatinske kapsule na poznati način, zatim se dobivene tablete ili kapsule pakira u zaštitna pakiranja otporna na vlagu na poznati način.
13. Postupak priprave tableta u skladu s patentnim zahtjevom 12, naznačen time što se 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 na osnovi težine tablete.
14. Postupak priprave kapsula u skladu s patentnim zahtjevom 12, naznačen time što se 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% antiadhezivnog sredstva, te po potrebi 10%-75%, po mogućnosti 45%-75%, poželjnije 55%-65% punila na osnovi težine tvari za punjenje kapsule.
HRP20191373 2008-09-30 2019-07-31 Pripravci koji sadrže amlodipin i bisoprolol HRP20191373T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
HU0800591A HU230877B1 (hu) 2008-09-30 2008-09-30 Stabil kombinációs gyógyszerkészítmény
PCT/HU2009/000085 WO2010038091A2 (en) 2008-09-30 2009-09-30 Stable combination pharmaceutical composition
EP09748467.9A EP2344141B1 (en) 2008-09-30 2009-09-30 Compositions comrrising amlodipine and bisoprolol

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HRP20191373T1 true HRP20191373T1 (hr) 2019-11-01

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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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HRP20200614TT HRP20200614T1 (hr) 2008-09-30 2020-04-08 Pripravci koji sadrže amlodipin i bisoprolol

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EP (2) EP2344141B1 (hr)
KR (1) KR101772619B1 (hr)
CN (1) CN102164585B (hr)
AT (2) AT14769U1 (hr)
BG (1) BG66274B1 (hr)
CH (1) CH702345B1 (hr)
CY (1) CY1122084T1 (hr)
CZ (2) CZ30825U1 (hr)
DE (1) DE202009019152U1 (hr)
DK (1) DK2344141T3 (hr)
EA (2) EA038392B1 (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) PL2344141T3 (hr)
PT (3) PT2344141T (hr)
RO (1) RO127490B1 (hr)
RS (3) RS60784B1 (hr)
RU (2) RU2687282C2 (hr)
SG (1) SG194392A1 (hr)
SI (2) SI2359815T1 (hr)
SK (2) SK7997Y1 (hr)
UA (1) UA101407C2 (hr)
WO (1) WO2010038091A2 (hr)

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EA201691869A1 (ru) 2017-04-28
HK1155976A1 (zh) 2012-06-01
GEP20135859B (en) 2013-06-25
PL394605A1 (pl) 2011-09-26
EE201100029A (et) 2011-06-15
RS59201B1 (sr) 2019-10-31
AT510866A3 (de) 2014-06-15
RS20110136A1 (en) 2012-08-31
CH702345B1 (de) 2014-05-15
RU2014139476A (ru) 2015-06-20
SK72017U1 (sk) 2017-08-02
RO127490B1 (ro) 2022-01-28
LT2344141T (lt) 2019-08-26
CY1122084T1 (el) 2020-11-25
RS60686B1 (sr) 2020-09-30
DE202009019152U1 (de) 2017-03-06
UA101407C2 (ru) 2013-03-25
MY175270A (en) 2020-06-17
SI2359815T1 (sl) 2020-10-30
WO2010038091A2 (en) 2010-04-08
CZ2011252A3 (cs) 2011-07-07
ES2385988B2 (es) 2013-12-11
CZ308237B6 (cs) 2020-03-18
LT2011012A (lt) 2011-10-25
CZ30825U1 (cs) 2017-07-11
HU0800591D0 (en) 2008-11-28
PT2359815T (pt) 2020-04-16
PL2344141T3 (pl) 2019-10-31
RU2011112047A (ru) 2012-11-10
HUP0800591A2 (en) 2010-10-28
LT2359815T (lt) 2020-04-27
HRP20110162A8 (hr) 2019-03-22
KR20110063563A (ko) 2011-06-10
ES2739900T3 (es) 2020-02-04
BG66274B1 (bg) 2012-12-28
PT2344141T (pt) 2019-08-06
KR101772619B1 (ko) 2017-08-29
EP2344141A2 (en) 2011-07-20
SK50232011A3 (sk) 2011-08-04
ME03774B (me) 2021-04-20
BG110927A (bg) 2011-09-30
WO2010038091A9 (en) 2011-04-07
LT5815B (lt) 2012-02-27
RU2549437C2 (ru) 2015-04-27
HUE045326T2 (hu) 2019-12-30
SK7997Y1 (sk) 2018-02-05
HUE049948T2 (hu) 2020-11-30
SG194392A1 (en) 2013-11-29
PL2359815T3 (pl) 2020-11-30
RS60784B1 (sr) 2020-10-30
PT2010038091Y (pt) 2020-02-10
DK2344141T3 (da) 2019-08-05
SK288593B6 (sk) 2018-09-03
AT510866A2 (de) 2012-07-15
EP2359815B1 (en) 2020-01-08
EA038392B1 (ru) 2021-08-20
EP2359815A1 (en) 2011-08-24
HU230877B1 (hu) 2018-11-29
HRP20200614T1 (hr) 2020-10-02
CN102164585B (zh) 2016-04-27
EA201100430A1 (ru) 2011-10-31
RO127490A2 (ro) 2012-06-29
SI2344141T1 (sl) 2019-09-30
HRP20110162B1 (hr) 2019-09-20
HRP20110162A2 (hr) 2011-06-30
CN102164585A (zh) 2011-08-24
EE05723B1 (et) 2014-10-15
EA026238B1 (ru) 2017-03-31
WO2010038091A3 (en) 2010-09-23
EP2344141B1 (en) 2019-05-01
MX2011003407A (es) 2011-06-20
EA026238B9 (ru) 2017-05-31
AT14769U1 (de) 2016-05-15
ES2385988A1 (es) 2012-08-06
RU2687282C2 (ru) 2019-05-13

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